ANTIZOL Drug Patent Profile
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Which patents cover Antizol, and when can generic versions of Antizol launch?
Antizol is a drug marketed by Par Pharm Inc and is included in one NDA. There is one patent protecting this drug and two Paragraph IV challenges.
This drug has nine patent family members in eight countries.
The generic ingredient in ANTIZOL 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 Antizol
A generic version of ANTIZOL 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 ANTIZOL?
- What are the global sales for ANTIZOL?
- What is Average Wholesale Price for ANTIZOL?
Summary for ANTIZOL
International Patents: | 9 |
US Patents: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 163 |
Clinical Trials: | 2 |
Patent Applications: | 1,735 |
Formulation / Manufacturing: | see details |
What excipients (inactive ingredients) are in ANTIZOL? | ANTIZOL excipients list |
DailyMed Link: | ANTIZOL at DailyMed |
![ANTIZOL drug patent expirations Drug patent expirations by year for ANTIZOL](/p/graph/s/t/ANTIZOL-patent-expirations.png)
Recent Clinical Trials for ANTIZOL
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Raptor Pharmaceuticals Inc. | Phase 2 |
Horizon Pharma USA, Inc. | Phase 2 |
Ted Daley, President | Phase 2 |
Paragraph IV (Patent) Challenges for ANTIZOL
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 ANTIZOL
ANTIZOL is protected by one US patents.
Patents protecting ANTIZOL
Ultrapure 4-methylpyrazole
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Par Pharm Inc | ANTIZOL | fomepizole | INJECTABLE;INJECTION | 020696-001 | Dec 4, 1997 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ 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 ANTIZOL
See the table below for patents covering ANTIZOL around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 1948613 | PROCEDE POUR LA PREPARATION DE LA 4-METHYLPYRAZOLE ULTRAPURE (PROCESS FOT THE PREPARATION OF ULTRAPURE 4-METHYLPYRAZOLE) | ⤷ 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 | |
Japan | 5378788 | ⤷ Sign Up | |
Japan | 2008538560 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |