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 two branded drugs marketed by Apotex, Lupin Ltd, MSN, and Intercept Pharms Inc, and is included in four NDAs. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

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

Summary for obeticholic acid

International Patents:	123
US Patents:	7
Tradenames:	2
Applicants:	4
NDAs:	4
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	65
Clinical Trials:	35
Patent Applications:	1,151
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
Intercept Pharmaceuticals	Phase 2/Phase 3
Universitaire Ziekenhuizen KU Leuven	N/A
Intercept Pharmaceuticals	N/A

See all obeticholic acid clinical trials

Generic filers with tentative approvals for OBETICHOLIC ACID

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	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	207999-001	May 27, 2016		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Intercept Pharms Inc	OCALIVA	obeticholic acid	TABLET;ORAL	207999-002	May 27, 2016		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Intercept Pharms Inc	OCALIVA	obeticholic acid	TABLET;ORAL	207999-002	May 27, 2016		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Lupin Ltd	OBETICHOLIC ACID	obeticholic acid	TABLET;ORAL	214980-002	May 30, 2023		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Intercept Pharms Inc	OCALIVA	obeticholic acid	TABLET;ORAL	207999-002	May 27, 2016		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up		Y		⤷ Sign Up
Intercept Pharms Inc	OCALIVA	obeticholic acid	TABLET;ORAL	207999-001	May 27, 2016		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Intercept Pharms Inc	OCALIVA	obeticholic acid	TABLET;ORAL	207999-001	May 27, 2016		RX	Yes	No	⤷ 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

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	⤷ Sign Up	⤷ Sign Up
Intercept Pharms Inc	OCALIVA	obeticholic acid	TABLET;ORAL	207999-002	May 27, 2016	⤷ Sign Up	⤷ Sign Up
Intercept Pharms Inc	OCALIVA	obeticholic acid	TABLET;ORAL	207999-002	May 27, 2016	⤷ Sign Up	⤷ Sign Up
Intercept Pharms Inc	OCALIVA	obeticholic acid	TABLET;ORAL	207999-001	May 27, 2016	⤷ Sign Up	⤷ Sign Up
Intercept Pharms Inc	OCALIVA	obeticholic acid	TABLET;ORAL	207999-001	May 27, 2016	⤷ Sign Up	⤷ Sign Up
Intercept Pharms Inc	OCALIVA	obeticholic acid	TABLET;ORAL	207999-002	May 27, 2016	⤷ Sign Up	⤷ Sign Up
>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
Australia	2016255045	Compositions of obeticholic acid and methods of use	⤷ Sign Up
Canada	2983609	COMPOSITIONS D'ACIDE OBETICHOLIQUE ET PROCEDES D'UTILISATION (COMPOSITIONS OF OBETICHOLIC ACID AND METHODS OF USE)	⤷ Sign Up
Singapore	11201805235X	POLYMORPHIC CRYSTALLINE FORMS OF OBETICHOLIC ACID	⤷ Sign Up
Japan	6941057		⤷ Sign Up
Japan	4021327		⤷ Sign Up
Brazil	112014031828	preparação, usos e formas sólidas de ácido obeticólico	⤷ Sign Up
South Africa	201707981	COMPOSITIONS OF OBETICHOLIC ACID AND METHODS OF USE	⤷ Sign Up
>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	598	Finland	⤷ Sign Up
1392714	CR 2017 00025	Denmark	⤷ Sign Up	PRODUCT NAME: OBETICHOLIC ACID; REG. NO/DATE: EU/1/16/1139 20161215
1392714	2017/019	Ireland	⤷ Sign Up	PRODUCT NAME: OBETICHOLIC ACID; REGISTRATION NO/DATE: EU/1/16/1139/001 EU/1/16/1139/002 20161212
1392714	1790020-0	Sweden	⤷ Sign Up	PRODUCT NAME: OBETICHOLIC ACID; REG. NO/DATE: EU/1/16/1139 20161215
1392714	CA 2017 00025	Denmark	⤷ Sign Up	PRODUCT NAME: OBETICHOLIC ACID; REG. NO/DATE: EU/1/16/1139 20161215
1392714	C01392714/01	Switzerland	⤷ Sign Up	PRODUCT NAME: ACIDUM OBETICHOLICUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66530 01.06.2018
1392714	132017000061826	Italy	⤷ Sign Up	PRODUCT NAME: ACIDO OBETICOLICO(OCALIVA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1139, 20161215
>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.