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Last Updated: February 26, 2021

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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, Perrigo Pharma Intl, Taro Pharms, Zo Skin Health, Dow Pharm, Mylan, Valeant Intl, Teva Pharms, and Wockhardt, and is included in thirty-two NDAs. There are three patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Tretinoin has thirty-seven patent family members in twenty-two countries.

There are twenty-six drug master file entries for tretinoin. Eighteen 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
Queen Mary University of LondonPhase 2
CelgenePhase 2
Medical Research CouncilPhase 2

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 NDA Submissiondate
RETIN-A MICRO GEL;TOPICAL tretinoin 020475 2010-12-20
RETIN-A-MICRO GEL;TOPICAL tretinoin 020475 2010-12-20
RETIN-A MICRO GEL;TOPICAL tretinoin 020475 2010-07-08
RETIN-A-MICRO GEL;TOPICAL tretinoin 020475 2010-07-08
RETIN-A GEL;TOPICAL tretinoin 017579

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
Cheplapharm VESANOID tretinoin CAPSULE;ORAL 020438-001 Nov 22, 1995 DISCN Yes No   Start Trial   Start Trial   Start Trial
Valeant Intl RETIN-A-MICRO tretinoin GEL;TOPICAL 020475-003 Jan 28, 2014 RX Yes Yes   Start Trial   Start Trial   Start Trial
Dow Pharm ATRALIN tretinoin GEL;TOPICAL 022070-001 Jul 26, 2007 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Allergan TRETINOIN tretinoin CREAM;TOPICAL 202209-001 Oct 11, 2012 DISCN No No   Start Trial   Start Trial   Start Trial
Allergan TRETINOIN tretinoin CREAM;TOPICAL 090098-001 Mar 22, 2010 DISCN No No   Start Trial   Start Trial   Start 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 ALTRENO tretinoin LOTION;TOPICAL 209353-001 Aug 23, 2018   Start Trial   Start Trial
Valeant Pharms North RETIN-A tretinoin CREAM;TOPICAL 017340-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Valeant Intl RETIN-A tretinoin GEL;TOPICAL 017955-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Mylan Pharms Inc AVITA tretinoin CREAM;TOPICAL 020404-003 Jan 14, 1997   Start Trial   Start Trial
Valeant Pharms North RENOVA tretinoin CREAM;TOPICAL 021108-001 Aug 31, 2000   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for tretinoin

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1304992 PA2013025 Lithuania   Start 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
1304992 C01304992/01 Switzerland   Start Trial PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014
0617614 11/2001 Austria   Start Trial PRODUCT NAME: ALITRETINOIN; REGISTRATION NO/DATE: EU/1/00/149/001 20001011
1304992 SPC/GB13/061 United Kingdom   Start Trial PRODUCT NAME: CLINDAMYCIN PHOSPHATE IN COMBINATION WITH TRETINOIN.; REGISTERED: IE PA1332/043/001 20130322; UK PL15142/0249 20130624
1304992 132013902214376 Italy   Start Trial PRODUCT NAME: CLINDAMICINA FOSFATO E TRETINOINA(ACNATAC); AUTHORISATION NUMBER(S) AND DATE(S): PA1332/043/001, 20130322;042056010/M - 022/M, 20130718
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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