Medication Guide App

Generic Protonix Availability

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)

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 ELIZABETH
    Approval date: February 7, 2011
    Strength(s): EQ 20MG BASE [AB], EQ 40MG BASE [AB]
  • Manufacturer: APOTEX INC
    Approval date: May 2, 2012
    Strength(s): EQ 20MG BASE [AB], EQ 40MG BASE [AB]
  • Manufacturer: AUROBINDO PHARMA LTD
    Approval date: September 28, 2012
    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: HETERO LABS LTD V
    Approval date: September 10, 2014
    Strength(s): EQ 20MG BASE [AB], EQ 40MG BASE [AB]
  • Manufacturer: JUBILANT GENERICS
    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: MYLAN PHARMS INC
    Approval date: January 19, 2011
    Strength(s): EQ 20MG BASE [AB], EQ 40MG BASE [AB]
  • Manufacturer: PERRIGO R AND D
    Approval date: May 7, 2014
    Strength(s): EQ 20MG BASE [AB]
  • Manufacturer: RANBAXY LABS LTD
    Approval date: May 2, 2012
    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
      ✓ 
      Pediatric exclusivity
  • 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
      ✓ 
      Drug product
    • December 7, 2026
      ✓ 
      Pediatric exclusivity
  • 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
      ✓ 
      Patent use: EROSIVE ESOPHAGITIS, HYPERSECRETORY CONDITIONS INCLUDING ZOLLINGER-ELLISON SYNDROME, MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS AND REDUCTION OF SYMPTOMS IN PATIENTS WITH GERD
    • March 30, 2025
      ✓ 
      Pediatric exclusivity
  • 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
      ✓ 
      Patent use: EROSIVE ESOPHAGITIS, HYPERSECRETORY CONDITIONS INCLUDING ZOLLINGER-ELLISON SYNDROME, MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS AND REDUCTION OF SYMPTOMS IN PATIENTS WITH GERD
    • March 30, 2025
      ✓ 
      Pediatric exclusivity
  • 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
      ✓ 
      Patent use: EROSIVE ESOPHAGITIS, HYPERSECRETORY CONDITIONS INCLUDING ZOLLINGER-ELLISON SYNDROME, MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS AND REDUCTION OF SYMPTOMS IN PATIENTS WITH GERD
      ✓ 
      Drug product
    • March 30, 2025
      ✓ 
      Pediatric exclusivity

Glossary

TermDefinition
Drug PatentA drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug ExclusivityExclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLDA Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.
ABProducts meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (i.e., identical active ingredients(s), dosage form, and route(s) of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (i.e., AB1, AB2, AB3, etc.). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.
Hide
(web5)