| Rx0000340 |
Carlsbad Technology, Inc. |
12/31/2023 |
61442011501 |
Glimepiride 1mg Tab 100 |
Generic |
FDA |
11/01/2023 |
35.00 |
42.00 |
None |
Non-innovator Multiple Source Drug |
41091 |
None |
Manufacturing Costs Increase |
None |
Manufacturing Costs Increase |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Rx0000340 |
Carlsbad Technology, Inc. |
12/31/2023 |
61442011505 |
Glimepiride 1mg Tab 500 |
Generic |
FDA |
11/01/2023 |
175.00 |
210.00 |
None |
Non-innovator Multiple Source Drug |
9918 |
None |
Manufacturing Costs Increase |
None |
Manufacturing Costs Increase |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Rx0000340 |
Carlsbad Technology, Inc. |
12/31/2023 |
61442011601 |
Glimepiride 2mg Tab 100 |
Generic |
FDA |
11/01/2023 |
61.00 |
69.00 |
None |
Non-innovator Multiple Source Drug |
84217 |
None |
Manufacturing Costs Increase |
None |
Manufacturing Costs Increase |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Rx0000340 |
Carlsbad Technology, Inc. |
12/31/2023 |
61442011605 |
Glimepiride 2mg Tab 500 |
Generic |
FDA |
11/01/2023 |
305.00 |
345.00 |
None |
Non-innovator Multiple Source Drug |
26434 |
None |
Manufacturing Costs Increase |
None |
Manufacturing Costs Increase |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Rx0000340 |
Carlsbad Technology, Inc. |
12/31/2023 |
61442011701 |
Glimepiride 4mg Tab 100 |
Generic |
FDA |
11/01/2023 |
113.00 |
126.00 |
None |
Non-innovator Multiple Source Drug |
117386 |
None |
Manufacturing Costs Increase |
None |
Manufacturing Costs Increase |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Rx0000340 |
Carlsbad Technology, Inc. |
12/31/2023 |
61442011705 |
Glimepiride 4mg Tab 500 |
Generic |
FDA |
11/01/2023 |
565.00 |
630.00 |
None |
Non-innovator Multiple Source Drug |
33103 |
None |
Manufacturing Costs Increase |
None |
Manufacturing Costs Increase |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Rx0000498 |
Catalyst Pharmaceuticals Inc |
03/31/2023 |
69616021103 |
Firdapse 10mg Tablet 240/Bottle |
Brand |
FDA |
01/09/2023 |
2787.72 |
52479.72 |
02/25/2037 |
Single Source Drug |
None |
1 |
response to recent economic conditions and inflation |
None |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Rx0000498 |
Catalyst Pharmaceuticals Inc |
03/31/2023 |
69616021106 |
FIRDAPSE Blister shelf pack of 120 - 10mg tablets |
Brand |
FDA |
01/09/2023 |
1393.86 |
26239.86 |
02/25/2037 |
Single Source Drug |
None |
1 |
response to recent economic conditions and inflation |
None |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Rx0000139 |
Chiesi USA |
03/31/2023 |
10122051001 |
Curosurf® 1.5ml |
Brand |
FDA |
01/01/2023 |
35.61 |
544.31 |
None |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
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 Chieisi USA believes is otherwise in the public domain or publicly available. (2) Columns N-T were intentionally left blank for this submission, as the drug was not acquired. |
| Rx0000139 |
Chiesi USA |
03/31/2023 |
10122051003 |
Curosurf® 3.0ml |
Brand |
FDA |
01/01/2023 |
70.22 |
1073.32 |
None |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
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 Chieisi USA believes is otherwise in the public domain or publicly available. (2) Columns N-T were intentionally left blank for this submission, as the drug was not acquired. |
| Rx0000139 |
Chiesi USA |
03/31/2023 |
10122010401 |
FERRIPROX® TD 1000mg Pack FILM COATED TABLETS |
Brand |
FDA |
01/04/2023 |
681.89 |
10423.12 |
10/25/2038 |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Rx0000139 |
Chiesi USA |
03/31/2023 |
10122062010 |
Kengreal for injection 50mg/10ML |
Brand |
FDA |
01/01/2023 |
583.55 |
8919.92 |
07/10/2035 |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Rx0000139 |
Chiesi USA |
03/31/2023 |
10122050201 |
Revcovi® (elapegademase-IvIr 1.6mg/ml) Injection |
Brand |
FDA |
01/04/2023 |
899.65 |
12145.24 |
None |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
11/24/2020 |
Leadiant Biosciences |
None |
1 |
None |
10109.30 |
9856.00 |
2018 |
9856.00 |
None |
New labeler code was launched 4/18/2022. |
| Rx0000320 |
CMP Pharma |
12/31/2023 |
46287002004 |
Carospir Suspension
Dosage Strength 25 mg/5mL
118 mL in 1 Bottle |
Brand |
FDA |
11/01/2023 |
16.70 |
432.20 |
10/28/2036 |
Single Source Drug |
None |
1 |
Increasing costs related to inflationary environment – materials, shipping, labor, overheads. A price increase is taken annually to keep up with inflation & rising costs. |
None |
The price increase is not necessitated by a change or improvement to the product. |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Rx0000320 |
CMP Pharma |
12/31/2023 |
46287002001 |
Carospir Suspension
Dosage Strength 25 mg/5mL
473 mL in 1 Bottle |
Brand |
FDA |
11/01/2023 |
66.60 |
1731.60 |
10/28/2036 |
Single Source Drug |
None |
1 |
Increasing costs related to inflationary environment – materials, shipping, labor, overheads. A price increase is taken annually to keep up with inflation & rising costs. |
None |
The price increase is not necessitated by a change or improvement to the product. |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Rx0000320 |
CMP Pharma |
12/31/2023 |
46287001430 |
Oracit Solution
Dosage Strength 640 mg/5mL, 490 mg/5mL
30 ml in 1 Bottle, 10 Bottle, Unit Dose 1 Carton |
Brand |
Medispan |
11/01/2023 |
8.80 |
53.00 |
None |
Non-innovator Multiple Source Drug |
None |
1 |
Increasing costs related to inflationary environment – materials, shipping, labor, overheads. A price increase is taken annually to keep up with inflation & rising costs. |
None |
The price increase is not necessitated by a change or improvement to the product. |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Rx0000320 |
CMP Pharma |
12/31/2023 |
46287001401 |
Oracit Solution
Dosage Strength 640 mg/5mL, 490 mg/5mL
500 ml in 1 Bottle |
Brand |
Medispan |
11/01/2023 |
7.20 |
43.10 |
None |
Non-innovator Multiple Source Drug |
None |
1 |
Increasing costs related to inflationary environment – materials, shipping, labor, overheads. A price increase is taken annually to keep up with inflation & rising costs. |
None |
The price increase is not necessitated by a change or improvement to the product. |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Rx0000320 |
CMP Pharma |
12/31/2023 |
46287002410 |
POTASSIUM PHOSPHATES, Injection, 300 mg/mL, 175 mg/mL, 10 VIAL, in 1 CARTON > 15 mL in 1 VIAL |
Brand |
FDA |
12/06/2023 |
75.00 |
374.00 |
04/19/2039 |
Single Source Drug |
None |
1 |
Increasing costs related to inflationary environment – materials, shipping, labor, overheads. A price increase is taken annually to keep up with inflation & rising costs. |
None |
The price increase is not necessitated by a change or improvement to the product. |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Rx0000200 |
Collegium Pharmaceuticals |
03/31/2023 |
24510010010 |
Nucynta 100mg, tablet, 100 pack |
Brand |
FDA |
01/01/2023 |
123.84 |
1499.80 |
06/27/2025 |
Single Source Drug |
None |
1 |
While Collegium's business pricing model is both proprietary and confidential, the decision to increase the WAC for Nucynta included a broad range of financial and non-financial factors including changing market dynamics, costs of labor and goods, post market requirements, support for the marketing and sales of Nucynta, and reinvestment in the product. Nucynta is an immediate-release formulation of tapentadol that is indicated for the management of acute adult pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. As such, it represents a valuable therapeutic treatment option. We have incurred substantial costs to obtain and maintain regulatory approval and continue to incur the substantial costs described above as well as the more traditional, general and administrative costs associated with our operations, resulting in a deficit of over $200 Million since our inception. In addition, we continue to reinvest in Nucynta’s manufacturing infrastructure to maintain sufficient supply. These increases in costs were considered as part of this decision to permit the company to increase the wholesale acquisition cost of Nucynta. |
None |
None |
1 |
02/14/2020 |
Assertio Therapeutics, Inc. |
375000000 |
None |
None |
1088.71 |
990.64 |
2009 |
265.00 |
None |
None |
| Rx0000200 |
Collegium Pharmaceuticals |
03/31/2023 |
24510005010 |
Nucynta 50mg, tablet, 100 pack |
Brand |
FDA |
01/01/2023 |
79.72 |
963.11 |
06/27/2025 |
Single Source Drug |
None |
1 |
While Collegium's business pricing model is both proprietary and confidential, the decision to increase the WAC for Nucynta included a broad range of financial and non-financial factors including changing market dynamics, costs of labor and goods, post market requirements, support for the marketing and sales of Nucynta, and reinvestment in the product. Nucynta is an immediate-release formulation of tapentadol that is indicated for the management of acute adult pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. As such, it represents a valuable therapeutic treatment option. We have incurred substantial costs to obtain and maintain regulatory approval and continue to incur the substantial costs described above as well as the more traditional, general and administrative costs associated with our operations, resulting in a deficit of over $200 Million since our inception. In addition, we continue to reinvest in Nucynta’s manufacturing infrastructure to maintain sufficient supply. These increases in costs were considered as part of this decision to permit the company to increase the wholesale acquisition cost of Nucynta. |
None |
None |
1 |
02/14/2020 |
Assertio Therapeutics, Inc. |
375000000 |
None |
None |
699.13 |
636.15 |
2009 |
170.00 |
None |
None |
| Rx0000200 |
Collegium Pharmaceuticals |
03/31/2023 |
24510007510 |
Nucynta 75mg, tablet, 100 pack |
Brand |
FDA |
01/01/2023 |
92.92 |
1125.31 |
06/27/2025 |
Single Source Drug |
None |
1 |
While Collegium's business pricing model is both proprietary and confidential, the decision to increase the WAC for Nucynta included a broad range of financial and non-financial factors including changing market dynamics, costs of labor and goods, post market requirements, support for the marketing and sales of Nucynta, and reinvestment in the product. Nucynta is an immediate-release formulation of tapentadol that is indicated for the management of acute adult pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. As such, it represents a valuable therapeutic treatment option. We have incurred substantial costs to obtain and maintain regulatory approval and continue to incur the substantial costs described above as well as the more traditional, general and administrative costs associated with our operations, resulting in a deficit of over $200 Million since our inception. In addition, we continue to reinvest in Nucynta’s manufacturing infrastructure to maintain sufficient supply. These increases in costs were considered as part of this decision to permit the company to increase the wholesale acquisition cost of Nucynta. |
None |
None |
1 |
02/14/2020 |
Assertio Therapeutics, Inc. |
375000000 |
None |
None |
816.86 |
743.28 |
2009 |
199.00 |
None |
None |
| Rx0000200 |
Collegium Pharmaceuticals |
03/31/2023 |
24510011660 |
Nucynta ER 100mg, tablet, 60 pack |
Brand |
FDA |
01/01/2023 |
82.36 |
1138.26 |
09/22/2028 |
Single Source Drug |
None |
1 |
While Collegium's business pricing model is both proprietary and confidential, the decision to increase the WAC for Nucynta ER included a broad range of financial and non-financial factors including changing market dynamics, costs of labor and goods, post market requirements, support for the marketing and sales of Nucynta ER, and reinvestment in the product. Nucynta ER is an extended-release formulation of tapentadol that is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment, including neuropathic pain associated with diabetic peripheral neuropathy in adults, and for which alternate treatment options are inadequate. As such, it represents a valuable therapeutic treatment option. We have incurred substantial costs to obtain and maintain regulatory approval and continue to incur the substantial costs described above as well as the more traditional general and administrative costs associated with our operations, resulting in a deficit of over $200 Million since our inception. In addition, we continue to reinvest in Nucynta ER’s manufacturing infrastructure to maintain sufficient supply. These increases in costs were considered as part of this decision to permit the company to increase the wholesale acquisition cost of Nucynta ER. |
None |
None |
1 |
02/14/2020 |
Assertio Therapeutics, Inc. |
375000000 |
None |
None |
835.46 |
760.20 |
2011 |
269.40 |
None |
None |
| Rx0000200 |
Collegium Pharmaceuticals |
03/31/2023 |
24510017460 |
Nucynta ER 150 mg, tablet, 60 pack |
Brand |
FDA |
01/01/2023 |
106.26 |
1468.55 |
09/22/2028 |
Single Source Drug |
None |
1 |
While Collegium's business pricing model is both proprietary and confidential, the decision to increase the WAC for Nucynta ER included a broad range of financial and non-financial factors including changing market dynamics, costs of labor and goods, post market requirements, support for the marketing and sales of Nucynta ER, and reinvestment in the product. Nucynta ER is an extended-release formulation of tapentadol that is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment, including neuropathic pain associated with diabetic peripheral neuropathy in adults, and for which alternate treatment options are inadequate. As such, it represents a valuable therapeutic treatment option. We have incurred substantial costs to obtain and maintain regulatory approval and continue to incur the substantial costs described above as well as the more traditional general and administrative costs associated with our operations, resulting in a deficit of over $200 Million since our inception. In addition, we continue to reinvest in Nucynta ER’s manufacturing infrastructure to maintain sufficient supply. These increases in costs were considered as part of this decision to permit the company to increase the wholesale acquisition cost of Nucynta ER. |
None |
None |
1 |
02/14/2020 |
Assertio Therapeutics, Inc. |
375000000 |
None |
None |
1077.89 |
980.79 |
2011 |
346.80 |
None |
None |
| Rx0000200 |
Collegium Pharmaceuticals |
03/31/2023 |
24510023260 |
Nucynta ER 200 mg, tablet, 60 pack |
Brand |
FDA |
01/01/2023 |
134.89 |
1864.24 |
09/22/2028 |
Single Source Drug |
None |
1 |
While Collegium's business pricing model is both proprietary and confidential, the decision to increase the WAC for Nucynta ER included a broad range of financial and non-financial factors including changing market dynamics, costs of labor and goods, post market requirements, support for the marketing and sales of Nucynta ER, and reinvestment in the product. Nucynta ER is an extended-release formulation of tapentadol that is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment, including neuropathic pain associated with diabetic peripheral neuropathy in adults, and for which alternate treatment options are inadequate. As such, it represents a valuable therapeutic treatment option. We have incurred substantial costs to obtain and maintain regulatory approval and continue to incur the substantial costs described above as well as the more traditional general and administrative costs associated with our operations, resulting in a deficit of over $200 Million since our inception. In addition, we continue to reinvest in Nucynta ER’s manufacturing infrastructure to maintain sufficient supply. These increases in costs were considered as part of this decision to permit the company to increase the wholesale acquisition cost of Nucynta ER. |
None |
None |
1 |
02/14/2020 |
Assertio Therapeutics, Inc. |
375000000 |
None |
None |
1368.32 |
1245.06 |
2011 |
441.60 |
None |
None |
| Rx0000200 |
Collegium Pharmaceuticals |
03/31/2023 |
24510029160 |
Nucynta ER 250 mg, tablet, 60 pack |
Brand |
FDA |
01/01/2023 |
168.76 |
2332.36 |
09/22/2028 |
Single Source Drug |
None |
1 |
While Collegium's business pricing model is both proprietary and confidential, the decision to increase the WAC for Nucynta ER included a broad range of financial and non-financial factors including changing market dynamics, costs of labor and goods, post market requirements, support for the marketing and sales of Nucynta ER, and reinvestment in the product. Nucynta ER is an extended-release formulation of tapentadol that is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment, including neuropathic pain associated with diabetic peripheral neuropathy in adults, and for which alternate treatment options are inadequate. As such, it represents a valuable therapeutic treatment option. We have incurred substantial costs to obtain and maintain regulatory approval and continue to incur the substantial costs described above as well as the more traditional general and administrative costs associated with our operations, resulting in a deficit of over $200 Million since our inception. In addition, we continue to reinvest in Nucynta ER’s manufacturing infrastructure to maintain sufficient supply. These increases in costs were considered as part of this decision to permit the company to increase the wholesale acquisition cost of Nucynta ER. |
None |
None |
1 |
02/14/2020 |
Assertio Therapeutics, Inc. |
375000000 |
None |
None |
1711.91 |
1557.70 |
2011 |
441.60 |
None |
None |
| Rx0000200 |
Collegium Pharmaceuticals |
03/31/2023 |
24510005860 |
Nucynta ER 50mg, tablet, 60 pack |
Brand |
FDA |
01/01/2023 |
44.53 |
615.46 |
09/22/2028 |
Single Source Drug |
None |
1 |
While Collegium's business pricing model is both proprietary and confidential, the decision to increase the WAC for Nucynta ER included a broad range of financial and non-financial factors including changing market dynamics, costs of labor and goods, post market requirements, support for the marketing and sales of Nucynta ER, and reinvestment in the product. Nucynta ER is an extended-release formulation of tapentadol that is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment, including neuropathic pain associated with diabetic peripheral neuropathy in adults, and for which alternate treatment options are inadequate. As such, it represents a valuable therapeutic treatment option. We have incurred substantial costs to obtain and maintain regulatory approval and continue to incur the substantial costs described above as well as the more traditional general and administrative costs associated with our operations, resulting in a deficit of over $200 Million since our inception. In addition, we continue to reinvest in Nucynta ER’s manufacturing infrastructure to maintain sufficient supply. These increases in costs were considered as part of this decision to permit the company to increase the wholesale acquisition cost of Nucynta ER. |
None |
None |
1 |
02/14/2020 |
Assertio Therapeutics, Inc. |
375000000 |
None |
None |
451.74 |
411.05 |
2011 |
145.80 |
None |
None |
| Rx0000200 |
Collegium Pharmaceuticals |
03/31/2023 |
24510011510 |
Xtampza ER 13.5mg, capsule, 100 pack |
Brand |
FDA |
01/01/2023 |
43.54 |
914.27 |
09/02/2036 |
Single Source Drug |
None |
1 |
While Collegium's business pricing model is both proprietary and confidential, the decision to increase the WAC for Xtampza ER included a broad range of financial and non-financial factors including changing market dynamics, costs of labor and goods, post market requirements, support for the marketing and sales of Xtampza ER, and reinvestment in the product. Xtampza ER is an abuse-deterrent, extended-release, oral formulation of oxycodone approved by the FDA in April 2016 for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. As such, it represents a valuable therapeutic treatment option. We have incurred substantial costs to obtain and maintain regulatory approval and continue to incur the substantial costs described above as well as the more traditional general and administrative costs associated with our operations, resulting in a deficit of over $200 million since our inception. In addition, we continue to reinvest in Xtampza ER’s manufacturing infrastructure to maintain sufficient supply. These increases in costs were considered as part of this decision to increase the wholesale acquisition cost of Xtampza ER. |
None |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Rx0000200 |
Collegium Pharmaceuticals |
03/31/2023 |
24510012010 |
Xtampza ER 18mg, capsule, 100 pack |
Brand |
FDA |
01/01/2023 |
55.21 |
1159.44 |
09/02/2036 |
Single Source Drug |
None |
1 |
While Collegium's business pricing model is both proprietary and confidential, the decision to increase the WAC for Xtampza ER included a broad range of financial and non-financial factors including changing market dynamics, costs of labor and goods, post market requirements, support for the marketing and sales of Xtampza ER, and reinvestment in the product. Xtampza ER is an abuse-deterrent, extended-release, oral formulation of oxycodone approved by the FDA in April 2016 for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. As such, it represents a valuable therapeutic treatment option. We have incurred substantial costs to obtain and maintain regulatory approval and continue to incur the substantial costs described above as well as the more traditional general and administrative costs associated with our operations, resulting in a deficit of over $200 million since our inception. In addition, we continue to reinvest in Xtampza ER’s manufacturing infrastructure to maintain sufficient supply. These increases in costs were considered as part of this decision to increase the wholesale acquisition cost of Xtampza ER. |
None |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Rx0000200 |
Collegium Pharmaceuticals |
03/31/2023 |
24510013010 |
Xtampza ER 27mg, capsule, 100 pack |
Brand |
FDA |
01/01/2023 |
76.80 |
1612.88 |
09/02/2036 |
Single Source Drug |
None |
1 |
While Collegium's business pricing model is both proprietary and confidential, the decision to increase the WAC for Xtampza ER included a broad range of financial and non-financial factors including changing market dynamics, costs of labor and goods, post market requirements, support for the marketing and sales of Xtampza ER, and reinvestment in the product. Xtampza ER is an abuse-deterrent, extended-release, oral formulation of oxycodone approved by the FDA in April 2016 for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. As such, it represents a valuable therapeutic treatment option. We have incurred substantial costs to obtain and maintain regulatory approval and continue to incur the substantial costs described above as well as the more traditional general and administrative costs associated with our operations, resulting in a deficit of over $200 million since our inception. In addition, we continue to reinvest in Xtampza ER’s manufacturing infrastructure to maintain sufficient supply. These increases in costs were considered as part of this decision to increase the wholesale acquisition cost of Xtampza ER. |
None |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Rx0000200 |
Collegium Pharmaceuticals |
03/31/2023 |
24510014010 |
Xtampza ER 36mg, capsule, 100 pack |
Brand |
FDA |
01/01/2023 |
94.53 |
1985.21 |
09/02/2036 |
Single Source Drug |
None |
1 |
While Collegium's business pricing model is both proprietary and confidential, the decision to increase the WAC for Xtampza ER included a broad range of financial and non-financial factors including changing market dynamics, costs of labor and goods, post market requirements, support for the marketing and sales of Xtampza ER, and reinvestment in the product. Xtampza ER is an abuse-deterrent, extended-release, oral formulation of oxycodone approved by the FDA in April 2016 for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. As such, it represents a valuable therapeutic treatment option. We have incurred substantial costs to obtain and maintain regulatory approval and continue to incur the substantial costs described above as well as the more traditional general and administrative costs associated with our operations, resulting in a deficit of over $200 million since our inception. In addition, we continue to reinvest in Xtampza ER’s manufacturing infrastructure to maintain sufficient supply. These increases in costs were considered as part of this decision to increase the wholesale acquisition cost of Xtampza ER. |
None |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Rx0000200 |
Collegium Pharmaceuticals |
03/31/2023 |
24510011010 |
Xtampza ER 9mg, capsule, 100 pack |
Brand |
FDA |
01/01/2023 |
29.58 |
621.18 |
09/02/2036 |
Single Source Drug |
None |
1 |
While Collegium's business pricing model is both proprietary and confidential, the decision to increase the WAC for Xtampza ER included a broad range of financial and non-financial factors including changing market dynamics, costs of labor and goods, post market requirements, support for the marketing and sales of Xtampza ER, and reinvestment in the product. Xtampza ER is an abuse-deterrent, extended-release, oral formulation of oxycodone approved by the FDA in April 2016 for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. As such, it represents a valuable therapeutic treatment option. We have incurred substantial costs to obtain and maintain regulatory approval and continue to incur the substantial costs described above as well as the more traditional general and administrative costs associated with our operations, resulting in a deficit of over $200 million since our inception. In addition, we continue to reinvest in Xtampza ER’s manufacturing infrastructure to maintain sufficient supply. These increases in costs were considered as part of this decision to increase the wholesale acquisition cost of Xtampza ER. |
None |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Rx0000154 |
Corcept Therapeutics Incorporated |
03/31/2023 |
76346007302 |
Korlym (mifepristone) 300mg Tablets 280-ct Bottle |
Brand |
FDA |
01/01/2023 |
15330.00 |
176890.00 |
08/22/2038 |
Single Source Drug |
None |
1 |
Corcept is committed to discovering, developing and making available to patients and physicians medicines that treat serious disorders for which their are few -or no- good treatment options. In setting Korlym's price, we weigh (i) the increased cost of administrative and commercial activities, (ii) the increased cost of discovering and developing innovative new drug candidates, and (iii) our commitment that no patient be denied Korlym for financial reasons. |
None |
N/A |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
WAC is reported at the package level. The information provided herein is provided to the best of our knowledge as of submission and based on our interpretation of applicable statutory and regulatory provisions. Information designated as confidential has been designated as such based on our understanding and belief that the subject information is non-public. Our provision of information shall not be interpreted as a waiver of any of our rights available under state, federal, or other applicable law with respect to the information contained herein or with respect to California SB 17, all of which we expressly reserve. Patent expiration dates do not reflect any pending patent applications, future filed patent applications, patent term extensions, data exclusivity (including orphan drug, pediatric, or other exclusivity), or patent-related litigation, each of which is speculative and which may extend or shorten the reported expiration date. |
| Rx0000154 |
Corcept Therapeutics Incorporated |
03/31/2023 |
76346007301 |
Korlym (mifepristone) 300mg Tablets 28-ct Bottle |
Brand |
FDA |
01/01/2023 |
1533.00 |
17689.00 |
08/22/2038 |
Single Source Drug |
None |
1 |
Corcept is committed to discovering, developing and making available to patients and physicians medicines that treat serious disorders for which their are few -or no- good treatment options. In setting Korlym's price, we weigh (i) the increased cost of administrative and commercial activities, (ii) the increased cost of discovering and developing innovative new drug candidates, and (iii) our commitment that no patient be denied Korlym for financial reasons. |
None |
N/A |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
WAC is reported at the package level. The information provided herein is provided to the best of our knowledge as of submission and based on our interpretation of applicable statutory and regulatory provisions. Information designated as confidential has been designated as such based on our understanding and belief that the subject information is non-public. Our provision of information shall not be interpreted as a waiver of any of our rights available under state, federal, or other applicable law with respect to the information contained herein or with respect to California SB 17, all of which we expressly reserve. Patent expiration dates do not reflect any pending patent applications, future filed patent applications, patent term extensions, data exclusivity (including orphan drug, pediatric, or other exclusivity), or patent-related litigation, each of which is speculative and which may extend or shorten the reported expiration date. |
| Rx0000184 |
Cosette Pharmaceuticals, Inc. |
06/30/2023 |
00713088530 |
Clomid (Clomiphene Citrate) Tablets 50 mg 30-count carton |
Generic |
FDA |
05/23/2023 |
76.50 |
195.00 |
None |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
09/01/2022 |
Par Pharmaceuticals |
None |
1 |
None |
56.00 |
56.00 |
2022 |
118.50 |
None |
None |
| Rx0000184 |
Cosette Pharmaceuticals, Inc. |
06/30/2023 |
00713088509 |
Clomid (Clomiphene Citrate) Tablets, USP 50 mg 10-count carton |
Generic |
FDA |
05/23/2023 |
25.30 |
65.00 |
None |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
09/01/2022 |
Par Pharmaceuticals |
None |
1 |
None |
20.00 |
20.00 |
2022 |
37.50 |
None |
None |
| Rx0000184 |
Cosette Pharmaceuticals, Inc. |
12/31/2023 |
00713085004 |
Griseofulvin Oral Suspension, USP Microsize 125 mg/5 mL 4 fl oz (118 mL) |
Generic |
FDA |
12/01/2023 |
147.22 |
200.00 |
None |
Non-innovator Multiple Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Rx0000184 |
Cosette Pharmaceuticals, Inc. |
03/31/2023 |
00713016612 |
Migergot Suppositories 2mg/100mg (ergotamine tartrate and caffeine suppositories, 2mg/100mg) |
Generic |
FDA |
02/01/2023 |
201.87 |
2240.97 |
None |
Single Source Drug |
None |
1 |
Operating primarily as a manufacturer of generic and over-the-counter drug products, Cosette Pharmaceuticals has a history of providing cost effective, high quality medications that help patients affected by various medical conditions. With that purpose in mind, Cosette carefully and holistically evaluates and weighs a variety of factors when pricing its medications, including: maintaining accessibility and affordability of its products for both patients and payors, market conditions, the overall increase in the cost of labor and goods, the required capital investment in manufacturing facilities and systems, and most importantly, the funding of research and new product development designed to meet the needs of patients and healthcare professionals today and in the future. It is critical to note that research and new product development is a high-risk endeavor, with significant costs being incurred on medications that eventually fail due to clinical, technical or commercial reasons. By considering all of these factors in pricing decisions, Cosette is taking the necessary steps to ensure the long-term availability of high quality prescription and over-the-counter drug products within its portfolio. |
None |
None |
1 |
06/28/2019 |
Horizon Therapeutics PLC |
None |
1 |
None |
842.76 |
766.80 |
1983 |
0.01 |
None |
WAC of the Product when it was introduced in 1983 is unknown. Per recommendation of Rodney Garcia, while the WAC Five Year History recites Cosette's NDC number, it actually incorporates three separate NDC numbers from the following owners: Horizon, Crealta and G&W. |
| Rx0000425 |
CSL Behring LLC |
03/31/2023 |
63833082502 |
Berinert 500 Units (500 IU / Solution / Pkg Size 1) |
Brand |
FDA |
01/01/2023 |
204.94 |
3620.69 |
None |
Single Source Drug |
None |
1 |
CSL Behring supports patient access to our lifesaving medicines which is reflected in our responsible approach to drug pricing consistent with the value our therapies deliver. |
None |
N/A |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
Please note that Berinert® is supplied with a Mix2Vial filter transfer set that is under patent until October 9, 2024 |
| Rx0000425 |
CSL Behring LLC |
09/30/2023 |
44206045291 |
Hizentra 10 ml (2g) - inner / 2gm Solution / UOM EA = 1 vial |
Brand |
FDA |
07/01/2023 |
8.42 |
429.10 |
06/09/2032 |
Single Source Drug |
None |
1 |
None |
1 |
N/A |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
CSL Behring supports patient access to our lifesaving medicines which is reflected in our responsible approach to drug pricing consistent with the value our therapies deliver. |
| Rx0000425 |
CSL Behring LLC |
09/30/2023 |
44206045795 |
Hizentra 10 ml (2g) PFS - inner / 2gm Solution / UOM EA = 1 vial |
Brand |
FDA |
07/01/2023 |
8.42 |
429.10 |
06/09/2032 |
Single Source Drug |
None |
1 |
None |
1 |
N/A |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
CSL Behring supports patient access to our lifesaving medicines which is reflected in our responsible approach to drug pricing consistent with the value our therapies deliver. |
| Rx0000425 |
CSL Behring LLC |
09/30/2023 |
44206045722 |
Hizentra 10 ml (2g) PFS / 2gm Solution / UOM EA = 1 vial |
Brand |
FDA |
07/01/2023 |
8.42 |
429.10 |
06/09/2032 |
Single Source Drug |
None |
1 |
None |
1 |
N/A |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
CSL Behring supports patient access to our lifesaving medicines which is reflected in our responsible approach to drug pricing consistent with the value our therapies deliver. |
| Rx0000425 |
CSL Behring LLC |
09/30/2023 |
44206045202 |
Hizentra 10 ml (2g) / 2gm Solution / UOM EA = 1 vial |
Brand |
FDA |
07/01/2023 |
8.42 |
429.10 |
06/09/2032 |
Single Source Drug |
None |
1 |
None |
1 |
N/A |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
CSL Behring supports patient access to our lifesaving medicines which is reflected in our responsible approach to drug pricing consistent with the value our therapies deliver. |
| Rx0000425 |
CSL Behring LLC |
09/30/2023 |
44206045492 |
Hizentra 20 ml (4g) - inner / 4gm Solution / UOM EA = 1 vial |
Brand |
FDA |
07/01/2023 |
16.84 |
858.20 |
06/09/2032 |
Single Source Drug |
None |
1 |
None |
1 |
N/A |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
CSL Behring supports patient access to our lifesaving medicines which is reflected in our responsible approach to drug pricing consistent with the value our therapies deliver. |
| Rx0000425 |
CSL Behring LLC |
09/30/2023 |
44206045896 |
Hizentra 20 ml (4g) PFS - inner / 4gm Solution / UOM EA = 1 vial |
Brand |
FDA |
07/01/2023 |
16.84 |
858.20 |
06/09/2032 |
Single Source Drug |
None |
1 |
None |
1 |
N/A |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
CSL Behring supports patient access to our lifesaving medicines which is reflected in our responsible approach to drug pricing consistent with the value our therapies deliver. |
| Rx0000425 |
CSL Behring LLC |
09/30/2023 |
44206045824 |
Hizentra 20 ml (4g) PFS / 4gm Solution / UOM EA = 1 vial |
Brand |
FDA |
07/01/2023 |
16.84 |
858.20 |
06/09/2032 |
Single Source Drug |
None |
1 |
None |
1 |
N/A |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
CSL Behring supports patient access to our lifesaving medicines which is reflected in our responsible approach to drug pricing consistent with the value our therapies deliver. |
| Rx0000425 |
CSL Behring LLC |
09/30/2023 |
44206045404 |
Hizentra 20 ml (4g) / 4gm Solution / UOM EA = 1 vial |
Brand |
FDA |
07/01/2023 |
16.84 |
858.20 |
06/09/2032 |
Single Source Drug |
None |
1 |
None |
1 |
N/A |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
CSL Behring supports patient access to our lifesaving medicines which is reflected in our responsible approach to drug pricing consistent with the value our therapies deliver. |
| Rx0000425 |
CSL Behring LLC |
09/30/2023 |
44206045190 |
Hizentra 5 ml (1g) - inner / 1gm Solution / UOM EA = 1 vial |
Brand |
FDA |
07/01/2023 |
4.21 |
214.55 |
06/09/2032 |
Single Source Drug |
None |
1 |
None |
1 |
N/A |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
CSL Behring supports patient access to our lifesaving medicines which is reflected in our responsible approach to drug pricing consistent with the value our therapies deliver. |
| Rx0000425 |
CSL Behring LLC |
09/30/2023 |
44206045101 |
Hizentra 5 ml (1g) / 1gm Solution / UOM EA = 1 vial |
Brand |
FDA |
07/01/2023 |
4.21 |
214.55 |
06/09/2032 |
Single Source Drug |
None |
1 |
None |
1 |
N/A |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
CSL Behring supports patient access to our lifesaving medicines which is reflected in our responsible approach to drug pricing consistent with the value our therapies deliver. |
| Rx0000425 |
CSL Behring LLC |
09/30/2023 |
44206045694 |
Hizentra 5 ml (1g) PFS - inner / 1gm Solution / UOM EA = 1 vial |
Brand |
FDA |
07/01/2023 |
4.21 |
214.55 |
06/09/2032 |
Single Source Drug |
None |
1 |
None |
1 |
N/A |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
CSL Behring supports patient access to our lifesaving medicines which is reflected in our responsible approach to drug pricing consistent with the value our therapies deliver. |
| Rx0000425 |
CSL Behring LLC |
09/30/2023 |
44206045621 |
Hizentra 5 ml (1g) PFS / 1gm Solution / UOM EA = 1 vial |
Brand |
FDA |
07/01/2023 |
4.21 |
214.55 |
06/09/2032 |
Single Source Drug |
None |
1 |
None |
1 |
N/A |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
CSL Behring supports patient access to our lifesaving medicines which is reflected in our responsible approach to drug pricing consistent with the value our therapies deliver. |
| Rx0000425 |
CSL Behring LLC |
09/30/2023 |
44206045593 |
Hizentra 50 ml (10g) - inner / 10gm Solution / UOM EA = 1 vial |
Brand |
FDA |
07/01/2023 |
42.10 |
2145.50 |
06/09/2032 |
Single Source Drug |
None |
1 |
None |
1 |
N/A |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
CSL Behring supports patient access to our lifesaving medicines which is reflected in our responsible approach to drug pricing consistent with the value our therapies deliver. |
| Rx0000425 |
CSL Behring LLC |
09/30/2023 |
44206045510 |
Hizentra 50 ml (10g) / 10gm Solution / UOM EA = 1 vial |
Brand |
FDA |
07/01/2023 |
42.10 |
2145.50 |
06/09/2032 |
Single Source Drug |
None |
1 |
None |
1 |
N/A |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
CSL Behring supports patient access to our lifesaving medicines which is reflected in our responsible approach to drug pricing consistent with the value our therapies deliver. |
| Rx0000425 |
CSL Behring LLC |
09/30/2023 |
44206043710 |
Privigen 100 ml (10g) / 10g Solution / UOM=1 EA vial |
Brand |
FDA |
07/01/2023 |
33.50 |
1708.20 |
08/03/2028 |
Single Source Drug |
None |
1 |
None |
1 |
N/A |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
CSL Behring supports patient access to our lifesaving medicines which is reflected in our responsible approach to drug pricing consistent with the value our therapies deliver. |
| Rx0000425 |
CSL Behring LLC |
09/30/2023 |
44206043791 |
Privigen 100 ml (10g) / inner 10g Solution / UOM=1 EA vial |
Brand |
FDA |
07/01/2023 |
33.50 |
1708.20 |
08/03/2028 |
Single Source Drug |
None |
1 |
None |
1 |
N/A |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
CSL Behring supports patient access to our lifesaving medicines which is reflected in our responsible approach to drug pricing consistent with the value our therapies deliver. |
| Rx0000425 |
CSL Behring LLC |
09/30/2023 |
44206043820 |
Privigen 200 ml (20g) / 20g Solution / UOM=1 EA vial |
Brand |
FDA |
07/01/2023 |
67.00 |
3416.40 |
08/03/2028 |
Single Source Drug |
None |
1 |
None |
1 |
N/A |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
CSL Behring supports patient access to our lifesaving medicines which is reflected in our responsible approach to drug pricing consistent with the value our therapies deliver. |
| Rx0000425 |
CSL Behring LLC |
09/30/2023 |
44206043892 |
Privigen 200 ml (20g) / inner 20g Solution / UOM=1 EA vial |
Brand |
FDA |
07/01/2023 |
67.00 |
3416.40 |
08/03/2028 |
Single Source Drug |
None |
1 |
None |
1 |
N/A |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
CSL Behring supports patient access to our lifesaving medicines which is reflected in our responsible approach to drug pricing consistent with the value our therapies deliver. |
| Rx0000425 |
CSL Behring LLC |
09/30/2023 |
44206043940 |
Privigen 400 ml (40g) / 40g Solution / UOM=1 EA vial |
Brand |
FDA |
07/01/2023 |
134.00 |
6832.80 |
08/03/2028 |
Single Source Drug |
None |
1 |
None |
1 |
N/A |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
CSL Behring supports patient access to our lifesaving medicines which is reflected in our responsible approach to drug pricing consistent with the value our therapies deliver. |
| Rx0000425 |
CSL Behring LLC |
09/30/2023 |
44206043993 |
Privigen 400 ml (40g) / inner 40g Solution / UOM=1 EA vial |
Brand |
FDA |
07/01/2023 |
134.00 |
6832.80 |
08/03/2028 |
Single Source Drug |
None |
1 |
None |
1 |
N/A |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
CSL Behring supports patient access to our lifesaving medicines which is reflected in our responsible approach to drug pricing consistent with the value our therapies deliver. |
| Rx0000425 |
CSL Behring LLC |
09/30/2023 |
44206043605 |
Privigen 50 ml (5g) / 5 gm Solution / UOM=1 EA vial |
Brand |
FDA |
07/01/2023 |
16.75 |
854.10 |
08/03/2028 |
Single Source Drug |
None |
1 |
None |
1 |
N/A |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
CSL Behring supports patient access to our lifesaving medicines which is reflected in our responsible approach to drug pricing consistent with the value our therapies deliver. |
| Rx0000425 |
CSL Behring LLC |
09/30/2023 |
44206043690 |
Privigen 50 ml (5g) / inner 5 gm Solution / UOM=1 EA vial |
Brand |
FDA |
07/01/2023 |
16.75 |
854.10 |
08/03/2028 |
Single Source Drug |
None |
1 |
None |
1 |
N/A |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
CSL Behring supports patient access to our lifesaving medicines which is reflected in our responsible approach to drug pricing consistent with the value our therapies deliver. |
| Rx0000399 |
CTI BioPharma Corp. |
03/31/2023 |
72482010012 |
VONJO 100 mg capsule, 120 capsules |
Brand |
FDA |
01/04/2023 |
2120.00 |
23550.00 |
03/25/2030 |
Single Source Drug |
3080 |
None |
A number of factors go into the pricing of VONJO including manufacturing, sales and marketing costs, and investments in continued research and development. |
None |
N/A |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
Sales volume reported reflects from launch (02/28/2022) through 12/31/2022 period. |
| Rx0000399 |
CTI BioPharma Corp. |
12/31/2023 |
72482010012 |
VONJO 100 mg capsule, 120 capsules |
Brand |
FDA |
10/01/2023 |
2331.45 |
25881.45 |
03/25/2030 |
Single Source Drug |
3080 |
None |
A number of factors were considered into increasing price, including overall increases in operational costs, that are impacted by inflation. |
None |
No change or improvement necessitated the price increase. |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Rx0000230 |
Cumberland Pharmaceuticals |
09/30/2023 |
66220028422 |
CALDOLOR IV BAGS 800mg/200mL - 20 200mL Bags Per Case |
Brand |
FDA |
07/05/2023 |
9.02 |
459.80 |
03/16/2032 |
Single Source Drug |
5178 |
None |
INCREASE IN COST OF GOODS. |
None |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Rx0000230 |
Cumberland Pharmaceuticals |
09/30/2023 |
66220028708 |
CALDOLOR VIALS 25 5mL VIALS PER CASE |
Brand |
FDA |
07/05/2023 |
16.75 |
575.18 |
09/14/2030 |
Single Source Drug |
3512 |
None |
INCREASE IN COST OF GOODS. |
None |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Rx0000230 |
Cumberland Pharmaceuticals |
09/30/2023 |
66220031522 |
VIBATIV 750MG CASE OF 12 SINGLE DOSE VIALS |
Brand |
FDA |
07/05/2023 |
208.02 |
7142.09 |
01/01/2027 |
Single Source Drug |
1731 |
None |
INCREASE IN COST OF GOODS. |
None |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Rx0000230 |
Cumberland Pharmaceuticals |
09/30/2023 |
66220031511 |
VIBATIV 750MG SINGLE DOSE VIAL |
Brand |
FDA |
07/05/2023 |
17.34 |
583.62 |
01/01/2027 |
Single Source Drug |
21184 |
None |
INCREASE IN COST OF GOODS. |
None |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |