Rx0000160 |
Incyte Corporation |
03/31/2023 |
50881001060 |
Jakafi Oral Tablet 10 mg 60 Pack |
Brand |
FDA |
01/09/2023 |
486.00 |
16686.00 |
12/12/2028 |
Single Source Drug |
None |
1 |
Incyte is driven by rigorous science and our pricing decisions allow us to invest in scientific advancements in areas of high unmet medical need. Incyte responsibly prices our medicines and makes price revisions with consideration to market conditions, patient access, and the clinical value that our medicines deliver to patients. |
None |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
Rx0000160 |
Incyte Corporation |
12/31/2023 |
50881001060 |
Jakafi Oral Tablet 10 mg 60 Pack |
Brand |
FDA |
10/01/2023 |
334.00 |
17020.00 |
12/12/2028 |
Single Source Drug |
None |
1 |
Incyte is driven by rigorous science and our pricing decisions allow us to invest in scientific advancements in areas of high unmet medical need. Incyte responsibly prices our medicines and makes price revisions with consideration to market conditions, patient access, and the clinical value that our medicines deliver to patients. |
None |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
Rx0000160 |
Incyte Corporation |
03/31/2023 |
50881001560 |
Jakafi Oral Tablet 15 mg 60 Pack |
Brand |
FDA |
01/09/2023 |
486.00 |
16686.00 |
12/12/2028 |
Single Source Drug |
None |
1 |
Incyte is driven by rigorous science and our pricing decisions allow us to invest in scientific advancements in areas of high unmet medical need. Incyte responsibly prices our medicines and makes price revisions with consideration to market conditions, patient access, and the clinical value that our medicines deliver to patients. |
None |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
Rx0000160 |
Incyte Corporation |
12/31/2023 |
50881001560 |
Jakafi Oral Tablet 15 mg 60 Pack |
Brand |
FDA |
10/01/2023 |
334.00 |
17020.00 |
12/12/2028 |
Single Source Drug |
None |
1 |
Incyte is driven by rigorous science and our pricing decisions allow us to invest in scientific advancements in areas of high unmet medical need. Incyte responsibly prices our medicines and makes price revisions with consideration to market conditions, patient access, and the clinical value that our medicines deliver to patients. |
None |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
Rx0000160 |
Incyte Corporation |
03/31/2023 |
50881002060 |
Jakafi Oral Tablet 20 mg 60 Pack |
Brand |
FDA |
01/09/2023 |
486.00 |
16686.00 |
12/12/2028 |
Single Source Drug |
None |
1 |
Incyte is driven by rigorous science and our pricing decisions allow us to invest in scientific advancements in areas of high unmet medical need. Incyte responsibly prices our medicines and makes price revisions with consideration to market conditions, patient access, and the clinical value that our medicines deliver to patients. |
None |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
Rx0000160 |
Incyte Corporation |
12/31/2023 |
50881002060 |
Jakafi Oral Tablet 20 mg 60 Pack |
Brand |
FDA |
10/01/2023 |
334.00 |
17020.00 |
12/12/2028 |
Single Source Drug |
None |
1 |
Incyte is driven by rigorous science and our pricing decisions allow us to invest in scientific advancements in areas of high unmet medical need. Incyte responsibly prices our medicines and makes price revisions with consideration to market conditions, patient access, and the clinical value that our medicines deliver to patients. |
None |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
Rx0000160 |
Incyte Corporation |
03/31/2023 |
50881002560 |
Jakafi Oral Tablet 25 mg 60 Pack |
Brand |
FDA |
01/09/2023 |
486.00 |
16686.00 |
12/12/2028 |
Single Source Drug |
None |
1 |
Incyte is driven by rigorous science and our pricing decisions allow us to invest in scientific advancements in areas of high unmet medical need. Incyte responsibly prices our medicines and makes price revisions with consideration to market conditions, patient access, and the clinical value that our medicines deliver to patients. |
None |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
Rx0000160 |
Incyte Corporation |
12/31/2023 |
50881002560 |
Jakafi Oral Tablet 25 mg 60 Pack |
Brand |
FDA |
10/01/2023 |
334.00 |
17020.00 |
12/12/2028 |
Single Source Drug |
None |
1 |
Incyte is driven by rigorous science and our pricing decisions allow us to invest in scientific advancements in areas of high unmet medical need. Incyte responsibly prices our medicines and makes price revisions with consideration to market conditions, patient access, and the clinical value that our medicines deliver to patients. |
None |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
Rx0000160 |
Incyte Corporation |
03/31/2023 |
50881000560 |
Jakafi Oral Tablet 5 mg 60 Pack |
Brand |
FDA |
01/09/2023 |
486.00 |
16686.00 |
12/12/2028 |
Single Source Drug |
None |
1 |
Incyte is driven by rigorous science and our pricing decisions allow us to invest in scientific advancements in areas of high unmet medical need. Incyte responsibly prices our medicines and makes price revisions with consideration to market conditions, patient access, and the clinical value that our medicines deliver to patients. |
None |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
Rx0000160 |
Incyte Corporation |
12/31/2023 |
50881000560 |
Jakafi Oral Tablet 5 mg 60 Pack |
Brand |
FDA |
10/01/2023 |
334.00 |
17020.00 |
12/12/2028 |
Single Source Drug |
None |
1 |
Incyte is driven by rigorous science and our pricing decisions allow us to invest in scientific advancements in areas of high unmet medical need. Incyte responsibly prices our medicines and makes price revisions with consideration to market conditions, patient access, and the clinical value that our medicines deliver to patients. |
None |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
Rx0000040 |
Ingenus Pharmaceuticals, LLC |
09/30/2023 |
50742044745 |
Carboplatin Injection 450mg, 45ml |
Generic |
FDA |
08/20/2023 |
33.27 |
75.00 |
None |
Non-innovator Multiple Source Drug |
120000 |
None |
Carboplatin 450mg/45mL and 600mg/60mL (ANDA 208487) has been priced in accordance with Ingenus Pharmaceuticals Contracts and Management Team policies and procedures. Establishing the WAC price at $75.00 and $100.00 constitutes a reasonable WAC price as we reenter the market after previously exiting due to competitive reasons. Our pricing analysis has been complete, our new WAC should help us compete in a market in which we were previously unable to. Several factors were taken into consideration while determining Ingenus’ WAC pricing including but limited to API, production, packaging, and shipping costs. Ingenus’ WAC pricing will enable it to: i) recoup the costs it incurred in evaluating the economic landscape surrounding prospective products; ii) cover distribution costs; iii) provide rebates and discounts as required by partners in the supply chain; and iv) earn a reasonable return on investment. |
None |
There was no change or improvement to the drug. |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
Rx0000040 |
Ingenus Pharmaceuticals, LLC |
09/30/2023 |
50742044860 |
Carboplatin Injection 600mg, 60ml |
Generic |
FDA |
08/20/2023 |
48.29 |
100.00 |
None |
Non-innovator Multiple Source Drug |
65000 |
None |
Carboplatin 450mg/45mL and 600mg/60mL (ANDA 208487) has been priced in accordance with Ingenus Pharmaceuticals Contracts and Management Team policies and procedures. Establishing the WAC price at $75.00 and $100.00 constitutes a reasonable WAC price as we reenter the market after previously exiting due to competitive reasons. Our pricing analysis has been complete, our new WAC should help us compete in a market in which we were previously unable to. Several factors were taken into consideration while determining Ingenus’ WAC pricing including but limited to API, production, packaging, and shipping costs. Ingenus’ WAC pricing will enable it to: i) recoup the costs it incurred in evaluating the economic landscape surrounding prospective products; ii) cover distribution costs; iii) provide rebates and discounts as required by partners in the supply chain; and iv) earn a reasonable return on investment. |
None |
There was no change or improvement to the drug. |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
Rx0000287 |
Insmed Incorporated |
03/31/2023 |
71558059028 |
Arikayce Inhalation Suspension 590 MG/8.4ML Package Size 8.4 ML Package Quantity/Vial Quantity 28 |
Brand |
FDA |
01/01/2023 |
1069.78 |
14441.99 |
None |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
Rx0000266 |
Intercept Pharmaceuticals, Inc. |
09/30/2023 |
69516001030 |
Ocaliva Oral Tablet 10mg 30 count in 1 bottle |
Brand |
FDA |
08/01/2023 |
502.63 |
9021.77 |
04/26/2036 |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
Rx0000266 |
Intercept Pharmaceuticals, Inc. |
09/30/2023 |
69516000530 |
Ocaliva Oral Tablet 5mg 30 count in 1 bottle |
Brand |
FDA |
08/01/2023 |
502.63 |
9021.77 |
04/26/2036 |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
Rx0000266 |
Intercept Pharmaceuticals, Inc. |
03/31/2023 |
69516001030 |
Ocaliva® (obeticholic acid) tablets 10mg, 30 Count Bottle |
Brand |
FDA |
01/19/2023 |
474.63 |
8519.14 |
04/26/2036 |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
This is a revision to the previously filed increase notice and report. |
Rx0000266 |
Intercept Pharmaceuticals, Inc. |
03/31/2023 |
69516000530 |
Ocaliva® (obeticholic acid) tablets 5mg 30 Count Bottle |
Brand |
FDA |
01/19/2023 |
474.63 |
8519.14 |
04/26/2036 |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
This is a revision to the previously filed increase notice and report. |
Rx0000214 |
Intra-Cellular Therapies, Inc. |
06/30/2023 |
72060014230 |
Caplyta Oral Capsule 42 MG 30 Pack |
Brand |
FDA |
05/29/2023 |
87.42 |
1569.17 |
None |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
Rx0000084 |
Ipsen Biopharmaceuticals, Inc. |
03/31/2023 |
15054104005 |
Drug product name: Increlex. Drug product strength: 10 mg/ml. Drug product dosage form: vial. Drug product package size: 1 vial (4ml). |
Brand |
FDA |
01/01/2023 |
253.00 |
5882.00 |
03/11/2033 |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
The information provided in response to 22 CCR § 96070(b)(6) is based upon patents listed in the FDA Orange Book.
The product was not acquired by Ipsen within the previous five years. |
Rx0000084 |
Ipsen Biopharmaceuticals, Inc. |
12/31/2023 |
15054004301 |
Drug product name: Onivyde. Drug product strength: 43 mg/10 ml (4.3 mg/ml). Drug product dosage form: vial. Drug product package size: 10ml. |
Brand |
FDA |
10/01/2023 |
67.00 |
2766.00 |
10/15/2036 |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
The information provided in response to 22 CCR § 96070(b)(6) is based upon patents listed in the FDA Orange Book. The information provided in response to 22 CCR § 96070(b)(11) contains price increases for the drug product when the NDC for the product was 69171-0398-01 |
Rx0000084 |
Ipsen Biopharmaceuticals, Inc. |
03/31/2023 |
72607010000 |
Drug product name: Tazverik. Drug product strength: 200mg. Drug product dosage form: tablet. Drug product package size: 1 bottle (240 tablets). |
Brand |
FDA |
02/15/2023 |
1104.00 |
18850.00 |
12/19/2035 |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
08/12/2022 |
Epizyme, Inc. |
None |
None |
For purposes of 22 CCR § 96070(b)(12)(c) (requirement to report the purchase price of the relevant drug, if the drug was acquired by the manufacturer within the previous five years), Ipsen purchased Epizyme, Inc. in August 2022, including Tazverik. The purchase price of the drug product (as Ipsen understands that data element) is not in the public domain or otherwise publicly available. However, information regarding Ipsen’s purchase of Epizyme, Inc. is available on p. 82, Note 1.2 of section 3.2.5 of the Registration Document located at: https://www.ipsen.com/websites/Ipsen_Online/wp-content/uploads/2023/04/06183729/EN_UNIVERSAL-REGISTRATION-DOCUMENT-2022-BD.pdf |
17746.00 |
16585.00 |
2020 |
15500.00 |
None |
The information provided in response to 22 CCR § 96070(b)(6) is based upon patents listed in the FDA Orange Book. |