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, Hibrow Hlthcare, Impax Labs Inc, Lannett Co Inc, Lgm Pharma, Norvium Bioscience, Rising, Rk Pharma, Strides Pharma, Teva Pharms, Zydus Lifesciences, Endo Operations, Epic Pharma Llc, Glenmark Pharms Ltd, and Teva Pharms Usa. and is included in twenty-two NDAs.
The generic ingredient in URSODIOL 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 Ursodiol
A generic version of URSODIOL was approved as ursodiol by EPIC PHARMA on March 14th, 2000.
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Questions you can ask:
- What is the 5 year forecast for URSODIOL?
- What are the global sales for URSODIOL?
- What is Average Wholesale Price for URSODIOL?
Summary for URSODIOL
| US Patents: | 0 |
| Applicants: | 19 |
| NDAs: | 22 |
| Finished Product Suppliers / Packagers: | 28 |
| Raw Ingredient (Bulk) Api Vendors: | 93 |
| Clinical Trials: | 38 |
| Patent Applications: | 4,515 |
| Drug Prices: | Drug price information for URSODIOL |
| Drug Sales Revenues: | Drug sales revenues 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 | Phase 1 |
| University of Minnesota - Clinical and Translational Science Institute | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Teva Pharms Usa | URSODIOL | ursodiol | TABLET;ORAL | 079184-002 | May 13, 2009 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Zydus Lifesciences | URSODIOL | ursodiol | TABLET;ORAL | 211145-001 | Oct 30, 2018 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Abhai Llc | URSODIOL | ursodiol | CAPSULE;ORAL | 210707-001 | May 17, 2018 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Endo Operations | URSODIOL | ursodiol | TABLET;ORAL | 202540-002 | Feb 14, 2013 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Impax Labs Inc | URSODIOL | ursodiol | TABLET;ORAL | 200826-002 | Dec 23, 2011 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Impax Labs Inc | URSODIOL | ursodiol | CAPSULE;ORAL | 077895-001 | Jul 27, 2006 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Chartwell Rx | URSODIOL | ursodiol | CAPSULE;ORAL | 213555-001 | Aug 17, 2020 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
