Rx0000063 |
Ferring Pharmaceuticals |
03/31/2019 |
55566280001 |
Cervidil 10MG VAGINAL INSERT (dinoprostone, 10mg) |
01/08/2019 |
35.62 |
410.59 |
None |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
10/01/2015 |
Allergan PLC |
None |
1 |
None |
306.27 |
None |
1995 |
140.00 |
None |
None |
Rx0000063 |
Ferring Pharmaceuticals |
03/31/2019 |
55566650003 |
Endometrin 100 MG SUPPOSITORY (progesteron vaginal inserts 100 mg) |
01/08/2019 |
14.14 |
249.70 |
11/17/2019 |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
Rx0000063 |
Ferring Pharmaceuticals |
06/30/2019 |
55566750102 |
MENOPUR (menotropins for injection) |
04/19/2019 |
55.95 |
988.25 |
None |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
Note: The package WAC price represents 5 Vials of Menopur. |
Rx0000129 |
Fresenius Kabi USA LLC |
06/30/2019 |
63323036061 |
Calcium Gluconate 10g 100mL Plastic Vial |
06/07/2019 |
300.00 |
900.00 |
None |
Innovator Multiple Source Drug |
None |
1 |
None |
1 |
No |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
The information contained in this report is subject to the following limitations and assumptions.
(1) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Fresenius Kabi USA (“Fresenius Kabi”) believes is otherwise in the public domain or publicly available. Where possible, Fresenius Kabi has used the non-public indicator to indicate it does not believe the corresponding data element is otherwise in the public domain or publicly available.
(2) For Column F, Fresenius Kabi did not provide a patent expiration date for products that have lost patent exclusivity.
(3) For Columns N-U, Fresenius Kabi has not provided a response for "drug products" (as defined in the regulations) that were not acquired in their finished form from an unrelated company in the previous 5 years.
(4) Fresenius Kabi USA's product portfolio, including this product, consists primarily of sterile injectable products administered during a patient's inpatient hospital stay. Such hospital stays are subject to variability depending upon a particular patient's needs. The dosing requirements as set forth in the prescribing information for these products are given as a range, based in large part on the number of days of the patient's admission. As such, Fresenius Kabi has based its calculations for purposes of this submission on the recommended dosage for the average length of stay within range present in the product's prescribing information. For example, if a product's prescribing information requires the administration of 1 vial of drug product per day over the course of a 3 to 5 day admission, Fresenius Kabi has based the calculation on 1 vial administered during a 4-day patient admission (an average of the 3-5 day range). |
Rx0000129 |
Fresenius Kabi USA LLC |
06/30/2019 |
63323036059 |
Calcium Gluconate 5g 50mL SDV Plastic |
06/07/2019 |
187.50 |
562.50 |
None |
Innovator Multiple Source Drug |
None |
1 |
None |
1 |
No |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
The information contained in this report is subject to the following limitations and assumptions.
(1) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Fresenius Kabi USA (“Fresenius Kabi”) believes is otherwise in the public domain or publicly available. Where possible, Fresenius Kabi has used the non-public indicator to indicate it does not believe the corresponding data element is otherwise in the public domain or publicly available.
(2) For Column F, Fresenius Kabi did not provide a patent expiration date for products that have lost patent exclusivity.
(3) For Columns N-U, Fresenius Kabi has not provided a response for "drug products" (as defined in the regulations) that were not acquired in their finished form from an unrelated company in the previous 5 years.
(4) Fresenius Kabi USA's product portfolio, including this product, consists primarily of sterile injectable products administered during a patient's inpatient hospital stay. Such hospital stays are subject to variability depending upon a particular patient's needs. The dosing requirements as set forth in the prescribing information for these products are given as a range, based in large part on the number of days of the patient's admission. As such, Fresenius Kabi has based its calculations for purposes of this submission on the recommended dosage for the average length of stay within range present in the product's prescribing information. For example, if a product's prescribing information requires the administration of 1 vial of drug product per day over the course of a 3 to 5 day admission, Fresenius Kabi has based the calculation on 1 vial administered during a 4-day patient admission (an average of the 3-5 day range). |
Rx0000129 |
Fresenius Kabi USA LLC |
09/30/2019 |
63323001095 |
Gentamicin 800mg 20mL MDV Premier Pro Rx (package size 25 vials) |
08/30/2019 |
102.00 |
556.75 |
None |
Non-innovator Multiple Source Drug |
None |
1 |
None |
1 |
No |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
The information contained in this report is subject to the following limitations and assumptions.
(1) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Fresenius Kabi USA (“Fresenius Kabi”) believes is otherwise in the public domain or publicly available. Where possible, Fresenius Kabi has used the non-public indicator to indicate it does not believe the corresponding data element is otherwise in the public domain or publicly available.
(2) For Column F, Fresenius Kabi did not provide a patent expiration date for products that have lost patent exclusivity.
(3) For Columns N-U, Fresenius Kabi has not provided a response for "drug products" (as defined in the regulations) that were not acquired in their finished form from an unrelated company in the previous 5 years.
(4) Fresenius Kabi USA's product portfolio, including this product, consists primarily of sterile injectable products administered during a patient's inpatient hospital stay. Such hospital stays are subject to variability depending upon a particular patient's needs. The dosing requirements as set forth in the prescribing information for these products are given as a range, based in large part on the number of days of the patient's admission. As such, Fresenius Kabi has based its calculations for purposes of this submission on the recommended dosage for the average length of stay within range present in the product's prescribing information. For example, if a product's prescribing information requires the administration of 1 vial of drug product per day over the course of a 3 to 5 day admission, Fresenius Kabi has based the calculation on 1 vial administered during a 4-day patient admission (an average of the 3-5 day range).
(5) Please note that although the WAC pricing provided in this submission is at that pack level for this reporting purpose, none of these products are administered at a pack level for course of therapy purposes. |
Rx0000129 |
Fresenius Kabi USA LLC |
06/30/2019 |
63323045909 |
Heparin Sodium 40,000USP 4mL MDV |
04/26/2019 |
67.50 |
248.75 |
None |
Innovator Multiple Source Drug |
None |
1 |
None |
1 |
No |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
The information contained in this report is subject to the following limitations and assumptions.
(1) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Fresenius Kabi USA (“Fresenius Kabi”) believes is otherwise in the public domain or publicly available. Where possible, Fresenius Kabi has used the non-public indicator to indicate it does not believe the corresponding data element is otherwise in the public domain or publicly available.
(2) For Column F, Fresenius Kabi did not provide a patent expiration date for products that have lost patent exclusivity.
(3) For Columns N-U, Fresenius Kabi has not provided a response for "drug products" (as defined in the regulations) that were not acquired in their finished form from an unrelated company in the previous 5 years.
(4) Fresenius Kabi USA's product portfolio, including this product, consists primarily of sterile injectable products administered during a patient's inpatient hospital stay. Such hospital stays are subject to variability depending upon a particular patient's needs. The dosing requirements as set forth in the prescribing information for these products are given as a range, based in large part on the number of days of the patient's admission. As such, Fresenius Kabi has based its calculations for purposes of this submission on the recommended dosage for the average length of stay within range present in the product's prescribing information. For example, if a product's prescribing information requires the administration of 1 vial of drug product per day over the course of a 3 to 5 day admission, Fresenius Kabi has based the calculation on 1 vial administered during a 4-day patient admission (an average of the 3-5 day range). |
Rx0000129 |
Fresenius Kabi USA LLC |
12/31/2019 |
63323026255 |
Heparin Sodium Inj NovaPlus Liquid 5000 usp 3mL |
10/01/2019 |
16.25 |
50.00 |
None |
Innovator Multiple Source Drug |
None |
1 |
None |
1 |
No |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
Rx0000129 |
Fresenius Kabi USA LLC |
09/30/2019 |
76045010810 |
Simplist® Heparin Sodium Injection, USP 5,000 Units 1 mL. (package size: 24 injections) |
07/17/2019 |
32.88 |
92.40 |
None |
Non-innovator Multiple Source Drug |
None |
1 |
None |
1 |
No |
None |
01/07/2016 |
Becton Dickinson and Company |
None |
1 |
This product was acquired when we purchased BDRx, Inc. The terms of this deal were not made public. The agreement was in the form of a stock deal, not an asset deal, so there is no way to determine the cost of this molecule individually. |
59.52 |
None |
2016 |
59.52 |
None |
The information contained in this report is subject to the following limitations and assumptions.
(1) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Fresenius Kabi USA (“Fresenius Kabi”) believes is otherwise in the public domain or publicly available. Where possible, Fresenius Kabi has used the non-public indicator to indicate it does not believe the corresponding data element is otherwise in the public domain or publicly available.
(2) For Column F, Fresenius Kabi did not provide a patent expiration date for products that have lost patent exclusivity.
(3) Fresenius Kabi USA's product portfolio, including this product, consists primarily of sterile injectable products administered during a patient's inpatient hospital stay. Such hospital stays are subject to variability depending upon a particular patient's needs. The dosing requirements as set forth in the prescribing information for these products are given as a range, based in large part on the number of days of the patient's admission. As such, Fresenius Kabi has based its calculations for purposes of this submission on the recommended dosage for the average length of stay within range present in the product's prescribing information. For example, if a product's prescribing information requires the administration of 1 vial of drug product per day over the course of a 3 to 5 day admission, Fresenius Kabi has based the calculation on 1 vial administered during a 4-day patient admission (an average of the 3-5 day range).
(4) Please note that although the WAC pricing provided in this submission is at that pack level for this reporting purpose, none of these products are administered at a pack level for course of therapy purposes.
(5) This product was not launched by prior manufacturer. It was first introduced to the market by Fresenius Kabi 11 months after the acquisition. |
Rx0000129 |
Fresenius Kabi USA LLC |
06/30/2019 |
76045010710 |
Simplist® Ketorolac Tromethamine Injection, USP 15 mg 1 mL |
04/26/2019 |
23.04 |
80.64 |
04/23/2032 |
Non-innovator Multiple Source Drug |
None |
1 |
None |
1 |
No |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
The information contained in this report is subject to the following limitations and assumptions.
(1) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Fresenius Kabi USA (“Fresenius Kabi”) believes is otherwise in the public domain or publicly available. Where possible, Fresenius Kabi has used the non-public indicator to indicate it does not believe the corresponding data element is otherwise in the public domain or publicly available.
(2) For Column F, Fresenius Kabi did not provide a patent expiration date for products that have lost patent exclusivity.
(3) For Columns N-U, Fresenius Kabi has not provided a response for "drug products" (as defined in the regulations) that were not acquired in their finished form from an unrelated company in the previous 5 years.
(4) Fresenius Kabi USA's product portfolio, including this product, consists primarily of sterile injectable products administered during a patient's inpatient hospital stay. Such hospital stays are subject to variability depending upon a particular patient's needs. The dosing requirements as set forth in the prescribing information for these products are given as a range, based in large part on the number of days of the patient's admission. As such, Fresenius Kabi has based its calculations for purposes of this submission on the recommended dosage for the average length of stay within range present in the product's prescribing information. For example, if a product's prescribing information requires the administration of 1 vial of drug product per day over the course of a 3 to 5 day admission, Fresenius Kabi has based the calculation on 1 vial administered during a 4-day patient admission (an average of the 3-5 day range).
(5) The patent for this product applies to the primary container (syringe), not the molecule. |
Rx0000129 |
Fresenius Kabi USA LLC |
09/30/2019 |
63323030502 |
Tobramycin 20mg 2mL Pediatric MDV (package size: 25 vials) |
08/30/2019 |
36.50 |
132.00 |
None |
Non-innovator Multiple Source Drug |
None |
1 |
None |
1 |
No |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
The information contained in this report is subject to the following limitations and assumptions.
(1) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Fresenius Kabi USA (“Fresenius Kabi”) believes is otherwise in the public domain or publicly available. Where possible, Fresenius Kabi has used the non-public indicator to indicate it does not believe the corresponding data element is otherwise in the public domain or publicly available.
(2) For Column F, Fresenius Kabi did not provide a patent expiration date for products that have lost patent exclusivity.
(3) For Columns N-U, Fresenius Kabi has not provided a response for "drug products" (as defined in the regulations) that were not acquired in their finished form from an unrelated company in the previous 5 years.
(4) Fresenius Kabi USA's product portfolio, including this product, consists primarily of sterile injectable products administered during a patient's inpatient hospital stay. Such hospital stays are subject to variability depending upon a particular patient's needs. The dosing requirements as set forth in the prescribing information for these products are given as a range, based in large part on the number of days of the patient's admission. As such, Fresenius Kabi has based its calculations for purposes of this submission on the recommended dosage for the average length of stay within range present in the product's prescribing information. For example, if a product's prescribing information requires the administration of 1 vial of drug product per day over the course of a 3 to 5 day admission, Fresenius Kabi has based the calculation on 1 vial administered during a 4-day patient admission (an average of the 3-5 day range).
(5) Please note that although the WAC pricing provided in this submission is at that pack level for this reporting purpose, none of these products are administered at a pack level for course of therapy purposes. |
Rx0000100 |
Fresenius Medical Care |
03/31/2019 |
49230064331 |
PHOSLYRA 667MG/5ML ORAL SOLUTION 473ML BOTTLE |
01/01/2019 |
7.04 |
147.86 |
02/23/2030 |
Single Source Drug |
None |
1 |
The increase in Wholesale Acquisition Cost (WAC) for the products is due to increases in the costs of manufacturing and distribution, specifically including increases in the cost of the active pharmaceutical ingredients (API) of the products, increases in shipping for the products, and increases in costs to market the products. |
None |
THIS WAC INCREASE IS NOT NECCESSITATED BY A CHANGE OR IMPROVEMENT IN THE PRESCRIPTION DRUG |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
Please note that this report and its contents are exempted from disclosure under the California Public Records Act, Cal. Gov. Code § 6250 et seq. (“PRA”) as the material contains and constitutes FUSA’s proprietary commercial information and otherwise would not be in the public interest to disclose. Please contact Domenic Gaeta at domenic.gaeta@fmc-na.com regarding any PRA requests so that we may take appropriate steps to protect such information.
Fresenius Medical Care did not acquire Phoslyra in the prior five year period. |
Rx0000100 |
Fresenius Medical Care |
12/31/2019 |
49230064331 |
PHOSLYRA 667MG/5ML ORAL SOLUTION 473ML BOTTLE |
10/01/2019 |
6.89 |
154.75 |
02/23/2030 |
Single Source Drug |
None |
1 |
The increase in Wholesale Acquisition Cost (WAC) for the products is due to increases in the costs of manufacturing and distribution, specifically including increases in the cost of the active pharmaceutical ingredients (API) of the products, increases in shipping for the products, and increases in costs to market the products. |
None |
This WAC increase is not necessitated by a change or improvement in the prescription drug. |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
Please note that this report and its contents are exempted from disclosure under the California Public Records Act, Cal. Gov. Code § 6250 et seq. (“PRA”) as the material contains and constitutes FUSA’s proprietary commercial information and otherwise would not be in the public interest to disclose. Please contact Domenic Gaeta at domenic.gaeta@fmc-na.com regarding any PRA requests so that we may take appropriate steps to protect such information.
Fresenius Medical Care did not acquire Phoslyra in the prior five year period. |
Rx0000100 |
Fresenius Medical Care |
03/31/2019 |
49230064551 |
VELPHORO 500MG CHEWABLE TABLETS 90 TABLET BOTTLE |
01/01/2019 |
56.92 |
1195.31 |
01/23/2030 |
Single Source Drug |
None |
1 |
The increase in Wholesale Acquisition Cost (WAC) for the products is due to increases in the costs of manufacturing and distribution, specifically including increases in the cost of the active pharmaceutical ingredients (API) of the products, increases in shipping for the products, and increases in costs to market the products. |
None |
THIS WAC INCREASE IS NOT NECCESSITATED BY A CHANGE OR IMPROVEMENT IN THE PRESCRIPTION DRUG |
None |
01/10/2014 |
Vifor Fresenius Medical Care Renal Pharma Ltd. |
None |
1 |
n/a |
855.00 |
None |
2014 |
855.00 |
None |
Please note that this report and its contents are exempted from disclosure under the California Public Records Act, Cal. Gov. Code § 6250 et seq. (“PRA”) as the material contains and constitutes FUSA’s proprietary commercial information and otherwise would not be in the public interest to disclose. Please contact Domenic Gaeta at domenic.gaeta@fmc-na.com regarding any PRA requests so that we may take appropriate steps to protect such information.
Fresenius is the authorized distributor for Velphoro. |
Rx0000100 |
Fresenius Medical Care |
12/31/2019 |
49230064551 |
VELPHORO 500MG CHEWABLE TABLETS 90 TABLET BOTTLE |
10/01/2019 |
55.70 |
1251.01 |
01/23/2030 |
Single Source Drug |
None |
1 |
The increase in Wholesale Acquisition Cost (WAC) for the products is due to increases in the costs of manufacturing and distribution, specifically including increases in the cost of the active pharmaceutical ingredients (API) of the products, increases in shipping for the products, and increases in costs to market the products. |
None |
This WAC increase is not necessitated by a change or improvement in the prescription drug. |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
Please note that this report and its contents are exempted from disclosure under the California Public Records Act, Cal. Gov. Code § 6250 et seq. (“PRA”) as the material contains and constitutes FUSA’s proprietary commercial information and otherwise would not be in the public interest to disclose. Please contact Domenic Gaeta at domenic.gaeta@fmc-na.com regarding any PRA requests so that we may take appropriate steps to protect such information.
Fresenius Medical Care is the authorized distributor for Velphoro.
Fresenius Medical Care did not acquire Velphoro in the prior five year period. |