FOMEPIZOLE Drug Patent Profile
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Which patents cover Fomepizole, and when can generic versions of Fomepizole launch?
Fomepizole is a drug marketed by Am Regent, Gland Pharma Ltd, Mylan Institutional, and Navinta Llc. and is included in five NDAs.
The generic ingredient in FOMEPIZOLE is fomepizole. There are five drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the fomepizole profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Fomepizole
A generic version of FOMEPIZOLE was approved as fomepizole by AM REGENT on December 14th, 2007.
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Questions you can ask:
- What is the 5 year forecast for FOMEPIZOLE?
- What are the global sales for FOMEPIZOLE?
- What is Average Wholesale Price for FOMEPIZOLE?
Summary for FOMEPIZOLE
| US Patents: | 0 |
| Applicants: | 4 |
| NDAs: | 5 |
| Finished Product Suppliers / Packagers: | 6 |
| Raw Ingredient (Bulk) Api Vendors: | 163 |
| Clinical Trials: | 5 |
| Patent Applications: | 1,735 |
| Drug Prices: | Drug price information for FOMEPIZOLE |
| DailyMed Link: | FOMEPIZOLE at DailyMed |
Recent Clinical Trials for FOMEPIZOLE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | Phase 2 |
| Richard Dart, MD, PhD | Phase 2 |
| University of Arizona | Early Phase 1 |
Pharmacology for FOMEPIZOLE
| Drug Class | Antidote |
Anatomical Therapeutic Chemical (ATC) Classes for FOMEPIZOLE
Paragraph IV (Patent) Challenges for FOMEPIZOLE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| ANTIZOL | Injection | fomepizole | 1.5 g/1.5 mL | 020696 | 1 | 2021-11-01 |
| ANTIZOL | Injection | fomepizole | 1.5 g/1.5 mL | 020696 | 1 | 2014-04-14 |
US Patents and Regulatory Information for FOMEPIZOLE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Am Regent | FOMEPIZOLE | fomepizole | INJECTABLE;INJECTION | 078368-001 | Dec 14, 2007 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Mylan Institutional | FOMEPIZOLE | fomepizole | INJECTABLE;INJECTION | 078639-001 | Mar 3, 2008 | AP | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Gland Pharma Ltd | FOMEPIZOLE | fomepizole | INJECTABLE;INJECTION | 216791-001 | Jul 6, 2023 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Mylan Institutional | FOMEPIZOLE | fomepizole | INJECTABLE;INJECTION | 079033-001 | Apr 7, 2009 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Navinta Llc | FOMEPIZOLE | fomepizole | INJECTABLE;INJECTION | 078537-001 | Mar 6, 2008 | AP | 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 |
