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Isotretinoin - Generic Drug Details

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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 five patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has ten patent family members in eight countries.

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

Summary for Generic Name: isotretinoin

Tradenames:7
Patents:5
Applicants:7
NDAs:9
Drug Master File Entries: see list11
Suppliers / Packaging: see list6
Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: isotretinoin

Ingredient-typeRetinoids
Drug ClassRetinoid
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dr Reddys Labs Ltd
ZENATANE
isotretinoin
CAPSULE;ORAL202099-003Mar 25, 2013RXNo► subscribe► subscribe
Dr Reddys Labs Ltd
ZENATANE
isotretinoin
CAPSULE;ORAL202099-004Feb 23, 2015RXNo► subscribe► subscribe
Teva Pharms Usa
CLARAVIS
isotretinoin
CAPSULE;ORAL076356-001Apr 11, 2003RXNo► subscribe► 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, 19834,464,394*PED► subscribe
Hoffmann La Roche
ACCUTANE
isotretinoin
CAPSULE;ORAL018662-002May 7, 19824,322,438► subscribe
Hoffmann La Roche
ACCUTANE
isotretinoin
CAPSULE;ORAL018662-004Mar 28, 19834,335,125► subscribe
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International Patent Family for Ingredient: isotretinoin

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)0224172► subscribe
European Patent Office2964195► 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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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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