Generic Symbyax Availability

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

SYMBYAX (fluoxetine hydrochloride; olanzapine - capsule;oral)

  • Manufacturer: LILLY
    Approval date: December 24, 2003
    Strength(s): EQ 25MG BASE;EQ 6MG BASE [AB], EQ 25MG BASE;EQ 12MG BASE [AB], EQ 50MG BASE;EQ 6MG BASE [RLD] [AB], EQ 50MG BASE;EQ 12MG BASE [AB]
  • Manufacturer: LILLY
    Approval date: April 9, 2007
    Strength(s): EQ 25MG BASE;EQ 3MG BASE [AB]

Has a generic version of Symbyax been approved?

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

OLANZAPINE AND FLUOXETINE HYDROCHLORIDE (fluoxetine hydrochloride; olanzapine capsule;oral)

  • Manufacturer: PAR PHARM
    Approval date: November 2, 2012
    Strength(s): EQ 25MG BASE;EQ 3MG BASE [AB], EQ 25MG BASE;EQ 6MG BASE [AB], EQ 25MG BASE;EQ 12MG BASE [AB], EQ 50MG BASE;EQ 6MG BASE [AB], EQ 50MG BASE;EQ 12MG BASE [AB]
  • Manufacturer: SANDOZ
    Approval date: November 16, 2012
    Strength(s): EQ 25MG BASE;EQ 3MG BASE [AB], EQ 25MG BASE;EQ 6MG BASE [AB], EQ 25MG BASE;EQ 12MG BASE [AB], EQ 50MG BASE;EQ 6MG BASE [AB], EQ 50MG BASE;EQ 12MG BASE [AB]
  • Manufacturer: TEVA PHARMS
    Approval date: June 19, 2012
    Strength(s): EQ 25MG BASE;EQ 6MG BASE [AB], EQ 25MG BASE;EQ 12MG BASE [AB], EQ 50MG BASE;EQ 6MG BASE [AB], EQ 50MG BASE;EQ 12MG BASE [AB]
  • Manufacturer: TEVA PHARMS
    Approval date: March 25, 2013
    Strength(s): EQ 25MG BASE;EQ 3MG BASE [AB]

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

  • Method for treating pain
    Patent 5,945,416
    Issued: August 31, 1999
    Inventor(s): Shannon; Harlan E. & Womer; Daniel E.
    Assignee(s): Eli Lilly and Company
    The present invention provides a method for treating pain using a composition comprising olanzapine and Drug Useful in the Treatment of Pain.
    Patent expiration dates:
    • March 24, 2017
      ✓ 
      Drug substance
      ✓ 
      Drug product
      ✓ 
      Sponsor has requested patent be delisted
  • 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: SYMBYAX IS INDICATED 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 -

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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