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Last Updated: April 17, 2024

DEOXYCHOLIC ACID - Generic Drug Details

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What are the generic drug sources for deoxycholic acid and what is the scope of freedom to operate?

Deoxycholic acid is the generic ingredient in two branded drugs marketed by Slayback Pharma Llc and Abbvie, and is included in two NDAs. There are fifteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Deoxycholic acid has one hundred and forty-one patent family members in thirty-seven countries.

There are thirty-three drug master file entries for deoxycholic acid. One supplier is listed for this compound.

Summary for DEOXYCHOLIC ACID

International Patents:	141
US Patents:	15
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	33
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	98
Clinical Trials:	19
Patent Applications:	6,163
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DEOXYCHOLIC ACID
What excipients (inactive ingredients) are in DEOXYCHOLIC ACID?	DEOXYCHOLIC ACID excipients list
DailyMed Link:	DEOXYCHOLIC ACID at DailyMed

Recent Clinical Trials for DEOXYCHOLIC ACID

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

Sponsor	Phase
Juva Skin & Laser Center	Phase 4
Allergan	Phase 4
University of California, San Diego	Early Phase 1

See all DEOXYCHOLIC ACID clinical trials

Pharmacology for DEOXYCHOLIC ACID

Drug Class	Cytolytic Agent
Physiological Effect	Decreased Cell Membrane Integrity

Medical Subject Heading (MeSH) Categories for DEOXYCHOLIC ACID

Cholagogues and Choleretics

Paragraph IV (Patent) Challenges for DEOXYCHOLIC ACID

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 DEOXYCHOLIC ACID

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Glossary

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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
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
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				⤷ 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 DEOXYCHOLIC ACID

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	2380576	Utilisation du désoxycholate de sodium pour l' élimination non chirurgicale de graisse (Use of sodium deoxycholate for the non-surgical removal of fat)	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2005112942		⤷ Try a Trial
South Korea	20150013305	SYNTHETIC BILE ACID COMPOSITION, METHOD, AND PREPARATION	⤷ Try a Trial
Portugal	1758590		⤷ Try a Trial
Japan	2007538104		⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2006086038		⤷ Try a Trial
Taiwan	200918550	Synthetic bile acid composition, method, and preparation	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for DEOXYCHOLIC ACID

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	122018000065	Germany	⤷ Try a Trial	PRODUCT NAME: DEOXYCHOLSAEURE NATRIUMSALZ; NAT. REGISTRATION NO/DATE: 98586.00.00 20180104; 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
1758590	300907	Netherlands	⤷ Try a Trial	PRODUCT NAME: DEOXYCHOLINEZUUR NATRIUMZOUT; REGISTRATION NO/DATE: RVG120593 20170804
1758590	CA 2017 00067	Denmark	⤷ Try a Trial	PRODUCT NAME: DEOXYCHOLSYRE NATRIUMSALT; NAT. REG. NO/DATE: 59040 20170703; FIRST REG. NO/DATE: IS IS/1/16/071/01 20160729
1758590	2017C/063	Belgium	⤷ Try a Trial	PRODUCT NAME: SEL DE SODIUM D'ACIDE DESOXYCHOLIQUE; AUTHORISATION NUMBER AND DATE: SE/H/1547/01/DC 20170612
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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