Last Updated: June 9, 2026

URSO Drug Patent Profile


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Which patents cover Urso, and when can generic versions of Urso launch?

Urso is a drug marketed by Abbvie, Abhai Llc, Amneal Pharms Co, Aurobindo Pharma Ltd, Chartwell Rx, Epic Pharma, Hibrow Hlthcare, Impax Labs Inc, Lannett Co Inc, Lgm Pharma, Quagen, Rising, Rk Pharma, Strides Pharma, Teva Pharms, Zydus Lifesciences, Epic Pharma Llc, Glenmark Pharms Ltd, Ph Health, and Teva Pharms Usa. and is included in twenty-three NDAs.

The generic ingredient in URSO is ursodiol. There are eight drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the ursodiol profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Urso

A generic version of URSO was approved as ursodiol by EPIC PHARMA on March 14th, 2000.

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Summary for URSO
US Patents:0
Applicants:20
NDAs:23
Drug Prices: Drug price information for URSO
DailyMed Link:URSO at DailyMed

US Patents and Regulatory Information for URSO

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Zydus Lifesciences URSODIOL ursodiol TABLET;ORAL 211145-001 Oct 30, 2018 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Strides Pharma URSODIOL ursodiol TABLET;ORAL 213504-001 Aug 20, 2020 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Zydus Lifesciences URSODIOL ursodiol TABLET;ORAL 211145-002 Oct 30, 2018 AB RX No Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Strides Pharma URSODIOL ursodiol TABLET;ORAL 213504-002 Aug 20, 2020 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Abbvie URSO 250 ursodiol TABLET;ORAL 020675-001 Dec 10, 1997 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Teva Pharms URSODIOL ursodiol CAPSULE;ORAL 075592-001 May 25, 2000 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Impax Labs Inc URSODIOL ursodiol TABLET;ORAL 200826-001 Dec 23, 2011 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>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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