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Last Updated: December 8, 2022

Tretinoin - Generic Drug Details


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What are the generic drug sources for tretinoin and what is the scope of patent protection?

Tretinoin is the generic ingredient in nine branded drugs marketed by Anchen Pharms, Barr Labs Inc, Glenmark Pharms Ltd, Cheplapharm, Mylan Pharms Inc, Valeant Pharms North, Valeant Bermuda, Allergan, Padagis Us, Taro Pharms, Zo Skin Health, Dow Pharm, Mylan, Valeant Intl, Teva Pharms, and Wockhardt, and is included in thirty-two 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 five patent family members in five countries.

There are twenty-six drug master file entries for tretinoin. Twenty 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
Valeant Intl RETIN-A-MICRO tretinoin GEL;TOPICAL 020475-003 Jan 28, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Teva Pharms TRETINOIN tretinoin SOLUTION;TOPICAL 074873-001 Jun 19, 1998 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Valeant Pharms North RENOVA tretinoin CREAM;TOPICAL 021108-001 Aug 31, 2000 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Valeant Intl RETIN-A tretinoin SOLUTION;TOPICAL 016921-001 Approved Prior to Jan 1, 1982 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Barr Labs Inc TRETINOIN tretinoin CAPSULE;ORAL 077684-001 Jun 22, 2007 AB RX No Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Padagis Us TRETINOIN tretinoin CREAM;TOPICAL 075213-001 Dec 24, 1998 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Glenmark Pharms Ltd TRETINOIN tretinoin CAPSULE;ORAL 208279-001 Dec 23, 2016 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 MICRO tretinoin GEL;TOPICAL 020475-002 May 10, 2002 See Plans and Pricing See Plans and Pricing
Valeant Bermuda RETIN-A tretinoin CREAM;TOPICAL 019049-001 Sep 16, 1988 See Plans and Pricing See Plans and Pricing
Valeant Intl RETIN-A MICRO tretinoin GEL;TOPICAL 020475-001 Feb 7, 1997 See Plans and Pricing See Plans and Pricing
Valeant Pharms North RETIN-A tretinoin CREAM;TOPICAL 017340-001 Approved Prior to Jan 1, 1982 See Plans and Pricing See Plans and Pricing
Valeant Intl RETIN-A-MICRO tretinoin GEL;TOPICAL 020475-003 Jan 28, 2014 See Plans and Pricing See Plans and Pricing
Mylan Pharms Inc AVITA tretinoin CREAM;TOPICAL 020404-003 Jan 14, 1997 See Plans and Pricing See Plans and Pricing
Valeant Intl RETIN-A tretinoin SOLUTION;TOPICAL 016921-001 Approved Prior to Jan 1, 1982 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for tretinoin

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2019195697 See Plans and Pricing
Brazil 112020020431 composições farmacêuticas tópicas para tratamento de condições de pele See Plans and Pricing
Canada 3095937 COMPOSITIONS PHARMACEUTIQUES TOPIQUES DESTINEES A TRAITER DES AFFECTIONS CUTANEES (TOPICAL PHARMACEUTICAL COMPOSITIONS FOR TREATING SKIN CONDITIONS) See Plans and Pricing
Argentina 114730 COMPOSICIONES FARMACÉUTICAS TÓPICAS PARA TRATAR CONDICIONES EN LA PIEL, KIT Y MÉTODO DE TRATAMIENTO See Plans and Pricing
European Patent Office 3773641 COMPOSITIONS PHARMACEUTIQUES TOPIQUES DESTINÉES À TRAITER DES AFFECTIONS CUTANÉES (TOPICAL PHARMACEUTICAL COMPOSITIONS FOR TREATING SKIN CONDITIONS) See Plans and Pricing
>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 See Plans and Pricing PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE
0617614 C300043 Netherlands See Plans and Pricing PRODUCT NAME: ALITRETINOIN; NAT. REGISTRATION NO/DATE: EU/1/00/149/001 20001011; FIRST REGISTRATION: EU/1/00/149/001 20001011
1304992 SPC/GB13/061 United Kingdom See Plans and Pricing PRODUCT NAME: CLINDAMYCIN PHOSPHATE IN COMBINATION WITH TRETINOIN.; REGISTERED: IE PA1332/043/001 20130322; UK PL15142/0249 20130624
1304992 C300617 Netherlands See Plans and Pricing 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 2013/044 Ireland See Plans and Pricing PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322
1304992 PA2013025,C1304992 Lithuania See Plans and Pricing 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
0617614 11/2001 Austria See Plans and Pricing PRODUCT NAME: ALITRETINOIN; REGISTRATION NO/DATE: EU/1/00/149/001 20001011
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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