ISOTRETINOIN | N021951 | SUN PHARMACEUTICAL INDUSTRIES INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
GALEPHAR PHARMACEUTICAL RESEARCH, INC. et al v. UPSHER-SMITH LABORATORIES, LLC 5 patentsANDA 212333isotretinoin | D.N.J. | 2019-01-30 | Terminated 2020-09-04 | — |
CIPHER PHARMACEUTICALS, INC. et al v. WATSON LABORATORIES, INC.-FLORIDA et al 1 patentANDA 205063isotretinoin | D.N.J. | 2013-10-29 | Terminated 2015-10-30 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Data Based Medicine Americas Ltd. FDA-2018-P-4088 Data Based Medicine Americas Ltd., represented by David Healy and colleagues, filed this citizen petition on October 26, 2018, requesting that the FDA immediately revise all isotretinoin product labels (both branded and generic formulations) to add warnings, precautions, highlights of prescribing in | Other | 2018-10-29 | Open | Data Based Medicine Americas Ltd. |
Suitability Petition AMENDMENT from Morgan Lewis & Bockius LLP FDA-2014-P-1282 Morgan Lewis & Bockius LLP filed an amendment to a suitability petition (Docket No. FDA-2014-P-1282) originally submitted July 17, 2014, seeking permission to file an ANDA for Isotretinoin Capsules in 15 mg, 25 mg, and 35 mg strengths. The petitioner provided complete proposed product labeling for t | Suitability | 2016-10-25 | Open | — |
Citizen Petition from Morgan Lewis & Bockius LLP FDA-2014-P-1282 Morgan Lewis & Bockius LLP filed this suitability petition on behalf of an unnamed client under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act, requesting that the FDA declare three new strengths of Isotretinoin Capsules USP (15 mg, 25 mg, and 35 mg) suitable for submission and FDA | Other | 2014-09-03 | Open | Morgan Lewis & Bockius LLP |
Acknowledgement Letter to Lachman Consultant Sevices, Inc. FDA-2012-P-0906 Lachman Consultant Services, Inc. filed a petition requesting that the FDA designate Absorica (isotretinoin capsules), the subject of NDA 021951 held by Cipher, as a second reference listed drug to permit submission of an ANDA for a duplicate version of that product. The petition was received and fi | Other | 2012-09-07 | Granted | — |
Lachman Consultant Services, Inc. - Citizen Petition FDA-2012-P-0906 Lachman Consultant Services, Inc. filed this citizen petition under Section 505(j) of the Federal Food, Drug and Cosmetic Act on August 15, 2012, requesting that the FDA designate Absorica (isotretinoin capsules), subject of NDA 021951 held by Cipher Pharmaceuticals, as a second reference listed dru | 505(q) | 2012-09-07 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$38.24
per ea
Lowest NADAC/Unit
$4.18
per ea
Brand NDCs
3
Generic NDCs
5
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 10631011731ABSORICA 30 MG CAPSULE | $38.24 | EA | Brand | $5.43 | 2026-10-21 |
| 10631011831ABSORICA 40 MG CAPSULE | $38.22 | EA | Brand | $5.83 | 2026-07-22 |
| 10631011631ABSORICA 20 MG CAPSULE | $35.74 | EA | Brand | $4.18 | 2026-07-22 |
| 57664002297ISOTRETINOIN 25 MG CAPSULE | $10.59 | EA | Generic | — | 2026-10-21 |
| 57664002597ISOTRETINOIN 40 MG CAPSULE | $5.83 | EA | Generic | — | 2026-10-21 |
| 57664002397ISOTRETINOIN 30 MG CAPSULE | $5.43 | EA | Generic | — | 2026-10-21 |
| 57664002097ISOTRETINOIN 10 MG CAPSULE | $4.21 | EA | Generic | — | 2026-10-21 |
| 57664002197ISOTRETINOIN 20 MG CAPSULE | $4.18 | EA | Generic | — | 2026-10-21 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.