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Last Updated: April 26, 2024

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 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

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	202567-001	Jul 17, 2013		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Anchen Pharms	TRETINOIN	tretinoin	CAPSULE;ORAL	201687-001	Oct 24, 2012	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Allergan	TRETINOIN	tretinoin	CREAM;TOPICAL	202209-001	Oct 11, 2012		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
>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
>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
Argentina	114730	COMPOSICIONES FARMACÉUTICAS TÓPICAS PARA TRATAR CONDICIONES EN LA PIEL, KIT Y MÉTODO DE TRATAMIENTO	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2019195697		⤷ Try a Trial
Brazil	112020020431	composições farmacêuticas tópicas para tratamento de condições de pele	⤷ 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	SPC/GB01/014	United Kingdom	⤷ Try a Trial	PRODUCT NAME: ALITRETINOIN; REGISTERED: UK EU/1/00/149/001 20001018
1304992	C01304992/01	Switzerland	⤷ Try a Trial	PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014
1304992	2013C/060	Belgium	⤷ Try a Trial	PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506
1304992	SPC/GB13/061	United Kingdom	⤷ Try a Trial	PRODUCT NAME: CLINDAMYCIN PHOSPHATE IN COMBINATION WITH TRETINOIN.; REGISTERED: IE PA1332/043/001 20130322; UK PL15142/0249 20130624
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.