KYBELLA Drug Patent Profile

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 2^nd, 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

See all KYBELLA clinical trials

Pharmacology for KYBELLA

Drug Class	Cytolytic Agent
Physiological Effect	Decreased Cell Membrane Integrity

Anatomical Therapeutic Chemical (ATC) Classes for KYBELLA

D11AX	Other dermatologicals
D11A	OTHER DERMATOLOGICAL PREPARATIONS
D11	OTHER DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

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

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
Kythera Biopharms	KYBELLA	deoxycholic acid	SOLUTION;SUBCUTANEOUS	206333-001	Apr 29, 2015	AP	RX	Yes	Yes			Y
Kythera Biopharms	KYBELLA	deoxycholic acid	SOLUTION;SUBCUTANEOUS	206333-001	Apr 29, 2015	AP	RX	Yes	Yes
Kythera Biopharms	KYBELLA	deoxycholic acid	SOLUTION;SUBCUTANEOUS	206333-001	Apr 29, 2015	AP	RX	Yes	Yes			Y
Kythera Biopharms	KYBELLA	deoxycholic acid	SOLUTION;SUBCUTANEOUS	206333-001	Apr 29, 2015	AP	RX	Yes	Yes			Y
Kythera Biopharms	KYBELLA	deoxycholic acid	SOLUTION;SUBCUTANEOUS	206333-001	Apr 29, 2015	AP	RX	Yes	Yes			Y
Kythera Biopharms	KYBELLA	deoxycholic acid	SOLUTION;SUBCUTANEOUS	206333-001	Apr 29, 2015	AP	RX	Yes	Yes

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

Australia

Brazil

Canada

Chile

China

Costa Rica

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Israel

Japan

Jordan

Malaysia

Mexico

New Zealand

Poland

Portugal

San Marino

Slovenia

South Africa

South Korea

Spain

Taiwan

United Kingdom

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
Portugal	1748780
New Zealand	586818	METHODS AND RELATED COMPOSITIONS FOR REDUCTION OF FAT
Canada	2690841	COMPOSITION, PROCEDE ET PREPARATION D'ACIDE BILIAIRE SYNTHETIQUE (SYNTHETIC BILE ACID COMPOSITION, METHOD, AND PREPARATION)
Taiwan	I503327
United Kingdom	0912493
South Korea	20160025044	합성 담즙산 조성물, 방법 및 제조물 (SYNTHETIC BILE ACID COMPOSITION, METHOD, AND PREPARATION)

Supplementary Protection Certificates for KYBELLA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2380576	41/2020	Austria		PRODUCT NAME: DESOXYCHOLSAEURE-NATRIUMSALZ; NAT. REGISTRATION NO/DATE: 137169 20160825; FIRST REGISTRATION: IS IS/1/16/071/01 20160729
1758590	LUC00029	Luxembourg		PRODUCT NAME: SEL DE SODIUM D'ACIDE DEOXYCHOLIQUE; AUTHORISATION NUMBER AND DATE: IS/1/16/071/01 20170401
2380576	2020/043	Ireland		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		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		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		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF OWNER(S) NAME
2380576	SPC/GB20/050	United Kingdom		PRODUCT NAME: DEOXYCHOLIC ACID SODIUM SALT; REGISTERED: UK PL 45496/0009 20170526