URSODIOL - Generic Drug Details

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What are the generic sources for ursodiol and what is the scope of freedom to operate?

Ursodiol is the generic ingredient in four branded drugs marketed by Teva Branded Pharm, 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, Allergan, Endo Operations, Epic Pharma Llc, Glenmark Pharms Ltd, and Teva Pharms Usa, and is included in twenty-four NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for ursodiol. Thirty suppliers are listed for this compound.

Summary for URSODIOL

US Patents:	0
Tradenames:	4
Applicants:	21
NDAs:	24
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	30
Raw Ingredient (Bulk) Api Vendors:	93
Clinical Trials:	38
Patent Applications:	6,578
Drug Prices:	Drug price trends 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

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See drug sales revenues 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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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
Rising	URSODIOL	ursodiol	CAPSULE;ORAL	213200-001	Feb 12, 2020	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Strides Pharma	URSODIOL	ursodiol	CAPSULE;ORAL	210344-001	Jan 22, 2021	AB	RX	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
Epic Pharma Llc	URSODIOL	ursodiol	TABLET;ORAL	214717-001	Aug 14, 2024	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

Expired US Patents for URSODIOL

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan	URSO 250	ursodiol	TABLET;ORAL	020675-001	Dec 10, 1997	⤷ Sign Up	⤷ Sign Up
Allergan	URSO FORTE	ursodiol	TABLET;ORAL	020675-002	Jul 21, 2004	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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