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Generated: May 30, 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, Mylan Pharms Inc, Torrent Pharms, Kremers Urban Pharms, Hetero Labs Ltd V, Sandoz Inc, Akorn Inc, and Actavis Totowa, and is included in twenty-three NDAs. There are nine patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Pantoprazole sodium has ninety-eight patent family members in forty-seven countries.

There are forty-six drug master file entries for pantoprazole sodium. Fifty-nine suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for Generic Name: pantoprazole sodium

Drug Master File Entries: see list46
Suppliers / Packagers: see list59
Bulk Api Vendors: see list105
Clinical Trials: see list979
Patent Applications: see list6,034
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. Strength Dosage Form
► Subscribe► Subscribe40MGINJECTABLE; INJECTION
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
TABLET, DELAYED RELEASE;ORAL202038-002Sep 28, 2012ABRXNoNo► Subscribe► Subscribe
Dr Reddys Labs Ltd
pantoprazole sodium
TABLET, DELAYED RELEASE;ORAL077619-002Jan 19, 2011ABRXNoNo► Subscribe► Subscribe
Apotex Inc
pantoprazole sodium
TABLET, DELAYED RELEASE;ORAL090807-002May 2, 2012ABRXNoNo► Subscribe► Subscribe
Actavis Totowa
pantoprazole sodium
TABLET, DELAYED RELEASE;ORAL090797-001Feb 7, 2011ABRXNoNo► Subscribe► Subscribe
Perrigo R And D
pantoprazole sodium
TABLET, DELAYED RELEASE;ORAL203024-001May 7, 2014ABRXNoNo► Subscribe► Subscribe
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