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Last Updated: July 5, 2020

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Obeticholic acid - Generic Drug Details

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

Obeticholic acid is the generic ingredient in one branded drug marketed by Intercept Pharms Inc and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Obeticholic acid has one hundred and four patent family members in thirty-three countries.

There is one drug master file entry for obeticholic acid. One supplier is listed for this compound.

Summary for obeticholic acid
International Patents:104
US Patents:7
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 1
Suppliers / Packagers: 1
Bulk Api Vendors: 42
Clinical Trials: 20
Patent Applications: 67
DailyMed Link:obeticholic acid at DailyMed
Recent Clinical Trials for obeticholic acid

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

SponsorPhase
GlaxoSmithKlinePhase 1
Sir Salimullah Medical College Mitford HospitalN/A
Intercept PharmaceuticalsPhase 4

See all obeticholic acid clinical trials

Pharmacology for obeticholic acid

US Patents and Regulatory Information for obeticholic acid

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Intercept Pharms Inc OCALIVA obeticholic acid TABLET;ORAL 207999-002 May 27, 2016 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Intercept Pharms Inc OCALIVA obeticholic acid TABLET;ORAL 207999-002 May 27, 2016 RX Yes Yes   Start Trial   Start Trial   Start Trial
Intercept Pharms Inc OCALIVA obeticholic acid TABLET;ORAL 207999-002 May 27, 2016 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 obeticholic acid

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1392714 598 Finland   Start Trial
1392714 122017000034 Germany   Start Trial PRODUCT NAME: OBETICHOLSAEURE; REGISTRATION NO/DATE: EU/1/16/1139 20161212
1392714 CA 2017 00025 Denmark   Start Trial PRODUCT NAME: OBETICHOLIC ACID; REG. NO/DATE: EU/1/16/1139 20161215
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Merck
Boehringer Ingelheim
Express Scripts
McKesson
Moodys
McKinsey

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