PROTONIX Drug Patent Profile
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Which patents cover Protonix, and when can generic versions of Protonix launch?
Protonix is a drug marketed by Wyeth Pharms and is included in three NDAs. There are four patents protecting this drug and two Paragraph IV challenges.
This drug has thirty-five patent family members in twenty-eight countries.
The generic ingredient in PROTONIX is pantoprazole sodium. There are forty-eight drug master file entries for this compound. Seventy-one suppliers are listed for this compound. Additional details are available on the pantoprazole sodium profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Protonix
A generic version of PROTONIX was approved as pantoprazole sodium by DR REDDYS LABS LTD on January 19th, 2011.
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Questions you can ask:
- What is the 5 year forecast for PROTONIX?
- What are the global sales for PROTONIX?
- What is Average Wholesale Price for PROTONIX?
Summary for PROTONIX
| International Patents: | 35 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 3 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 107 |
| Clinical Trials: | 32 |
| Patent Applications: | 3,613 |
| Drug Prices: | Drug price information for PROTONIX |
| Drug Sales Revenues: | Drug sales revenues for PROTONIX |
| What excipients (inactive ingredients) are in PROTONIX? | PROTONIX excipients list |
| DailyMed Link: | PROTONIX at DailyMed |
Recent Clinical Trials for PROTONIX
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
| Drug Class | Proton Pump Inhibitor |
| Mechanism of Action | Proton Pump Inhibitors |
Paragraph IV (Patent) Challenges for PROTONIX
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| PROTONIX | for Delayed-release Oral Suspension | pantoprazole sodium | 40 mg | 022020 | 1 | 2019-09-13 |
| PROTONIX | Delayed-release Tablets | pantoprazole sodium | 20 mg and 40 mg | 020987 | 2004-02-02 |
US Patents and Regulatory Information for PROTONIX
| 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 | pantoprazole sodium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 022020-001 | Nov 14, 2007 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Wyeth Pharms | PROTONIX IV | pantoprazole sodium | INJECTABLE;INTRAVENOUS | 020988-001 | Mar 22, 2001 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Wyeth Pharms | PROTONIX | pantoprazole sodium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 022020-001 | Nov 14, 2007 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Wyeth Pharms | PROTONIX | pantoprazole sodium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 022020-001 | Nov 14, 2007 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Wyeth Pharms | PROTONIX | pantoprazole sodium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 022020-001 | Nov 14, 2007 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | 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 |
Expired US Patents for PROTONIX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Wyeth Pharms | PROTONIX | pantoprazole sodium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 022020-001 | Nov 14, 2007 | ⤷ Sign Up | ⤷ Sign Up |
| Wyeth Pharms | PROTONIX | pantoprazole sodium | TABLET, DELAYED RELEASE;ORAL | 020987-002 | Jun 12, 2001 | ⤷ Sign Up | ⤷ Sign Up |
| Wyeth Pharms | PROTONIX | pantoprazole sodium | TABLET, DELAYED RELEASE;ORAL | 020987-001 | Feb 2, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| Wyeth Pharms | PROTONIX | pantoprazole sodium | TABLET, DELAYED RELEASE;ORAL | 020987-001 | Feb 2, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| Wyeth Pharms | PROTONIX | pantoprazole sodium | TABLET, DELAYED RELEASE;ORAL | 020987-002 | Jun 12, 2001 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for PROTONIX
See the table below for patents covering PROTONIX around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| South Korea | 100254021 | ⤷ Sign Up | |
| South Africa | 9204386 | ⤷ Sign Up | |
| Taiwan | I372066 | ⤷ Sign Up | |
| Bulgaria | 61796 | ⤷ Sign Up | |
| Germany | 19475025 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for PROTONIX
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0166287 | 96C0032 | Belgium | ⤷ Sign Up | PRODUCT NAME: PANTOPRAZOL. NATR. SESQUIHYDRAS PANTOPRAZOLE; NAT. REGISTRATION NO/DATE: 127 IS 98 F 3 19960222; FIRST REGISTRATION: SE 12131 19940506 |
| 0166287 | 96C0033 | Belgium | ⤷ Sign Up | PRODUCT NAME: EPTACOG ALFA (ACTIVATED); REGISTRATION NO/DATE: EU/1/96/006/002 19960223 |
| 0166287 | SPC/GB96/056 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: PANTOPRAZOLE AND ITS SALTS, HYDRATES AND HYDRATES OF ITS SALTS; REGISTERED: SE SE12131 19940506; UK 04889/0010 19960604 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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.
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