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 ten branded drugs marketed by Barr Labs Inc, Endo Operations, Glenmark Pharms Ltd, Cheplapharm, Mylan Pharms Inc, Valeant Pharms North, Bausch, Valeant Bermuda, Alembic, Allergan, Padagis Us, Taro, Zo Skin Health, Zydus Lifesciences, Dow Pharm, Norvium Bioscience, Valeant Intl, Mylan, Encube, Teva Pharms, and Wockhardt, and is included in thirty-six 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 eight patent family members in eight countries.

There are twenty-six drug master file entries for tretinoin. Twenty-six suppliers are listed for this compound.

Summary for TRETINOIN

International Patents:	8
US Patents:	2
Tradenames:	10
Applicants:	21
NDAs:	36
Drug Master File Entries:	26
Finished Product Suppliers / Packagers:	26
Raw Ingredient (Bulk) Api Vendors:	140
Clinical Trials:	119
Patent Applications:	6,020
Drug Prices:	Drug price trends for TRETINOIN
Drug Sales Revenues:	Drug sales revenues for TRETINOIN
What excipients (inactive ingredients) are in TRETINOIN?	TRETINOIN excipients list
DailyMed Link:	TRETINOIN at DailyMed

See drug prices for TRETINOIN

See drug sales revenues for TRETINOIN

Recent Clinical Trials for TRETINOIN

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Texas Southwestern Medical Center	Phase 2
Genentech, Inc.	Phase 2
Indonesia University	N/A

See all TRETINOIN clinical trials

Pharmacology for TRETINOIN

Drug Class	Retinoid

Medical Subject Heading (MeSH) Categories for TRETINOIN

Antineoplastic Agents
Keratolytic Agents

Anatomical Therapeutic Chemical (ATC) Classes for TRETINOIN

D10AD	Retinoids for topical use in acne
D10A	ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10	ANTI-ACNE PREPARATIONS
D	Dermatologicals

L01XF	Retinoids for cancer treatment
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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

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Glossary

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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	075265-001	Dec 24, 1998	AB1	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zydus Lifesciences	TRETINOIN	tretinoin	CREAM;TOPICAL	218561-001	Apr 25, 2024	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bausch	RETIN-A	tretinoin	CREAM;TOPICAL	019049-001	Sep 16, 1988	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Norvium Bioscience	TRETINOIN	tretinoin	GEL;TOPICAL	202567-001	Jul 17, 2013		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Padagis Us	TRETINOIN	tretinoin	GEL;TOPICAL	075529-001	Feb 22, 2000	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Valeant Pharms North	RENOVA	tretinoin	CREAM;TOPICAL	019963-001	Dec 29, 1995		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Valeant Intl	RETIN-A	tretinoin	GEL;TOPICAL	017579-002	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Valeant Intl	RETIN-A	tretinoin	GEL;TOPICAL	017955-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Valeant Pharms North	RENOVA	tretinoin	CREAM;TOPICAL	019963-001	Dec 29, 1995	⤷ Sign Up	⤷ Sign Up
Bausch	RETIN-A MICRO	tretinoin	GEL;TOPICAL	020475-002	May 10, 2002	⤷ Sign Up	⤷ Sign Up
Valeant Pharms North	RETIN-A	tretinoin	CREAM;TOPICAL	017340-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Valeant Bermuda	RETIN-A	tretinoin	CREAM;TOPICAL	017522-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for TRETINOIN

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Country	Patent Number	Title	Estimated Expiration
Mexico	2020010381	COMPOSICIONES FARMACÉUTICAS TÓPICAS PARA TRATAR ENFERMEDADES CUTÁNEAS. (TOPICAL PHARMACEUTICAL COMPOSITIONS FOR TREATING SKIN CONDITIONS.)	⤷ Sign Up
Spain	2974819		⤷ Sign Up
European Patent Office	3773641	COMPOSITIONS PHARMACEUTIQUES TOPIQUES DESTINÉES À TRAITER DES AFFECTIONS CUTANÉES (TOPICAL PHARMACEUTICAL COMPOSITIONS FOR TREATING SKIN CONDITIONS)	⤷ Sign Up
Canada	3095937	COMPOSITIONS PHARMACEUTIQUES TOPIQUES DESTINEES A TRAITER DES AFFECTIONS CUTANEES (TOPICAL PHARMACEUTICAL COMPOSITIONS FOR TREATING SKIN CONDITIONS)	⤷ Sign Up
Brazil	112020020431	composições farmacêuticas tópicas para tratamento de condições de pele	⤷ Sign Up
Poland	3773641		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for TRETINOIN

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1304992	SPC/GB13/061	United Kingdom	⤷ Sign Up	PRODUCT NAME: CLINDAMYCIN PHOSPHATE IN COMBINATION WITH TRETINOIN.; REGISTERED: IE PA1332/043/001 20130322; UK PL15142/0249 20130624
1304992	PA2013025,C1304992	Lithuania	⤷ Sign Up	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
1304992	CR 2013 00053	Denmark	⤷ Sign Up	PRODUCT NAME: CLINDAMYCIN (SOM CLINDAMYCIN PHOSPHATE) OG TRETINOIN; NAT. REG. NO/DATE: 48954 20130416; FIRST REG. NO/DATE: IE PA1332/043/001 20130322
1304992	PA2013025	Lithuania	⤷ Sign Up	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	C300617	Netherlands	⤷ Sign Up	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	1390049-3	Sweden	⤷ Sign Up	PRODUCT NAME: KLINDAMYCIN (SOM KLINDAMYCINFOSFAT) OCH TRETINOIN; NAT. REG. NO/DATE: MTNR 46193 20130503; FIRST REG.: IR PA1332/043/001 20130322
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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