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Last Updated: March 19, 2024

KYBELLA Drug Patent Profile


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Which patents cover Kybella, and when can generic versions of Kybella launch?

Kybella is a drug marketed by Abbvie and is included in one NDA. There are fifteen patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and forty patent family members in thirty-seven 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.

DrugPatentWatch® Litigation and Generic Entry Outlook for Kybella

A generic version of KYBELLA was approved as deoxycholic acid by SLAYBACK PHARMA LLC on April 2nd, 2021.

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Drug patent expirations by year for KYBELLA
Recent Clinical Trials for KYBELLA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Johns Hopkins UniversityPhase 1
Beer, Kenneth R., M.D., PAPhase 4
Massachusetts General HospitalPhase 1

See all KYBELLA clinical trials

Pharmacology for KYBELLA
Drug ClassCytolytic Agent
Physiological EffectDecreased Cell Membrane Integrity
Paragraph IV (Patent) Challenges for KYBELLA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
KYBELLA Injection deoxycholic acid 10 mg/mL (2 mL) 206333 1 2018-07-13

US Patents and Regulatory Information for KYBELLA

KYBELLA is protected by fifteen US patents.

Patents protecting KYBELLA

Formulations of deoxycholic acid and salts thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Methods and compositions for the non-surgical removal of fat
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD FOR REDUCTION OF SUBMENTAL FAT

Methods and related compositions for reduction of fat
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD FOR REDUCTION OF SUBMENTAL FAT

Formulations of deoxycholic acid and salts thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Synthetic bile acid compositions and methods
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Methods and related compositions for the non-surgical removal of fat
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD FOR REDUCTION OF SUBMENTAL FAT

Formulations of deoxycholic acid and salts thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Synthetic bile acid compositions and methods
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Synthetic bile acid compositions and methods
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD FOR REDUCTION OF SUBMENTAL FAT

Compositions comprising deoxycholic acid and salts thereof suitable for use in treating fat deposits
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Methods and related compositions for reduction of fat and skin tightening
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD FOR REDUCTION OF SUBMENTAL FAT

Synthetic bile acid compositions and methods
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Synthetic bile acid compositions and methods
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: IMPROVEMENT IN THE APPEARANCE OF MODERATE TO SEVERE CONVEXITY OR FULLNESS ASSOCIATED WITH SUBMENTAL FAT IN ADULTS BY MEANS OF REDUCING SUBMENTAL FAT VOLUME AS DESCRIBED IN THE APPROVED LABELING

Synthetic bile acid compositions and methods
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: IMPROVEMENT IN THE APPEARANCE OF MODERATE TO SEVERE CONVEXITY OR FULLNESS ASSOCIATED WITH SUBMENTAL FAT IN ADULTS BY MEANS OF REDUCING SUBMENTAL FAT VOLUME AS DESCRIBED IN THE APPROVED LABELING

Synthetic bile acid compositions and methods
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: IMPROVEMENT IN THE APPEARANCE OF MODERATE TO SEVERE CONVEXITY OR FULLNESS ASSOCIATED WITH SUBMENTAL FAT IN ADULTS BY MEANS OF REDUCING SUBMENTAL FAT VOLUME AS DESCRIBED IN THE APPROVED LABELING

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abbvie KYBELLA deoxycholic acid SOLUTION;SUBCUTANEOUS 206333-001 Apr 29, 2015 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Abbvie KYBELLA deoxycholic acid SOLUTION;SUBCUTANEOUS 206333-001 Apr 29, 2015 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Abbvie KYBELLA deoxycholic acid SOLUTION;SUBCUTANEOUS 206333-001 Apr 29, 2015 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for KYBELLA

When does loss-of-exclusivity occur for KYBELLA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 7440
Estimated Expiration: ⤷  Try a Trial

Patent: 2325
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 08265721
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0813140
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 90841
Estimated Expiration: ⤷  Try a Trial

Patent: 89109
Estimated Expiration: ⤷  Try a Trial

Chile

Patent: 08001783
Estimated Expiration: ⤷  Try a Trial

China

Patent: 1711254
Estimated Expiration: ⤷  Try a Trial

Patent: 6083969
Estimated Expiration: ⤷  Try a Trial

Patent: 6146594
Estimated Expiration: ⤷  Try a Trial

Patent: 8191940
Estimated Expiration: ⤷  Try a Trial

Costa Rica

Patent: 174
Estimated Expiration: ⤷  Try a Trial

Patent: 170070
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0150879
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 16700
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 07475
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 0806
Estimated Expiration: ⤷  Try a Trial

Patent: 1000032
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 69383
Estimated Expiration: ⤷  Try a Trial

Patent: 07475
Estimated Expiration: ⤷  Try a Trial

Patent: 02290
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 65807
Estimated Expiration: ⤷  Try a Trial

Patent: 23372
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 25909
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 2203
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 89102
Estimated Expiration: ⤷  Try a Trial

Patent: 10530876
Estimated Expiration: ⤷  Try a Trial

Patent: 13075918
Estimated Expiration: ⤷  Try a Trial

Jordan

Patent: 0180077
Estimated Expiration: ⤷  Try a Trial

Patent: 72
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 0040
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 0094
Estimated Expiration: ⤷  Try a Trial

Patent: 09013664
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 1081
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 07475
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 07475
Estimated Expiration: ⤷  Try a Trial

San Marino

Patent: 201000003
Estimated Expiration: ⤷  Try a Trial

Patent: 01000003
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 07475
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 0907928
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1598402
Estimated Expiration: ⤷  Try a Trial

Patent: 1863131
Estimated Expiration: ⤷  Try a Trial

Patent: 1916024
Estimated Expiration: ⤷  Try a Trial

Patent: 2061001
Estimated Expiration: ⤷  Try a Trial

Patent: 100031512
Estimated Expiration: ⤷  Try a Trial

Patent: 130133881
Estimated Expiration: ⤷  Try a Trial

Patent: 150013305
Estimated Expiration: ⤷  Try a Trial

Patent: 160025044
Estimated Expiration: ⤷  Try a Trial

Patent: 160150646
Estimated Expiration: ⤷  Try a Trial

Patent: 180061401
Estimated Expiration: ⤷  Try a Trial

Patent: 180122483
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 50504
Estimated Expiration: ⤷  Try a Trial

Patent: 26429
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 03327
Estimated Expiration: ⤷  Try a Trial

Patent: 03396
Estimated Expiration: ⤷  Try a Trial

Patent: 0918550
Estimated Expiration: ⤷  Try a Trial

Patent: 1534684
Estimated Expiration: ⤷  Try a Trial

United Kingdom

Patent: 07615
Estimated Expiration: ⤷  Try a Trial

Patent: 12493
Estimated Expiration: ⤷  Try a Trial

Patent: 52358
Estimated Expiration: ⤷  Try a Trial

Patent: 60350
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering KYBELLA around the world.

Country Patent Number Title Estimated Expiration
Japan 5279274 ⤷  Try a Trial
China 108191940 合成胆汁酸组合物、方法和制剂 (Synthetic bile acid composition, method, and preparation) ⤷  Try a Trial
European Patent Office 3002290 SYNTHESE D'ACIDE DESOXYCHOLIQUE (DCA) (SYNTHESIS OF DEOXYCHOLIC ACID (DCA)) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for KYBELLA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2380576 SPC/GB20/050 United Kingdom ⤷  Try a Trial PRODUCT NAME: DEOXYCHOLIC ACID SODIUM SALT; REGISTERED: UK PL 45496/0009 20170526
2380576 41/2020 Austria ⤷  Try a Trial PRODUCT NAME: DESOXYCHOLSAEURE-NATRIUMSALZ; NAT. REGISTRATION NO/DATE: 137169 20160825; FIRST REGISTRATION: IS IS/1/16/071/01 20160729
2380576 122020000056 Germany ⤷  Try a Trial PRODUCT NAME: DEOXYCHOLSAEURE NATRIUMSALZ; NAT. REGISTRATION NO/DATE: 98586.00.00 20180104; FIRST REGISTRATION: EWR IS/1/16/071/01 20160729
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 verification 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.