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Generated: November 18, 2017

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Pantoprazole sodium - Generic Drug Details

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What are the generic drug sources for pantoprazole sodium and what is the scope of pantoprazole sodium freedom to operate?

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 Pharm Inds Ltd, Exela Pharma Scs Llc, Mylan Pharms Inc, Torrent Pharms, Kremers Urban Pharms, Hetero Labs Ltd V, Sandoz Inc, Akorn Inc, and Actavis Totowa, and is included in twenty-four NDAs. There are eight patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Pantoprazole sodium has one hundred and five patent family members in forty-seven countries and two supplementary protection certificates in two countries.

There are forty-seven drug master file entries for pantoprazole sodium. Sixty-two suppliers are listed for this compound. There are two tentative approvals for this compound.

Pharmacology for pantoprazole sodium

Drug ClassProton Pump Inhibitor
Mechanism of ActionProton Pump Inhibitors

Tentative approvals for PANTOPRAZOLE SODIUM

Applicant Application No. Strength Dosage Form
u► Subscribe40MGINJECTABLE; INJECTION
u► SubscribeEQ 40MG BASE/VIALINJECTABLE; IV (INFUSION)
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aurobindo Pharma Ltd
PANTOPRAZOLE SODIUM
pantoprazole sodium
TABLET, DELAYED RELEASE;ORAL202038-001Sep 28, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe
Teva
PANTOPRAZOLE SODIUM
pantoprazole sodium
TABLET, DELAYED RELEASE;ORAL077056-001Aug 2, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
Wockhardt
PANTOPRAZOLE SODIUM
pantoprazole sodium
TABLET, DELAYED RELEASE;ORAL091231-002Jan 19, 2011ABRXNoNo► Subscribe► Subscribe► Subscribe
Sun Pharm Inds Ltd
PANTOPRAZOLE SODIUM
pantoprazole sodium
TABLET, DELAYED RELEASE;ORAL200794-001May 2, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe
Sun Pharm Inds Ltd
PANTOPRAZOLE SODIUM
pantoprazole sodium
TABLET, DELAYED RELEASE;ORAL077058-002Sep 10, 2007DISCNNoNo► Subscribe► Subscribe► Subscribe
Mylan Pharms Inc
PANTOPRAZOLE SODIUM
pantoprazole sodium
TABLET, DELAYED RELEASE;ORAL090970-001Jan 19, 2011ABRXNoNo► Subscribe► Subscribe► Subscribe
Jubilant Generics
PANTOPRAZOLE SODIUM
pantoprazole sodium
TABLET, DELAYED RELEASE;ORAL090901-002Aug 30, 2011ABRXNoNo► Subscribe► Subscribe► Subscribe
Amneal Pharms
PANTOPRAZOLE SODIUM
pantoprazole sodium
TABLET, DELAYED RELEASE;ORAL205119-002Jan 26, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Wyeth Pharms Inc
PROTONIX IV
pantoprazole sodium
INJECTABLE;IV (INFUSION)020988-001Mar 22, 2001APRXYesYes► Subscribe► SubscribeY► Subscribe
Apotex Inc
PANTOPRAZOLE SODIUM
pantoprazole sodium
TABLET, DELAYED RELEASE;ORAL090807-001May 2, 2012ABRXNoNo► Subscribe► Subscribe► 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
TABLET, DELAYED RELEASE;ORAL020987-001Feb 2, 2000► Subscribe► Subscribe
Wyeth Pharms Inc
PROTONIX
pantoprazole sodium
FOR SUSPENSION, DELAYED RELEASE;ORAL022020-001Nov 14, 2007► Subscribe► Subscribe
Wyeth Pharms Inc
PROTONIX
pantoprazole sodium
TABLET, DELAYED RELEASE;ORAL020987-002Jun 12, 2001► Subscribe► Subscribe
Wyeth Pharms Inc
PROTONIX
pantoprazole sodium
TABLET, DELAYED RELEASE;ORAL020987-001Feb 2, 2000► Subscribe► Subscribe
Wyeth Pharms Inc
PROTONIX
pantoprazole sodium
TABLET, DELAYED RELEASE;ORAL020987-002Jun 12, 2001► Subscribe► Subscribe
Wyeth Pharms Inc
PROTONIX IV
pantoprazole sodium
INJECTABLE;IV (INFUSION)020988-001Mar 22, 2001► Subscribe► Subscribe
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International Patent Family for Ingredient: pantoprazole sodium

Country Document Number Estimated Expiration
South Korea20030055308► Subscribe
Czech Republic304348► Subscribe
Finland935677► Subscribe
Serbia52024► Subscribe
European Patent Office0589981► Subscribe
South Korea100910606► Subscribe
MexicoPA03004548► Subscribe
CroatiaP920162► Subscribe
Hungary219247► Subscribe
World Intellectual Property Organization (WIPO)0241919► 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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Serving leading biopharmaceutical companies globally:

Medtronic
Federal Trade Commission
Healthtrust
Chubb
Argus Health
AstraZeneca
Julphar
US Army
McKinsey
Farmers Insurance

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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