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Last Updated: July 21, 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.

Recent Clinical Trials for DEOXYCHOLIC ACID

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

SponsorPhase
Johns Hopkins UniversityPhase 1
Massachusetts General HospitalPhase 1
Juva Skin & Laser CenterPhase 4

See all DEOXYCHOLIC ACID clinical trials

Pharmacology for DEOXYCHOLIC ACID
Drug ClassCytolytic Agent
Physiological EffectDecreased Cell Membrane Integrity
Medical Subject Heading (MeSH) Categories for DEOXYCHOLIC ACID
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

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 ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Abbvie KYBELLA deoxycholic acid SOLUTION;SUBCUTANEOUS 206333-001 Apr 29, 2015 AP RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Abbvie KYBELLA deoxycholic acid SOLUTION;SUBCUTANEOUS 206333-001 Apr 29, 2015 AP RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Abbvie KYBELLA deoxycholic acid SOLUTION;SUBCUTANEOUS 206333-001 Apr 29, 2015 AP RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Abbvie KYBELLA deoxycholic acid SOLUTION;SUBCUTANEOUS 206333-001 Apr 29, 2015 AP RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Abbvie KYBELLA deoxycholic acid SOLUTION;SUBCUTANEOUS 206333-001 Apr 29, 2015 AP RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Abbvie KYBELLA deoxycholic acid SOLUTION;SUBCUTANEOUS 206333-001 Apr 29, 2015 AP RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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

Country Patent Number Title Estimated Expiration
United Kingdom 2460350 Preparation of bile acids and intermediates thereof ⤷  Sign Up
Japan 2010530876 ⤷  Sign Up
China 106146594 合成胆汁酸组合物、方法和制剂 (Synthetic bile acid composition, method, and preparation) ⤷  Sign Up
France 23C1018 ⤷  Sign Up
Portugal 2380576 ⤷  Sign Up
Spain 2795749 ⤷  Sign Up
Japan 2013139460 METHOD AND RELATED COMPOSITION FOR REDUCING FAT AND TIGHTENING SKIN ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for DEOXYCHOLIC ACID

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2380576 122020000056 Germany ⤷  Sign Up PRODUCT NAME: DEOXYCHOLSAEURE NATRIUMSALZ; NAT. REGISTRATION NO/DATE: 98586.00.00 20180104; FIRST REGISTRATION: EWR IS/1/16/071/01 20160729
1758590 CR 2017 00067 Denmark ⤷  Sign Up PRODUCT NAME: DEOXYCHOLSYRE NATRIUMSALT; NAT. REG. NO/DATE: 59040 (DK) 20170703; FIRST REG. NO/DATE: IS IS/1/16/071/01 20160729
1758590 CA 2017 00067 Denmark ⤷  Sign Up PRODUCT NAME: DEOXYCHOLSYRE NATRIUMSALT; NAT. REG. NO/DATE: 59040 20170703; FIRST REG. NO/DATE: IS IS/1/16/071/01 20160729
1758590 300907 Netherlands ⤷  Sign Up PRODUCT NAME: DEOXYCHOLINEZUUR NATRIUMZOUT; REGISTRATION NO/DATE: RVG120593 20170804
2380576 SPC/GB20/050 United Kingdom ⤷  Sign Up PRODUCT NAME: DEOXYCHOLIC ACID SODIUM SALT; REGISTERED: UK PL 45496/0009 20170526
1758590 LUC00029 Luxembourg ⤷  Sign Up PRODUCT NAME: SEL DE SODIUM D'ACIDE DEOXYCHOLIQUE; AUTHORISATION NUMBER AND DATE: IS/1/16/071/01 20170401
3692995 301229 Netherlands ⤷  Sign Up PRODUCT NAME: DEOXYCHOLAAT; NATIONAL REGISTRATION NO/DATE: RVG120593 20170804; FIRST REGISTRATION: IS IS/1/16/071/01 20160729
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.