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Serving leading biopharmaceutical companies globally:

Fuji
Federal Trade Commission
Teva
Citi
Merck
Novartis
AstraZeneca
Covington
Cantor Fitzgerald
Baxter

Generated: February 20, 2018

DrugPatentWatch Database Preview

KYBELLA Drug Profile

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Which patents cover Kybella, and what generic 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-three patent family members in thirty countries.

The generic ingredient in KYBELLA is deoxycholic acid. There are thirty-three 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 KYBELLA
Drug patent expirations by year for KYBELLA
Pharmacology for KYBELLA
Medical Subject Heading (MeSH) Categories for KYBELLA

US Patents and Regulatory Information 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;SUBCUTANEOUS 206333-001 Apr 29, 2015 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Kythera Biopharms KYBELLA deoxycholic acid SOLUTION;SUBCUTANEOUS 206333-001 Apr 29, 2015 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Kythera Biopharms KYBELLA deoxycholic acid SOLUTION;SUBCUTANEOUS 206333-001 Apr 29, 2015 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Kythera Biopharms KYBELLA deoxycholic acid SOLUTION;SUBCUTANEOUS 206333-001 Apr 29, 2015 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Kythera Biopharms KYBELLA deoxycholic acid SOLUTION;SUBCUTANEOUS 206333-001 Apr 29, 2015 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Kythera Biopharms KYBELLA deoxycholic acid SOLUTION;SUBCUTANEOUS 206333-001 Apr 29, 2015 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Kythera Biopharms KYBELLA deoxycholic acid SOLUTION;SUBCUTANEOUS 206333-001 Apr 29, 2015 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Kythera Biopharms KYBELLA deoxycholic acid SOLUTION;SUBCUTANEOUS 206333-001 Apr 29, 2015 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Kythera Biopharms KYBELLA deoxycholic acid SOLUTION;SUBCUTANEOUS 206333-001 Apr 29, 2015 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Kythera Biopharms KYBELLA deoxycholic acid SOLUTION;SUBCUTANEOUS 206333-001 Apr 29, 2015 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Non-Orange Book US Patents for 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
9,186,364 Formulations of deoxycholic acid and salts thereof ➤ Try a Free Trial
7,994,351 Preparation of bile acids and intermediates thereof ➤ Try a Free Trial
8,362,285 Preparation of bile acids and intermediates thereof ➤ Try a Free Trial
9,050,349 Synthetic bile acid compositions and methods ➤ Try a Free Trial
9,150,607 Preparation of bile acids and intermediates thereof ➤ Try a Free Trial
8,367,852 Preparation of bile acids and intermediates thereof ➤ Try a Free Trial
9,737,549 Formulations of deoxycholic acid and salts thereof ➤ Try a Free Trial
9,724,356 Formulations of deoxycholic acid and salts thereof ➤ Try a Free Trial
7,902,387 Preparation of bile acids and intermediates thereof ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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International Patents for KYBELLA

Supplementary Protection Certificates for KYBELLA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2017006 Lithuania ➤ Try a Free Trial PRODUCT NAME: DEZOKSICHOLIO RUGSTIES NATRIO DRUSKA; REGISTRATION NO/DATE: LT/1/16/3960/001 20160909
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Healthtrust
Mallinckrodt
Teva
Express Scripts
Fuji
Farmers Insurance
Colorcon
US Army

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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