You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 29, 2024

Details for New Drug Application (NDA): 020987


✉ Email this page to a colleague

« Back to Dashboard


NDA 020987 describes PROTONIX, which is a drug marketed by Wyeth Pharms and is included in three NDAs. It is available from two suppliers. There are four 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-seven suppliers are listed for this compound. Additional details are available on the pantoprazole sodium profile page.
Summary for 020987
Tradename:PROTONIX
Applicant:Wyeth Pharms
Ingredient:pantoprazole sodium
Patents:0
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 0008-0841-81 90 TABLET, DELAYED RELEASE in 1 BOTTLE (0008-0841-81)
PROTONIX pantoprazole sodium TABLET, DELAYED RELEASE;ORAL 020987 NDA Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. 0008-0843 0008-0843-81 90 TABLET, DELAYED RELEASE in 1 BOTTLE (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 PROTONIX pantoprazole sodium TABLET, DELAYED RELEASE;ORAL 020987-002 Jun 12, 2001 ⤷  Try a Trial ⤷  Try a Trial
Wyeth Pharms PROTONIX pantoprazole sodium TABLET, DELAYED RELEASE;ORAL 020987-002 Jun 12, 2001 ⤷  Try a Trial ⤷  Try a Trial
Wyeth Pharms PROTONIX pantoprazole sodium TABLET, DELAYED RELEASE;ORAL 020987-001 Feb 2, 2000 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.