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Ursodiol - Generic Drug Details

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Ursodiol is the generic ingredient in four branded drugs marketed by Glenmark Generics, Epic Pharma, Impax Labs Inc, Mylan, Par Pharm, Forest Labs Inc, Lannett, Teva Pharms Usa, Teva Pharms, Allergan Sales Llc, and Corepharma, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for ursodiol. Twenty-eight suppliers are listed for this compound.

Summary for Generic Name: ursodiol

Drug Master File Entries: see list5
Suppliers / Packagers: see list28
Bulk Api Vendors: see list47
Clinical Trials: see list8
Patent Applications: see list3,564
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:ursodiol at DailyMed

Pharmacology for Ingredient: ursodiol

Ingredient-typeBile Acids and Salts
Drug ClassBile Acid
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
CAPSULE;ORAL079082-001Dec 15, 2008RXNoNo► subscribe► subscribe
Par Pharm
TABLET;ORAL202540-002Feb 14, 2013RXNoNo► subscribe► subscribe
Allergan Sales Llc
CAPSULE;ORAL019594-002Dec 31, 1987RXYesYes► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: ursodiol

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Forest Labs Inc
URSO 250
TABLET;ORAL020675-001Dec 10, 19974,859,660► subscribe
Forest Labs Inc
TABLET;ORAL020675-002Jul 21, 20044,859,660► subscribe
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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 verifification 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.