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, Aurobindo Pharma Ltd, Mylan, Norvium Bioscience, Teva Pharms, Wockhardt, and Encube. and is included in twenty-three NDAs.
The generic ingredient in TRETINOIN is tretinoin. There are twenty-six drug master file entries for this compound. Twenty-four 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.
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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: | 15 |
NDAs: | 23 |
Finished Product Suppliers / Packagers: | 16 |
Raw Ingredient (Bulk) Api Vendors: | 140 |
Clinical Trials: | 119 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Padagis Us | TRETINOIN | tretinoin | CREAM;TOPICAL | 075264-001 | Dec 24, 1998 | AB | RX | No | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | |||
Padagis Us | TRETINOIN | tretinoin | CREAM;TOPICAL | 075265-001 | Dec 24, 1998 | AB1 | RX | No | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | |||
Padagis Us | TRETINOIN | tretinoin | GEL;TOPICAL | 075529-001 | Feb 22, 2000 | AB | RX | No | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | |||
Barr Labs Inc | TRETINOIN | tretinoin | CAPSULE;ORAL | 077684-001 | Jun 22, 2007 | AB | RX | No | Yes | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | |||
Norvium Bioscience | TRETINOIN | tretinoin | GEL;TOPICAL | 202026-001 | Jul 17, 2013 | DISCN | No | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
Taro | TRETINOIN | tretinoin | CREAM;TOPICAL | 211645-001 | Jan 22, 2019 | AB | RX | No | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | |||
Alembic | TRETINOIN | tretinoin | CREAM;TOPICAL | 217804-001 | Apr 29, 2024 | AB | RX | No | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Market Dynamics and Financial Trajectory of Tretinoin
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