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Generated: December 18, 2017

DrugPatentWatch Database Preview

RETIN-A MICRO Drug Profile

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Which patents cover Retin-a Micro, and what generic alternatives are available?

Retin-a Micro is a drug marketed by Valeant Intl and is included in one NDA. There is one patent protecting this drug and two Paragraph IV challenges.

This drug has nineteen patent family members in nine countries and twelve supplementary protection certificates in nine countries.

The generic ingredient in RETIN-A MICRO is tretinoin. There are twenty-four drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the tretinoin profile page.
Drug patent expirations by year for RETIN-A MICRO

Pharmacology for RETIN-A MICRO

Ingredient-typeRetinoids
Drug ClassRetinoid

Medical Subject Heading (MeSH) Categories for RETIN-A MICRO

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Valeant IntlRETIN-A MICROtretinoinGEL;TOPICAL020475-002May 10, 2002ABRXYesYes► Subscribe► Subscribe► Subscribe
Valeant IntlRETIN-A MICROtretinoinGEL;TOPICAL020475-001Feb 7, 1997ABRXYesYes► Subscribe► SubscribeY► Subscribe
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Expired Patents for Tradename: RETIN-A MICRO

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant IntlRETIN-A MICROtretinoinGEL;TOPICAL020475-002May 10, 2002► Subscribe► Subscribe
Valeant IntlRETIN-A MICROtretinoinGEL;TOPICAL020475-001Feb 7, 1997► Subscribe► Subscribe
Valeant IntlRETIN-A MICROtretinoinGEL;TOPICAL020475-001Feb 7, 1997► Subscribe► Subscribe
Valeant IntlRETIN-A MICROtretinoinGEL;TOPICAL020475-002May 10, 2002► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for RETIN-A MICRO

Drugname Dosage Strength RLD Submissiondate
tretinoinGel0.04%Retin-A Micro12/20/2010
tretinoinGel0.1%Retin-A Micro7/8/2010

Non-Orange Book Patents for Tradename: RETIN-A MICRO

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,145,675 Two step method for preparation of controlled release formulations► Subscribe
5,879,716 Methods and compositions for topical delivery of benzoyl peroxide► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: RETIN-A MICRO

Country Document Number Estimated Expiration
JapanH01500756► Subscribe
JapanH01131112► Subscribe
Australia7858087► Subscribe
Canada1303991► Subscribe
Austria106235► Subscribe
Australia613398► Subscribe
European Patent Office0306236► Subscribe
Japan2793188► Subscribe
South Korea960013701► Subscribe
Germany3789956► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: RETIN-A MICRO

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
01/009Ireland► SubscribePRODUCT NAME: PANRETIN-ALITRETINOIN
00617Netherlands► SubscribePRODUCT 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
2013025Lithuania► SubscribePRODUCT 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
/2001Austria► SubscribePRODUCT NAME: ALITRETINOIN; REGISTRATION NO/DATE: EU/1/00/149/001 20001011
1304992/01Switzerland► SubscribePRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014
13/044Ireland► SubscribePRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322
401Luxembourg► SubscribePRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE
00043Netherlands► SubscribePRODUCT NAME: ALITRETINOIN; NAT. REGISTRATION NO/DATE: EU/1/00/149/001 20001011; FIRST REGISTRATION: EU/1/00/149/001 20001011
2013 00053Denmark► SubscribePRODUCT NAME: CLINDAMYCIN (SOM CLINDAMYCIN PHOSPHATE) OG TRETINOIN; NAT. REG. NO/DATE: 48954 20130416; FIRST REG. NO/DATE: IE PA1332/043/001 20130322
90049-3Sweden► SubscribePRODUCT NAME: KLINDAMYCIN (SOM KLINDAMYCINFOSFAT) OCH TRETINOIN; NAT. REG. NO/DATE: MTNR 46193 20130503; FIRST REG.: IR PA1332/043/001 20130322
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Serving leading biopharmaceutical companies globally:

Citi
US Department of Justice
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Chinese Patent Office
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