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BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

McKinsey
McKesson
Fish and Richardson
Deloitte
QuintilesIMS
Johnson and Johnson
Dow
Medtronic
Merck
Daiichi Sankyo

Generated: November 22, 2017

DrugPatentWatch Database Preview

KYBELLA Drug Profile

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Which patents cover Kybella, and what generic Kybella alternatives are available?

Kybella is a drug marketed by Kythera Biopharms and is included in one NDA. There are thirteen patents protecting this drug.

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

The generic ingredient in KYBELLA is deoxycholic acid. There are thirty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the deoxycholic acid profile page.

Pharmacology for KYBELLA

Medical Subject Heading (MeSH) Categories for KYBELLA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Kythera Biopharms
KYBELLA
deoxycholic acid
SOLUTION;SUBCUTANEOUS206333-001Apr 29, 2015RXYesYes► Subscribe► SubscribeY ► Subscribe
Kythera Biopharms
KYBELLA
deoxycholic acid
SOLUTION;SUBCUTANEOUS206333-001Apr 29, 2015RXYesYes► Subscribe► Subscribe ► Subscribe
Kythera Biopharms
KYBELLA
deoxycholic acid
SOLUTION;SUBCUTANEOUS206333-001Apr 29, 2015RXYesYes► Subscribe► Subscribe ► Subscribe
Kythera Biopharms
KYBELLA
deoxycholic acid
SOLUTION;SUBCUTANEOUS206333-001Apr 29, 2015RXYesYes► Subscribe► SubscribeY ► Subscribe
Kythera Biopharms
KYBELLA
deoxycholic acid
SOLUTION;SUBCUTANEOUS206333-001Apr 29, 2015RXYesYes► Subscribe► SubscribeY ► Subscribe
Kythera Biopharms
KYBELLA
deoxycholic acid
SOLUTION;SUBCUTANEOUS206333-001Apr 29, 2015RXYesYes► Subscribe► Subscribe ► Subscribe
Kythera Biopharms
KYBELLA
deoxycholic acid
SOLUTION;SUBCUTANEOUS206333-001Apr 29, 2015RXYesYes► Subscribe► Subscribe ► Subscribe
Kythera Biopharms
KYBELLA
deoxycholic acid
SOLUTION;SUBCUTANEOUS206333-001Apr 29, 2015RXYesYes► Subscribe► SubscribeY ► Subscribe
Kythera Biopharms
KYBELLA
deoxycholic acid
SOLUTION;SUBCUTANEOUS206333-001Apr 29, 2015RXYesYes► Subscribe► Subscribe ► Subscribe
Kythera Biopharms
KYBELLA
deoxycholic acid
SOLUTION;SUBCUTANEOUS206333-001Apr 29, 2015RXYesYes► Subscribe► SubscribeY ► Subscribe
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Non-Orange Book Patents for Tradename: KYBELLA

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
7,994,351Preparation of bile acids and intermediates thereof► Subscribe
8,362,285Preparation of bile acids and intermediates thereof► Subscribe
9,150,607Preparation of bile acids and intermediates thereof► Subscribe
9,050,349Synthetic bile acid compositions and methods► Subscribe
9,737,549Formulations of deoxycholic acid and salts thereof► Subscribe
8,367,852Preparation of bile acids and intermediates thereof► Subscribe
7,902,387Preparation of bile acids and intermediates thereof► Subscribe
9,724,356Formulations of deoxycholic acid and salts 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 Tradename: KYBELLA

Country Document Number Estimated Expiration
Mexico2009013664► Subscribe
South Korea20160025044► Subscribe
Spain2550504► Subscribe
LithuaniaPA2017006► Subscribe
European Patent Office2407475► Subscribe
South Korea20070110351► Subscribe
World Intellectual Property Organization (WIPO)2006086038► Subscribe
China101018553► Subscribe
Portugal1758590► Subscribe
MexicoPA06013437► 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: KYBELLA

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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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Chubb
McKinsey
Argus Health
Medtronic
Johnson and Johnson
UBS
Moodys
Teva
US Army
QuintilesIMS

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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