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Last Updated: September 28, 2021

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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 two branded drugs marketed by Slayback Pharma Llc and Kythera Biopharms, 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 thirty 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
AllerganPhase 4
Juva Skin & Laser CenterPhase 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 AP RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Kythera Biopharms KYBELLA deoxycholic acid SOLUTION;SUBCUTANEOUS 206333-001 Apr 29, 2015 AP RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Kythera Biopharms KYBELLA deoxycholic acid SOLUTION;SUBCUTANEOUS 206333-001 Apr 29, 2015 AP RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Kythera Biopharms KYBELLA deoxycholic acid SOLUTION;SUBCUTANEOUS 206333-001 Apr 29, 2015 AP RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Kythera Biopharms KYBELLA deoxycholic acid SOLUTION;SUBCUTANEOUS 206333-001 Apr 29, 2015 AP RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Kythera Biopharms KYBELLA deoxycholic acid SOLUTION;SUBCUTANEOUS 206333-001 Apr 29, 2015 AP RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Kythera Biopharms KYBELLA deoxycholic acid SOLUTION;SUBCUTANEOUS 206333-001 Apr 29, 2015 AP RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever 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 132017000066197 Italy ⤷  Free Forever 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 ⤷  Free Forever Trial PRODUCT NAME: DEOXYCHOLINEZUUR NATRIUMZOUT
1758590 LUC00029 Luxembourg ⤷  Free Forever Trial PRODUCT NAME: SEL DE SODIUM D'ACIDE DEOXYCHOLIQUE; AUTHORISATION NUMBER AND DATE: IS/1/16/071/01 20170401
2380576 122020000056 Germany ⤷  Free Forever Trial PRODUCT NAME: DEOXYCHOLSAEURE NATRIUMSALZ; NAT. REGISTRATION NO/DATE: 98586.00.00 20180104; FIRST REGISTRATION: EWR IS/1/16/071/01 20160729
1758590 CA 2017 00067 Denmark ⤷  Free Forever Trial PRODUCT NAME: DEOXYCHOLSYRE NATRIUMSALT; NAT. REG. NO/DATE: 59040 20170703; FIRST REG. NO/DATE: IS IS/1/16/071/01 20160729
1758590 122018000065 Germany ⤷  Free Forever Trial PRODUCT NAME: DEOXYCHOLSAEURE NATRIUMSALZ; NAT. REGISTRATION NO/DATE: 98586.00.00 20180104; FIRST REGISTRATION: IS IS/1/16/071/01 20160729
1758590 PA2017006 Lithuania ⤷  Free Forever Trial PRODUCT NAME: DEZOKSICHOLIO RUGSTIES NATRIO DRUSKA; REGISTRATION NO/DATE: LT/1/16/3960/001 20160909
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Dow
Moodys
Colorcon
Baxter
McKesson
AstraZeneca

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