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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:	121
Patent Applications:	4,037
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		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 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 Intl	RETIN-A	tretinoin	GEL;TOPICAL	017579-002	Approved Prior to Jan 1, 1982
Valeant Pharms North	RETIN-A	tretinoin	CREAM;TOPICAL	017340-001	Approved Prior to Jan 1, 1982
Valeant Intl	RETIN-A	tretinoin	GEL;TOPICAL	017955-001	Approved Prior to Jan 1, 1982
Valeant Intl	RETIN-A	tretinoin	GEL;TOPICAL	017579-002	Approved Prior to Jan 1, 1982

International Patents for RETIN-A

Country	Patent Number	Estimated Expiration
Japan	S5082223
Philippines	11954
Canada	1031259
Norway	137627
Italy	1059655
France	2247203

Supplementary Protection Certificates for RETIN-A

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	122013000081	Germany		PRODUCT NAME: CLINDAMYCIN (ALS CLINDAMYCIN-PHOSPHAT) UND TRETINOIN; NAT. REGISTRATION NO/DATE: 85210.00.00 20130611; FIRST REGISTRATION: IRLAND PA1332/043/001 20130322
0617614	11/2001	Austria		PRODUCT NAME: ALITRETINOIN; REGISTRATION NO/DATE: EU/1/00/149/001 20001011
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	SPC/GB13/061	United Kingdom		PRODUCT NAME: CLINDAMYCIN PHOSPHATE IN COMBINATION WITH TRETINOIN.; REGISTERED: IE PA1332/043/001 20130322; UK PL15142/0249 20130624
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