Friday, October 7, 2016

Prilosec


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 10MG BASE/PACKET [RLD], EQ 2.5MG BASE/PACKET

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

    Approval date: April 17, 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: 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: LEK PHARMS

    Approval date: January 28, 2003

    Strength(s): 10MG [AB], 20MG [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 21, 2009

    Strength(s): 40MG [AB]


  • Manufacturer: WATSON LABS FLORIDA

    Approval date: May 30, 2008

    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



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:
    • March 20, 2011 - NEW PATIENT POPULATION

    • September 20, 2011 - PEDIATRIC EXCLUSIVITY

See also...

  • Prilosec Consumer Information (Drugs.com)
  • Prilosec Delayed-Release Capsules Consumer Information (Wolters Kluwer)
  • Prilosec Suspension Consumer Information (Wolters Kluwer)
  • Prilosec Consumer Information (Cerner Multum)
  • Prilosec Advanced Consumer Information (Micromedex)
  • Omeprazole Consumer Information (Drugs.com)
  • Omeprazole Delayed-Release Capsules Consumer Information (Wolters Kluwer)
  • Omeprazole Delayed-Release Tablets Consumer Information (Wolters Kluwer)
  • Omeprazole Magnesium Delayed-Release Capsules Consumer Information (Wolters Kluwer)
  • Omeprazole Suspension Consumer Information (Wolters Kluwer)
  • Omeprazole Consumer Information (Cerner Multum)
  • Omeprazole Advanced Consumer Information (Micromedex)
  • Omeprazole AHFS DI Monographs (ASHP)
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