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Last Updated: January 20, 2021

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KYBELLA Drug 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 twenty-seven 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.

US ANDA Litigation and Generic Entry Outlook for Kybella

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 16, 2028. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for KYBELLA
Generic Entry Opportunity Date for KYBELLA
Generic Entry Date for KYBELLA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;SUBCUTANEOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for KYBELLA

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

SponsorPhase
Juva Skin & Laser CenterPhase 4
University of California, San DiegoEarly Phase 1
Zeltiq AestheticsPhase 4

See all KYBELLA clinical trials

Pharmacology for KYBELLA
Paragraph IV (Patent) Challenges for KYBELLA
Tradename Dosage Ingredient NDA Submissiondate
KYBELLA SOLUTION;SUBCUTANEOUS deoxycholic acid 206333 2018-07-13

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

Supplementary Protection Certificates for KYBELLA

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

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Serving leading biopharmaceutical companies globally:

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Harvard Business School
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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.