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Last Updated: May 25, 2022

Tretinoin - Generic Drug Details


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

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 is one patent 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
University Hospital Inselspital, BerneN/A
Dr.dr.Irma Bernadette, SpKK (K)Phase 1
Dwight OwenPhase 1

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 075264-001 Dec 24, 1998 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mylan Pharms Inc AVITA tretinoin CREAM;TOPICAL 020404-003 Jan 14, 1997 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mylan TRETINOIN tretinoin GEL;TOPICAL 202026-001 Jul 17, 2013 DISCN 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 020475-001 Feb 7, 1997 See Plans and Pricing See Plans and Pricing
Valeant Pharms North RENOVA tretinoin CREAM;TOPICAL 019963-001 Dec 29, 1995 See Plans and Pricing See Plans and Pricing
Valeant Pharms North RENOVA tretinoin CREAM;TOPICAL 021108-001 Aug 31, 2000 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
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 122013000081 Germany See Plans and Pricing PRODUCT NAME: CLINDAMYCIN (ALS CLINDAMYCIN-PHOSPHAT) UND TRETINOIN; NAT. REGISTRATION NO/DATE: 85210.00.00 20130611; FIRST REGISTRATION: IRLAND PA1332/043/001 20130322
1304992 1390049-3 Sweden See Plans and Pricing PRODUCT NAME: KLINDAMYCIN (SOM KLINDAMYCINFOSFAT) OCH TRETINOIN; NAT. REG. NO/DATE: MTNR 46193 20130503; FIRST REG.: IR PA1332/043/001 20130322
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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