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, Mylan, Valeant Intl, 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 six patent family members in six countries.

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

Summary for TRETINOIN

International Patents:	6
US Patents:	2
Tradenames:	10
Applicants:	20
NDAs:	36
Drug Master File Entries:	26
Finished Product Suppliers / Packagers:	25
Raw Ingredient (Bulk) Api Vendors:	140
Clinical Trials:	117
Patent Applications:	6,020
Formulation / Manufacturing:	see details
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
Montefiore Medical Center	N/A
Merete Haedersdal	Phase 2
University Hospital Inselspital, Berne	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
Endo Operations	TRETINOIN	tretinoin	CAPSULE;ORAL	201687-001	Oct 24, 2012	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Padagis Us	TRETINOIN	tretinoin	GEL;TOPICAL	075589-001	Jun 11, 2002	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mylan	TRETINOIN	tretinoin	GEL;TOPICAL	202026-001	Jul 17, 2013		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Alembic	TRETINOIN	tretinoin	CREAM;TOPICAL	217804-001	Apr 29, 2024	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Taro	TRETINOIN	tretinoin	CREAM;TOPICAL	211644-001	Jan 25, 2019	AB1	RX	No	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 Bermuda	RETIN-A	tretinoin	CREAM;TOPICAL	017522-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Valeant Intl	RETIN-A	tretinoin	GEL;TOPICAL	017579-002	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Valeant Pharms North	RENOVA	tretinoin	CREAM;TOPICAL	021108-001	Aug 31, 2000	⤷ Sign Up	⤷ Sign Up
Bausch	RETIN-A MICRO	tretinoin	GEL;TOPICAL	020475-001	Feb 7, 1997	⤷ Sign Up	⤷ Sign Up
Valeant Pharms North	RENOVA	tretinoin	CREAM;TOPICAL	019963-001	Dec 29, 1995	⤷ 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
Brazil	112020020431	composições farmacêuticas tópicas para tratamento de condições de pele	⤷ Sign Up
Mexico	2020010381	COMPOSICIONES FARMACÉUTICAS TÓPICAS PARA TRATAR ENFERMEDADES CUTÁNEAS. (TOPICAL PHARMACEUTICAL COMPOSITIONS FOR TREATING SKIN CONDITIONS.)	⤷ Sign Up
Argentina	114730	COMPOSICIONES FARMACÉUTICAS TÓPICAS PARA TRATAR CONDICIONES EN LA PIEL, KIT Y MÉTODO DE TRATAMIENTO	⤷ 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
>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
0617614	C300043	Netherlands	⤷ Sign Up	PRODUCT NAME: ALITRETINOIN; NAT. REGISTRATION NO/DATE: EU/1/00/149/001 20001011; FIRST REGISTRATION: EU/1/00/149/001 20001011
0617614	11/2001	Austria	⤷ Sign Up	PRODUCT NAME: ALITRETINOIN; REGISTRATION NO/DATE: EU/1/00/149/001 20001011
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	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
1304992	92401	Luxembourg	⤷ Sign Up	PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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