Obeticholic acid - Generic Drug Details

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What are the generic 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 ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

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

Summary for obeticholic acid

International Patents:	124
US Patents:	10
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	62
Clinical Trials:	33
Patent Applications:	2,112
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for obeticholic acid
What excipients (inactive ingredients) are in obeticholic acid?	obeticholic acid excipients list
DailyMed Link:	obeticholic acid at DailyMed

Recent Clinical Trials for obeticholic acid

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

Sponsor	Phase
M.D. Anderson Cancer Center	Phase 1
National Cancer Institute (NCI)	Phase 2
Nanjing Chia-tai Tianqing Pharmaceutical	Phase 3

See all obeticholic acid clinical trials

Generic filers with tentative approvals for OBETICHOLIC ACID

Applicant	Application No.	Strength	Dosage Form
See Plans and Pricing	See Plans and Pricing	10mg	TABLET; ORAL
See Plans and Pricing	See Plans and Pricing	10mg	TABLET; ORAL
See Plans and Pricing	See Plans and Pricing	10MG	TABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for obeticholic acid

Drug Class	Farnesoid X Receptor Agonist
Mechanism of Action	Farnesoid X Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for obeticholic acid

A05AA	Bile acids and derivatives
A05A	BILE THERAPY
A05	BILE AND LIVER THERAPY
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for OBETICHOLIC ACID

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
OCALIVA	Tablets	obeticholic acid	5 mg and 10 mg	207999	5	2020-05-27

US Patents and Regulatory Information for obeticholic 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
Intercept Pharms Inc	OCALIVA	obeticholic acid	TABLET;ORAL	207999-002	May 27, 2016		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Intercept Pharms Inc	OCALIVA	obeticholic acid	TABLET;ORAL	207999-001	May 27, 2016		RX	Yes	No	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
Intercept Pharms Inc	OCALIVA	obeticholic acid	TABLET;ORAL	207999-001	May 27, 2016		RX	Yes	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Intercept Pharms Inc	OCALIVA	obeticholic acid	TABLET;ORAL	207999-002	May 27, 2016		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Intercept Pharms Inc	OCALIVA	obeticholic acid	TABLET;ORAL	207999-001	May 27, 2016		RX	Yes	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for obeticholic acid

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Intercept Pharms Inc	OCALIVA	obeticholic acid	TABLET;ORAL	207999-001	May 27, 2016	See Plans and Pricing	See Plans and Pricing
Intercept Pharms Inc	OCALIVA	obeticholic acid	TABLET;ORAL	207999-002	May 27, 2016	See Plans and Pricing	See Plans and Pricing
Intercept Pharms Inc	OCALIVA	obeticholic acid	TABLET;ORAL	207999-001	May 27, 2016	See Plans and Pricing	See Plans and Pricing
Intercept Pharms Inc	OCALIVA	obeticholic acid	TABLET;ORAL	207999-002	May 27, 2016	See Plans and Pricing	See Plans and Pricing
Intercept Pharms Inc	OCALIVA	obeticholic acid	TABLET;ORAL	207999-002	May 27, 2016	See Plans and Pricing	See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for obeticholic acid

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
ADVANZ PHARMA Limited	Ocaliva	obeticholic acid	EMEA/H/C/004093 Ocaliva is indicated for the treatment of primary biliary cholangitis (also known as primary biliary cirrhosis) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA.	Authorised	no	no	yes	2016-12-12
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for obeticholic acid

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Country	Patent Number	Title	Estimated Expiration
Costa Rica	20170492	COMPOSICIONES DE ÁCIDO OBETICÓLICO Y MÉTODOS DE USO.	See Plans and Pricing
Canada	2877122	PREPARATION, UTILISATIONS ET FORMES SOLIDES D'ACIDE OBETICHOLIQUE (PREPARATION, USES AND SOLID FORMS OF OBETICHOLIC ACID)	See Plans and Pricing
Taiwan	201703773	Compositions of obeticholic acid and methods of use	See Plans and Pricing
European Patent Office	1392714	STEROIDES COMME AGONISTES DE FXR (STEROIDS AS AGONISTS FOR FXR)	See Plans and Pricing
Japan	2021183651	オベチコール酸の組成物および使用方法 (COMPOSITIONS OF OBETICHOLIC ACID AND METHODS OF USE)	See Plans and Pricing
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for obeticholic acid

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1392714	2017/019	Ireland	See Plans and Pricing	PRODUCT NAME: OBETICHOLIC ACID; REGISTRATION NO/DATE: EU/1/16/1139/001 EU/1/16/1139/002 20161212
1392714	CR 2017 00025	Denmark	See Plans and Pricing	PRODUCT NAME: OBETICHOLIC ACID; REG. NO/DATE: EU/1/16/1139 20161215
1392714	122017000034	Germany	See Plans and Pricing	PRODUCT NAME: OBETICHOLSAEURE; REGISTRATION NO/DATE: EU/1/16/1139 20161212
1392714	1790020-0	Sweden	See Plans and Pricing	PRODUCT NAME: OBETICHOLIC ACID; REG. NO/DATE: EU/1/16/1139 20161215
1392714	CA 2017 00025	Denmark	See Plans and Pricing	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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