URSO 250 Drug Patent Profile

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Which patents cover Urso 250, and what generic alternatives are available?

Urso 250 is a drug marketed by Abbvie and is included in one NDA.

The generic ingredient in URSO 250 is ursodiol. There are eight drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the ursodiol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Urso 250

A generic version of URSO 250 was approved as ursodiol by EPIC PHARMA on March 14^th, 2000.

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Summary for URSO 250

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for URSO 250

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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
Abbvie	URSO 250	ursodiol	TABLET;ORAL	020675-001	Dec 10, 1997		DISCN	Yes	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

International Patents for URSO 250

See the table below for patents covering URSO 250 around the world.

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Country	Patent Number	Title	Estimated Expiration
Canada	1318590	COMPOSITIONS PHARMACEUTIQUES CONTENANT DE L'ACIDE URSODESOXYCHOLIQUE (PHARMACEUTICAL COMPOSITIONS CONTAINING URSODEOXYCHOLIC ACID)	⤷ Start Trial
European Patent Office	0269516		⤷ Start Trial
France	2607005	COMPOSITIONS PHARMACEUTIQUES CONTENANT DE L'ACIDE URSODESOXYCHOLIQUE	⤷ Start Trial
Japan	S63141929	MEDICINAL COMPOSITION CONTAINING ULSODEOXYCHOLIC ACID	⤷ Start Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Last updated: July 11, 2026

URSO 250 (ursodiol 250 mg) investment scenario and fundamentals analysis: exclusivity, patent risk, FDA status, and revenue outlook

Executive summary: URSO 250 is an ursodiol (ursodeoxycholic acid) immediate-release tablet product. From an IP and competition standpoint, ursodiol is a legacy bile-acid therapy with extensive, time-limited patent coverage around specific formulations, strengths, and manufacturing methods, while the core drug substance is widely generic. Investment-relevant risk is driven less by long-running “brand” exclusivity and more by (1) Orange Book status for the specific URSO 250 NDC/strength, (2) whether any late-life, product-specific patents still block ANDA filings, and (3) pricing and market-share erosion from low-cost generics and pharmacy-channel stocking dynamics. On the FDA fundamentals side, ursodiol has a mature, predictable prescribing footprint in cholestatic and hepatobiliary indications, but URSO 250 competes primarily through price and formulary access rather than differentiated clinical innovation.

Because a complete fundamentals pack requires the exact URSO 250 NDC(s), Orange Book listing(s), and current prescribing/revenue data for the brand product line, the analysis cannot be produced accurately without those specifics.

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Summary for URSO 250

URSO 250 (ursodiol 250 mg) investment scenario and fundamentals analysis: exclusivity, patent risk, FDA status, and revenue outlook

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