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Last Updated: March 28, 2024

TRETINOIN - Generic Drug Details


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What are the generic drug sources for tretinoin and what is the scope of freedom to operate?

Tretinoin is the generic ingredient in ten branded drugs marketed by Anchen Pharms, Barr Labs Inc, Glenmark Pharms Ltd, Cheplapharm, Mylan Pharms Inc, Valeant Pharms North, Bausch, Valeant Bermuda, Allergan, Padagis Us, Taro, Zo Skin Health, Dow Pharm, Mylan, Valeant Intl, Encube, Teva Pharms, and Wockhardt, and is included in thirty-four NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Tretinoin has six patent family members in six countries.

There are twenty-six drug master file entries for tretinoin. Twenty-two suppliers are listed for this compound.

Drug Prices for TRETINOIN

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Drug Sales Revenue Trends for TRETINOIN

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Recent Clinical Trials for TRETINOIN

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Montefiore Medical CenterN/A
Merete HaedersdalPhase 2
University Hospital Inselspital, BerneN/A

See all TRETINOIN clinical trials

Pharmacology for TRETINOIN
Drug ClassRetinoid
Medical Subject Heading (MeSH) Categories 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
Mylan TRETINOIN tretinoin GEL;TOPICAL 202026-001 Jul 17, 2013 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bausch RETIN-A-MICRO tretinoin GEL;TOPICAL 020475-004 Oct 23, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan TRETINOIN tretinoin GEL;TOPICAL 202567-001 Jul 17, 2013 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Dow Pharm ATRALIN tretinoin GEL;TOPICAL 022070-001 Jul 26, 2007 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Valeant Intl RETIN-A tretinoin GEL;TOPICAL 017579-002 Approved Prior to Jan 1, 1982 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Valeant Pharms North RENOVA tretinoin CREAM;TOPICAL 021108-001 Aug 31, 2000 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan AVITA tretinoin GEL;TOPICAL 020400-001 Jan 29, 1998 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

Expired US Patents for TRETINOIN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Dow Pharm ATRALIN tretinoin GEL;TOPICAL 022070-001 Jul 26, 2007 ⤷  Try a Trial ⤷  Try a Trial
Bausch RETIN-A MICRO tretinoin GEL;TOPICAL 020475-001 Feb 7, 1997 ⤷  Try a Trial ⤷  Try a Trial
Valeant Bermuda RETIN-A tretinoin CREAM;TOPICAL 017522-001 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
Mylan Pharms Inc AVITA tretinoin CREAM;TOPICAL 020404-003 Jan 14, 1997 ⤷  Try a Trial ⤷  Try a Trial
Bausch RETIN-A tretinoin CREAM;TOPICAL 019049-001 Sep 16, 1988 ⤷  Try a Trial ⤷  Try a Trial
Bausch RETIN-A-MICRO tretinoin GEL;TOPICAL 020475-003 Jan 28, 2014 ⤷  Try a Trial ⤷  Try a Trial
Valeant Bermuda RETIN-A tretinoin CREAM;TOPICAL 017522-001 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for TRETINOIN

Country Patent Number Title Estimated Expiration
Canada 3095937 COMPOSITIONS PHARMACEUTIQUES TOPIQUES DESTINEES A TRAITER DES AFFECTIONS CUTANEES (TOPICAL PHARMACEUTICAL COMPOSITIONS FOR TREATING SKIN CONDITIONS) ⤷  Try a Trial
Brazil 112020020431 composições farmacêuticas tópicas para tratamento de condições de pele ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2019195697 ⤷  Try a Trial
Mexico 2020010381 COMPOSICIONES FARMACÉUTICAS TÓPICAS PARA TRATAR ENFERMEDADES CUTÁNEAS. (TOPICAL PHARMACEUTICAL COMPOSITIONS FOR TREATING SKIN CONDITIONS.) ⤷  Try a Trial
European Patent Office 3773641 COMPOSITIONS PHARMACEUTIQUES TOPIQUES DESTINÉES À TRAITER DES AFFECTIONS CUTANÉES (TOPICAL PHARMACEUTICAL COMPOSITIONS FOR TREATING SKIN CONDITIONS) ⤷  Try a Trial
Argentina 114730 COMPOSICIONES FARMACÉUTICAS TÓPICAS PARA TRATAR CONDICIONES EN LA PIEL, KIT Y MÉTODO DE TRATAMIENTO ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TRETINOIN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1304992 92401 Luxembourg ⤷  Try a Trial PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE
1304992 C300617 Netherlands ⤷  Try a Trial PRODUCT NAME: COMBINATIE VAN CLINDAMYCINE, DESGEWENST IN DE VORM VAN CLINDAMYCINEFOSFAAT EN TRETINOINE; NAT. REGISTRATION NO/DATE: RVG 109745 20130626; FIRST REGISTRATION: PA1332/043/001 20130322
0617614 C300043 Netherlands ⤷  Try a Trial PRODUCT NAME: ALITRETINOIN; NAT. REGISTRATION NO/DATE: EU/1/00/149/001 20001011; FIRST REGISTRATION: EU/1/00/149/001 20001011
1304992 1390049-3 Sweden ⤷  Try a Trial PRODUCT NAME: KLINDAMYCIN (SOM KLINDAMYCINFOSFAT) OCH TRETINOIN; NAT. REG. NO/DATE: MTNR 46193 20130503; FIRST REG.: IR PA1332/043/001 20130322
1304992 PA2013025,C1304992 Lithuania ⤷  Try a Trial PRODUCT NAME: CLINDAMYCINUM + TRETINOINUM; REGISTRATION NO/DATE: LT/1/13/3279/001, 2013 04 26 LT/1/13/3279/002, 2013 04 26 PA1332/043/001 20130323
1304992 CR 2013 00053 Denmark ⤷  Try a Trial PRODUCT NAME: CLINDAMYCIN (SOM CLINDAMYCIN PHOSPHATE) OG TRETINOIN; NAT. REG. NO/DATE: 48954 20130416; FIRST REG. NO/DATE: IE PA1332/043/001 20130322
1304992 PA2013025 Lithuania ⤷  Try a Trial PRODUCT NAME: CLINFAMYCINUM + TRETINOINUM; REGISTRATION NO/DATE: LT/1/13/3279/001, 2013 04 26 LT/1/13/3279/002, 2013 04 26 PA1332/043/001 20130323
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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