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-nine patent family members in thirty-six 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.
Summary for KYBELLA
International Patents: | 139 |
US Patents: | 15 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 97 |
Clinical Trials: | 13 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for KYBELLA |
What excipients (inactive ingredients) are in KYBELLA? | KYBELLA excipients list |
DailyMed Link: | KYBELLA at DailyMed |

Recent Clinical Trials for KYBELLA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Johns Hopkins University | Phase 1 |
Beer, Kenneth R., M.D., PA | Phase 4 |
Massachusetts General Hospital | Phase 1 |
Pharmacology for KYBELLA
Drug Class | Cytolytic Agent |
Physiological Effect | Decreased Cell Membrane Integrity |
Anatomical Therapeutic Chemical (ATC) Classes 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: ⤷ 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
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 | |
Portugal | 1748780 | ⤷ Try a Trial | |
New Zealand | 586818 | METHODS AND RELATED COMPOSITIONS FOR REDUCTION OF FAT | ⤷ Try a Trial |
Canada | 2690841 | COMPOSITION, PROCEDE ET PREPARATION D'ACIDE BILIAIRE SYNTHETIQUE (SYNTHETIC BILE ACID COMPOSITION, METHOD, AND PREPARATION) | ⤷ Try a Trial |
Taiwan | I503327 | ⤷ Try a Trial | |
United Kingdom | 0912493 | ⤷ Try a Trial | |
South Korea | 20160025044 | 합성 담즙산 조성물, 방법 및 제조물 (SYNTHETIC BILE ACID COMPOSITION, METHOD, AND PREPARATION) | ⤷ 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 | 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 |
1758590 | LUC00029 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: SEL DE SODIUM D'ACIDE DEOXYCHOLIQUE; AUTHORISATION NUMBER AND DATE: IS/1/16/071/01 20170401 |
2380576 | 2020/043 | Ireland | ⤷ Try a Trial | PRODUCT NAME: DEOXYCHOLIC ACID SODIUM SALT; NAT REGISTRATION NO/DATE: PA2103/003/001 20170602; FIRST REGISTRATION NO/DATE: SE/H/1547/001/DC 20160729 |
1758590 | 132017000066197 | Italy | ⤷ Try a Trial | PRODUCT NAME: SALE SODICO DI ACIDO DESOSSICOLICO(BELKYRA); AUTHORISATION NUMBER(S) AND DATE(S): 044896013, 20161219;IS/1/16/071/01, 20160729 |
1758590 | CR 2017 00067 | Denmark | ⤷ Try a Trial | PRODUCT NAME: DEOXYCHOLSYRE NATRIUMSALT; NAT. REG. NO/DATE: 59040 (DK) 20170703; FIRST REG. NO/DATE: IS IS/1/16/071/01 20160729 |
1758590 | 300907 | Netherlands | ⤷ Try a Trial | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF OWNER(S) NAME |
2380576 | SPC/GB20/050 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: DEOXYCHOLIC ACID SODIUM SALT; REGISTERED: UK PL 45496/0009 20170526 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |