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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 24th, 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 |



Pharmacology for RETIN-A
Drug Class | Retinoid |
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 | Start Trial | Start Trial | Start Trial | |||
Valeant Intl | RETIN-A | tretinoin | SWAB;TOPICAL | 016921-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Valeant Intl | RETIN-A | tretinoin | GEL;TOPICAL | 017955-001 | Approved Prior to Jan 1, 1982 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
Valeant Intl | RETIN-A MICRO | tretinoin | GEL;TOPICAL | 020475-002 | May 10, 2002 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
Valeant Bermuda | RETIN-A | tretinoin | CREAM;TOPICAL | 017522-001 | Approved Prior to Jan 1, 1982 | AB1 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
Valeant Pharms North | RETIN-A | tretinoin | CREAM;TOPICAL | 017340-001 | Approved Prior to Jan 1, 1982 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start 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 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 | Start Trial | Start Trial |
Valeant Bermuda | RETIN-A | tretinoin | CREAM;TOPICAL | 017522-001 | Approved Prior to Jan 1, 1982 | Start Trial | Start Trial |
Valeant Intl | RETIN-A | tretinoin | GEL;TOPICAL | 017579-002 | Approved Prior to Jan 1, 1982 | Start Trial | Start Trial |
Valeant Pharms North | RETIN-A | tretinoin | CREAM;TOPICAL | 017340-001 | Approved Prior to Jan 1, 1982 | Start Trial | Start Trial |
Valeant Intl | RETIN-A | tretinoin | GEL;TOPICAL | 017955-001 | Approved Prior to Jan 1, 1982 | Start Trial | Start Trial |
Valeant Intl | RETIN-A | tretinoin | GEL;TOPICAL | 017579-002 | Approved Prior to Jan 1, 1982 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for RETIN-A
Country | Patent Number | Estimated Expiration |
---|---|---|
Japan | S5082223 | Start Trial |
Philippines | 11954 | Start Trial |
Canada | 1031259 | Start Trial |
Norway | 137627 | Start Trial |
Italy | 1059655 | Start Trial |
France | 2247203 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for RETIN-A
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1304992 | 132013902214376 | Italy | Start Trial | 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 | Start Trial | 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 | Start Trial | PRODUCT NAME: ALITRETINOIN; REGISTRATION NO/DATE: EU/1/00/149/001 20001011 |
1304992 | CR 2013 00053 | Denmark | Start Trial | 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 | Start Trial | PRODUCT NAME: CLINDAMYCIN PHOSPHATE IN COMBINATION WITH TRETINOIN.; REGISTERED: IE PA1332/043/001 20130322; UK PL15142/0249 20130624 |
1304992 | 1390049-3 | Sweden | Start Trial | PRODUCT NAME: KLINDAMYCIN (SOM KLINDAMYCINFOSFAT) OCH TRETINOIN; NAT. REG. NO/DATE: MTNR 46193 20130503; FIRST REG.: IR PA1332/043/001 20130322 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |