URSODIOL Drug Patent Profile
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Which patents cover Ursodiol, and what generic alternatives are available?
Ursodiol is a drug marketed by Abhai Llc, Amneal Pharms Co, Aurobindo Pharma Ltd, Chartwell Rx, Epic Pharma, Eywa Pharma, Impax Labs Inc, Lannett Co Inc, Lgm Pharma, Mylan, Rising, Rk Pharma, Strides Pharma, Teva Pharms, Zydus, Glenmark Generics, Par Pharm, and Teva Pharms Usa. and is included in twenty-one NDAs.
The generic ingredient in URSODIOL is ursodiol. There are eight drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the ursodiol profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Ursodiol
A generic version of URSODIOL was approved as ursodiol by EPIC PHARMA on March 14th, 2000.
Summary for URSODIOL
US Patents: | 0 |
Applicants: | 18 |
NDAs: | 21 |
Finished Product Suppliers / Packagers: | 26 |
Raw Ingredient (Bulk) Api Vendors: | 93 |
Clinical Trials: | 38 |
Patent Applications: | 4,741 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for URSODIOL |
What excipients (inactive ingredients) are in URSODIOL? | URSODIOL excipients list |
DailyMed Link: | URSODIOL at DailyMed |
Recent Clinical Trials for URSODIOL
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Asmaa Abdelfattah Elsayed | Phase 4 |
University of Minnesota - Clinical and Translational Science Institute | Phase 1 |
University of Minnesota | Phase 1 |
Pharmacology for URSODIOL
Drug Class | Bile 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Zydus | URSODIOL | ursodiol | TABLET;ORAL | 211145-002 | Oct 30, 2018 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Abhai Llc | URSODIOL | ursodiol | CAPSULE;ORAL | 210707-001 | May 17, 2018 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Glenmark Generics | URSODIOL | ursodiol | TABLET;ORAL | 090801-002 | Jul 12, 2011 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Strides Pharma | URSODIOL | ursodiol | TABLET;ORAL | 213504-002 | Aug 20, 2020 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Impax Labs Inc | URSODIOL | ursodiol | CAPSULE;ORAL | 077895-001 | Jul 27, 2006 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |