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Deoxycholic acid - Generic Drug Details

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

Deoxycholic acid is the generic ingredient in one branded drug marketed by Kythera Biopharms and is included in one NDA. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Deoxycholic acid has seventy-six patent family members in twenty-seven countries.

There are thirty-one drug master file entries for deoxycholic acid. One supplier is listed for this compound.

Summary for Generic Name: deoxycholic acid

Tradenames:1
Patents:12
Applicants:1
NDAs:1
Drug Master File Entries: see list31
Suppliers / Packagers: see list1
Bulk Api Vendors: see list38
Clinical Trials: see list2,071
Patent Applications: see list23,365
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:deoxycholic acid at DailyMed

Pharmacology for Ingredient: deoxycholic acid

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Kythera Biopharms
KYBELLA
deoxycholic acid
SOLUTION;SUBCUTANEOUS206333-001Apr 29, 2015RXYesYes8,242,294► SubscribeY ► Subscribe
Kythera Biopharms
KYBELLA
deoxycholic acid
SOLUTION;SUBCUTANEOUS206333-001Apr 29, 2015RXYesYes7,622,130► Subscribe ► Subscribe
Kythera Biopharms
KYBELLA
deoxycholic acid
SOLUTION;SUBCUTANEOUS206333-001Apr 29, 2015RXYesYes8,846,066► Subscribe ► Subscribe
Kythera Biopharms
KYBELLA
deoxycholic acid
SOLUTION;SUBCUTANEOUS206333-001Apr 29, 2015RXYesYes8,367,649► SubscribeY ► Subscribe
Kythera Biopharms
KYBELLA
deoxycholic acid
SOLUTION;SUBCUTANEOUS206333-001Apr 29, 2015RXYesYes8,653,058► SubscribeY ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: deoxycholic 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
7,902,387Preparation of bile acids and intermediates thereof► Subscribe
9,186,364Formulations of deoxycholic acid and salts thereof► Subscribe
9,150,607Preparation of bile acids and intermediates thereof► Subscribe
7,994,351Preparation of bile acids and intermediates thereof► Subscribe
9,050,349Synthetic bile acid compositions and methods► 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: deoxycholic acid

Country Document Number Estimated Expiration
Hong Kong1165807► Subscribe
Taiwan201534684► Subscribe
Israel202203► Subscribe
China101711254► Subscribe
European Patent Office2550968► 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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