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 one Paragraph IV challenge.
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. Four 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.
Summary for ANTIZOL
| International Patents: | 9 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 163 |
| Clinical Trials: | 2 |
| Patent Applications: | 2,036 |
| Formulation / Manufacturing: | see details |
| What excipients (inactive ingredients) are in ANTIZOL? | ANTIZOL excipients list |
| DailyMed Link: | ANTIZOL at DailyMed |
Recent Clinical Trials for ANTIZOL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Horizon Pharma USA, Inc. | Phase 2 |
| Ted Daley, President | Phase 2 |
| Raptor Pharmaceuticals Inc. | Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for ANTIZOL
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 |
US Patents and Regulatory Information for ANTIZOL
ANTIZOL is protected by one US patents.
Patents protecting ANTIZOL
Ultrapure 4-methylpyrazole
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Par Pharm Inc | ANTIZOL | fomepizole | INJECTABLE;INJECTION | 020696-001 | Dec 4, 1997 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ 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 |
International Patents for ANTIZOL
See the table below for patents covering ANTIZOL around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Canada | 2605413 | 4-METHYLPYRAZOLE ULTRAPUR (PROCESS FOR THE PREPARATION OF ULTRAPURE 4-METHYLPYRAZOLE) | ⤷ Try a Trial |
| European Patent Office | 1948613 | PROCEDE POUR LA PREPARATION DE LA 4-METHYLPYRAZOLE ULTRAPURE (PROCESS FOT THE PREPARATION OF ULTRAPURE 4-METHYLPYRAZOLE) | ⤷ Try a Trial |
| World Intellectual Property Organization (WIPO) | 2006115626 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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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.
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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2023, www.DrugPatentWatch.com.
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