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Ursodiol - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for ursodiol?

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, and Allergan Sales Llc, and is included in eleven NDAs. There is one patent protecting this compound. 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

Tradenames:4
Patents:1
Applicants:10
NDAs:11
Drug Master File Entries: see list5
Suppliers / Packagers: see list28
Bulk Api Vendors: see list47
Clinical Trials: see list8
Patent Applications: see list5,050
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
Teva Pharms Usa
URSODIOL
ursodiol
TABLET;ORAL079184-002May 13, 2009DISCNNoNo► Subscribe► Subscribe
Teva Pharms Usa
URSODIOL
ursodiol
TABLET;ORAL079184-001May 13, 2009DISCNNoNo► Subscribe► Subscribe
Glenmark Generics
URSODIOL
ursodiol
TABLET;ORAL090801-002Jul 12, 2011RXNoNo► Subscribe► Subscribe
Impax Labs Inc
URSODIOL
ursodiol
TABLET;ORAL200826-002Dec 23, 2011RXNoNo► Subscribe► Subscribe
Impax Labs Inc
URSODIOL
ursodiol
CAPSULE;ORAL077895-001Jul 27, 2006RXNoNo► 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
ursodiol
TABLET;ORAL020675-001Dec 10, 19974,859,660► Subscribe
Forest Labs Inc
URSO FORTE
ursodiol
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.

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