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Last Updated: August 4, 2020

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Deoxycholic acid - Generic Drug Details

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What are the generic drug sources for deoxycholic acid and what is the scope of patent protection?

Deoxycholic acid is the generic ingredient in one branded drug marketed by Kythera Biopharms and is included in one NDA. 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 twenty-one patent family members in thirty-four countries.

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

Recent Clinical Trials for deoxycholic acid

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

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

See all deoxycholic acid clinical trials

Pharmacology for deoxycholic acid
Medical Subject Heading (MeSH) Categories for deoxycholic acid
Paragraph IV (Patent) Challenges for DEOXYCHOLIC ACID
Tradename Dosage Ingredient NDA Submissiondate
KYBELLA SOLUTION;SUBCUTANEOUS deoxycholic acid 206333 2018-07-13

US Patents and Regulatory Information for deoxycholic acid

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

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 PA2017006 Lithuania   Start Trial PRODUCT NAME: DEZOKSICHOLIO RUGSTIES NATRIO DRUSKA; REGISTRATION NO/DATE: LT/1/16/3960/001 20160909
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 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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AstraZeneca

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