PROTONIX IV Drug Patent Profile
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When do Protonix Iv patents expire, and what generic alternatives are available?
Protonix Iv is a drug marketed by Wyeth Pharms and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.
This drug has fifty-eight patent family members in forty countries.
The generic ingredient in PROTONIX IV is pantoprazole sodium. There are forty-eight drug master file entries for this compound. Sixty-two suppliers are listed for this compound. Additional details are available on the pantoprazole sodium profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Protonix Iv
A generic version of PROTONIX IV was approved as pantoprazole sodium by DR REDDYS LABS LTD on January 19th, 2011.
Summary for PROTONIX IV
International Patents: | 58 |
US Patents: | 3 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 28 |
Clinical Trials: | 32 |
Patent Applications: | 792 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for PROTONIX IV |
DailyMed Link: | PROTONIX IV at DailyMed |


Recent Clinical Trials for PROTONIX IV
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Pfizer | Phase 2 |
Mirati Therapeutics Inc. | Phase 1 |
Assiut University | Phase 2 |
Pharmacology for PROTONIX IV
Drug Class | Proton Pump Inhibitor |
Mechanism of Action | Proton Pump Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for PROTONIX IV
Paragraph IV (Patent) Challenges for PROTONIX IV
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
PROTONIX IV | For Injection | pantoprazole sodium | 40 mg/vial | 020988 | 1 | 2005-04-07 |
US Patents and Regulatory Information for PROTONIX IV
PROTONIX IV is protected by two US patents.
Patents protecting PROTONIX IV
Freeze-dried pantoprazole preparation and pantoprazole injection
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Freeze-dried pantoprazole preparation and pantoprazole injection
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Wyeth Pharms | PROTONIX IV | pantoprazole sodium | INJECTABLE;INTRAVENOUS | 020988-001 | Mar 22, 2001 | AP | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Wyeth Pharms | PROTONIX IV | pantoprazole sodium | INJECTABLE;INTRAVENOUS | 020988-001 | Mar 22, 2001 | AP | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Wyeth Pharms | PROTONIX IV | pantoprazole sodium | INJECTABLE;INTRAVENOUS | 020988-001 | Mar 22, 2001 | AP | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 |
Expired US Patents for PROTONIX IV
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Wyeth Pharms | PROTONIX IV | pantoprazole sodium | INJECTABLE;INTRAVENOUS | 020988-001 | Mar 22, 2001 | ⤷ Try a Trial | ⤷ Try a Trial |
Wyeth Pharms | PROTONIX IV | pantoprazole sodium | INJECTABLE;INTRAVENOUS | 020988-001 | Mar 22, 2001 | ⤷ Try a Trial | ⤷ Try a Trial |
Wyeth Pharms | PROTONIX IV | pantoprazole sodium | INJECTABLE;INTRAVENOUS | 020988-001 | Mar 22, 2001 | ⤷ Try a Trial | ⤷ Try a Trial |
Wyeth Pharms | PROTONIX IV | pantoprazole sodium | INJECTABLE;INTRAVENOUS | 020988-001 | Mar 22, 2001 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for PROTONIX IV
See the table below for patents covering PROTONIX IV around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Poland | 201188 | ⤷ Try a Trial | |
Canada | 1254215 | DIALKOXYPIRIDINES, ET LEUR PREPARATION (DIALKOXYPYRIDINES AND PROCESS FOR THEIR PREPARATION) | ⤷ Try a Trial |
New Zealand | 212415 | 2-BENZIMIDAZOLYL 2-PYRIDYLMETHYLSULPHIDE DERIVATIVES AND PHARMACEUTICAL COMPOSITIONS | ⤷ Try a Trial |
South Korea | 20080003010 | ⤷ Try a Trial | |
Czech Republic | 304348 | Způsob výroby lyofilizovaného prostředku (Process for preparing lyophilized preparation) | ⤷ Try a Trial |
Israel | 75400 | DIALKOXYPYRIDINE METHYL(SULFINYL OR SULFONYL)BENZIMIDAZOLES,PROCESSES FOR THE PREPARATION THEREOF AND PHARMACEUTICAL COMPOSITIONS CONTAINING THE SAME | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for PROTONIX IV
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0166287 | SPC/GB96/056 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: PANTOPRAZOLE AND ITS SALTS, HYDRATES AND HYDRATES OF ITS SALTS; REGISTERED: SE SE12131 19940506; UK 04889/0010 19960604 |
0166287 | 96C0033 | Belgium | ⤷ Try a Trial | PRODUCT NAME: EPTACOG ALFA (ACTIVATED); REGISTRATION NO/DATE: EU/1/96/006/002 19960223 |
0166287 | 96C0032 | Belgium | ⤷ Try a Trial | PRODUCT NAME: PANTOPRAZOL. NATR. SESQUIHYDRAS PANTOPRAZOLE; NAT. REGISTRATION NO/DATE: 127 IS 98 F 3 19960222; FIRST REGISTRATION: SE 12131 19940506 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |