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.

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

Sponsor

Phase

Asmaa Abdelfattah Elsayed

Phase 4

University of Minnesota - Clinical and Translational Science Institute

Phase 1

University of Minnesota

Phase 1

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
Lannett Co Inc	URSODIOL	ursodiol	CAPSULE;ORAL	079082-001	Dec 15, 2008	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Impax Labs Inc	URSODIOL	ursodiol	CAPSULE;ORAL	077895-001	Jul 27, 2006		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Chartwell Rx	URSODIOL	ursodiol	CAPSULE;ORAL	213555-001	Aug 17, 2020	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hibrow Hlthcare	URSODIOL	ursodiol	CAPSULE;ORAL	212452-001	Oct 30, 2019	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva Branded Pharm	ACTIGALL	ursodiol	CAPSULE;ORAL	019594-002	Dec 31, 1987	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Allergan	URSO 250	ursodiol	TABLET;ORAL	020675-001	Dec 10, 1997	AB	RX	Yes	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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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

Applicant

Tradename

Generic Name

Dosage

NDA

Approval Date

Patent No.

Patent Expiration

TABLET;ORAL

Dec 10, 1997

⤷ Sign Up

TABLET;ORAL

Jul 21, 2004

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>Applicant

>Tradename

>Generic Name

>Dosage

>NDA

>Approval Date

>Patent No.

>Patent Expiration

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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

URSODIOL - Generic Drug Details

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

Summary for URSODIOL

Recent Clinical Trials for URSODIOL

Pharmacology for URSODIOL

US Patents and Regulatory Information for URSODIOL

Expired US Patents for URSODIOL

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