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Generated: December 16, 2017

DrugPatentWatch Database Preview

PROTONIX Drug Profile

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Which patents cover Protonix, and what generic alternatives are available?

Protonix is a drug marketed by Wyeth Pharms Inc and is included in three NDAs. There are eight patents protecting this drug and one Paragraph IV challenge.

This drug has forty-seven patent family members in thirty-three countries and two supplementary protection certificates in two countries.

The generic ingredient in PROTONIX is pantoprazole sodium. There are forty-seven drug master file entries for this compound. Sixty-one suppliers are listed for this compound. Additional details are available on the pantoprazole sodium profile page.

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Wyeth Pharms IncPROTONIXpantoprazole sodiumFOR SUSPENSION, DELAYED RELEASE;ORAL022020-001Nov 14, 2007RXYesYes► Subscribe► SubscribeY► Subscribe
Wyeth Pharms IncPROTONIX IVpantoprazole sodiumINJECTABLE;IV (INFUSION)020988-001Mar 22, 2001APRXYesYes► Subscribe► SubscribeY► Subscribe
Wyeth Pharms IncPROTONIXpantoprazole sodiumFOR SUSPENSION, DELAYED RELEASE;ORAL022020-001Nov 14, 2007RXYesYes► Subscribe► SubscribeY► Subscribe
Wyeth Pharms IncPROTONIX IVpantoprazole sodiumINJECTABLE;IV (INFUSION)020988-001Mar 22, 2001APRXYesYes► Subscribe► SubscribeY► Subscribe
Wyeth Pharms IncPROTONIXpantoprazole sodiumFOR SUSPENSION, DELAYED RELEASE;ORAL022020-001Nov 14, 2007RXYesYes► Subscribe► SubscribeY► Subscribe
Wyeth Pharms IncPROTONIXpantoprazole sodiumFOR SUSPENSION, DELAYED RELEASE;ORAL022020-001Nov 14, 2007RXYesYes► Subscribe► SubscribeY► Subscribe
Wyeth Pharms IncPROTONIXpantoprazole sodiumTABLET, DELAYED RELEASE;ORAL020987-001Feb 2, 2000ABRXYesYes► Subscribe► SubscribeY► Subscribe
Wyeth Pharms IncPROTONIXpantoprazole sodiumTABLET, DELAYED RELEASE;ORAL020987-002Jun 12, 2001ABRXYesNo► Subscribe► SubscribeY► Subscribe
Wyeth Pharms IncPROTONIX IVpantoprazole sodiumINJECTABLE;IV (INFUSION)020988-001Mar 22, 2001APRXYesYes► Subscribe► SubscribeY► Subscribe
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Expired Patents for Tradename: PROTONIX

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Wyeth Pharms IncPROTONIXpantoprazole sodiumTABLET, DELAYED RELEASE;ORAL020987-001Feb 2, 2000► Subscribe► Subscribe
Wyeth Pharms IncPROTONIXpantoprazole sodiumFOR SUSPENSION, DELAYED RELEASE;ORAL022020-001Nov 14, 2007► Subscribe► Subscribe
Wyeth Pharms IncPROTONIXpantoprazole sodiumTABLET, DELAYED RELEASE;ORAL020987-001Feb 2, 2000► Subscribe► Subscribe
Wyeth Pharms IncPROTONIXpantoprazole sodiumTABLET, DELAYED RELEASE;ORAL020987-002Jun 12, 2001► Subscribe► Subscribe
Wyeth Pharms IncPROTONIXpantoprazole sodiumTABLET, DELAYED RELEASE;ORAL020987-002Jun 12, 2001► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for PROTONIX

Drugname Dosage Strength RLD Submissiondate
pantoprazole sodiumDelayed-release Tablets20 mg and 40 mgProtonix2/2/2004

International Patent Family for Tradename: PROTONIX

Country Document Number Estimated Expiration
European Patent Office0519365► Subscribe
European Patent Office0589981► Subscribe
Denmark0589981► Subscribe
South Africa9204386► Subscribe
Germany59207438► Subscribe
Mexico9202961► Subscribe
Germany4219390► Subscribe
Bulgaria61796► Subscribe
China1037932► Subscribe
Japan3338052► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: PROTONIX

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0032Belgium► SubscribePRODUCT NAME: PANTOPRAZOL. NATR. SESQUIHYDRAS PANTOPRAZOLE; NAT. REGISTRATION NO/DATE: 127 IS 98 F 3 19960222; FIRST REGISTRATION: SE 12131 19940506
C/GB96/056United Kingdom► SubscribePRODUCT NAME: PANTOPRAZOLE AND ITS SALTS, HYDRATES AND HYDRATES OF ITS SALTS; REGISTERED: SE SE12131 19940506; UK 04889/0010 19960604
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Serving leading biopharmaceutical companies globally:

Moodys
Baxter
Chubb
Mallinckrodt
Chinese Patent Office
McKinsey
Accenture
Teva
Express Scripts
Federal Trade Commission

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 verifification 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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