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Generic Prozac Availability

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: ELI LILLY AND CO
    Approval date: December 29, 1987
    Strength(s): EQ 20MG BASE [AB1]
  • Manufacturer: ELI LILLY AND CO
    Approval date: December 23, 1992
    Strength(s): EQ 10MG BASE [AB1]
  • Manufacturer: ELI LILLY AND CO
    Approval date: June 15, 1999
    Strength(s): EQ 40MG BASE [RLD] [AB], EQ 60MG BASE

PROZAC (fluoxetine hydrochloride - solution;oral)

  • Manufacturer: LILLY
    Approval date: April 24, 1991
    Strength(s): EQ 20MG BASE/5ML

PROZAC (fluoxetine hydrochloride - tablet;oral)

  • Manufacturer: LILLY
    Approval date: March 9, 1999
    Strength(s): EQ 10MG BASE, EQ 20MG BASE

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: 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: DR REDDYS LABS LTD
    Approval date: August 2, 2001
    Strength(s): EQ 40MG BASE [AB]
  • Manufacturer: DR REDDYS LABS LTD
    Approval date: January 29, 2002
    Strength(s): EQ 10MG BASE [AB1], EQ 20MG BASE [AB1]
  • Manufacturer: HERITAGE PHARMS INC
    Approval date: October 1, 2012
    Strength(s): EQ 10MG BASE [AB1], EQ 20MG BASE [AB1], EQ 40MG BASE [AB]
  • 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: MYLAN PHARMS INC
    Approval date: January 29, 2002
    Strength(s): EQ 10MG BASE [AB1], EQ 20MG BASE [AB1]
  • Manufacturer: PAR PHARM
    Approval date: December 16, 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: SCIEGEN PHARMS INC
    Approval date: March 16, 2015
    Strength(s): EQ 10MG BASE [AB1], EQ 20MG BASE [AB1], EQ 40MG BASE [AB]
  • Manufacturer: SUN PHARM INDS LTD
    Approval date: December 13, 2004
    Strength(s): 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: TEVA PHARMS USA
    Approval date: January 29, 2002
    Strength(s): EQ 10MG BASE [AB1], EQ 20MG BASE [AB1]

Note: No generic formulation of the following products are available.

  • fluoxetine hydrochloride - solution;oral
  • fluoxetine hydrochloride - tablet;oral

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:
    • July 26, 2016 - NEW PATIENT POPULATION
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More about Prozac (fluoxetine)

Consumer resources

Other brands: Sarafem, Rapiflux, Selfemra

Professional resources

Other Formulations

Related treatment guides

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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