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Pantoprazole sodium - Generic Drug Details

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Pantoprazole sodium is the generic ingredient in three branded drugs marketed by Jubilant Generics, Apotex Inc, Amneal Pharms, Dr Reddys Labs Ltd, Wyeth Pharms Inc, Macleods Pharms Ltd, Perrigo R And D, Wockhardt, Aurobindo Pharma Ltd, Orchid Hlthcare, Teva, Sun Pharma Global, Mylan Pharms Inc, Torrent Pharms, Kremers Urban Pharms, Hetero Labs Ltd V, Sun Pharm Inds Ltd, Sandoz Inc, Akorn Inc, and Actavis Totowa, and is included in twenty-three NDAs. There are eight patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has ninety-eight patent family members in forty-seven countries.

There are forty-six drug master file entries for pantoprazole sodium. Sixty suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: pantoprazole sodium

Tradenames:3
Patents:8
Applicants:20
NDAs:23
Drug Master File Entries: see list46
Suppliers / Packagers: see list60
Bulk Api Vendors: see list105
Clinical Trials: see list979
Patent Applications: see list3,506
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:pantoprazole sodium at DailyMed

Pharmacology for Ingredient: pantoprazole sodium

Drug ClassProton Pump Inhibitor
Mechanism of ActionProton Pump Inhibitors

Tentative approvals for PANTOPRAZOLE SODIUM

Applicant Application No. Form Dosage
<disabled><disabled>INJECTABLE; INJECTION40MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharm Inds Ltd
PANTOPRAZOLE SODIUM
pantoprazole sodium
TABLET, DELAYED RELEASE;ORAL200794-002May 2, 2012RXNoNo► subscribe► subscribe
Actavis Totowa
PANTOPRAZOLE SODIUM
pantoprazole sodium
TABLET, DELAYED RELEASE;ORAL090797-001Feb 7, 2011RXNoNo► subscribe► subscribe
Wyeth Pharms Inc
PROTONIX IV
pantoprazole sodium
INJECTABLE;IV (INFUSION)020988-001Mar 22, 2001RXYesYes8,754,108*PED► subscribeY► subscribe
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Expired Orange Book Patents for Generic Ingredient: pantoprazole sodium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Wyeth Pharms Inc
PROTONIX
pantoprazole sodium
FOR SUSPENSION, DELAYED RELEASE;ORAL022020-001Nov 14, 20074,758,579*PED► subscribe
Wyeth Pharms Inc
PROTONIX
pantoprazole sodium
TABLET, DELAYED RELEASE;ORAL020987-002Jun 12, 20014,758,579*PED► subscribe
Wyeth Pharms Inc
PROTONIX IV
pantoprazole sodium
INJECTABLE;IV (INFUSION)020988-001Mar 22, 20014,758,579*PED► subscribe
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International Patent Family for Ingredient: pantoprazole sodium

Country Document Number Estimated Expiration
Portugal1339430► subscribe
Cyprus1107896► subscribe
Poland361118► 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: PANTOPRAZOLE SODIUM

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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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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