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Last Updated: February 27, 2021

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RETIN-A Drug Profile

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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.

  Start Trial

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   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

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

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