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Last Updated: December 9, 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 Barr Labs Inc, Endo Operations, Glenmark Pharms Ltd, Cheplapharm, Mylan Pharms Inc, Valeant Pharms North, Bausch, Valeant Bermuda, Alembic, Allergan, Padagis Us, Taro, Zo Skin Health, Zydus Lifesciences, Dow Pharm, Norvium Bioscience, Valeant Intl, Mylan, Encube, Teva Pharms, and Wockhardt, and is included in thirty-six 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 eight patent family members in eight countries.

There are twenty-six drug master file entries for tretinoin. Twenty-six 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
University of Texas Southwestern Medical CenterPhase 2
Genentech, Inc.Phase 2
Indonesia UniversityN/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
Padagis Us TRETINOIN tretinoin CREAM;TOPICAL 075265-001 Dec 24, 1998 AB1 RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Zydus Lifesciences TRETINOIN tretinoin CREAM;TOPICAL 218561-001 Apr 25, 2024 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bausch RETIN-A tretinoin CREAM;TOPICAL 019049-001 Sep 16, 1988 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Norvium Bioscience TRETINOIN tretinoin GEL;TOPICAL 202567-001 Jul 17, 2013 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Padagis Us TRETINOIN tretinoin GEL;TOPICAL 075529-001 Feb 22, 2000 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Valeant Pharms North RENOVA tretinoin CREAM;TOPICAL 019963-001 Dec 29, 1995 DISCN Yes 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

Expired US Patents for TRETINOIN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Intl RETIN-A tretinoin GEL;TOPICAL 017579-002 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
Valeant Intl RETIN-A tretinoin GEL;TOPICAL 017955-001 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
Valeant Pharms North RENOVA tretinoin CREAM;TOPICAL 019963-001 Dec 29, 1995 ⤷  Sign Up ⤷  Sign Up
Bausch RETIN-A MICRO tretinoin GEL;TOPICAL 020475-002 May 10, 2002 ⤷  Sign Up ⤷  Sign Up
Valeant Pharms North RETIN-A tretinoin CREAM;TOPICAL 017340-001 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
Valeant Bermuda RETIN-A tretinoin CREAM;TOPICAL 017522-001 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for TRETINOIN

Country Patent Number Title Estimated Expiration
Mexico 2020010381 COMPOSICIONES FARMACÉUTICAS TÓPICAS PARA TRATAR ENFERMEDADES CUTÁNEAS. (TOPICAL PHARMACEUTICAL COMPOSITIONS FOR TREATING SKIN CONDITIONS.) ⤷  Sign Up
Spain 2974819 ⤷  Sign Up
European Patent Office 3773641 COMPOSITIONS PHARMACEUTIQUES TOPIQUES DESTINÉES À TRAITER DES AFFECTIONS CUTANÉES (TOPICAL PHARMACEUTICAL COMPOSITIONS FOR TREATING SKIN CONDITIONS) ⤷  Sign Up
Canada 3095937 COMPOSITIONS PHARMACEUTIQUES TOPIQUES DESTINEES A TRAITER DES AFFECTIONS CUTANEES (TOPICAL PHARMACEUTICAL COMPOSITIONS FOR TREATING SKIN CONDITIONS) ⤷  Sign Up
Brazil 112020020431 composições farmacêuticas tópicas para tratamento de condições de pele ⤷  Sign Up
Poland 3773641 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TRETINOIN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1304992 SPC/GB13/061 United Kingdom ⤷  Sign Up PRODUCT NAME: CLINDAMYCIN PHOSPHATE IN COMBINATION WITH TRETINOIN.; REGISTERED: IE PA1332/043/001 20130322; UK PL15142/0249 20130624
1304992 PA2013025,C1304992 Lithuania ⤷  Sign Up 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 ⤷  Sign Up 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 ⤷  Sign Up 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
1304992 C300617 Netherlands ⤷  Sign Up 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
1304992 1390049-3 Sweden ⤷  Sign Up PRODUCT NAME: KLINDAMYCIN (SOM KLINDAMYCINFOSFAT) OCH TRETINOIN; NAT. REG. NO/DATE: MTNR 46193 20130503; FIRST REG.: IR PA1332/043/001 20130322
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.