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 Anchen Pharms, Barr Labs Inc, Glenmark Pharms Ltd, Allergan, Padagis Us, Taro, Zo Skin Health, Mylan, Teva Pharms, Wockhardt, and Encube. and is included in twenty NDAs.
The generic ingredient in TRETINOIN is tretinoin. There are twenty-six drug master file entries for this compound. Twenty-two 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.
Summary for TRETINOIN
| US Patents: | 0 |
| Applicants: | 11 |
| NDAs: | 20 |
| Finished Product Suppliers / Packagers: | 15 |
| Raw Ingredient (Bulk) Api Vendors: | 140 |
| Clinical Trials: | 117 |
| 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 |
|---|---|
| Montefiore Medical Center | N/A |
| Merete Haedersdal | Phase 2 |
| University Hospital Inselspital, Berne | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Anchen Pharms | TRETINOIN | tretinoin | CAPSULE;ORAL | 201687-001 | Oct 24, 2012 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Teva Pharms | TRETINOIN | tretinoin | SOLUTION;TOPICAL | 074873-001 | Jun 19, 1998 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Padagis Us | TRETINOIN | tretinoin | CREAM;TOPICAL | 075265-001 | Dec 24, 1998 | AB1 | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Allergan | TRETINOIN | tretinoin | CREAM;TOPICAL | 090098-001 | Mar 22, 2010 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Zo Skin Health | TRETINOIN | tretinoin | CREAM;TOPICAL | 076498-001 | Sep 15, 2005 | DISCN | 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 |
