| Rx0000191 |
Jaguar Health |
12/31/2022 |
70564080260 |
Mytesi Oral Tablet Delayed Release 125 MG 60 Tabs |
12/01/2022 |
102.25 |
2374.55 |
None |
Single Source Drug |
1 |
None |
Napo Pharmaceuticals has made the decision to increase the WAC price of Mytesi® by 4.5% effective December 1st, 2022. This price change is due to increases in the cost of business operations related to Mytesi that are consistent with inflation over the past 12 months. The last Mytesi price increase was 12 months ago. |
None |
Napo Pharmaceuticals has made the decision to increase the WAC price of Mytesi® by 4.5% effective December 1st, 2022. This price change is due to increases in the cost of business operations related to Mytesi that are consistent with inflation over the past 12 months. The last Mytesi price increase was 12 months ago. |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Rx0000248 |
Janssen Biotech, Inc. |
09/30/2022 |
57894050205 |
DARZALEX™ (daratumumab)Strength:100 mg 5 mL Package Size:1 Form:1 single vial |
09/15/2022 |
26.39 |
640.19 |
09/25/2029 |
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 on Janssenpatents.com as of October 4, 2022. |
| Rx0000248 |
Janssen Biotech, Inc. |
09/30/2022 |
57894050220 |
DARZALEX™ (daratumumab)Strength:400 mg 20 mL Package Size:1 Form:1 single vial |
09/15/2022 |
105.57 |
2560.76 |
09/25/2029 |
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 on Janssenpatents.com as of October 4, 2022. |
| Rx0000253 |
Janssen Pharmaceuticals, Inc. |
09/30/2022 |
50458056201 |
INVEGA® SUSTENNA® Strength:117 mg Package Size:1 Form:Disposable Syringe/Dose Pack |
09/15/2022 |
46.48 |
1595.84 |
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 October 4, 2022. |
| Rx0000253 |
Janssen Pharmaceuticals, Inc. |
09/30/2022 |
50458056301 |
INVEGA® SUSTENNA® Strength:156 mg Package Size:1 Form:Disposable Syringe/Dose Pack |
09/15/2022 |
61.98 |
2127.87 |
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 October 4, 2022. |
| Rx0000253 |
Janssen Pharmaceuticals, Inc. |
09/30/2022 |
50458056401 |
INVEGA® SUSTENNA® Strength:234 mg Package Size:1 Form:Disposable Syringe/Dose Pack |
09/15/2022 |
92.96 |
3191.73 |
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 October 4, 2022. |
| Rx0000253 |
Janssen Pharmaceuticals, Inc. |
09/30/2022 |
50458056001 |
INVEGA® SUSTENNA® Strength:39 mg Package Size:1 Form:Disposable Syringe/Dose Pack |
09/15/2022 |
15.49 |
531.92 |
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 October 4, 2022. |
| Rx0000253 |
Janssen Pharmaceuticals, Inc. |
09/30/2022 |
50458056101 |
INVEGA® SUSTENNA® Strength:78 mg Package Size:1 Form:Disposable Syringe/Dose Pack |
09/15/2022 |
30.99 |
1063.88 |
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 October 4, 2022. |
| Rx0000253 |
Janssen Pharmaceuticals, Inc. |
09/30/2022 |
50458060601 |
INVEGA® TRINZA® Strength:273 mg Package Size:1 Form:Disposable Syringe/Dose Pack |
09/15/2022 |
92.96 |
3191.63 |
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 October 4, 2022. |
| Rx0000253 |
Janssen Pharmaceuticals, Inc. |
09/30/2022 |
50458060701 |
INVEGA® TRINZA® Strength:410 mg Package Size:1 Form:Disposable Syringe/Dose Pack |
09/15/2022 |
139.44 |
4787.52 |
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 October 4, 2022. |
| Rx0000253 |
Janssen Pharmaceuticals, Inc. |
09/30/2022 |
50458060801 |
INVEGA® TRINZA® Strength:546 mg Package Size:1 Form:Disposable Syringe/Dose Pack |
09/15/2022 |
185.93 |
6383.61 |
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 October 4, 2022. |
| Rx0000253 |
Janssen Pharmaceuticals, Inc. |
09/30/2022 |
50458060901 |
INVEGA® TRINZA® Strength:819 mg Package Size:1 Form:Disposable Syringe/Dose Pack |
09/15/2022 |
278.89 |
9575.20 |
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 October 4, 2022. |
| Rx0000250 |
Janssen Products, LP |
09/30/2022 |
59676003056 |
BALVERSA® (erdafitinib) Strength:3 MG Package Size:56 Form:Tablet |
09/15/2022 |
750.48 |
18203.48 |
02/02/2038 |
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 October 4, 2022. |
| Rx0000250 |
Janssen Products, LP |
09/30/2022 |
59676003084 |
BALVERSA® (erdafitinib) Strength:3 MG Package Size:84 Form:Tablet |
09/15/2022 |
1125.72 |
27305.21 |
02/02/2038 |
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 October 4, 2022. |
| Rx0000250 |
Janssen Products, LP |
09/30/2022 |
59676004028 |
BALVERSA® (erdafitinib) Strength:4 MG Package Size:28 Form:Tablet |
09/15/2022 |
500.32 |
12135.65 |
02/02/2038 |
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 October 4, 2022. |
| Rx0000250 |
Janssen Products, LP |
09/30/2022 |
59676004056 |
BALVERSA® (erdafitinib) Strength:4 MG Package Size:56 Form:Tablet |
09/15/2022 |
1000.64 |
24271.31 |
02/02/2038 |
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 October 4, 2022. |
| Rx0000250 |
Janssen Products, LP |
09/30/2022 |
59676005028 |
BALVERSA® (erdafitinib) Strength:5 MG Package Size:28 Form:Tablet |
09/15/2022 |
625.40 |
15169.57 |
02/02/2038 |
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 October 4, 2022. |
| Rx0000250 |
Janssen Products, LP |
09/30/2022 |
59676057530 |
PREZCOBIX™ (darunavir 800mg, cobicistat 150mg) Strength:800 MG/150 MG Package Size:30 Form:Tablet |
09/15/2022 |
66.81 |
2293.94 |
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 October 4, 2022. |
| Rx0000250 |
Janssen Products, LP |
09/30/2022 |
59676056401 |
PREZISTA® Strength:150 MG Package Size:240 Form:Tablet |
09/15/2022 |
58.46 |
2006.98 |
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 October 4, 2022. |
| Rx0000250 |
Janssen Products, LP |
09/30/2022 |
59676056201 |
PREZISTA® Strength:600 MG Package Size:60 Form:Tablet |
09/15/2022 |
58.46 |
2006.98 |
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 October 4, 2022. |
| Rx0000250 |
Janssen Products, LP |
09/30/2022 |
59676056301 |
PREZISTA® Strength:75 MG Package Size:480 Form:Tablet |
09/15/2022 |
58.46 |
2006.98 |
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 October 4, 2022. |
| Rx0000250 |
Janssen Products, LP |
09/30/2022 |
59676056630 |
PREZISTA® Strength:800 MG Package Size:30 Form:Tablet |
09/15/2022 |
58.46 |
2006.98 |
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 October 4, 2022. |
| Rx0000250 |
Janssen Products, LP |
09/30/2022 |
59676056501 |
PREZISTA® ORAL SUSPENSION Strength:100MG/mL Package Size:200mL Form:Oral Suspension |
09/15/2022 |
32.47 |
1114.91 |
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 October 4, 2022. |
| Rx0000008 |
Jazz Pharmaceuticals, Inc. |
03/31/2022 |
68727010001 |
Xyrem 500 MG/ML Oral Solution 180 ml |
01/10/2022 |
465.52 |
6010.00 |
09/15/2033 |
Single Source Drug |
None |
1 |
"Jazz Pharmaceuticals manufactures Specialty Pharmacy drugs for rare diseases that require a higher level of administration and effort to support patients. Product prices are determined by conducting extensive market research with Healthcare Providers (HCPs) to assess their perceptions of the clinical value delivered by our products. Jazz also evaluates relevant market analogues to support a price increase. Jazz engages its Pricing Committee to make price increase decisions. In doing so, the Pricing Committee balances capturing the product’s value with the priority of ensuring patient access. Specifically, the Pricing Committee considers the following factors in determining whether a price increase is warranted:
• Clinical value;
• HCP and Payer perceptions of a product’s clinical value;
• Patient access and affordability, in order to ensure our products are broadly available to HCPs and patients;
• Research and Development costs associated with production of the drug;
• Historic WAC price;
• Jazz’s fiduciary responsibility to its shareholders." |
None |
None |
1 |
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 26, 2022. 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.
Unit Sales Volume and Change Improvement: Per CA Health & Safety Code Section 127681(c) Jazz Pharmaceuticals respectfully declines to submit this information, as it is not otherwise in the public domain or publicly available. Columns N-U are intentionally left blank as this drug was not was acquired from another manufacturer within the last five years. " |