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Last Updated: April 23, 2024

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 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

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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
Mylan	TRETINOIN	tretinoin	GEL;TOPICAL	202026-001	Jul 17, 2013		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Dow Pharm	ATRALIN	tretinoin	GEL;TOPICAL	022070-001	Jul 26, 2007	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Valeant Pharms North	RETIN-A	tretinoin	CREAM;TOPICAL	017340-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Valeant Intl	RETIN-A	tretinoin	SOLUTION;TOPICAL	016921-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Encube	TRETINOIN MICROSPHERE	tretinoin	GEL;TOPICAL	215609-001	Aug 22, 2023	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a 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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	RETIN-A MICRO	tretinoin	GEL;TOPICAL	020475-001	Feb 7, 1997	⤷ Try a Trial	⤷ Try a Trial
Bausch	RETIN-A MICRO	tretinoin	GEL;TOPICAL	020475-001	Feb 7, 1997	⤷ Try a Trial	⤷ Try a Trial
Valeant Pharms North	RENOVA	tretinoin	CREAM;TOPICAL	019963-001	Dec 29, 1995	⤷ Try a Trial	⤷ Try a Trial
Valeant Pharms North	RENOVA	tretinoin	CREAM;TOPICAL	019963-001	Dec 29, 1995	⤷ Try a Trial	⤷ Try a Trial
Valeant Pharms North	RENOVA	tretinoin	CREAM;TOPICAL	021108-001	Aug 31, 2000	⤷ Try a Trial	⤷ Try a Trial
>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
World Intellectual Property Organization (WIPO)	2019195697		⤷ Try a Trial
Argentina	114730	COMPOSICIONES FARMACÉUTICAS TÓPICAS PARA TRATAR CONDICIONES EN LA PIEL, KIT Y MÉTODO DE TRATAMIENTO	⤷ Try a Trial
Canada	3095937	COMPOSITIONS PHARMACEUTIQUES TOPIQUES DESTINEES A TRAITER DES AFFECTIONS CUTANEES (TOPICAL PHARMACEUTICAL COMPOSITIONS FOR TREATING SKIN CONDITIONS)	⤷ Try a Trial
European Patent Office	3773641	COMPOSITIONS PHARMACEUTIQUES TOPIQUES DESTINÉES À TRAITER DES AFFECTIONS CUTANÉES (TOPICAL PHARMACEUTICAL COMPOSITIONS FOR TREATING SKIN CONDITIONS)	⤷ Try a Trial
Mexico	2020010381	COMPOSICIONES FARMACÉUTICAS TÓPICAS PARA TRATAR ENFERMEDADES CUTÁNEAS. (TOPICAL PHARMACEUTICAL COMPOSITIONS FOR TREATING SKIN CONDITIONS.)	⤷ Try a Trial
>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	2001/009	Ireland	⤷ Try a Trial	PRODUCT NAME: PANRETIN-ALITRETINOIN
1304992	2013C/060	Belgium	⤷ Try a Trial	PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506
1304992	PA2013025,C1304992	Lithuania	⤷ Try a Trial	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	122013000081	Germany	⤷ Try a 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	⤷ Try a Trial	PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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