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Obeticholic acid - Generic Drug Details

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Obeticholic acid is the generic ingredient in one branded drug marketed by Intercept Pharms Inc and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has thirty-three patent family members in twenty-three countries.

One supplier is listed for this compound.

Summary for Generic Name: obeticholic acid

Tradenames:1
Patents:4
Applicants:1
NDAs:1
Drug Master File Entries: 0
Suppliers / Packaging: see list1
Drug Prices:see low prices

Pharmacology for Ingredient: obeticholic acid

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Intercept Pharms Inc
OCALIVA
obeticholic acid
TABLET;ORAL207999-001May 27, 2016RXNo► subscribe► subscribe
Intercept Pharms Inc
OCALIVA
obeticholic acid
TABLET;ORAL207999-001May 27, 2016RXNo8,058,267► subscribe ► subscribe
Intercept Pharms Inc
OCALIVA
obeticholic acid
TABLET;ORAL207999-002May 27, 2016RXYes9,238,673► subscribeY ► subscribe
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Non-Orange Book Patents for Generic Ingredient: obeticholic acid

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
8,969,330Steroids as agonists for FXR► subscribe
7,786,102Steroids as agonists for FXR► 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: obeticholic acid

Country Document Number Estimated Expiration
Taiwan201410699► subscribe
Australia2002308295► subscribe
Canada2440680► 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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