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Last Updated: May 20, 2022

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 Kythera Biopharms and is included in one NDA. There are fifteen patents protecting this drug and one Paragraph IV challenge.

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

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
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods and compositions for the non-surgical removal of fat
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD FOR REDUCTION OF SUBMENTAL FAT

Methods and related compositions for reduction of fat
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD FOR REDUCTION OF SUBMENTAL FAT

Formulations of deoxycholic acid and salts thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Synthetic bile acid compositions and methods
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods and related compositions for the non-surgical removal of fat
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD FOR REDUCTION OF SUBMENTAL FAT

Formulations of deoxycholic acid and salts thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Synthetic bile acid compositions and methods
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Synthetic bile acid compositions and methods
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD FOR REDUCTION OF SUBMENTAL FAT

Compositions comprising deoxycholic acid and salts thereof suitable for use in treating fat deposits
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods and related compositions for reduction of fat and skin tightening
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD FOR REDUCTION OF SUBMENTAL FAT

Synthetic bile acid compositions and methods
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Synthetic bile acid compositions and methods
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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
Kythera Biopharms KYBELLA deoxycholic acid SOLUTION;SUBCUTANEOUS 206333-001 Apr 29, 2015 AP RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Kythera Biopharms KYBELLA deoxycholic acid SOLUTION;SUBCUTANEOUS 206333-001 Apr 29, 2015 AP RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Kythera Biopharms KYBELLA deoxycholic acid SOLUTION;SUBCUTANEOUS 206333-001 Apr 29, 2015 AP RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Kythera Biopharms KYBELLA deoxycholic acid SOLUTION;SUBCUTANEOUS 206333-001 Apr 29, 2015 AP RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Kythera Biopharms KYBELLA deoxycholic acid SOLUTION;SUBCUTANEOUS 206333-001 Apr 29, 2015 AP RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Kythera Biopharms KYBELLA deoxycholic acid SOLUTION;SUBCUTANEOUS 206333-001 Apr 29, 2015 AP RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Kythera Biopharms KYBELLA deoxycholic acid SOLUTION;SUBCUTANEOUS 206333-001 Apr 29, 2015 AP RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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: See Plans and Pricing

Patent: 2325
Estimated Expiration: See Plans and Pricing

Australia

Patent: 08265721
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0813140
Estimated Expiration: See Plans and Pricing

Canada

Patent: 90841
Estimated Expiration: See Plans and Pricing

Patent: 89109
Estimated Expiration: See Plans and Pricing

Chile

Patent: 08001783
Estimated Expiration: See Plans and Pricing

China

Patent: 1711254
Estimated Expiration: See Plans and Pricing

Patent: 6083969
Estimated Expiration: See Plans and Pricing

Patent: 6146594
Estimated Expiration: See Plans and Pricing

Patent: 8191940
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 174
Estimated Expiration: See Plans and Pricing

Patent: 170070
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0150879
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 16700
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 07475
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 0806
Estimated Expiration: See Plans and Pricing

Patent: 1000032
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 69383
Estimated Expiration: See Plans and Pricing

Patent: 07475
Estimated Expiration: See Plans and Pricing

Patent: 02290
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 65807
Estimated Expiration: See Plans and Pricing

Patent: 23372
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 25909
Estimated Expiration: See Plans and Pricing

Israel

Patent: 2203
Estimated Expiration: See Plans and Pricing

Japan

Patent: 89102
Estimated Expiration: See Plans and Pricing

Patent: 10530876
Estimated Expiration: See Plans and Pricing

Patent: 13075918
Estimated Expiration: See Plans and Pricing

Jordan

Patent: 0180077
Estimated Expiration: See Plans and Pricing

Patent: 72
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 0040
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 0094
Estimated Expiration: See Plans and Pricing

Patent: 09013664
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 1081
Estimated Expiration: See Plans and Pricing

Poland

Patent: 07475
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 07475
Estimated Expiration: See Plans and Pricing

San Marino

Patent: 201000003
Estimated Expiration: See Plans and Pricing

Patent: 01000003
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 07475
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0907928
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1598402
Estimated Expiration: See Plans and Pricing

Patent: 1863131
Estimated Expiration: See Plans and Pricing

Patent: 1916024
Estimated Expiration: See Plans and Pricing

Patent: 2061001
Estimated Expiration: See Plans and Pricing

Patent: 100031512
Estimated Expiration: See Plans and Pricing

Patent: 130133881
Estimated Expiration: See Plans and Pricing

Patent: 150013305
Estimated Expiration: See Plans and Pricing

Patent: 160025044
Estimated Expiration: See Plans and Pricing

Patent: 160150646
Estimated Expiration: See Plans and Pricing

Patent: 180061401
Estimated Expiration: See Plans and Pricing

Patent: 180122483
Estimated Expiration: See Plans and Pricing

Spain

Patent: 50504
Estimated Expiration: See Plans and Pricing

Patent: 26429
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 03327
Estimated Expiration: See Plans and Pricing

Patent: 03396
Estimated Expiration: See Plans and Pricing

Patent: 0918550
Estimated Expiration: See Plans and Pricing

Patent: 1534684
Estimated Expiration: See Plans and Pricing

United Kingdom

Patent: 07615
Estimated Expiration: See Plans and Pricing

Patent: 12493
Estimated Expiration: See Plans and Pricing

Patent: 52358
Estimated Expiration: See Plans and Pricing

Patent: 60350
Estimated Expiration: See Plans and Pricing

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
Canada 2567298 PROCEDES ET COMPOSITIONS ASSOCIES POUR LA REDUCTION DE GRAISSE (METHODS AND RELATED COMPOSITIONS FOR REDUCTION OF FAT) See Plans and Pricing
Costa Rica 20170070 COMPOSICIÓN, MÉTODO Y PREPARACIÓN DEL ÁCIDO BILIAR SINTÉTICO See Plans and Pricing
European Patent Office 2572718 Procédés et compositions correspondantes pour la réduction de graisses (Methods and related compositions for reduction of fat) See Plans and Pricing
United Kingdom 0912493 See Plans and Pricing
South Korea 20100031512 SYNTHETIC BILE ACID COMPOSITION, METHOD, AND PREPARATION See Plans and Pricing
Hungary E038247 See Plans and Pricing
Costa Rica 11174 COMPOSICION, METODO Y PREPARACION DEL ACIDO BILIAR SINTETICO See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for KYBELLA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1758590 132017000066197 Italy See Plans and Pricing PRODUCT NAME: SALE SODICO DI ACIDO DESOSSICOLICO(BELKYRA); AUTHORISATION NUMBER(S) AND DATE(S): 044896013, 20161219;IS/1/16/071/01, 20160729
1758590 122018000065 Germany See Plans and Pricing PRODUCT NAME: DEOXYCHOLSAEURE NATRIUMSALZ; NAT. REGISTRATION NO/DATE: 98586.00.00 20180104; FIRST REGISTRATION: IS IS/1/16/071/01 20160729
2380576 SPC/GB20/050 United Kingdom See Plans and Pricing PRODUCT NAME: DEOXYCHOLIC ACID SODIUM SALT; REGISTERED: UK PL 45496/0009 20170526
1758590 LUC00029 Luxembourg See Plans and Pricing PRODUCT NAME: SEL DE SODIUM D'ACIDE DEOXYCHOLIQUE; AUTHORISATION NUMBER AND DATE: IS/1/16/071/01 20170401
1758590 300907 Netherlands See Plans and Pricing PRODUCT NAME: DEOXYCHOLINEZUUR NATRIUMZOUT
1758590 2017C/063 Belgium See Plans and Pricing PRODUCT NAME: SEL DE SODIUM D'ACIDE DESOXYCHOLIQUE; AUTHORISATION NUMBER AND DATE: SE/H/1547/01/DC 20170612
1758590 CA 2017 00067 Denmark See Plans and Pricing PRODUCT NAME: DEOXYCHOLSYRE NATRIUMSALT; NAT. REG. NO/DATE: 59040 20170703; FIRST REG. NO/DATE: IS IS/1/16/071/01 20160729
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Moodys
Harvard Business School
AstraZeneca
Merck
Colorcon
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 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.