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Serving 500+ biopharmaceutical companies globally:

Cipla
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McKesson
US Department of Justice
Merck
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Generated: June 28, 2017

DrugPatentWatch Database Preview

Isotretinoin - Generic Drug Details

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

Isotretinoin
is the generic ingredient in seven branded drugs marketed by Sun Pharm Inds Ltd, Teva Pharms Usa, Mylan Pharms Inc, Ranbaxy, Hoffmann La Roche, Douglas Pharms, and Dr Reddys Labs Ltd, and is included in nine NDAs. There are six patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Isotretinoin has ten patent family members in eight countries.

There are eleven drug master file entries for isotretinoin. Five suppliers are listed for this compound.

Summary for Generic Name: isotretinoin

Tradenames:7
Patents:6
Applicants:7
NDAs:9
Drug Master File Entries: see list11
Suppliers / Packagers: see list5
Bulk Api Vendors: see list37
Clinical Trials: see list103
Patent Applications: see list7,781
Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:isotretinoin at DailyMed

Pharmacology for Ingredient: isotretinoin

Ingredient-typeRetinoids
Drug ClassRetinoid
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ranbaxy
ABSORICA
isotretinoin
CAPSULE;ORAL021951-006Aug 15, 2014RXYesNo8,367,102► Subscribe ► Subscribe
Ranbaxy
ABSORICA
isotretinoin
CAPSULE;ORAL021951-005Aug 15, 2014RXYesNo9,078,925► SubscribeY ► Subscribe
Hoffmann La Roche
ACCUTANE
isotretinoin
CAPSULE;ORAL018662-003May 7, 1982DISCNYesNo► Subscribe► Subscribe
Ranbaxy
ABSORICA
isotretinoin
CAPSULE;ORAL021951-005Aug 15, 2014RXYesNo8,367,102► Subscribe ► Subscribe
Ranbaxy
ABSORICA
isotretinoin
CAPSULE;ORAL021951-004May 25, 2012BXRXYesYes9,078,925► SubscribeY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: isotretinoin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Hoffmann La Roche
ACCUTANE
isotretinoin
CAPSULE;ORAL018662-004Mar 28, 19834,200,647► Subscribe
Hoffmann La Roche
ACCUTANE
isotretinoin
CAPSULE;ORAL018662-004Mar 28, 19834,335,125► Subscribe
Hoffmann La Roche
ACCUTANE
isotretinoin
CAPSULE;ORAL018662-002May 7, 19824,200,647► Subscribe
Hoffmann La Roche
ACCUTANE
isotretinoin
CAPSULE;ORAL018662-002May 7, 19824,464,394*PED► Subscribe
Hoffmann La Roche
ACCUTANE
isotretinoin
CAPSULE;ORAL018662-003May 7, 19824,464,394*PED► Subscribe
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International Patent Family for Ingredient: isotretinoin

Country Document Number Estimated Expiration
Canada2423170► Subscribe
Canada2836228► Subscribe
Australia8943801► Subscribe
European Patent Office1318791► Subscribe
Spain2225600► 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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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Baxter
Chinese Patent Office
McKesson
Queensland Health
Argus Health
Daiichi Sankyo
Teva
Medtronic
Cantor Fitzgerald
Dow

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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