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Serving 500+ biopharmaceutical companies globally:

Colorcon
Cantor Fitzgerald
Farmers Insurance
QuintilesIMS
Boehringer Ingelheim
Queensland Health
McKesson
Cipla
Baxter
Johnson and Johnson

Generated: July 21, 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 twelve patents protecting this drug.

This drug has eighty patent family members in twenty-eight countries.

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.

Summary for Tradename: KYBELLA

Patents:12
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list37
Clinical Trials: see list5
Patent Applications: see list7,408
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:KYBELLA at DailyMed

Pharmacology for Tradename: 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, 2015RXYesYes8,242,294► SubscribeY ► Subscribe
Kythera Biopharms
KYBELLA
deoxycholic acid
SOLUTION;SUBCUTANEOUS206333-001Apr 29, 2015RXYesYes9,522,155► SubscribeY ► Subscribe
Kythera Biopharms
KYBELLA
deoxycholic acid
SOLUTION;SUBCUTANEOUS206333-001Apr 29, 2015RXYesYes8,883,770► SubscribeY ► Subscribe
Kythera Biopharms
KYBELLA
deoxycholic acid
SOLUTION;SUBCUTANEOUS206333-001Apr 29, 2015RXYesYes8,546,367► SubscribeY ► Subscribe
Kythera Biopharms
KYBELLA
deoxycholic acid
SOLUTION;SUBCUTANEOUS206333-001Apr 29, 2015RXYesYes8,846,066► Subscribe ► 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
8,367,852Preparation of bile acids and intermediates thereof► Subscribe
9,050,349Synthetic bile acid compositions and methods► 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
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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
South Korea101598402► Subscribe
Slovenia2407475► Subscribe
Austria521355► Subscribe
Taiwan200918550► Subscribe
European Patent Office1758590► 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 500+ biopharmaceutical companies globally:

Queensland Health
Teva
Chubb
Johnson and Johnson
Argus Health
Cipla
Merck
Baxter
Express Scripts
McKesson

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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