TRETINOIN Drug Patent Profile
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When do Tretinoin patents expire, and what generic alternatives are available?
Tretinoin is a drug marketed by Barr Labs Inc, Endo Operations, Glenmark Pharms Ltd, Alembic, Allergan, Padagis Us, Taro, Zo Skin Health, Zydus Lifesciences, Mylan, Teva Pharms, Wockhardt, and Encube. and is included in twenty-two NDAs.
The generic ingredient in TRETINOIN is tretinoin. There are twenty-six drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the tretinoin profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Tretinoin
A generic version of TRETINOIN was approved as tretinoin by PADAGIS US on December 24th, 1998.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for TRETINOIN?
- What are the global sales for TRETINOIN?
- What is Average Wholesale Price for TRETINOIN?
Summary for TRETINOIN
| US Patents: | 0 |
| Applicants: | 13 |
| NDAs: | 22 |
| Finished Product Suppliers / Packagers: | 18 |
| Raw Ingredient (Bulk) Api Vendors: | 140 |
| Clinical Trials: | 119 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for TRETINOIN |
| Drug Sales Revenues: | Drug sales revenues for TRETINOIN |
| What excipients (inactive ingredients) are in TRETINOIN? | TRETINOIN excipients list |
| DailyMed Link: | TRETINOIN at DailyMed |
Recent Clinical Trials for TRETINOIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Texas Southwestern Medical Center | Phase 2 |
| Genentech, Inc. | Phase 2 |
| Indonesia University | N/A |
Pharmacology for TRETINOIN
| Drug Class | Retinoid |
Medical Subject Heading (MeSH) Categories for TRETINOIN
Anatomical Therapeutic Chemical (ATC) Classes for TRETINOIN
Paragraph IV (Patent) Challenges for TRETINOIN
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| RETIN-A-MICRO | Gel | tretinoin | 0.04% | 020475 | 1 | 2010-12-20 |
| RETIN-A-MICRO | Gel | tretinoin | 0.1% | 020475 | 1 | 2010-07-08 |
US Patents and Regulatory Information for TRETINOIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Barr Labs Inc | TRETINOIN | tretinoin | CAPSULE;ORAL | 077684-001 | Jun 22, 2007 | AB | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Padagis Us | TRETINOIN | tretinoin | GEL;TOPICAL | 075589-001 | Jun 11, 2002 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Padagis Us | TRETINOIN | tretinoin | CREAM;TOPICAL | 075264-001 | Dec 24, 1998 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Alembic | TRETINOIN | tretinoin | CREAM;TOPICAL | 217804-001 | Apr 29, 2024 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
