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Serving leading biopharmaceutical companies globally:

McKinsey
Chubb
Express Scripts
Teva
Medtronic
QuintilesIMS
Moodys
Argus Health
UBS
Deloitte

Generated: January 22, 2018

DrugPatentWatch Database Preview

TRETINOIN - Generic Drug Details

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

Tretinoin
is the generic ingredient in eight branded drugs marketed by Anchen Pharms, Barr Labs Inc, Glenmark Pharms Ltd, Cheplapharm, Mylan Pharms Inc, Valeant Pharms North, Valeant Bermuda, Allergan Sales Llc, Perrigo Pharma Intl, Zo Skin Health, Dow Pharm, Mylan, Valeant Intl, Teva Pharms, and Wockhardt, 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.

There are twenty-four drug master file entries for tretinoin. Twenty-six suppliers are listed for this compound.
Pharmacology for TRETINOIN
Ingredient-typeRetinoids
Drug ClassRetinoid
Medical Subject Heading (MeSH) Categories for TRETINOIN

US Patents and Regulatory Information for TRETINOIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Pharms Inc TRETINOIN tretinoin GEL;TOPICAL 202567-001 Jul 17, 2013 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Teva Pharms TRETINOIN tretinoin SOLUTION;TOPICAL 074873-001 Jun 19, 1998 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Valeant Intl RETIN-A tretinoin GEL;TOPICAL 017579-002 Approved Prior to Jan 1, 1982 AB RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Perrigo Pharma Intl TRETINOIN tretinoin CREAM;TOPICAL 075213-001 Dec 24, 1998 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Mylan AVITA tretinoin GEL;TOPICAL 020400-001 Jan 29, 1998 BT RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Valeant Pharms North RETIN-A tretinoin CREAM;TOPICAL 017340-001 Approved Prior to Jan 1, 1982 AB RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Mylan Pharms Inc AVITA tretinoin CREAM;TOPICAL 020404-003 Jan 14, 1997 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Glenmark Pharms Ltd TRETINOIN tretinoin CAPSULE;ORAL 208279-001 Dec 23, 2016 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Mylan Pharms Inc TRETINOIN tretinoin GEL;TOPICAL 207955-001 Aug 13, 2015 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Valeant Intl RETIN-A-MICRO tretinoin GEL;TOPICAL 020475-004 Oct 23, 2017 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for TRETINOIN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Intl RETIN-A MICRO tretinoin GEL;TOPICAL 020475-001 Feb 7, 1997 ➤ Subscribe ➤ Subscribe
Valeant Bermuda RETIN-A tretinoin CREAM;TOPICAL 017522-001 Approved Prior to Jan 1, 1982 ➤ Subscribe ➤ Subscribe
Valeant Intl RETIN-A tretinoin GEL;TOPICAL 017955-001 Approved Prior to Jan 1, 1982 ➤ Subscribe ➤ Subscribe
Valeant Bermuda RETIN-A tretinoin CREAM;TOPICAL 019049-001 Sep 16, 1988 ➤ Subscribe ➤ Subscribe
Mylan Pharms Inc AVITA tretinoin CREAM;TOPICAL 020404-003 Jan 14, 1997 ➤ Subscribe ➤ Subscribe
Valeant Intl RETIN-A MICRO tretinoin GEL;TOPICAL 020475-002 May 10, 2002 ➤ Subscribe ➤ Subscribe
Dow Pharm ATRALIN tretinoin GEL;TOPICAL 022070-001 Jul 26, 2007 ➤ Subscribe ➤ Subscribe
Valeant Intl RETIN-A tretinoin GEL;TOPICAL 017579-002 Approved Prior to Jan 1, 1982 ➤ Subscribe ➤ Subscribe
Valeant Pharms North RENOVA tretinoin CREAM;TOPICAL 019963-001 Dec 29, 1995 ➤ Subscribe ➤ Subscribe
Valeant Intl RETIN-A tretinoin GEL;TOPICAL 017955-001 Approved Prior to Jan 1, 1982 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for 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
Patent No. Title Estimated Patent Expiration

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International Patents for TRETINOIN

Supplementary Protection Certificates for TRETINOIN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
01/009 Ireland ➤ Subscribe PRODUCT NAME: PANRETIN-ALITRETINOIN
90049-3 Sweden ➤ Subscribe PRODUCT NAME: KLINDAMYCIN (SOM KLINDAMYCINFOSFAT) OCH TRETINOIN; NAT. REG. NO/DATE: MTNR 46193 20130503; FIRST REG.: IR PA1332/043/001 20130322
00617 Netherlands ➤ Subscribe 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
13/044 Ireland ➤ Subscribe PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322
2013025 Lithuania ➤ Subscribe 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
C/GB01/014 United Kingdom ➤ Subscribe PRODUCT NAME: ALITRETINOIN; REGISTERED: UK EU/1/00/149/001 20001018
2013025,C1304992 Lithuania ➤ Subscribe 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
/2001 Austria ➤ Subscribe PRODUCT NAME: ALITRETINOIN; REGISTRATION NO/DATE: EU/1/00/149/001 20001011
1304992/01 Switzerland ➤ Subscribe PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014
00043 Netherlands ➤ Subscribe PRODUCT NAME: ALITRETINOIN; NAT. REGISTRATION NO/DATE: EU/1/00/149/001 20001011; FIRST REGISTRATION: EU/1/00/149/001 20001011
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Accenture
Moodys
Fuji
US Department of Justice
Julphar
Chubb
Citi
Chinese Patent Office
Medtronic

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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