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Serving 500+ biopharmaceutical companies globally:

Accenture
US Department of Justice
Cipla
AstraZeneca
Express Scripts
Citi
Teva
Colorcon
Healthtrust
McKinsey

Generated: July 27, 2017

DrugPatentWatch Database Preview

Obeticholic acid - Generic Drug Details

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What are the generic sources for obeticholic acid and what is the scope of obeticholic acid freedom to operate?

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.

Obeticholic acid has thirty-eight 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
Suppliers / Packagers: see list1
Bulk Api Vendors: see list25
Clinical Trials: see list4,837
Patent Applications: see list33
Drug Prices:see low prices
DailyMed Link:obeticholic acid at DailyMed

Pharmacology for Ingredient: obeticholic acid

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Intercept Pharms Inc
OCALIVA
obeticholic acid
TABLET;ORAL207999-002May 27, 2016RXYesYes► Subscribe► Subscribe ► Subscribe
Intercept Pharms Inc
OCALIVA
obeticholic acid
TABLET;ORAL207999-002May 27, 2016RXYesYes► Subscribe► Subscribe► Subscribe
Intercept Pharms Inc
OCALIVA
obeticholic acid
TABLET;ORAL207999-002May 27, 2016RXYesYes► Subscribe► Subscribe► Subscribe
Intercept Pharms Inc
OCALIVA
obeticholic acid
TABLET;ORAL207999-002May 27, 2016RXYesYes► Subscribe► SubscribeY ► Subscribe
Intercept Pharms Inc
OCALIVA
obeticholic acid
TABLET;ORAL207999-001May 27, 2016RXYesNo► Subscribe► Subscribe ► 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
7,786,102Steroids as agonists for FXR► Subscribe
8,969,330Steroids 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
Australia2016200832► Subscribe
Spain2248581► Subscribe
South Korea20150022974► Subscribe
Singapore10201610434Y► Subscribe
Israel157816► 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:

Colorcon
Chinese Patent Office
Chubb
Deloitte
Citi
Queensland Health
McKesson
Johnson and Johnson
Novartis
Federal Trade Commission

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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