See also: Generic Protonix IV
Protonix is a brand name of pantoprazole, approved by the FDA in the following formulation(s):
PROTONIX (pantoprazole sodium - for suspension, delayed release; oral)
Manufacturer: WYETH PHARMS INC
Approval date: November 14, 2007
Strength(s): EQ 40MG BASE [RLD]
PROTONIX (pantoprazole sodium - tablet, delayed release; oral)
Manufacturer: WYETH PHARMS INC
Approval date: February 2, 2000
Strength(s): EQ 40MG BASE [RLD][AB]
Manufacturer: WYETH PHARMS INC
Approval date: June 12, 2001
Strength(s): EQ 20MG BASE [AB]
Has a generic version of Protonix been approved?
A generic version of Protonix has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Protonix and have been approved by the FDA:
pantoprazole sodium tablet, delayed release; oral
Manufacturer: ACTAVIS TOTOWA
Approval date: February 7, 2011
Strength(s): EQ 20MG BASE [AB], EQ 40MG BASE [AB]
Manufacturer: DR REDDYS LABS LTD
Approval date: January 19, 2011
Strength(s): EQ 20MG BASE [AB], EQ 40MG BASE [AB]
Manufacturer: JUBILANT ORGANOSYS
Approval date: August 30, 2011
Strength(s): EQ 20MG BASE [AB], EQ 40MG BASE [AB]
Manufacturer: KUDCO IRELAND
Approval date: January 20, 2011
Strength(s): EQ 20MG BASE [AB], EQ 40MG BASE [AB]
Manufacturer: MACLEODS PHARMS LTD
Approval date: February 16, 2012
Strength(s): EQ 20MG BASE [AB], EQ 40MG BASE [AB]
Manufacturer: MATRIX LABS LTD
Approval date: January 19, 2011
Strength(s): EQ 20MG BASE [AB], EQ 40MG BASE [AB]
Manufacturer: SUN PHARMA GLOBAL
Approval date: September 10, 2007
Strength(s): EQ 20MG BASE [AB], EQ 40MG BASE [AB]
Manufacturer: TEVA
Approval date: August 2, 2007
Strength(s): EQ 20MG BASE [AB], EQ 40MG BASE [AB]
Manufacturer: TORRENT PHARMS
Approval date: January 19, 2011
Strength(s): EQ 20MG BASE [AB], EQ 40MG BASE [AB]
Manufacturer: WOCKHARDT
Approval date: January 19, 2011
Strength(s): EQ 20MG BASE [AB], EQ 40MG BASE [AB]
Note: No generic formulation of the following product is available.
- pantoprazole sodium - for suspension, delayed release; oral
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Protonix. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: About generic drugs.
Related Patents
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
Oral-administration forms of a medicament containing pantoprazol
Patent 5,997,903
Issued: December 7, 1999
Inventor(s): Dietrich; Rango & Ney; Hartmut
Assignee(s): Byk Gulden Lomberg Chemische Fabrik GmbH
The invention relates to oral presentation forms for pantoprazole, which consist of a core, an intermediate layer and an outer layer which is resistant to gastric juice.Patent expiration dates:
- December 7, 2016
- June 7, 2017✓
- December 7, 2016
Pantoprazole multiparticulate formulations
Patent 7,544,370
Issued: June 9, 2009
Inventor(s): Venkata Ramana Rao; Sripriya & Shah; Syed M. & Tatapudy; Hanumantharao & Saunders; Richard William & Fawzi; Mahdi & Nagi; Arwinder & Singh; Shailesh & Hasan; Sumon A.
Assignee(s): Wyeth
Pantoprazole sodium multiparticulates are described which avoid sticking to nasogastric and gastronomy tubes. The pantoprazole multiparticulates have a spheroid core of pantoprazole or an enantiomer thereof, or a salt thereof, a surfactant, and a distintegrant; a sub coat which is comprised of hydroxypropyl methylcellulose (hypromellose) and water, an enteric coat on the sub-coat, and a final seal coat over the enteric coat, which is composed of hydroxypropyl methylcellulose (hypromellose) and water.Patent expiration dates:
- June 7, 2026✓
- December 7, 2026✓
- June 7, 2026
Pantoprazole multiparticulate formulations
Patent 7,550,153
Issued: June 23, 2009
Inventor(s): Venkata Ramana Rao; Sripriya & Shah; Syed M. & Tatapudy; Hanumantharao & Saunders; Richard William & Fawzi; Mahdi & Nagi; Arwinder & Singh; Shailesh & Hasan; Sumon A
Assignee(s): Wyeth
Pantoprazole sodium multiparticulates are described which avoid sticking to nasogastric and gastronomy tubes. The pantoprazole multiparticulates have a spheroid core of pantoprazole or an enantiomer thereof, or a salt thereof, a surfactant, and a disintegrant; a sub coat which is comprised of hydroxypropyl methylcellulose(hypromellose) and water, an enteric coat on the sub-coat, and a final seal coat over the enteric coat, which is composed of hydroxypropyl methylcellulose(hypromellose) and water.Patent expiration dates:
- September 30, 2024✓
- March 30, 2025✓
- September 30, 2024
Pantoprazole multiparticulate formulations
Patent 7,553,498
Issued: June 30, 2009
Inventor(s): Venkata Ramana Rao; Sripriya & Shah; Syed M. & Tatapudy; Hanumantharao & Saunders; Richard William & Fawzi; Mahdi & Nagi; Arwinder & Singh; Shailesh & Hasan; Sumon A
Assignee(s): Wyeth
A method of treating gastroesophageal reflux disease (GERD), ulcers of the stomach or duodenum, or Zollinger-Ellison Syndrome in a human, by administering pantoprazole sodium multiparticulates is described. The pantoprazole multiparticulates have a spheroid core of pantoprazole or an enantiomer thereof, or a salt thereof, a surfactant, and a disintegrant; a sub coat which is comprised of hydroxypropyl methylcellulose (hypromellose) and water, an enteric coat on the subcoat, and a final seal coat over the enteric coat, which is composed of hydroxypropyl methylcellulose (hypromellose) and water.Patent expiration dates:
- September 30, 2024✓
- March 30, 2025✓
- September 30, 2024
Pantoprazole multiparticulate formulations
Patent 7,838,027
Issued: November 23, 2010
Inventor(s): Venkata Ramana Rao; Sripriya & Shah; Syed M. & Tatapudy; Hanumantharao & Saunders; Richard William & Fawzi; Mahdi & Nagi; Arwinder & Singh; Shailesh & Hasan; Sumon A.
Assignee(s): Wyeth LLC
Pantoprazole sodium multiparticulates are described which avoid sticking to nasogastric and gastronomy tubes. The pantoprazole multiparticulates have a spheroid core of pantoprazole or an enantiomer thereof, or a salt thereof, a surfactant, and a disintegrant; a sub coat which is comprised of hydroxypropyl methylcellulose (hypromellose) and water, an enteric coat on the sub-coat, and a final seal coat over the enteric coat, which is composed of hydroxypropyl methylcellulose (hypromellose) and water.Patent expiration dates:
- September 30, 2024✓✓
- March 30, 2025✓
- September 30, 2024
Related Exclusivities
Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.
- Exclusivity expiration dates:
- November 12, 2012 - INFORMATION FROM PEDIATRIC STUDIES ADDED TO LABEL
- November 12, 2012 - SHORT TERM TREATMENT OF EROSIVE ESOPHAGITIS ASSOCIATED WITH GERD IN PEDIATRIC PATIENTS AGES FIVE YEARS AND OLDER
- May 12, 2013 - PEDIATRIC EXCLUSIVITY
See also...
- Protonix Consumer Information (Drugs.com)
- Protonix Delayed-Release Tablets Consumer Information (Wolters Kluwer)
- Protonix Suspension Consumer Information (Wolters Kluwer)
- Protonix Consumer Information (Cerner Multum)
- Protonix Advanced Consumer Information (Micromedex)
- Protonix Intravenous Advanced Consumer Information (Micromedex)
- Protonix AHFS DI Monographs (ASHP)
- Pantoprazole Consumer Information (Wolters Kluwer)
- Pantoprazole Delayed-Release Tablets Consumer Information (Wolters Kluwer)
- Pantoprazole Suspension Consumer Information (Wolters Kluwer)
- Pantoprazole Consumer Information (Cerner Multum)
- Pantoprazole Advanced Consumer Information (Micromedex)
- Pantoprazole Intravenous Advanced Consumer Information (Micromedex)
- Pantoprazole Sodium AHFS DI Monographs (ASHP)
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