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Last Updated: August 3, 2020

DrugPatentWatch Database Preview

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 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-five 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

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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
Teva Pharms TRETINOIN tretinoin SOLUTION;TOPICAL 074873-001 Jun 19, 1998 DISCN No No   Start Trial   Start Trial   Start Trial
Dow Pharm ALTRENO tretinoin LOTION;TOPICAL 209353-001 Aug 23, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Taro Pharms TRETINOIN tretinoin CREAM;TOPICAL 211644-001 Jan 25, 2019 AB1 RX No No   Start Trial   Start Trial   Start Trial
Valeant Intl RETIN-A tretinoin SOLUTION;TOPICAL 016921-001 Approved Prior to Jan 1, 1982 DISCN Yes No   Start Trial   Start Trial   Start Trial
Valeant Intl RETIN-A MICRO tretinoin GEL;TOPICAL 020475-002 May 10, 2002 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Mylan TRETINOIN tretinoin GEL;TOPICAL 202026-001 Jul 17, 2013 AB RX 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
Valeant Pharms North RETIN-A tretinoin CREAM;TOPICAL 017340-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Valeant Bermuda RETIN-A tretinoin CREAM;TOPICAL 017522-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Valeant Pharms North RENOVA tretinoin CREAM;TOPICAL 019963-001 Dec 29, 1995   Start Trial   Start Trial
Valeant Intl RETIN-A MICRO tretinoin GEL;TOPICAL 020475-002 May 10, 2002   Start Trial   Start Trial
Valeant Intl RETIN-A tretinoin SOLUTION;TOPICAL 016921-001 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
>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 122013000081 Germany   Start Trial PRODUCT NAME: CLINDAMYCIN (ALS CLINDAMYCIN-PHOSPHAT) UND TRETINOIN; NAT. REGISTRATION NO/DATE: 85210.00.00 20130611; FIRST REGISTRATION: IRLAND PA1332/043/001 20130322
1304992 2013/044 Ireland   Start Trial PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322
0617614 2001/009 Ireland   Start Trial PRODUCT NAME: PANRETIN-ALITRETINOIN
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
0617614 C300043 Netherlands   Start Trial PRODUCT NAME: ALITRETINOIN; NAT. REGISTRATION NO/DATE: EU/1/00/149/001 20001011; FIRST REGISTRATION: 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:

Mallinckrodt
Moodys
Baxter
Medtronic
AstraZeneca
McKinsey

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