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RETIN-A Drug Profile

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

Retin-a is a drug marketed by 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. Eighteen suppliers are listed for this compound. Additional details are available on the tretinoin profile page.

US ANDA Litigation and Generic Entry Outlook for Retin-a

A generic version of RETIN-A was approved as tretinoin by PERRIGO PHARMA INTL on December 24^th, 1998.

Summary for RETIN-A

US Patents:	0
Applicants:	3
NDAs:	7
Suppliers / Packagers:	4
Bulk Api Vendors:	116
Patent Applications:	7,753
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for RETIN-A
Drug Sales Revenues:	Drug sales revenues for RETIN-A
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

Paragraph IV (Patent) Challenges for RETIN-A

Tradename	Dosage	Ingredient	NDA	Submissiondate
RETIN-A	GEL;TOPICAL	tretinoin	017579

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
Valeant Bermuda	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
Valeant Intl	RETIN-A MICRO	tretinoin	GEL;TOPICAL	020475-002	May 10, 2002	AB	RX	Yes	Yes
Valeant Bermuda	RETIN-A	tretinoin	CREAM;TOPICAL	017522-001	Approved Prior to Jan 1, 1982	AB1	RX	Yes	Yes
Valeant Pharms North	RETIN-A	tretinoin	CREAM;TOPICAL	017340-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes

Expired US Patents for RETIN-A

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Valeant Intl	RETIN-A	tretinoin	GEL;TOPICAL	017955-001	Approved Prior to Jan 1, 1982
Valeant Intl	RETIN-A	tretinoin	GEL;TOPICAL	017955-001	Approved Prior to Jan 1, 1982
Valeant Bermuda	RETIN-A	tretinoin	CREAM;TOPICAL	019049-001	Sep 16, 1988
Valeant Bermuda	RETIN-A	tretinoin	CREAM;TOPICAL	017522-001	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	RETIN-A	tretinoin	CREAM;TOPICAL	017340-001	Approved Prior to Jan 1, 1982

International Patents for RETIN-A

Country	Patent Number	Estimated Expiration
Sweden	7412743
Japan	S5082223
Philippines	11954
France	2070083
Norway	743650
South Africa	7406498

Supplementary Protection Certificates for RETIN-A

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1304992	1390049-3	Sweden		PRODUCT NAME: KLINDAMYCIN (SOM KLINDAMYCINFOSFAT) OCH TRETINOIN; NAT. REG. NO/DATE: MTNR 46193 20130503; FIRST REG.: IR PA1332/043/001 20130322
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	2013/044	Ireland		PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322
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	C01304992/01	Switzerland		PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014
0617614	SPC/GB01/014	United Kingdom		PRODUCT NAME: ALITRETINOIN; REGISTERED: UK EU/1/00/149/001 20001018