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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
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Generated: November 20, 2017

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Tretinoin - Generic Drug Details

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What are the generic sources for tretinoin and what is the scope of tretinoin patent protection?

Tretinoin
is the generic ingredient in eight branded drugs marketed by Mylan, Mylan Pharms Inc, Valeant Pharms North, Allergan Sales Llc, Perrigo Pharma Intl, Valeant Intl, Valeant Bermuda, Cheplapharm, Wockhardt, Dow Pharm, Teva Pharms, Glenmark Pharms Ltd, Barr Labs Inc, Anchen Pharms, and Zo Skin Health, and is included in twenty-nine NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

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

There are twenty-four drug master file entries for tretinoin. Twenty-seven suppliers are listed for this compound.

Pharmacology for tretinoin

Ingredient-typeRetinoids
Drug ClassRetinoid

Medical Subject Heading (MeSH) Categories for tretinoin

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;TOPICAL020475-002May 10, 2002ABRXYesYes► Subscribe► Subscribe ► Subscribe
Valeant Intl
RETIN-A-MICRO
tretinoin
GEL;TOPICAL020475-003Jan 28, 2014RXYesYes► Subscribe► SubscribeY ► Subscribe
Perrigo Pharma Intl
TRETINOIN
tretinoin
CREAM;TOPICAL075213-001Dec 24, 1998ABRXNoNo► Subscribe► Subscribe► Subscribe
Teva Pharms
TRETINOIN
tretinoin
SOLUTION;TOPICAL074873-001Jun 19, 1998DISCNNoNo► Subscribe► Subscribe► Subscribe
Mylan Pharms Inc
TRETINOIN
tretinoin
GEL;TOPICAL207955-001Aug 13, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Valeant Pharms North
RENOVA
tretinoin
CREAM;TOPICAL021108-001Aug 31, 2000RXYesYes► Subscribe► Subscribe ► Subscribe
Zo Skin Health
TRETINOIN
tretinoin
CREAM;TOPICAL076498-001Sep 15, 2005AB2RXNoNo► Subscribe► Subscribe► Subscribe
Mylan Pharms Inc
TRETINOIN
tretinoin
GEL;TOPICAL202567-001Jul 17, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe
Valeant Pharms North
RENOVA
tretinoin
CREAM;TOPICAL019963-001Dec 29, 1995AB2RXYesYes► Subscribe► Subscribe► Subscribe
Wockhardt
TRETINOIN
tretinoin
SOLUTION;TOPICAL075260-001Jan 25, 1999DISCNNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: tretinoin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Pharms North
RENOVA
tretinoin
CREAM;TOPICAL019963-001Dec 29, 1995► Subscribe► Subscribe
Valeant Intl
RETIN-A
tretinoin
GEL;TOPICAL017955-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Valeant Intl
RETIN-A
tretinoin
GEL;TOPICAL017955-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Mylan Pharms Inc
AVITA
tretinoin
CREAM;TOPICAL020404-003Jan 14, 1997► Subscribe► Subscribe
Valeant Intl
RETIN-A
tretinoin
GEL;TOPICAL017579-002Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Valeant Intl
RETIN-A MICRO
tretinoin
GEL;TOPICAL020475-002May 10, 2002► Subscribe► Subscribe
Valeant Pharms North
RENOVA
tretinoin
CREAM;TOPICAL021108-001Aug 31, 2000► Subscribe► Subscribe
Valeant Intl
RETIN-A
tretinoin
SOLUTION;TOPICAL016921-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Valeant Intl
RETIN-A MICRO
tretinoin
GEL;TOPICAL020475-002May 10, 2002► Subscribe► Subscribe
Valeant Intl
RETIN-A MICRO
tretinoin
GEL;TOPICAL020475-001Feb 7, 1997► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: tretinoin

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 Ingredient: tretinoin

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)8801164► Subscribe
South Africa8906012► Subscribe
Canada1310583► Subscribe
South Korea960013701► Subscribe
Austria106235► Subscribe
Australia7858087► Subscribe
JapanH01131112► Subscribe
Germany3880593► Subscribe
JapanH01500756► Subscribe
Japan2793188► 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: TRETINOIN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90049-3Sweden► SubscribePRODUCT NAME: KLINDAMYCIN (SOM KLINDAMYCINFOSFAT) OCH TRETINOIN; NAT. REG. NO/DATE: MTNR 46193 20130503; FIRST REG.: IR PA1332/043/001 20130322
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
2013025,C1304992Lithuania► SubscribePRODUCT 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
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
13/044Ireland► SubscribePRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322
/2001Austria► SubscribePRODUCT NAME: ALITRETINOIN; REGISTRATION NO/DATE: 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
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
01/009Ireland► SubscribePRODUCT NAME: PANRETIN-ALITRETINOIN
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Serving leading biopharmaceutical companies globally:

Deloitte
Harvard Business School
Boehringer Ingelheim
Moodys
AstraZeneca
Mallinckrodt
Cerilliant
Novartis
McKesson
Express Scripts

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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