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Last Updated: November 21, 2024

URSODIOL Drug Patent Profile

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Which patents cover Ursodiol, and what generic alternatives are available?

Ursodiol is a drug marketed by Abhai Llc, Amneal Pharms Co, Aurobindo Pharma Ltd, Chartwell Rx, Epic Pharma, Hibrow Hlthcare, Impax Labs Inc, Lannett Co Inc, Lgm Pharma, Norvium Bioscience, Rising, Rk Pharma, Strides Pharma, Teva Pharms, Zydus Lifesciences, Endo Operations, Epic Pharma Llc, Glenmark Pharms Ltd, and Teva Pharms Usa. and is included in twenty-two NDAs.

The generic ingredient in URSODIOL is ursodiol. There are eight drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the ursodiol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ursodiol

A generic version of URSODIOL was approved as ursodiol by EPIC PHARMA on March 14^th, 2000.

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Summary for URSODIOL

US Patents:	0
Applicants:	19
NDAs:	22
Finished Product Suppliers / Packagers:	28
Raw Ingredient (Bulk) Api Vendors:	93
Clinical Trials:	38
Patent Applications:	4,515
Drug Prices:	Drug price information for URSODIOL
Drug Sales Revenues:	Drug sales revenues for URSODIOL
What excipients (inactive ingredients) are in URSODIOL?	URSODIOL excipients list
DailyMed Link:	URSODIOL at DailyMed

Drug patent expirations by year for URSODIOL

Drug Prices for URSODIOL

Recent Clinical Trials for URSODIOL

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

Sponsor	Phase
Asmaa Abdelfattah Elsayed	Phase 4
University of Minnesota - Clinical and Translational Science Institute	Phase 1
University of Minnesota	Phase 1

See all URSODIOL clinical trials

Pharmacology for URSODIOL

Drug Class	Bile Acid

US Patents and Regulatory Information for URSODIOL

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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
Teva Pharms Usa	URSODIOL	ursodiol	TABLET;ORAL	079184-002	May 13, 2009		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zydus Lifesciences	URSODIOL	ursodiol	TABLET;ORAL	211145-001	Oct 30, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abhai Llc	URSODIOL	ursodiol	CAPSULE;ORAL	210707-001	May 17, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Endo Operations	URSODIOL	ursodiol	TABLET;ORAL	202540-002	Feb 14, 2013	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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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.