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Last Updated: February 27, 2021

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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, 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
Medical Research CouncilPhase 2
Queen Mary University of LondonPhase 2
CelgenePhase 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
Taro Pharms TRETINOIN tretinoin CREAM;TOPICAL 211644-001 Jan 25, 2019 AB1 RX No No   Start Trial   Start Trial   Start Trial
Perrigo Pharma Intl TRETINOIN tretinoin CREAM;TOPICAL 075264-001 Dec 24, 1998 AB RX No No   Start Trial   Start Trial   Start Trial
Valeant Intl RETIN-A tretinoin GEL;TOPICAL 017955-001 Approved Prior to Jan 1, 1982 AB RX Yes Yes   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
>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 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 474 Finland   Start Trial
0617614 11/2001 Austria   Start Trial 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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Serving leading biopharmaceutical companies globally:

Medtronic
Harvard Business School
Johnson and Johnson
AstraZeneca
Dow
Colorcon

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