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Last Updated: October 20, 2021

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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 Allergan, Abhai Llc, Amneal Pharms Co, Epic Pharma, Eywa Pharma, Impax Labs Inc, Lannett Co Inc, Lgm Pharma, Mylan, Rising, Strides Pharma, Teva Pharms, Upsher Smith Labs, Vgyaan, Zydus, Glenmark Generics, Par Pharm, and Teva Pharms Usa, and is included in twenty-two NDAs. Additional information is available in the individual branded drug profile pages.

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

Drug Prices for ursodiol

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Drug Sales Revenue Trends for ursodiol

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Recent Clinical Trials for ursodiol

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SponsorPhase
Asmaa Abdelfattah ElsayedPhase 4
MallinckrodtPhase 2
University Medical Center RegensburgPhase 2

See all ursodiol clinical trials

Pharmacology for ursodiol
Drug ClassBile Acid

US Patents and Regulatory Information for ursodiol

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Upsher Smith Labs URSODIOL ursodiol CAPSULE;ORAL 213555-001 Aug 17, 2020 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Rising URSODIOL ursodiol CAPSULE;ORAL 213200-001 Feb 12, 2020 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Impax Labs Inc URSODIOL ursodiol CAPSULE;ORAL 077895-001 Jul 27, 2006 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Lgm Pharma URSODIOL ursodiol CAPSULE;ORAL 205789-002 May 8, 2020 RX No Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Allergan ACTIGALL ursodiol CAPSULE;ORAL 019594-001 Dec 31, 1987 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
>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

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

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Serving leading biopharmaceutical companies globally:

Merck
Dow
Boehringer Ingelheim
Baxter
Medtronic
McKinsey

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.