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Last Updated: June 6, 2020

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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.

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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 AB 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 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 017955-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
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 Pharms North RETIN-A tretinoin CREAM;TOPICAL 017340-001 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
>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 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
1304992 PA2013025 Lithuania   Start Trial 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   Start Trial PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: 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 C01304992/01 Switzerland   Start Trial PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014
0617614 SPC/GB01/014 United Kingdom   Start Trial PRODUCT NAME: ALITRETINOIN; REGISTERED: UK EU/1/00/149/001 20001018
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKesson
Merck
Boehringer Ingelheim
Moodys
Medtronic
Johnson and Johnson

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