Wednesday 26 January 2011

Prozac


See also: Generic Prozac Weekly


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


PROZAC (fluoxetine hydrochloride - capsule; oral)



  • Manufacturer: LILLY

    Approval date: December 29, 1987

    Strength(s): EQ 20MG BASE [AB1]


  • Manufacturer: LILLY

    Approval date: December 23, 1992

    Strength(s): EQ 10MG BASE [AB1]


  • Manufacturer: LILLY

    Approval date: June 15, 1999

    Strength(s): EQ 40MG BASE [RLD][AB]

Has a generic version of Prozac been approved?


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


fluoxetine hydrochloride capsule; oral



  • Manufacturer: ALEMBIC PHARMS LTD

    Approval date: March 19, 2009

    Strength(s): EQ 10MG BASE [AB1], EQ 20MG BASE [AB1], EQ 40MG BASE [AB]


  • Manufacturer: ALPHAPHARM

    Approval date: January 29, 2002

    Strength(s): EQ 10MG BASE [AB1], EQ 20MG BASE [AB1]


  • Manufacturer: AUROBINDO PHARMA

    Approval date: January 31, 2008

    Strength(s): EQ 10MG BASE [AB1], EQ 20MG BASE [AB1], EQ 40MG BASE [AB]


  • Manufacturer: BARR

    Approval date: August 2, 2001

    Strength(s): EQ 20MG BASE [AB1]


  • Manufacturer: BARR

    Approval date: January 30, 2002

    Strength(s): EQ 10MG BASE [AB1]


  • Manufacturer: BEIJING DOUBLE CRANE

    Approval date: February 1, 2002

    Strength(s): EQ 10MG BASE [AB1], EQ 20MG BASE [AB1]


  • Manufacturer: CARLSBAD

    Approval date: January 30, 2002

    Strength(s): EQ 10MG BASE [AB1], EQ 20MG BASE [AB1]


  • Manufacturer: DR REDDYS LABS INC

    Approval date: August 2, 2001

    Strength(s): EQ 40MG BASE [AB]


  • Manufacturer: DR REDDYS LABS INC

    Approval date: January 29, 2002

    Strength(s): EQ 10MG BASE [AB1], EQ 20MG BASE [AB1]


  • Manufacturer: IVAX SUB TEVA PHARMS

    Approval date: January 31, 2002

    Strength(s): EQ 10MG BASE [AB1], EQ 20MG BASE [AB1]


  • Manufacturer: IVAX SUB TEVA PHARMS

    Approval date: September 28, 2004

    Strength(s): EQ 40MG BASE [AB]


  • Manufacturer: LANDELA PHARM

    Approval date: January 30, 2002

    Strength(s): EQ 10MG BASE [AB1], EQ 20MG BASE [AB1]


  • Manufacturer: MALLINCKRODT

    Approval date: January 29, 2002

    Strength(s): EQ 10MG BASE [AB1], EQ 20MG BASE [AB1]


  • Manufacturer: MYLAN

    Approval date: January 30, 2002

    Strength(s): EQ 10MG BASE [AB1], EQ 20MG BASE [AB1]


  • Manufacturer: MYLAN

    Approval date: May 25, 2007

    Strength(s): EQ 40MG BASE [AB]


  • Manufacturer: PLIVA

    Approval date: January 29, 2002

    Strength(s): EQ 10MG BASE [AB1], EQ 20MG BASE [AB1]


  • Manufacturer: RANBAXY

    Approval date: December 13, 2004

    Strength(s): EQ 40MG BASE [AB]


  • Manufacturer: SANDOZ

    Approval date: August 2, 2001

    Strength(s): EQ 10MG BASE [AB1]


  • Manufacturer: SANDOZ

    Approval date: January 29, 2002

    Strength(s): EQ 20MG BASE [AB1], EQ 40MG BASE [AB]


  • Manufacturer: TEVA

    Approval date: January 29, 2002

    Strength(s): EQ 10MG BASE [AB1], EQ 20MG BASE [AB1], EQ 40MG BASE [AB]


  • Manufacturer: WOCKHARDT

    Approval date: January 16, 2008

    Strength(s): EQ 10MG BASE [AB1], EQ 20MG BASE [AB1], EQ 40MG BASE [AB]

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




  • Combination therapy for treatment of refractory depression
    Patent 6,960,577
    Issued: November 1, 2005
    Inventor(s): Tollefson; Gary Dennis
    Assignee(s): Eli Lilly and Company
    Methods for treating a patient suffering from or susceptible to treatment resistant major depression comprising administering olanzapine and fluoxetine are disclosed.
    Patent expiration dates:

    • November 1, 2017
      ✓ 
      Patent use: PROZAC AND OLANZAPINE IN COMBINATION FOR THE ACUTE TREATMENT OF TREATMENT RESISTANT DEPRESSION IN ADULTS



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 19, 2012 - TREATMENT OF TREATMENT RESISTANT DEPRESSION (TRD) IN COMBINATION WITH OLANZAPINE

See also...

  • Prozac Consumer Information (Drugs.com)
  • Prozac Consumer Information (Wolters Kluwer)
  • Prozac Solution Consumer Information (Wolters Kluwer)
  • Prozac Consumer Information (Cerner Multum)
  • Prozac Advanced Consumer Information (Micromedex)
  • Fluoxetine Consumer Information (Drugs.com)
  • Fluoxetine Consumer Information (Wolters Kluwer)
  • Fluoxetine Delayed-Release Capsules Consumer Information (Wolters Kluwer)
  • Fluoxetine Solution Consumer Information (Wolters Kluwer)
  • Fluoxetine Consumer Information (Cerner Multum)
  • Alti-Fluoxetine Hydrochloride Advanced Consumer Information (Micromedex)
  • Phl-Fluoxetine Advanced Consumer Information (Micromedex)
  • Fluoxetine Advanced Consumer Information (Micromedex)
  • Fluoxetine Hydrochloride AHFS DI Monographs (ASHP)
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