Tretinoin - Generic Drug Details

What are the generic sources for tretinoin and what is the scope of freedom to operate?

Tretinoin is the generic ingredient in ten branded drugs marketed by Anchen Pharms, Barr Labs Inc, Glenmark Pharms Ltd, Cheplapharm, Mylan Pharms Inc, Valeant Pharms North, Bausch, Valeant Bermuda, Allergan, Padagis Us, Taro, Zo Skin Health, Dow Pharm, Mylan, Valeant Intl, Encube, Teva Pharms, and Wockhardt, and is included in thirty-four 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-two suppliers are listed for this compound.

Summary for tretinoin

International Patents:	6
US Patents:	2
Tradenames:	10
Applicants:	18
NDAs:	34
Drug Master File Entries:	26
Finished Product Suppliers / Packagers:	22
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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch	RETIN-A-MICRO	tretinoin	GEL;TOPICAL	020475-003	Jan 28, 2014	AB	RX	Yes	Yes
Padagis Us	TRETINOIN	tretinoin	GEL;TOPICAL	075589-001	Jun 11, 2002	AB	RX	No	No
Allergan	TRETINOIN	tretinoin	CREAM;TOPICAL	090098-001	Mar 22, 2010		DISCN	No	No
Bausch	RETIN-A-MICRO	tretinoin	GEL;TOPICAL	020475-004	Oct 23, 2017		RX	Yes	Yes
Valeant Intl	RETIN-A	tretinoin	GEL;TOPICAL	017955-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes
Zo Skin Health	TRETINOIN	tretinoin	CREAM;TOPICAL	076498-001	Sep 15, 2005		DISCN	No	No
Padagis Us	TRETINOIN	tretinoin	CREAM;TOPICAL	075213-001	Dec 24, 1998	AB	RX	No	No

Expired US Patents for tretinoin

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
Valeant Pharms North	RENOVA	tretinoin	CREAM;TOPICAL	021108-001	Aug 31, 2000
Valeant Intl	RETIN-A	tretinoin	SOLUTION;TOPICAL	016921-001	Approved Prior to Jan 1, 1982
Valeant Pharms North	RETIN-A	tretinoin	CREAM;TOPICAL	017340-001	Approved Prior to Jan 1, 1982
Valeant Pharms North	RENOVA	tretinoin	CREAM;TOPICAL	021108-001	Aug 31, 2000
Dow Pharm	ATRALIN	tretinoin	GEL;TOPICAL	022070-001	Jul 26, 2007
Bausch	RETIN-A MICRO	tretinoin	GEL;TOPICAL	020475-001	Feb 7, 1997

International Patents for tretinoin

Country	Patent Number	Title	Estimated Expiration
Mexico	2020010381	COMPOSICIONES FARMACÉUTICAS TÓPICAS PARA TRATAR ENFERMEDADES CUTÁNEAS. (TOPICAL PHARMACEUTICAL COMPOSITIONS FOR TREATING SKIN CONDITIONS.)
Argentina	114730	COMPOSICIONES FARMACÉUTICAS TÓPICAS PARA TRATAR CONDICIONES EN LA PIEL, KIT Y MÉTODO DE TRATAMIENTO
Canada	3095937	COMPOSITIONS PHARMACEUTIQUES TOPIQUES DESTINEES A TRAITER DES AFFECTIONS CUTANEES (TOPICAL PHARMACEUTICAL COMPOSITIONS FOR TREATING SKIN CONDITIONS)
European Patent Office	3773641	COMPOSITIONS PHARMACEUTIQUES TOPIQUES DESTINÉES À TRAITER DES AFFECTIONS CUTANÉES (TOPICAL PHARMACEUTICAL COMPOSITIONS FOR TREATING SKIN CONDITIONS)
World Intellectual Property Organization (WIPO)	2019195697
Brazil	112020020431	composições farmacêuticas tópicas para tratamento de condições de pele

Supplementary Protection Certificates for tretinoin

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0617614	11/2001	Austria		PRODUCT NAME: ALITRETINOIN; REGISTRATION NO/DATE: EU/1/00/149/001 20001011
1304992	SPC/GB13/061	United Kingdom		PRODUCT NAME: CLINDAMYCIN PHOSPHATE IN COMBINATION WITH TRETINOIN.; REGISTERED: IE PA1332/043/001 20130322; UK PL15142/0249 20130624
1304992	132013902214376	Italy		PRODUCT NAME: CLINDAMICINA FOSFATO E TRETINOINA(ACNATAC); AUTHORISATION NUMBER(S) AND DATE(S): PA1332/043/001, 20130322;042056010/M - 022/M, 20130718
1304992	CR 2013 00053	Denmark		PRODUCT NAME: CLINDAMYCIN (SOM CLINDAMYCIN PHOSPHATE) OG TRETINOIN; NAT. REG. NO/DATE: 48954 20130416; FIRST REG. NO/DATE: IE PA1332/043/001 20130322
1304992	2013C/060	Belgium		PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506
1304992	C01304992/01	Switzerland		PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014
0617614	2001/009	Ireland		PRODUCT NAME: PANRETIN-ALITRETINOIN