Generic Prilosec Availability

Prilosec is a brand name of omeprazole, approved by the FDA in the following formulation(s):

PRILOSEC (omeprazole - capsule, delayed rel pellets;oral)

  • Manufacturer: ASTRAZENECA
    Approval date: September 14, 1989
    Strength(s): 20MG [RLD] [AB]
  • Manufacturer: ASTRAZENECA
    Approval date: October 5, 1995
    Strength(s): 10MG [AB]
  • Manufacturer: ASTRAZENECA
    Approval date: January 15, 1998
    Strength(s): 40MG [RLD] [AB]

PRILOSEC (omeprazole magnesium - for suspension, delayed release;oral)

  • Manufacturer: ASTRAZENECA
    Approval date: March 20, 2008
    Strength(s): EQ 2.5MG BASE/PACKET, EQ 10MG BASE/PACKET [RLD]

Has a generic version of Prilosec been approved?

A generic version of Prilosec 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 Prilosec and have been approved by the FDA:

omeprazole capsule, delayed rel pellets;oral

  • Manufacturer: APOTEX
    Approval date: October 22, 2007
    Strength(s): 10MG [AB], 20MG [AB]
  • Manufacturer: APOTEX
    Approval date: January 21, 2009
    Strength(s): 40MG [AB]
  • Manufacturer: DR REDDYS LABS LTD
    Approval date: October 22, 2007
    Strength(s): 10MG [AB], 20MG [AB]
  • Manufacturer: DR REDDYS LABS LTD
    Approval date: January 21, 2009
    Strength(s): 40MG [AB]
  • Manufacturer: DR REDDYS LABS LTD
    Approval date: March 16, 2009
    Strength(s): 10MG [AB], 20MG [AB]
  • Manufacturer: DR REDDYS LABS LTD
    Approval date: April 17, 2009
    Strength(s): 40MG [AB]
  • Manufacturer: IMPAX LABS
    Approval date: October 22, 2007
    Strength(s): 10MG [AB], 20MG [AB]
  • Manufacturer: IMPAX LABS
    Approval date: January 21, 2009
    Strength(s): 40MG [AB]
  • Manufacturer: KREMERS URBAN PHARMS
    Approval date: November 1, 2002
    Strength(s): 10MG [AB], 20MG [AB]
  • Manufacturer: KREMERS URBAN PHARMS
    Approval date: January 23, 2009
    Strength(s): 40MG [AB]
  • Manufacturer: MYLAN
    Approval date: May 29, 2003
    Strength(s): 10MG [AB], 20MG [AB]
  • Manufacturer: MYLAN
    Approval date: January 21, 2009
    Strength(s): 40MG [AB]
  • Manufacturer: SANDOZ
    Approval date: January 28, 2003
    Strength(s): 10MG [AB], 20MG [AB]
  • Manufacturer: SANDOZ
    Approval date: January 21, 2009
    Strength(s): 40MG [AB]
  • Manufacturer: WATSON LABS FLORIDA
    Approval date: May 30, 2008
    Strength(s): 10MG [AB], 20MG [AB], 40MG [AB]
  • Manufacturer: ZYDUS PHARMS USA INC
    Approval date: November 19, 2012
    Strength(s): 10MG [AB], 20MG [AB], 40MG [AB]

Note: No generic formulation of the following product is available.

  • omeprazole magnesium - for suspension, delayed release;oral

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Prilosec. 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.

  • Pharmaceutical formulation of omeprazole
    Patent 5,690,960
    Issued: November 25, 1997
    Inventor(s): Bengtsson; Inga Siv & Lovgren; Kurt Ingmar
    Assignee(s): Astra Aktiebolag
    A new oral pharmaceutical formulation containing a novel physical form of a magnesium salt of omeprazole, a method for the manufacture of such a formulation, and the use of such a formulation in medicine.
    Patent expiration dates:
    • November 25, 2014
      ✓ 
      Patent use: PEDIATRIC USE AGES 1-2 YEARS, GERD AND EROSIVE ESOPHAGITIS
      ✓ 
      Drug product
  • Omeprazole magnesium salt form
    Patent 5,900,424
    Issued: May 4, 1999
    Inventor(s): Kallstrom; Lars .ANG.ke & Nygren; Monica Annelie
    Assignee(s): Astra Aktiebolag
    A novel compound form of magnesium omeprazole useful in the manufacture of pharmaceutical formulations, the use of the product and the process for its production are described.
    Patent expiration dates:
    • May 4, 2016
      ✓ 
      Patent use: PEDIATRIC USE AGES 1-2 YEARS, GERD AND EROSIVE ESOPHAGITIS
      ✓ 
      Drug substance
  • Omeprazole process and compositions thereof
    Patent 6,147,103
    Issued: November 14, 2000
    Inventor(s): Anousis; Nick & McManus; James W. & Banks; Benjamin Newton & Zhou; Lingwen
    Assignee(s): Merck & Co., Inc.
    The present invention describes an improved process for the preparation, isolation, and purification of the anti-ulcer agent omeprazole whereby the sulfide precursor pyrmetazole is reacted subsurfacely with exactly one molar equivalent of meta-chloroperoxybenzoic acid in methylene chloride or toluene solution; residual organic solvent is removed from the aqueous layer by vacuum distillation; crude product is obtained by reactive crystallization with an alkyl formate and seeding; and pure product is isolated by recrystallization in methanol-water containing aqueous NaOH by subsurface addition of aqueous acetic acid to pH 9.0, seeding, filtration, washing, and drying. Compositions of omeprazole containing no chromatographically detectable levels of residual non-alcoholic organic reaction solvent are also described.
    Patent expiration dates:
    • October 9, 2018
    • April 9, 2019
      ✓ 
      Pediatric exclusivity
  • Crystalline form of omeprazole
    Patent 6,150,380
    Issued: November 21, 2000
    Inventor(s): Lovqvist; Karin & Sunden; Gunnel & Noreland; David & Ymen; Ingvar
    Assignee(s): Astra Aktiebolag
    The present invention relates to a novel crystalline form of 5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benz imidazole, known under the generic name omeprazole. Further, the present invention also relates to the use of the novel crystalline form of 5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benz imidazole for the treatment of gastrointestinal disorders, pharmaceutical compositions containing it as well as processes for the preparation of the novel crystalline form of 5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benz imidazole.
    Patent expiration dates:
    • November 10, 2018
    • May 10, 2019
      ✓ 
      Pediatric exclusivity
  • Omeprazole process and compositions thereof
    Patent 6,166,213
    Issued: December 26, 2000
    Inventor(s): Anousis; Nick & McManus; James W. & Banks; Benjamin Newton & Zhou; Lingwen & Liu; Hui
    Assignee(s): Merck & Co., Inc.
    The present invention describes an improved process for the preparation, isolation, and purification of the anti-ulcer agent omeprazole whereby the sulfide precursor pyrmetazole is reacted subsurfacely with exactly one molar equivalent of meta-chloroperoxybenzoic acid in methylene chloride or toluene solution; residual organic solvent is removed from the aqueous layer by vacuum distillation; crude product is obtained by reactive crystallization with an alkyl formate and seeding; and pure product is isolated by recrystallization in methanol-water containing aqueous NaOH by subsurface addition of aqueous acetic acid to pH 9.0, seeding, filtration, washing, and drying. Compositions of omeprazole containing no chromatographically detectable levels of residual non-alcoholic organic reaction solvent are also described.
    Patent expiration dates:
    • October 9, 2018
    • April 9, 2019
      ✓ 
      Pediatric exclusivity
  • Omerazole process and compositions thereof
    Patent 6,191,148
    Issued: February 20, 2001
    Inventor(s): McManus; James W. & Anousis; Nick & Banks; Benjamin Newton & Liu; Hui & Zhou; Lingwen
    Assignee(s): Merck & Co., Inc.
    The present invention describes an improved process for the preparation, isolation, and purification of the anti-ulcer agent omeprazole whereby the sulfide precursor pyrmetazole is reacted subsurfacely with exactly one molar equivalent of meta-chloroperoxybenzoic acid in a chlorinated aliphatic hydrocarbon or aromatic hydrocarbon solvent, such as methylene chloride or toluene; residual organic solvent is removed from the aqueous layer by vacuum distillation; crude product is obtained by reactive crystallization with an alkyl formate or formic acid solution and seeding; and pure product is isolated by recrystallization in methanol-water containing aqueous NaOH by subsurface addition of aqueous acetic acid to pH 9.0, seeding, filtration, washing, and drying. Omeprazole and compositions of omeprazole containing no chromatographically detectable levels of residual non-alcoholic organic reaction solvent and diminished levels of alcoholic solvent are also described.
    Patent expiration dates:
    • October 9, 2018
    • April 9, 2019
      ✓ 
      Pediatric exclusivity
  • Pharmaceutical formulation comprising omeprazole
    Patent 6,428,810
    Issued: August 6, 2002
    Inventor(s): Pontus; Bergstrand & Peter; Wang
    Assignee(s): AstraZeneca AB
    An enteric coated oral pharmaceutical formulation comprising as active ingredient a compound selected from the group of omeprazole, an alkaline salt of omeprazole, one of the single enantiomers of omeprazole and an alkaline salt of one of the single enantiomers of omeprazole, wherein the formulation comprises a core material that comprises the active ingredient and optionally an alkaline reacting compound, the active ingredient is in admixture with a pharmaceutically acceptable excipient, such as for instance a binding agent, and on said core material a separating layer and an enteric coating layer. A hydroxypropyl cellulose (HPC) with a specific cloud point is used in the manufacture of the claimed pharmaceutical formulations. Furthermore, the application describes the processes for their preparation and the use of the claimed formulations in medicine.
    Patent expiration dates:
    • November 3, 2019
      ✓ 
      Patent use: PEDIATRIC USE AGES 1-2 YEARS, GERD AND EROSIVE ESOPHAGITIS
      ✓ 
      Drug product

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.
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