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Tretinoin - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for tretinoin?

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, Spear Pharms Inc, Roche, Wockhardt, Dow Pharm, Teva Pharms, Glenmark Generics, Barr Labs Inc, Anchen Pharms, and Zo Skin Health, and is included in twenty-nine NDAs. There are three 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-five suppliers are listed for this compound.

Summary for Generic Name: tretinoin

Tradenames:8
Patents:3
Applicants:16
NDAs:29
Drug Master File Entries: see list24
Suppliers / Packagers: see list25
Bulk Api Vendors: see list93
Clinical Trials: see list40
Patent Applications: see list9,907
Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:tretinoin at DailyMed

Pharmacology for Ingredient: tretinoin

Ingredient-typeRetinoids
Drug ClassRetinoid
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Valeant Intl
RETIN-A MICRO
tretinoin
GEL;TOPICAL020475-001Feb 7, 1997RXYesYes5,955,109► SubscribeY ► Subscribe
Valeant Bermuda
RETIN-A
tretinoin
CREAM;TOPICAL019049-001Sep 16, 1988RXYesYes► Subscribe► Subscribe
Valeant Pharms North
RETIN-A
tretinoin
CREAM;TOPICAL017340-001Approved Prior to Jan 1, 1982RXYesYes► Subscribe► Subscribe
Barr Labs Inc
TRETINOIN
tretinoin
CAPSULE;ORAL077684-001Jun 22, 2007RXNoYes► Subscribe► Subscribe
Mylan Pharms Inc
AVITA
tretinoin
CREAM;TOPICAL020404-003Jan 14, 1997RXNoNo► 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, 19954,877,805► Subscribe
Valeant Intl
RETIN-A-MICRO
tretinoin
GEL;TOPICAL020475-003Jan 28, 20145,955,109► Subscribe
Valeant Intl
RETIN-A
tretinoin
GEL;TOPICAL017955-001Approved Prior to Jan 1, 19823,729,568► Subscribe
Mylan Pharms Inc
AVITA
tretinoin
CREAM;TOPICAL020404-003Jan 14, 19974,971,800► Subscribe
Valeant Bermuda
RETIN-A
tretinoin
CREAM;TOPICAL019049-001Sep 16, 19883,729,568► 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
South Africa8806284► Subscribe
European Patent Office0306236► Subscribe
European Patent Office0277211► Subscribe
Canada1310583► Subscribe
JapanH01500756► 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
1304992/01Switzerland► SubscribePRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014
00043Netherlands► SubscribePRODUCT NAME: ALITRETINOIN; NAT. REGISTRATION NO/DATE: EU/1/00/149/001 20001011; FIRST REGISTRATION: EU/1/00/149/001 20001011
90049-3Sweden► SubscribePRODUCT NAME: KLINDAMYCIN (SOM KLINDAMYCINFOSFAT) OCH TRETINOIN; NAT. REG. NO/DATE: MTNR 46193 20130503; FIRST REG.: IR PA1332/043/001 20130322
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
01/009Ireland► SubscribePRODUCT NAME: PANRETIN-ALITRETINOIN
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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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