FOMEPIZOLE - Generic Drug Details
✉ Email this page to a colleague
What are the generic sources for fomepizole and what is the scope of patent protection?
Fomepizole
is the generic ingredient in two branded drugs marketed by Par Pharm Inc, Am Regent, Gland Pharma Ltd, Mylan Institutional, and Navinta Llc, and is included in six NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.Fomepizole has nine patent family members in eight countries.
There are five drug master file entries for fomepizole. Six suppliers are listed for this compound.
Summary for FOMEPIZOLE
| International Patents: | 9 |
| US Patents: | 1 |
| Tradenames: | 2 |
| Applicants: | 5 |
| NDAs: | 6 |
| Drug Master File Entries: | 5 |
| Finished Product Suppliers / Packagers: | 6 |
| Raw Ingredient (Bulk) Api Vendors: | 163 |
| Clinical Trials: | 5 |
| Patent Applications: | 3,087 |
| Drug Prices: | Drug price trends for FOMEPIZOLE |
| What excipients (inactive ingredients) are in FOMEPIZOLE? | FOMEPIZOLE excipients list |
| DailyMed Link: | FOMEPIZOLE at DailyMed |
Recent Clinical Trials for FOMEPIZOLE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Richard Dart, MD, PhD | Phase 2 |
| Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | |||
| Am Regent | FOMEPIZOLE | fomepizole | INJECTABLE;INJECTION | 078368-001 | Dec 14, 2007 | AP | RX | No | No | ⤷ 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 | |||
| Par Pharm Inc | ANTIZOL | fomepizole | INJECTABLE;INJECTION | 020696-001 | Dec 4, 1997 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Mylan Institutional | FOMEPIZOLE | fomepizole | INJECTABLE;INJECTION | 078639-001 | Mar 3, 2008 | AP | RX | No | Yes | ⤷ 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 |
International Patents for FOMEPIZOLE
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| China | 101163679 | Method of preparing ultrapure 4-methylpyrazole | ⤷ Sign Up |
| Mexico | 2007013118 | PROCESO PARA LA PREPARACION DE 4-METILPIRAZOL ULTRAPURO. (PROCESS FOR THE PREPARATION OF ULTRAPURE 4-METHYLPRAZOLE.) | ⤷ Sign Up |
| Japan | 2008538560 | ⤷ Sign Up | |
| Canada | 2605413 | 4-METHYLPYRAZOLE ULTRAPUR (PROCESS FOR THE PREPARATION OF ULTRAPURE 4-METHYLPYRAZOLE) | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 2006115626 | ⤷ Sign Up | |
| Australia | 2006240490 | Process for the preparation of ultrapure 4-methylprazole | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2024 - 2025
NCE-1 Patent Challenge Dates 2024 - 2025
Trigger-based marketing for the life sciences
Get DrugPatentWatch Business Intelligence Reports at Amazon.com
DrugChatter - AI-based answers to questions about drugs
RxJam - Digital Marketing for Life Sciences
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
See Primary Research Papers Citing DrugPatentWatch
Follow DrugPatentWatch:
