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Citi
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Cantor Fitzgerald
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Harvard Business School
Express Scripts
Colorcon
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Generated: May 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020987

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NDA 020987 describes PROTONIX, which is a drug marketed by Wyeth Pharms Inc and is included in three NDAs. It is available from nine suppliers. There are seven patents protecting this drug and one Paragraph IV challenge. Additional details are available on the PROTONIX profile page.

The generic ingredient in PROTONIX is pantoprazole sodium. There are forty-eight drug master file entries for this compound. Sixty-three suppliers are listed for this compound. Additional details are available on the pantoprazole sodium profile page.
Summary for 020987
Tradename:PROTONIX
Applicant:Wyeth Pharms Inc
Ingredient:pantoprazole sodium
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 020987
Mechanism of ActionProton Pump Inhibitors
Suppliers and Packaging for NDA: 020987
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROTONIX pantoprazole sodium TABLET, DELAYED RELEASE;ORAL 020987 NDA Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. 0008-0841 N 0008-0841-81
PROTONIX pantoprazole sodium TABLET, DELAYED RELEASE;ORAL 020987 NDA Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. 0008-0843 N 0008-0843-81

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 40MG BASE
Approval Date:Feb 2, 2000TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 20MG BASE
Approval Date:Jun 12, 2001TE:ABRLD:Yes

Expired US Patents for NDA 020987

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Wyeth Pharms Inc PROTONIX pantoprazole sodium TABLET, DELAYED RELEASE;ORAL 020987-002 Jun 12, 2001 ➤ Try a Free Trial ➤ Try a Free Trial
Wyeth Pharms Inc PROTONIX pantoprazole sodium TABLET, DELAYED RELEASE;ORAL 020987-001 Feb 2, 2000 ➤ Try a Free Trial ➤ Try a Free Trial
Wyeth Pharms Inc PROTONIX pantoprazole sodium TABLET, DELAYED RELEASE;ORAL 020987-002 Jun 12, 2001 ➤ Try a Free Trial ➤ Try a Free Trial
Wyeth Pharms Inc PROTONIX pantoprazole sodium TABLET, DELAYED RELEASE;ORAL 020987-001 Feb 2, 2000 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Cipla
Colorcon
Teva
Baxter
Dow
Fish and Richardson
Covington
Argus Health

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