Table: q1_q4_2021_prescription_drug_wac_increases , manufacturer_name like J*

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oshpd_id manufacturer_name date_reported ndc_number drug_product_description wac_effective_date wac_increase_amount wac_after_increase patent_expiration_date drug_source_type unit_sales_volume_in_us unit_sales_volume_non_public_indicator cost_increase_factors cost_increase_factors_non_public_indicator change_improvement_description change_improvement_non_public_indicator acquisition_date company_acquired_from acquisition_price acquisition_price_non_public_indicator acquisition_price_comment wac_at_acquisition wac_year_prior_to_acquisition year_drug_introduced_to_market wac_at_intro_to_market supporting_documents general_comments
Rx0000248 Janssen Biotech, Inc. 03/31/2021 57894007101 SIMPONI® (golimumab) Prefilled Syringe Strength:100mg/1mL Package Size:1 Form:1 Single syringe 01/15/2021 277.40 6056.66 02/03/2024 Single Source Drug None 1 Many factors contribute to price increases. After we receive FDA approval, we continue to conduct research on our medicines, including studies to understand how the medicine works in real-world setting. We continue to monitor for safety and to secure regulatory approval for new indications, dosages, or improved product formulations - investments that enhance the value of our medicines for patients and society. Additional regulatory requirements, upgrading or building new manufacturing facilities, an increase in the cost of goods sold, and other market dynamics also play a role. And finally, we must continue to generate returns to invest in R&D. None Not Applicable None None None None None None None None None None None Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Johnson & Johnson believes is otherwise in the public domain or publicly available. This product is not listed in the Orange Book, and the patent expiration date provided is the latest projected patent expiration date Johnson & Johnson has or otherwise intends to make publicly available.
Rx0000248 Janssen Biotech, Inc. 03/31/2021 57894007001 SIMPONI® (golimumab) Prefilled Syringe Strength:50mg/0.5mL Package Size:1 Form:1 Single syringe 01/15/2021 241.22 5266.65 02/03/2024 Single Source Drug None 1 Many factors contribute to price increases. After we receive FDA approval, we continue to conduct research on our medicines, including studies to understand how the medicine works in real-world setting. We continue to monitor for safety and to secure regulatory approval for new indications, dosages, or improved product formulations - investments that enhance the value of our medicines for patients and society. Additional regulatory requirements, upgrading or building new manufacturing facilities, an increase in the cost of goods sold, and other market dynamics also play a role. And finally, we must continue to generate returns to invest in R&D. None Not Applicable None None None None None None None None None None None Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Johnson & Johnson believes is otherwise in the public domain or publicly available. This product is not listed in the Orange Book, and the patent expiration date provided is the latest projected patent expiration date Johnson & Johnson has or otherwise intends to make publicly available.
Rx0000248 Janssen Biotech, Inc. 03/31/2021 57894007102 SIMPONI® (golimumab) SmartJect® xAutoinjector Strength:100mg/1mL Package Size:1 Form:1 Single Autoinjector 01/15/2021 277.40 6056.66 02/03/2024 Single Source Drug None 1 Many factors contribute to price increases. After we receive FDA approval, we continue to conduct research on our medicines, including studies to understand how the medicine works in real-world setting. We continue to monitor for safety and to secure regulatory approval for new indications, dosages, or improved product formulations - investments that enhance the value of our medicines for patients and society. Additional regulatory requirements, upgrading or building new manufacturing facilities, an increase in the cost of goods sold, and other market dynamics also play a role. And finally, we must continue to generate returns to invest in R&D. None Not Applicable None None None None None None None None None None None Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Johnson & Johnson believes is otherwise in the public domain or publicly available. This product is not listed in the Orange Book, and the patent expiration date provided is the latest projected patent expiration date Johnson & Johnson has or otherwise intends to make publicly available.
Rx0000248 Janssen Biotech, Inc. 03/31/2021 57894007002 SIMPONI® (golimumab) SmartJect® xAutoinjector Strength:50mg/0.5mL Package Size:1 Form:1 Single Autoinjector 01/15/2021 241.22 5266.65 02/03/2024 Single Source Drug None 1 Many factors contribute to price increases. After we receive FDA approval, we continue to conduct research on our medicines, including studies to understand how the medicine works in real-world setting. We continue to monitor for safety and to secure regulatory approval for new indications, dosages, or improved product formulations - investments that enhance the value of our medicines for patients and society. Additional regulatory requirements, upgrading or building new manufacturing facilities, an increase in the cost of goods sold, and other market dynamics also play a role. And finally, we must continue to generate returns to invest in R&D. None Not Applicable None None None None None None None None None None None Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Johnson & Johnson believes is otherwise in the public domain or publicly available. This product is not listed in the Orange Book, and the patent expiration date provided is the latest projected patent expiration date Johnson & Johnson has or otherwise intends to make publicly available.
Rx0000248 Janssen Biotech, Inc. 03/31/2021 57894006003 STELARA® (ustekinumab) prefilled syringe Strength:45mg/0.5mL Package Size:1 Form:1 Single syringe 01/15/2021 553.99 12095.41 09/25/2023 Single Source Drug None 1 Many factors contribute to price increases. After we receive FDA approval, we continue to conduct research on our medicines, including studies to understand how the medicine works in real-world setting. We continue to monitor for safety and to secure regulatory approval for new indications, dosages, or improved product formulations - investments that enhance the value of our medicines for patients and society. Additional regulatory requirements, upgrading or building new manufacturing facilities, an increase in the cost of goods sold, and other market dynamics also play a role. And finally, we must continue to generate returns to invest in R&D. None Not Applicable None None None None None None None None None None None Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Johnson & Johnson believes is otherwise in the public domain or publicly available. This product is not listed in the Orange Book, and the patent expiration date provided is the latest projected patent expiration date Johnson & Johnson has or otherwise intends to make publicly available.
Rx0000248 Janssen Biotech, Inc. 03/31/2021 57894006103 STELARA® (ustekinumab) prefilled syringe Strength:90mg/1mL Package Size:1 Form:1 Single syringe 01/15/2021 1107.98 24190.82 09/25/2023 Single Source Drug None 1 Many factors contribute to price increases. After we receive FDA approval, we continue to conduct research on our medicines, including studies to understand how the medicine works in real-world setting. We continue to monitor for safety and to secure regulatory approval for new indications, dosages, or improved product formulations - investments that enhance the value of our medicines for patients and society. Additional regulatory requirements, upgrading or building new manufacturing facilities, an increase in the cost of goods sold, and other market dynamics also play a role. And finally, we must continue to generate returns to invest in R&D. None Not Applicable None None None None None None None None None None None Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Johnson & Johnson believes is otherwise in the public domain or publicly available. This product is not listed in the Orange Book, and the patent expiration date provided is the latest projected patent expiration date Johnson & Johnson has or otherwise intends to make publicly available.
Rx0000248 Janssen Biotech, Inc. 03/31/2021 57894006002 STELARA® (ustekinumab) vial Strength:45mg Package Size:1 Form:1 Single vial 01/15/2021 553.99 12095.41 09/25/2023 Single Source Drug None 1 Many factors contribute to price increases. After we receive FDA approval, we continue to conduct research on our medicines, including studies to understand how the medicine works in real-world setting. We continue to monitor for safety and to secure regulatory approval for new indications, dosages, or improved product formulations - investments that enhance the value of our medicines for patients and society. Additional regulatory requirements, upgrading or building new manufacturing facilities, an increase in the cost of goods sold, and other market dynamics also play a role. And finally, we must continue to generate returns to invest in R&D. None Not Applicable None None None None None None None None None None None Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Johnson & Johnson believes is otherwise in the public domain or publicly available. This product is not listed in the Orange Book, and the patent expiration date provided is the latest projected patent expiration date Johnson & Johnson has or otherwise intends to make publicly available.
Rx0000248 Janssen Biotech, Inc. 03/31/2021 57894064001 TREMFYA™ (guselkumab) prefilled syringe Strength:100mg/1mL Package Size:1 Form:1 Single syringe 01/15/2021 546.80 11938.37 01/18/2031 Single Source Drug None 1 Many factors contribute to price increases. After we receive FDA approval, we continue to conduct research on our medicines, including studies to understand how the medicine works in real-world setting. We continue to monitor for safety and to secure regulatory approval for new indications, dosages, or improved product formulations - investments that enhance the value of our medicines for patients and society. Additional regulatory requirements, upgrading or building new manufacturing facilities, an increase in the cost of goods sold, and other market dynamics also play a role. And finally, we must continue to generate returns to invest in R&D. None Not Applicable None None None None None None None None None None None Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Johnson & Johnson believes is otherwise in the public domain or publicly available. This product is not listed in the Orange Book, and the patent expiration date provided is the latest projected patent expiration date Johnson & Johnson has or otherwise intends to make publicly available, and includes pending patent term extension.
Rx0000253 Janssen Pharmaceuticals, Inc. 03/31/2021 50458056201 INVEGA® SUSTENNA® Strength:117 mg Package Size:1 Form:Disposable Syringe/Dose Pack 01/15/2021 67.33 1469.98 01/26/2031 Single Source Drug None 1 Many factors contribute to price increases. After we receive FDA approval, we continue to conduct research on our medicines, including studies to understand how the medicine works in real-world setting. We continue to monitor for safety and to secure regulatory approval for new indications, dosages, or improved product formulations - investments that enhance the value of our medicines for patients and society. Additional regulatory requirements, upgrading or building new manufacturing facilities, an increase in the cost of goods sold, and other market dynamics also play a role. And finally, we must continue to generate returns to invest in R&D. None Not Applicable None None None None None None None None None None None Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Johnson & Johnson believes is otherwise in the public domain or publicly available. The patent expiration date provided is the latest projected patent expiration date for patents listed in Orange Book as of March 31, 2021.
Rx0000253 Janssen Pharmaceuticals, Inc. 03/31/2021 50458056301 INVEGA® SUSTENNA® Strength:156 mg Package Size:1 Form:Disposable Syringe/Dose Pack 01/15/2021 89.77 1960.05 01/26/2031 Single Source Drug None 1 Many factors contribute to price increases. After we receive FDA approval, we continue to conduct research on our medicines, including studies to understand how the medicine works in real-world setting. We continue to monitor for safety and to secure regulatory approval for new indications, dosages, or improved product formulations - investments that enhance the value of our medicines for patients and society. Additional regulatory requirements, upgrading or building new manufacturing facilities, an increase in the cost of goods sold, and other market dynamics also play a role. And finally, we must continue to generate returns to invest in R&D. None Not Applicable None None None None None None None None None None None Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Johnson & Johnson believes is otherwise in the public domain or publicly available. The patent expiration date provided is the latest projected patent expiration date for patents listed in Orange Book as of March 31, 2021.
Rx0000253 Janssen Pharmaceuticals, Inc. 03/31/2021 50458056401 INVEGA® SUSTENNA® Strength:234 mg Package Size:1 Form:Disposable Syringe/Dose Pack 01/15/2021 134.66 2940.01 01/26/2031 Single Source Drug None 1 Many factors contribute to price increases. After we receive FDA approval, we continue to conduct research on our medicines, including studies to understand how the medicine works in real-world setting. We continue to monitor for safety and to secure regulatory approval for new indications, dosages, or improved product formulations - investments that enhance the value of our medicines for patients and society. Additional regulatory requirements, upgrading or building new manufacturing facilities, an increase in the cost of goods sold, and other market dynamics also play a role. And finally, we must continue to generate returns to invest in R&D. None Not Applicable None None None None None None None None None None None Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Johnson & Johnson believes is otherwise in the public domain or publicly available. The patent expiration date provided is the latest projected patent expiration date for patents listed in Orange Book as of March 31, 2021.
Rx0000253 Janssen Pharmaceuticals, Inc. 03/31/2021 50458056001 INVEGA® SUSTENNA® Strength:39 mg Package Size:1 Form:Disposable Syringe/Dose Pack 01/15/2021 22.44 489.97 01/26/2031 Single Source Drug None 1 Many factors contribute to price increases. After we receive FDA approval, we continue to conduct research on our medicines, including studies to understand how the medicine works in real-world setting. We continue to monitor for safety and to secure regulatory approval for new indications, dosages, or improved product formulations - investments that enhance the value of our medicines for patients and society. Additional regulatory requirements, upgrading or building new manufacturing facilities, an increase in the cost of goods sold, and other market dynamics also play a role. And finally, we must continue to generate returns to invest in R&D. None Not Applicable None None None None None None None None None None None Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Johnson & Johnson believes is otherwise in the public domain or publicly available. The patent expiration date provided is the latest projected patent expiration date for patents listed in Orange Book as of March 31, 2021.
Rx0000253 Janssen Pharmaceuticals, Inc. 03/31/2021 50458056101 INVEGA® SUSTENNA® Strength:78 mg Package Size:1 Form:Disposable Syringe/Dose Pack 01/15/2021 44.88 979.97 01/26/2031 Single Source Drug None 1 Many factors contribute to price increases. After we receive FDA approval, we continue to conduct research on our medicines, including studies to understand how the medicine works in real-world setting. We continue to monitor for safety and to secure regulatory approval for new indications, dosages, or improved product formulations - investments that enhance the value of our medicines for patients and society. Additional regulatory requirements, upgrading or building new manufacturing facilities, an increase in the cost of goods sold, and other market dynamics also play a role. And finally, we must continue to generate returns to invest in R&D. None Not Applicable None None None None None None None None None None None Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Johnson & Johnson believes is otherwise in the public domain or publicly available. The patent expiration date provided is the latest projected patent expiration date for patents listed in Orange Book as of March 31, 2021.
Rx0000253 Janssen Pharmaceuticals, Inc. 03/31/2021 50458060601 INVEGA® TRINZA® Strength:273 mg Package Size:1 Form:Disposable Syringe/Dose Pack 01/15/2021 134.65 2939.91 04/05/2036 Single Source Drug None 1 Many factors contribute to price increases. After we receive FDA approval, we continue to conduct research on our medicines, including studies to understand how the medicine works in real-world setting. We continue to monitor for safety and to secure regulatory approval for new indications, dosages, or improved product formulations - investments that enhance the value of our medicines for patients and society. Additional regulatory requirements, upgrading or building new manufacturing facilities, an increase in the cost of goods sold, and other market dynamics also play a role. And finally, we must continue to generate returns to invest in R&D. None Not Applicable None None None None None None None None None None None Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Johnson & Johnson believes is otherwise in the public domain or publicly available. The patent expiration date provided is the latest projected patent expiration date for patents listed in Orange Book as of March 31, 2021.
Rx0000253 Janssen Pharmaceuticals, Inc. 03/31/2021 50458060701 INVEGA® TRINZA® Strength:410 mg Package Size:1 Form:Disposable Syringe/Dose Pack 01/15/2021 202.00 4409.94 04/05/2036 Single Source Drug None 1 Many factors contribute to price increases. After we receive FDA approval, we continue to conduct research on our medicines, including studies to understand how the medicine works in real-world setting. We continue to monitor for safety and to secure regulatory approval for new indications, dosages, or improved product formulations - investments that enhance the value of our medicines for patients and society. Additional regulatory requirements, upgrading or building new manufacturing facilities, an increase in the cost of goods sold, and other market dynamics also play a role. And finally, we must continue to generate returns to invest in R&D. None Not Applicable None None None None None None None None None None None Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Johnson & Johnson believes is otherwise in the public domain or publicly available. The patent expiration date provided is the latest projected patent expiration date for patents listed in Orange Book as of March 31, 2021.
Rx0000253 Janssen Pharmaceuticals, Inc. 03/31/2021 50458060801 INVEGA® TRINZA® Strength:546 mg Package Size:1 Form:Disposable Syringe/Dose Pack 01/15/2021 269.30 5880.15 04/05/2036 Single Source Drug None 1 Many factors contribute to price increases. After we receive FDA approval, we continue to conduct research on our medicines, including studies to understand how the medicine works in real-world setting. We continue to monitor for safety and to secure regulatory approval for new indications, dosages, or improved product formulations - investments that enhance the value of our medicines for patients and society. Additional regulatory requirements, upgrading or building new manufacturing facilities, an increase in the cost of goods sold, and other market dynamics also play a role. And finally, we must continue to generate returns to invest in R&D. None Not Applicable None None None None None None None None None None None Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Johnson & Johnson believes is otherwise in the public domain or publicly available. The patent expiration date provided is the latest projected patent expiration date for patents listed in Orange Book as of March 31, 2021.
Rx0000253 Janssen Pharmaceuticals, Inc. 03/31/2021 50458060901 INVEGA® TRINZA® Strength:819 mg Package Size:1 Form:Disposable Syringe/Dose Pack 01/15/2021 403.99 8820.03 04/05/2036 Single Source Drug None 1 Many factors contribute to price increases. After we receive FDA approval, we continue to conduct research on our medicines, including studies to understand how the medicine works in real-world setting. We continue to monitor for safety and to secure regulatory approval for new indications, dosages, or improved product formulations - investments that enhance the value of our medicines for patients and society. Additional regulatory requirements, upgrading or building new manufacturing facilities, an increase in the cost of goods sold, and other market dynamics also play a role. And finally, we must continue to generate returns to invest in R&D. None Not Applicable None None None None None None None None None None None Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Johnson & Johnson believes is otherwise in the public domain or publicly available. The patent expiration date provided is the latest projected patent expiration date for patents listed in Orange Book as of March 31, 2021.
Rx0000253 Janssen Pharmaceuticals, Inc. 03/31/2021 50458054360 INVOKAMET® Strength:150/1000 MG Package Size:60 Form:Tablet 01/15/2021 24.89 543.43 02/26/2029 Single Source Drug None 1 Many factors contribute to price increases. After we receive FDA approval, we continue to conduct research on our medicines, including studies to understand how the medicine works in real-world setting. We continue to monitor for safety and to secure regulatory approval for new indications, dosages, or improved product formulations - investments that enhance the value of our medicines for patients and society. Additional regulatory requirements, upgrading or building new manufacturing facilities, an increase in the cost of goods sold, and other market dynamics also play a role. And finally, we must continue to generate returns to invest in R&D. None Not Applicable None None None None None None None None None None None Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Johnson & Johnson believes is otherwise in the public domain or publicly available. The patent expiration date provided is the latest projected patent expiration date for patents listed in Orange Book as of March 31, 2021.
Rx0000253 Janssen Pharmaceuticals, Inc. 03/31/2021 50458054260 INVOKAMET® Strength:150/500 MG Package Size:60 Form:Tablet 01/15/2021 24.89 543.43 02/26/2029 Single Source Drug None 1 Many factors contribute to price increases. After we receive FDA approval, we continue to conduct research on our medicines, including studies to understand how the medicine works in real-world setting. We continue to monitor for safety and to secure regulatory approval for new indications, dosages, or improved product formulations - investments that enhance the value of our medicines for patients and society. Additional regulatory requirements, upgrading or building new manufacturing facilities, an increase in the cost of goods sold, and other market dynamics also play a role. And finally, we must continue to generate returns to invest in R&D. None Not Applicable None None None None None None None None None None None Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Johnson & Johnson believes is otherwise in the public domain or publicly available. The patent expiration date provided is the latest projected patent expiration date for patents listed in Orange Book as of March 31, 2021.
Rx0000253 Janssen Pharmaceuticals, Inc. 03/31/2021 50458054160 INVOKAMET® Strength:50/1000 MG Package Size:60 Form:Tablet 01/15/2021 24.89 543.43 02/26/2029 Single Source Drug None 1 Many factors contribute to price increases. After we receive FDA approval, we continue to conduct research on our medicines, including studies to understand how the medicine works in real-world setting. We continue to monitor for safety and to secure regulatory approval for new indications, dosages, or improved product formulations - investments that enhance the value of our medicines for patients and society. Additional regulatory requirements, upgrading or building new manufacturing facilities, an increase in the cost of goods sold, and other market dynamics also play a role. And finally, we must continue to generate returns to invest in R&D. None Not Applicable None None None None None None None None None None None Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Johnson & Johnson believes is otherwise in the public domain or publicly available. The patent expiration date provided is the latest projected patent expiration date for patents listed in Orange Book as of March 31, 2021.
Rx0000253 Janssen Pharmaceuticals, Inc. 03/31/2021 50458054060 INVOKAMET® Strength:50/500 MG Package Size:60 Form:Tablet 01/15/2021 24.89 543.43 02/26/2029 Single Source Drug None 1 Many factors contribute to price increases. After we receive FDA approval, we continue to conduct research on our medicines, including studies to understand how the medicine works in real-world setting. We continue to monitor for safety and to secure regulatory approval for new indications, dosages, or improved product formulations - investments that enhance the value of our medicines for patients and society. Additional regulatory requirements, upgrading or building new manufacturing facilities, an increase in the cost of goods sold, and other market dynamics also play a role. And finally, we must continue to generate returns to invest in R&D. None Not Applicable None None None None None None None None None None None Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Johnson & Johnson believes is otherwise in the public domain or publicly available. The patent expiration date provided is the latest projected patent expiration date for patents listed in Orange Book as of March 31, 2021.
Rx0000253 Janssen Pharmaceuticals, Inc. 03/31/2021 50458094301 INVOKAMET® XR Strength:150/1000 MG Package Size:60 Form:Tablet 01/15/2021 24.89 543.43 02/26/2029 Single Source Drug None 1 Many factors contribute to price increases. After we receive FDA approval, we continue to conduct research on our medicines, including studies to understand how the medicine works in real-world setting. We continue to monitor for safety and to secure regulatory approval for new indications, dosages, or improved product formulations - investments that enhance the value of our medicines for patients and society. Additional regulatory requirements, upgrading or building new manufacturing facilities, an increase in the cost of goods sold, and other market dynamics also play a role. And finally, we must continue to generate returns to invest in R&D. None Not Applicable None None None None None None None None None None None Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Johnson & Johnson believes is otherwise in the public domain or publicly available. The patent expiration date provided is the latest projected patent expiration date for patents listed in Orange Book as of March 31, 2021.
Rx0000253 Janssen Pharmaceuticals, Inc. 03/31/2021 50458094201 INVOKAMET® XR Strength:150/500 MG Package Size:60 Form:Tablet 01/15/2021 24.89 543.43 02/26/2029 Single Source Drug None 1 Many factors contribute to price increases. After we receive FDA approval, we continue to conduct research on our medicines, including studies to understand how the medicine works in real-world setting. We continue to monitor for safety and to secure regulatory approval for new indications, dosages, or improved product formulations - investments that enhance the value of our medicines for patients and society. Additional regulatory requirements, upgrading or building new manufacturing facilities, an increase in the cost of goods sold, and other market dynamics also play a role. And finally, we must continue to generate returns to invest in R&D. None Not Applicable None None None None None None None None None None None Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Johnson & Johnson believes is otherwise in the public domain or publicly available. The patent expiration date provided is the latest projected patent expiration date for patents listed in Orange Book as of March 31, 2021.
Rx0000253 Janssen Pharmaceuticals, Inc. 03/31/2021 50458094101 INVOKAMET® XR Strength:50/1000 MG Package Size:60 Form:Tablet 01/15/2021 24.89 543.43 02/26/2029 Single Source Drug None 1 Many factors contribute to price increases. After we receive FDA approval, we continue to conduct research on our medicines, including studies to understand how the medicine works in real-world setting. We continue to monitor for safety and to secure regulatory approval for new indications, dosages, or improved product formulations - investments that enhance the value of our medicines for patients and society. Additional regulatory requirements, upgrading or building new manufacturing facilities, an increase in the cost of goods sold, and other market dynamics also play a role. And finally, we must continue to generate returns to invest in R&D. None Not Applicable None None None None None None None None None None None Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Johnson & Johnson believes is otherwise in the public domain or publicly available. The patent expiration date provided is the latest projected patent expiration date for patents listed in Orange Book as of March 31, 2021.
Rx0000253 Janssen Pharmaceuticals, Inc. 03/31/2021 50458094001 INVOKAMET® XR Strength:50/500 MG Package Size:60 Form:Tablet 01/15/2021 24.89 543.43 02/26/2029 Single Source Drug None 1 Many factors contribute to price increases. After we receive FDA approval, we continue to conduct research on our medicines, including studies to understand how the medicine works in real-world setting. We continue to monitor for safety and to secure regulatory approval for new indications, dosages, or improved product formulations - investments that enhance the value of our medicines for patients and society. Additional regulatory requirements, upgrading or building new manufacturing facilities, an increase in the cost of goods sold, and other market dynamics also play a role. And finally, we must continue to generate returns to invest in R&D. None Not Applicable None None None None None None None None None None None Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Johnson & Johnson believes is otherwise in the public domain or publicly available. The patent expiration date provided is the latest projected patent expiration date for patents listed in Orange Book as of March 31, 2021.
Rx0000253 Janssen Pharmaceuticals, Inc. 03/31/2021 50458014030 INVOKANA® Strength:100mg Package Size:30 Form:Tablet 01/15/2021 24.90 543.43 05/11/2031 Single Source Drug None 1 Many factors contribute to price increases. After we receive FDA approval, we continue to conduct research on our medicines, including studies to understand how the medicine works in real-world setting. We continue to monitor for safety and to secure regulatory approval for new indications, dosages, or improved product formulations - investments that enhance the value of our medicines for patients and society. Additional regulatory requirements, upgrading or building new manufacturing facilities, an increase in the cost of goods sold, and other market dynamics also play a role. And finally, we must continue to generate returns to invest in R&D. None Not Applicable None None None None None None None None None None None Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Johnson & Johnson believes is otherwise in the public domain or publicly available. The patent expiration date provided is the latest projected patent expiration date for patents listed in Orange Book as of March 31, 2021.
Rx0000253 Janssen Pharmaceuticals, Inc. 03/31/2021 50458014090 INVOKANA® Strength:100mg Package Size:90 Form:Tablet 01/15/2021 74.67 1630.28 05/11/2031 Single Source Drug None 1 Many factors contribute to price increases. After we receive FDA approval, we continue to conduct research on our medicines, including studies to understand how the medicine works in real-world setting. We continue to monitor for safety and to secure regulatory approval for new indications, dosages, or improved product formulations - investments that enhance the value of our medicines for patients and society. Additional regulatory requirements, upgrading or building new manufacturing facilities, an increase in the cost of goods sold, and other market dynamics also play a role. And finally, we must continue to generate returns to invest in R&D. None Not Applicable None None None None None None None None None None None Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Johnson & Johnson believes is otherwise in the public domain or publicly available. The patent expiration date provided is the latest projected patent expiration date for patents listed in Orange Book as of March 31, 2021.
Rx0000253 Janssen Pharmaceuticals, Inc. 03/31/2021 50458014130 INVOKANA® Strength:300mg Package Size:30 Form:Tablet 01/15/2021 24.90 543.43 05/11/2031 Single Source Drug None 1 Many factors contribute to price increases. After we receive FDA approval, we continue to conduct research on our medicines, including studies to understand how the medicine works in real-world setting. We continue to monitor for safety and to secure regulatory approval for new indications, dosages, or improved product formulations - investments that enhance the value of our medicines for patients and society. Additional regulatory requirements, upgrading or building new manufacturing facilities, an increase in the cost of goods sold, and other market dynamics also play a role. And finally, we must continue to generate returns to invest in R&D. None Not Applicable None None None None None None None None None None None Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Johnson & Johnson believes is otherwise in the public domain or publicly available. The patent expiration date provided is the latest projected patent expiration date for patents listed in Orange Book as of March 31, 2021.
Rx0000253 Janssen Pharmaceuticals, Inc. 03/31/2021 50458014190 INVOKANA® Strength:300mg Package Size:90 Form:Tablet 01/15/2021 74.67 1630.28 05/11/2031 Single Source Drug None 1 Many factors contribute to price increases. After we receive FDA approval, we continue to conduct research on our medicines, including studies to understand how the medicine works in real-world setting. We continue to monitor for safety and to secure regulatory approval for new indications, dosages, or improved product formulations - investments that enhance the value of our medicines for patients and society. Additional regulatory requirements, upgrading or building new manufacturing facilities, an increase in the cost of goods sold, and other market dynamics also play a role. And finally, we must continue to generate returns to invest in R&D. None Not Applicable None None None None None None None None None None None Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Johnson & Johnson believes is otherwise in the public domain or publicly available. The patent expiration date provided is the latest projected patent expiration date for patents listed in Orange Book as of March 31, 2021.
Rx0000253 Janssen Pharmaceuticals, Inc. 03/31/2021 50458030911 RISPERDAL® CONSTA® Strength:12.5 mg Package Size:1 Form:Disposable Syringe/Dose Pack 01/15/2021 12.20 266.47 None Single Source Drug None 1 Many factors contribute to price increases. After we receive FDA approval, we continue to conduct research on our medicines, including studies to understand how the medicine works in real-world setting. We continue to monitor for safety and to secure regulatory approval for new indications, dosages, or improved product formulations - investments that enhance the value of our medicines for patients and society. Additional regulatory requirements, upgrading or building new manufacturing facilities, an increase in the cost of goods sold, and other market dynamics also play a role. And finally, we must continue to generate returns to invest in R&D. None Not Applicable None None None None None None None None None None None Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Johnson & Johnson believes is otherwise in the public domain or publicly available.  There are no patents listed in the Orange Book for this product as of March 31, 2021. Patent expiration date was 11/25/2020
Rx0000253 Janssen Pharmaceuticals, Inc. 03/31/2021 50458030611 RISPERDAL® CONSTA® Strength:25 mg Package Size:1 Form:Disposable Syringe/Dose Pack 01/15/2021 24.41 532.91 None Single Source Drug None 1 Many factors contribute to price increases. After we receive FDA approval, we continue to conduct research on our medicines, including studies to understand how the medicine works in real-world setting. We continue to monitor for safety and to secure regulatory approval for new indications, dosages, or improved product formulations - investments that enhance the value of our medicines for patients and society. Additional regulatory requirements, upgrading or building new manufacturing facilities, an increase in the cost of goods sold, and other market dynamics also play a role. And finally, we must continue to generate returns to invest in R&D. None Not Applicable None None None None None None None None None None None Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Johnson & Johnson believes is otherwise in the public domain or publicly available. The patent expiration date provided is the latest projected patent expiration date for patents listed in Orange Book as of March 31, 2021 and includes 6 months of pediatric exclusivity. Patent expiration date was 11/25/2020
Rx0000253 Janssen Pharmaceuticals, Inc. 03/31/2021 50458030711 RISPERDAL® CONSTA® Strength:37.5 mg Package Size:1 Form:Disposable Syringe/Dose Pack 01/15/2021 36.61 799.40 None Single Source Drug None 1 Many factors contribute to price increases. After we receive FDA approval, we continue to conduct research on our medicines, including studies to understand how the medicine works in real-world setting. We continue to monitor for safety and to secure regulatory approval for new indications, dosages, or improved product formulations - investments that enhance the value of our medicines for patients and society. Additional regulatory requirements, upgrading or building new manufacturing facilities, an increase in the cost of goods sold, and other market dynamics also play a role. And finally, we must continue to generate returns to invest in R&D. None Not Applicable None None None None None None None None None None None Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Johnson & Johnson believes is otherwise in the public domain or publicly available. The patent expiration date provided is the latest projected patent expiration date for patents listed in Orange Book as of March 31, 2021 and includes 6 months of pediatric exclusivity. Patent expiration date was 11/25/2020
Rx0000253 Janssen Pharmaceuticals, Inc. 03/31/2021 50458030811 RISPERDAL® CONSTA® Strength:50 mg Package Size:1 Form:Disposable Syringe/Dose Pack 01/15/2021 48.82 1065.89 None Single Source Drug None 1 Many factors contribute to price increases. After we receive FDA approval, we continue to conduct research on our medicines, including studies to understand how the medicine works in real-world setting. We continue to monitor for safety and to secure regulatory approval for new indications, dosages, or improved product formulations - investments that enhance the value of our medicines for patients and society. Additional regulatory requirements, upgrading or building new manufacturing facilities, an increase in the cost of goods sold, and other market dynamics also play a role. And finally, we must continue to generate returns to invest in R&D. None Not Applicable None None None None None None None None None None None Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Johnson & Johnson believes is otherwise in the public domain or publicly available. The patent expiration date provided is the latest projected patent expiration date for patents listed in Orange Book as of March 31, 2021 and includes 6 months of pediatric exclusivity. Patent expiration date was 11/25/2020
Rx0000253 Janssen Pharmaceuticals, Inc. 03/31/2021 50458058451 XARELTO Starter Pack™ Strength:15mg/20mg Package Size:51 Form:Tablet 01/15/2021 38.35 837.25 02/17/2034 Single Source Drug None 1 Many factors contribute to price increases. After we receive FDA approval, we continue to conduct research on our medicines, including studies to understand how the medicine works in real-world setting. We continue to monitor for safety and to secure regulatory approval for new indications, dosages, or improved product formulations - investments that enhance the value of our medicines for patients and society. Additional regulatory requirements, upgrading or building new manufacturing facilities, an increase in the cost of goods sold, and other market dynamics also play a role. And finally, we must continue to generate returns to invest in R&D. None Not Applicable None None None None None None None None None None None Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Johnson & Johnson believes is otherwise in the public domain or publicly available. The patent expiration date provided is the latest projected patent expiration date for patents listed in Orange Book as of March 31, 2021.
Rx0000253 Janssen Pharmaceuticals, Inc. 03/31/2021 50458057710 XARELTO® Strength: 2.5 mg Package Size: 100 Form: Tablet 01/15/2021 37.60 820.83 01/31/2039 Single Source Drug None 1 Many factors contribute to price increases. After we receive FDA approval, we continue to conduct research on our medicines, including studies to understand how the medicine works in real-world setting. We continue to monitor for safety and to secure regulatory approval for new indications, dosages, or improved product formulations - investments that enhance the value of our medicines for patients and society. Additional regulatory requirements, upgrading or building new manufacturing facilities, an increase in the cost of goods sold, and other market dynamics also play a role. And finally, we must continue to generate returns to invest in R&D. None Not Applicable None None None None None None None None None None None Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Johnson & Johnson believes is otherwise in the public domain or publicly available. The patent expiration date provided is the latest projected patent expiration date for patents listed in Orange Book as of March 31, 2021.
Rx0000253 Janssen Pharmaceuticals, Inc. 03/31/2021 50458057718 XARELTO® Strength: 2.5 mg Package Size: 180 Form: Tablet 01/15/2021 67.67 1477.48 01/31/2039 Single Source Drug None 1 Many factors contribute to price increases. After we receive FDA approval, we continue to conduct research on our medicines, including studies to understand how the medicine works in real-world setting. We continue to monitor for safety and to secure regulatory approval for new indications, dosages, or improved product formulations - investments that enhance the value of our medicines for patients and society. Additional regulatory requirements, upgrading or building new manufacturing facilities, an increase in the cost of goods sold, and other market dynamics also play a role. And finally, we must continue to generate returns to invest in R&D. None Not Applicable None None None None None None None None None None None Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Johnson & Johnson believes is otherwise in the public domain or publicly available. The patent expiration date provided is the latest projected patent expiration date for patents listed in Orange Book as of March 31, 2021.
Rx0000253 Janssen Pharmaceuticals, Inc. 03/31/2021 50458057760 XARELTO® Strength: 2.5 mg Package Size: 60 Form: Tablet 01/15/2021 22.56 492.50 01/31/2039 Single Source Drug None 1 Many factors contribute to price increases. After we receive FDA approval, we continue to conduct research on our medicines, including studies to understand how the medicine works in real-world setting. We continue to monitor for safety and to secure regulatory approval for new indications, dosages, or improved product formulations - investments that enhance the value of our medicines for patients and society. Additional regulatory requirements, upgrading or building new manufacturing facilities, an increase in the cost of goods sold, and other market dynamics also play a role. And finally, we must continue to generate returns to invest in R&D. None Not Applicable None None None None None None None None None None None Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Johnson & Johnson believes is otherwise in the public domain or publicly available. The patent expiration date provided is the latest projected patent expiration date for patents listed in Orange Book as of March 31, 2021.
Rx0000253 Janssen Pharmaceuticals, Inc. 03/31/2021 50458058010 XARELTO® Strength:10 mg Package Size:100 Form:Tablet 01/15/2021 75.19 1641.65 02/17/2034 Single Source Drug None 1 Many factors contribute to price increases. After we receive FDA approval, we continue to conduct research on our medicines, including studies to understand how the medicine works in real-world setting. We continue to monitor for safety and to secure regulatory approval for new indications, dosages, or improved product formulations - investments that enhance the value of our medicines for patients and society. Additional regulatory requirements, upgrading or building new manufacturing facilities, an increase in the cost of goods sold, and other market dynamics also play a role. And finally, we must continue to generate returns to invest in R&D. None Not Applicable None None None None None None None None None None None Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Johnson & Johnson believes is otherwise in the public domain or publicly available. The patent expiration date provided is the latest projected patent expiration date for patents listed in Orange Book as of March 31, 2021.
Rx0000253 Janssen Pharmaceuticals, Inc. 03/31/2021 50458058030 XARELTO® Strength:10 mg Package Size:30 Form:Tablet 01/15/2021 22.56 492.50 02/17/2034 Single Source Drug None 1 Many factors contribute to price increases. After we receive FDA approval, we continue to conduct research on our medicines, including studies to understand how the medicine works in real-world setting. We continue to monitor for safety and to secure regulatory approval for new indications, dosages, or improved product formulations - investments that enhance the value of our medicines for patients and society. Additional regulatory requirements, upgrading or building new manufacturing facilities, an increase in the cost of goods sold, and other market dynamics also play a role. And finally, we must continue to generate returns to invest in R&D. None Not Applicable None None None None None None None None None None None Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Johnson & Johnson believes is otherwise in the public domain or publicly available. The patent expiration date provided is the latest projected patent expiration date for patents listed in Orange Book as of March 31, 2021.
Rx0000253 Janssen Pharmaceuticals, Inc. 03/31/2021 50458058090 XARELTO® Strength:10 mg Package Size:90 Form:Tablet 01/15/2021 67.67 1477.48 02/17/2034 Single Source Drug None 1 Many factors contribute to price increases. After we receive FDA approval, we continue to conduct research on our medicines, including studies to understand how the medicine works in real-world setting. We continue to monitor for safety and to secure regulatory approval for new indications, dosages, or improved product formulations - investments that enhance the value of our medicines for patients and society. Additional regulatory requirements, upgrading or building new manufacturing facilities, an increase in the cost of goods sold, and other market dynamics also play a role. And finally, we must continue to generate returns to invest in R&D. None Not Applicable None None None None None None None None None None None Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Johnson & Johnson believes is otherwise in the public domain or publicly available. The patent expiration date provided is the latest projected patent expiration date for patents listed in Orange Book as of March 31, 2021.
Rx0000253 Janssen Pharmaceuticals, Inc. 03/31/2021 50458057810 XARELTO® Strength:15 mg Package Size:100 Form:Tablet 01/15/2021 75.19 1641.65 02/17/2034 Single Source Drug None 1 Many factors contribute to price increases. After we receive FDA approval, we continue to conduct research on our medicines, including studies to understand how the medicine works in real-world setting. We continue to monitor for safety and to secure regulatory approval for new indications, dosages, or improved product formulations - investments that enhance the value of our medicines for patients and society. Additional regulatory requirements, upgrading or building new manufacturing facilities, an increase in the cost of goods sold, and other market dynamics also play a role. And finally, we must continue to generate returns to invest in R&D. None Not Applicable None None None None None None None None None None None Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Johnson & Johnson believes is otherwise in the public domain or publicly available. The patent expiration date provided is the latest projected patent expiration date for patents listed in Orange Book as of March 31, 2021.
Rx0000253 Janssen Pharmaceuticals, Inc. 03/31/2021 50458057830 XARELTO® Strength:15 mg Package Size:30 Form:Tablet 01/15/2021 22.56 492.50 02/17/2034 Single Source Drug None 1 Many factors contribute to price increases. After we receive FDA approval, we continue to conduct research on our medicines, including studies to understand how the medicine works in real-world setting. We continue to monitor for safety and to secure regulatory approval for new indications, dosages, or improved product formulations - investments that enhance the value of our medicines for patients and society. Additional regulatory requirements, upgrading or building new manufacturing facilities, an increase in the cost of goods sold, and other market dynamics also play a role. And finally, we must continue to generate returns to invest in R&D. None Not Applicable None None None None None None None None None None None Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Johnson & Johnson believes is otherwise in the public domain or publicly available. The patent expiration date provided is the latest projected patent expiration date for patents listed in Orange Book as of March 31, 2021.
Rx0000253 Janssen Pharmaceuticals, Inc. 03/31/2021 50458057890 XARELTO® Strength:15 mg Package Size:90 Form:Tablet 01/15/2021 67.67 1477.48 02/17/2034 Single Source Drug None 1 Many factors contribute to price increases. After we receive FDA approval, we continue to conduct research on our medicines, including studies to understand how the medicine works in real-world setting. We continue to monitor for safety and to secure regulatory approval for new indications, dosages, or improved product formulations - investments that enhance the value of our medicines for patients and society. Additional regulatory requirements, upgrading or building new manufacturing facilities, an increase in the cost of goods sold, and other market dynamics also play a role. And finally, we must continue to generate returns to invest in R&D. None Not Applicable None None None None None None None None None None None Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Johnson & Johnson believes is otherwise in the public domain or publicly available. The patent expiration date provided is the latest projected patent expiration date for patents listed in Orange Book as of March 31, 2021.
Rx0000253 Janssen Pharmaceuticals, Inc. 03/31/2021 50458057910 XARELTO® Strength:20 mg Package Size:100 Form:Tablet 01/15/2021 75.19 1641.65 02/17/2034 Single Source Drug None 1 Many factors contribute to price increases. After we receive FDA approval, we continue to conduct research on our medicines, including studies to understand how the medicine works in real-world setting. We continue to monitor for safety and to secure regulatory approval for new indications, dosages, or improved product formulations - investments that enhance the value of our medicines for patients and society. Additional regulatory requirements, upgrading or building new manufacturing facilities, an increase in the cost of goods sold, and other market dynamics also play a role. And finally, we must continue to generate returns to invest in R&D. None Not Applicable None None None None None None None None None None None Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Johnson & Johnson believes is otherwise in the public domain or publicly available. The patent expiration date provided is the latest projected patent expiration date for patents listed in Orange Book as of March 31, 2021.
Rx0000253 Janssen Pharmaceuticals, Inc. 03/31/2021 50458057930 XARELTO® Strength:20 mg Package Size:30 Form:Tablet 01/15/2021 22.56 492.50 02/17/2034 Single Source Drug None 1 Many factors contribute to price increases. After we receive FDA approval, we continue to conduct research on our medicines, including studies to understand how the medicine works in real-world setting. We continue to monitor for safety and to secure regulatory approval for new indications, dosages, or improved product formulations - investments that enhance the value of our medicines for patients and society. Additional regulatory requirements, upgrading or building new manufacturing facilities, an increase in the cost of goods sold, and other market dynamics also play a role. And finally, we must continue to generate returns to invest in R&D. None Not Applicable None None None None None None None None None None None Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Johnson & Johnson believes is otherwise in the public domain or publicly available. The patent expiration date provided is the latest projected patent expiration date for patents listed in Orange Book as of March 31, 2021.
Rx0000253 Janssen Pharmaceuticals, Inc. 03/31/2021 50458057990 XARELTO® Strength:20 mg Package Size:90 Form:Tablet 01/15/2021 67.67 1477.48 02/17/2034 Single Source Drug None 1 Many factors contribute to price increases. After we receive FDA approval, we continue to conduct research on our medicines, including studies to understand how the medicine works in real-world setting. We continue to monitor for safety and to secure regulatory approval for new indications, dosages, or improved product formulations - investments that enhance the value of our medicines for patients and society. Additional regulatory requirements, upgrading or building new manufacturing facilities, an increase in the cost of goods sold, and other market dynamics also play a role. And finally, we must continue to generate returns to invest in R&D. None Not Applicable None None None None None None None None None None None Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Johnson & Johnson believes is otherwise in the public domain or publicly available. The patent expiration date provided is the latest projected patent expiration date for patents listed in Orange Book as of March 31, 2021.
Rx0000250 Janssen Products, LP 03/31/2021 59676027801 EDURANT Strength:25 MG Package Size:30 Form:Tablet 01/15/2021 52.44 1217.73 04/21/2025 Single Source Drug None 1 Many factors contribute to price increases. After we receive FDA approval, we continue to conduct research on our medicines, including studies to understand how the medicine works in real-world setting. We continue to monitor for safety and to secure regulatory approval for new indications, dosages, or improved product formulations - investments that enhance the value of our medicines for patients and society. Additional regulatory requirements, upgrading or building new manufacturing facilities, an increase in the cost of goods sold, and other market dynamics also play a role. And finally, we must continue to generate returns to invest in R&D. None Not Applicable None None None None None None None None None None None Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Johnson & Johnson believes is otherwise in the public domain or publicly available. The patent expiration date provided is the latest projected patent expiration date for patents listed in Orange Book as of March 31, 2021.
Rx0000250 Janssen Products, LP 03/31/2021 59676060012 ERLEADA™ Strength: 60 mg Package Size:120 Form: Tablet 01/15/2021 587.78 12833.26 04/30/2038 Single Source Drug None 1 Many factors contribute to price increases. After we receive FDA approval, we continue to conduct research on our medicines, including studies to understand how the medicine works in real-world setting. We continue to monitor for safety and to secure regulatory approval for new indications, dosages, or improved product formulations - investments that enhance the value of our medicines for patients and society. Additional regulatory requirements, upgrading or building new manufacturing facilities, an increase in the cost of goods sold, and other market dynamics also play a role. And finally, we must continue to generate returns to invest in R&D. None Not Applicable None None None None None None None None None None None Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Johnson & Johnson believes is otherwise in the public domain or publicly available. The patent expiration date provided is the latest projected patent expiration date for patents listed in Orange Book as of March 31, 2021.
Rx0000250 Janssen Products, LP 03/31/2021 59676057530 PREZCOBIX™ (darunavir 800mg, cobicistat 150mg) Strength:800 MG/150 MG Package Size:30 Form:Tablet 01/15/2021 90.82 2109.02 10/06/2032 Single Source Drug None 1 Many factors contribute to price increases. After we receive FDA approval, we continue to conduct research on our medicines, including studies to understand how the medicine works in real-world setting. We continue to monitor for safety and to secure regulatory approval for new indications, dosages, or improved product formulations - investments that enhance the value of our medicines for patients and society. Additional regulatory requirements, upgrading or building new manufacturing facilities, an increase in the cost of goods sold, and other market dynamics also play a role. And finally, we must continue to generate returns to invest in R&D. None Not Applicable None None None None None None None None None None None Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Johnson & Johnson believes is otherwise in the public domain or publicly available. The patent expiration date provided is the latest projected patent expiration date for patents listed in Orange Book as of March 31, 2021.
Rx0000250 Janssen Products, LP 03/31/2021 59676056401 PREZISTA® Strength:150 MG Package Size:240 Form:Tablet 01/15/2021 79.46 1845.19 06/26/2027 Single Source Drug None 1 Many factors contribute to price increases. After we receive FDA approval, we continue to conduct research on our medicines, including studies to understand how the medicine works in real-world setting. We continue to monitor for safety and to secure regulatory approval for new indications, dosages, or improved product formulations - investments that enhance the value of our medicines for patients and society. Additional regulatory requirements, upgrading or building new manufacturing facilities, an increase in the cost of goods sold, and other market dynamics also play a role. And finally, we must continue to generate returns to invest in R&D. None Not Applicable None None None None None None None None None None None Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Johnson & Johnson believes is otherwise in the public domain or publicly available. The patent expiration date provided is the latest projected patent expiration date for patents listed in Orange Book as of March 31, 2021 and includes 6 months of pediatric exclusivity.
Rx0000250 Janssen Products, LP 03/31/2021 59676056201 PREZISTA® Strength:600 MG Package Size:60 Form:Tablet 01/15/2021 79.46 1845.19 06/26/2027 Innovator Multiple Source Drug None 1 Many factors contribute to price increases. After we receive FDA approval, we continue to conduct research on our medicines, including studies to understand how the medicine works in real-world setting. We continue to monitor for safety and to secure regulatory approval for new indications, dosages, or improved product formulations - investments that enhance the value of our medicines for patients and society. Additional regulatory requirements, upgrading or building new manufacturing facilities, an increase in the cost of goods sold, and other market dynamics also play a role. And finally, we must continue to generate returns to invest in R&D. None Not Applicable None None None None None None None None None None None Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Johnson & Johnson believes is otherwise in the public domain or publicly available. The patent expiration date provided is the latest projected patent expiration date for patents listed in Orange Book as of March 31, 2021 and includes 6 months of pediatric exclusivity.
Rx0000250 Janssen Products, LP 03/31/2021 59676056301 PREZISTA® Strength:75 MG Package Size:480 Form:Tablet 01/15/2021 79.46 1845.19 06/26/2027 Single Source Drug None 1 Many factors contribute to price increases. After we receive FDA approval, we continue to conduct research on our medicines, including studies to understand how the medicine works in real-world setting. We continue to monitor for safety and to secure regulatory approval for new indications, dosages, or improved product formulations - investments that enhance the value of our medicines for patients and society. Additional regulatory requirements, upgrading or building new manufacturing facilities, an increase in the cost of goods sold, and other market dynamics also play a role. And finally, we must continue to generate returns to invest in R&D. None Not Applicable None None None None None None None None None None None Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Johnson & Johnson believes is otherwise in the public domain or publicly available. The patent expiration date provided is the latest projected patent expiration date for patents listed in Orange Book as of March 31, 2021 and includes 6 months of pediatric exclusivity.
Rx0000250 Janssen Products, LP 03/31/2021 59676056630 PREZISTA® Strength:800 MG Package Size:30 Form:Tablet 01/15/2021 79.46 1845.19 06/26/2027 Single Source Drug None 1 Many factors contribute to price increases. After we receive FDA approval, we continue to conduct research on our medicines, including studies to understand how the medicine works in real-world setting. We continue to monitor for safety and to secure regulatory approval for new indications, dosages, or improved product formulations - investments that enhance the value of our medicines for patients and society. Additional regulatory requirements, upgrading or building new manufacturing facilities, an increase in the cost of goods sold, and other market dynamics also play a role. And finally, we must continue to generate returns to invest in R&D. None Not Applicable None None None None None None None None None None None Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Johnson & Johnson believes is otherwise in the public domain or publicly available. The patent expiration date provided is the latest projected patent expiration date for patents listed in Orange Book as of March 31, 2021 and includes 6 months of pediatric exclusivity.
Rx0000250 Janssen Products, LP 03/31/2021 59676056501 PREZISTA® ORAL SUSPENSION Strength:100MG/mL Package Size:200mL Form:Oral Suspension 01/15/2021 44.14 1025.04 06/26/2027 Single Source Drug None 1 Many factors contribute to price increases. After we receive FDA approval, we continue to conduct research on our medicines, including studies to understand how the medicine works in real-world setting. We continue to monitor for safety and to secure regulatory approval for new indications, dosages, or improved product formulations - investments that enhance the value of our medicines for patients and society. Additional regulatory requirements, upgrading or building new manufacturing facilities, an increase in the cost of goods sold, and other market dynamics also play a role. And finally, we must continue to generate returns to invest in R&D. None Not Applicable None None None None None None None None None None None Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Johnson & Johnson believes is otherwise in the public domain or publicly available. The patent expiration date provided is the latest projected patent expiration date for patents listed in Orange Book as of March 31, 2021 and includes 6 months of pediatric exclusivity.
Rx0000250 Janssen Products, LP 03/31/2021 59676080030 SYMTUZA™ Strength: (darunavir 800mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg) Package Size: 30 Form: Tablet 01/15/2021 175.04 4064.80 07/19/2038 Single Source Drug None 1 Many factors contribute to price increases. After we receive FDA approval, we continue to conduct research on our medicines, including studies to understand how the medicine works in real-world setting. We continue to monitor for safety and to secure regulatory approval for new indications, dosages, or improved product formulations - investments that enhance the value of our medicines for patients and society. Additional regulatory requirements, upgrading or building new manufacturing facilities, an increase in the cost of goods sold, and other market dynamics also play a role. And finally, we must continue to generate returns to invest in R&D. None Not Applicable None None None None None None None None None None None Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Johnson & Johnson believes is otherwise in the public domain or publicly available. The patent expiration date provided is the latest projected patent expiration date for patents listed in Orange Book as of March 31, 2021.
Rx0000008 Jazz Pharmaceuticals, Inc. 03/31/2021 68727010001 Xyrem 500 MG/ML Oral Solution 180 ml 01/07/2021 8.50 5544.48 09/15/2033 Single Source Drug 1741758000 None None 1 A change or improvement to the drug did not necessitate the price increase None None None None None None None None None None None The patent expiration date contained in this report is limited to the patent information reported in the federal Food and Drug Administration’s Orange Book, as of April 30, 2019. As a result, the reported patent expiration date is limited to issued U.S. patents. Further, the reported patent expiration date does not reflect any pending patents, patent term extensions, pediatric exclusivity, or patent-related litigation, each of which is speculative and which may extend or shorten the reported expiration date. The drug was not was acquired from another manufacturer within the last five years.