ISOTRETINOIN Drug Patent Profile
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When do Isotretinoin patents expire, and when can generic versions of Isotretinoin launch?
Isotretinoin is a drug marketed by Actavis Labs Fl, Amneal Pharms Ny, Aurobindo Pharma, Upsher Smith Labs, and Zydus Pharms. and is included in six NDAs.
The generic ingredient in ISOTRETINOIN is isotretinoin. There are thirteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the isotretinoin profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Isotretinoin
A generic version of ISOTRETINOIN was approved as isotretinoin by AMNEAL PHARMS NY on September 29th, 2017.
Summary for ISOTRETINOIN
| US Patents: | 0 |
| Applicants: | 5 |
| NDAs: | 6 |
| Finished Product Suppliers / Packagers: | 7 |
| Raw Ingredient (Bulk) Api Vendors: | 73 |
| Clinical Trials: | 143 |
| Patent Applications: | 7,499 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for ISOTRETINOIN |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ISOTRETINOIN |
| What excipients (inactive ingredients) are in ISOTRETINOIN? | ISOTRETINOIN excipients list |
| DailyMed Link: | ISOTRETINOIN at DailyMed |
Recent Clinical Trials for ISOTRETINOIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| South Valley University | N/A |
| Tanta University | Phase 4 |
| Assiut University | Phase 4 |
Pharmacology for ISOTRETINOIN
| Drug Class | Retinoid |
Medical Subject Heading (MeSH) Categories for ISOTRETINOIN
Anatomical Therapeutic Chemical (ATC) Classes for ISOTRETINOIN
Paragraph IV (Patent) Challenges for ISOTRETINOIN
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| ABSORICA | Capsules | isotretinoin | 25 mg | 021951 | 1 | 2016-05-16 |
| ABSORICA | Capsules | isotretinoin | 35 mg | 021951 | 1 | 2015-11-25 |
| ABSORICA | Capsules | isotretinoin | 10 mg | 021951 | 1 | 2013-06-20 |
| ABSORICA | Capsules | isotretinoin | 20 mg | 021951 | 1 | 2013-01-07 |
| ABSORICA | Capsules | isotretinoin | 40 mg | 021951 | 1 | 2012-12-31 |
US Patents and Regulatory Information for ISOTRETINOIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Actavis Labs Fl | ISOTRETINOIN | isotretinoin | CAPSULE;ORAL | 205063-001 | Mar 31, 2021 | AB2 | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Upsher Smith Labs | ISOTRETINOIN | isotretinoin | CAPSULE;ORAL | 212333-002 | Sep 21, 2021 | AB2 | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Zydus Pharms | ISOTRETINOIN | isotretinoin | CAPSULE;ORAL | 211568-004 | Aug 29, 2023 | AB1 | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Amneal Pharms Ny | ISOTRETINOIN | isotretinoin | CAPSULE;ORAL | 207792-001 | Sep 29, 2017 | AB1 | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Actavis Labs Fl | ISOTRETINOIN | isotretinoin | CAPSULE;ORAL | 205063-004 | Mar 31, 2021 | AB2 | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Aurobindo Pharma | ISOTRETINOIN | isotretinoin | CAPSULE;ORAL | 218194-002 | Jan 29, 2024 | AB2 | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Upsher Smith Labs | ISOTRETINOIN | isotretinoin | CAPSULE;ORAL | 213571-001 | Apr 12, 2021 | AB2 | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
