RETIN-A Drug Patent Profile

Which patents cover Retin-a, and what generic alternatives are available?

Retin-a is a drug marketed by Bausch, Valeant Bermuda, Valeant Pharms North, and Valeant Intl. and is included in seven NDAs.

The generic ingredient in RETIN-A is tretinoin. There are twenty-six drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the tretinoin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Retin-a

A generic version of RETIN-A was approved as tretinoin by PADAGIS US on December 24^th, 1998.

Summary for RETIN-A

US Patents:	0
Applicants:	4
NDAs:	7
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	140
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for RETIN-A
Drug Sales Revenues:	Drug sales revenues for RETIN-A
What excipients (inactive ingredients) are in RETIN-A?	RETIN-A excipients list
DailyMed Link:	RETIN-A at DailyMed

See drug prices for RETIN-A

See drug sales revenues for RETIN-A

Pharmacology for RETIN-A

Drug Class

Retinoid

Anatomical Therapeutic Chemical (ATC) Classes for RETIN-A

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

US Patents and Regulatory Information for RETIN-A

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	tretinoin	CREAM;TOPICAL	019049-001	Sep 16, 1988	AB	RX	Yes	Yes
Valeant Intl	RETIN-A	tretinoin	SWAB;TOPICAL	016921-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Valeant Intl	RETIN-A	tretinoin	GEL;TOPICAL	017955-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes
Bausch	RETIN-A MICRO	tretinoin	GEL;TOPICAL	020475-002	May 10, 2002		RX	Yes	Yes
Valeant Bermuda	RETIN-A	tretinoin	CREAM;TOPICAL	017522-001	Approved Prior to Jan 1, 1982	AB1	RX	Yes	Yes

Expired US Patents for RETIN-A

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Valeant Pharms North	RETIN-A	tretinoin	CREAM;TOPICAL	017340-001	Approved Prior to Jan 1, 1982
Valeant Bermuda	RETIN-A	tretinoin	CREAM;TOPICAL	017522-001	Approved Prior to Jan 1, 1982
Bausch	RETIN-A	tretinoin	CREAM;TOPICAL	019049-001	Sep 16, 1988
Valeant Intl	RETIN-A	tretinoin	SOLUTION;TOPICAL	016921-001	Approved Prior to Jan 1, 1982
Valeant Bermuda	RETIN-A	tretinoin	CREAM;TOPICAL	017522-001	Approved Prior to Jan 1, 1982

International Patents for RETIN-A

See the table below for patents covering RETIN-A around the world.

Country	Patent Number	Title	Estimated Expiration
India	140593	PROCESS FOR PREPARING STABILIZED TRETIN-OIN CREAM EMULSION FOR TOPICAL APPLICATION
United Kingdom	1450507
South Africa	7006459
United Kingdom	1325732
France	2070083

Supplementary Protection Certificates for RETIN-A

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1304992	PA2013025,C1304992	Lithuania		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	92401	Luxembourg		PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE
1304992	PA2013025	Lithuania		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	2013C/060	Belgium		PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506
0617614	2001/009	Ireland		PRODUCT NAME: PANRETIN-ALITRETINOIN