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Serving leading biopharmaceutical companies globally:

US Department of Justice
Daiichi Sankyo
Merck
McKinsey
Colorcon
Julphar
AstraZeneca
Fish and Richardson
Cipla
Fuji

Generated: December 15, 2017

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Deoxycholic acid - Generic Drug Details

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

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

Deoxycholic acid has ninety-four patent family members in twenty-nine countries and one supplementary protection certificate in one country.

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

Pharmacology for deoxycholic acid

Medical Subject Heading (MeSH) Categories for deoxycholic acid

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Kythera BiopharmsKYBELLAdeoxycholic acidSOLUTION;SUBCUTANEOUS206333-001Apr 29, 2015RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Kythera BiopharmsKYBELLAdeoxycholic acidSOLUTION;SUBCUTANEOUS206333-001Apr 29, 2015RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Kythera BiopharmsKYBELLAdeoxycholic acidSOLUTION;SUBCUTANEOUS206333-001Apr 29, 2015RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Kythera BiopharmsKYBELLAdeoxycholic acidSOLUTION;SUBCUTANEOUS206333-001Apr 29, 2015RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Kythera BiopharmsKYBELLAdeoxycholic acidSOLUTION;SUBCUTANEOUS206333-001Apr 29, 2015RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Kythera BiopharmsKYBELLAdeoxycholic acidSOLUTION;SUBCUTANEOUS206333-001Apr 29, 2015RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Kythera BiopharmsKYBELLAdeoxycholic acidSOLUTION;SUBCUTANEOUS206333-001Apr 29, 2015RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Kythera BiopharmsKYBELLAdeoxycholic acidSOLUTION;SUBCUTANEOUS206333-001Apr 29, 2015RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Kythera BiopharmsKYBELLAdeoxycholic acidSOLUTION;SUBCUTANEOUS206333-001Apr 29, 2015RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Kythera BiopharmsKYBELLAdeoxycholic acidSOLUTION;SUBCUTANEOUS206333-001Apr 29, 2015RXYesYes► Subscribe► Subscribe► Subscribe► 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
9,186,364Formulations of deoxycholic acid and salts thereof► Subscribe
7,902,387Preparation of bile acids and intermediates thereof► Subscribe
9,724,356Formulations of deoxycholic acid and salts thereof► Subscribe
9,737,549Formulations of deoxycholic acid and salts thereof► Subscribe
9,150,607Preparation of bile acids and intermediates thereof► Subscribe
8,367,852Preparation of bile acids and intermediates thereof► Subscribe
9,050,349Synthetic bile acid compositions and methods► Subscribe
8,362,285Preparation of bile acids and intermediates thereof► Subscribe
7,994,351Preparation of bile acids and intermediates thereof► 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
New Zealand581081► Subscribe
Costa Rica20170070► Subscribe
Canada2789109► Subscribe
Canada2690841► Subscribe
Cyprus1112204► Subscribe
Slovenia1758590► Subscribe
Denmark1758590► Subscribe
European Patent Office2550968► Subscribe
China105233287► Subscribe
Mexico2009013664► 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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Supplementary Protection Certificates for Tradename: DEOXYCHOLIC ACID

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2017006Lithuania► SubscribePRODUCT NAME: DEZOKSICHOLIO RUGSTIES NATRIO DRUSKA; REGISTRATION NO/DATE: LT/1/16/3960/001 20160909
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Serving leading biopharmaceutical companies globally:

UBS
Federal Trade Commission
Healthtrust
Fuji
Chinese Patent Office
Mallinckrodt
Teva
Johnson and Johnson
Deloitte
Cipla

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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