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Last Updated: June 3, 2020

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RETIN-A-MICRO Drug Profile


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When do Retin-a-micro patents expire, and what generic alternatives are available?

Retin-a-micro is a drug marketed by Valeant Intl and is included in one NDA.

The generic ingredient in RETIN-A-MICRO 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-micro

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

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Summary for RETIN-A-MICRO
Drug patent expirations by year for RETIN-A-MICRO
Pharmacology for RETIN-A-MICRO
Drug ClassRetinoid
Paragraph IV (Patent) Challenges for RETIN-A-MICRO
Tradename Dosage Ingredient NDA Submissiondate
RETIN-A MICRO GEL;TOPICAL tretinoin 020475 2010-12-20
RETIN-A-MICRO GEL;TOPICAL tretinoin 020475 2010-12-20
RETIN-A-MICRO GEL;TOPICAL tretinoin 020475 2010-07-08
RETIN-A MICRO GEL;TOPICAL tretinoin 020475 2010-07-08

US Patents and Regulatory Information for RETIN-A-MICRO

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Valeant Intl RETIN-A-MICRO tretinoin GEL;TOPICAL 020475-004 Oct 23, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Valeant Intl RETIN-A-MICRO tretinoin GEL;TOPICAL 020475-003 Jan 28, 2014 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

Supplementary Protection Certificates for RETIN-A-MICRO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
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 C300617 Netherlands   Start Trial PRODUCT NAME: COMBINATIE VAN CLINDAMYCINE, DESGEWENST IN DE VORM VAN CLINDAMYCINEFOSFAAT EN TRETINOINE; NAT. REGISTRATION NO/DATE: RVG 109745 20130626; FIRST REGISTRATION: PA1332/043/001 20130322
0617614 11/2001 Austria   Start Trial PRODUCT NAME: ALITRETINOIN; REGISTRATION NO/DATE: EU/1/00/149/001 20001011
1304992 PA2013025,C1304992 Lithuania   Start Trial PRODUCT NAME: CLINDAMYCINUM + 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 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
0617614 C300043 Netherlands   Start Trial PRODUCT NAME: ALITRETINOIN; NAT. REGISTRATION NO/DATE: EU/1/00/149/001 20001011; FIRST REGISTRATION: EU/1/00/149/001 20001011
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
Boehringer Ingelheim
Merck
Harvard Business School
Baxter
AstraZeneca

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