Generic Zyprexa Availability

See also: Generic Zyprexa Relprevv, Generic Zyprexa Zydis

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

ZYPREXA (olanzapine - injectable; intramuscular)

  • Manufacturer: LILLY
    Approval date: March 29, 2004
    Strength(s): 10MG/VIAL [RLD] [AP]

ZYPREXA (olanzapine - tablet; oral)

  • Manufacturer: LILLY
    Approval date: September 30, 1996
    Strength(s): 10MG [AB], 2.5MG [AB], 5MG [RLD] [AB], 7.5MG [AB]
  • Manufacturer: LILLY
    Approval date: September 9, 1997
    Strength(s): 15MG [AB], 20MG [AB]

Has a generic version of Zyprexa been approved?

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

olanzapine injectable; intramuscular

  • Manufacturer: LUITPOLD
    Approval date: March 20, 2012
    Strength(s): 10MG/VIAL [AP]
  • Manufacturer: SANDOZ INC
    Approval date: October 24, 2011
    Strength(s): 10MG/VIAL [AP]

olanzapine tablet; oral

  • Manufacturer: APOTEX INC
    Approval date: April 23, 2012
    Strength(s): 10MG [AB], 15MG [AB], 2.5MG [AB], 20MG [AB], 5MG [AB], 7.5MG [AB]
  • Manufacturer: AUROBINDO PHARMA LTD
    Approval date: April 23, 2012
    Strength(s): 10MG [AB], 15MG [AB], 2.5MG [AB], 20MG [AB], 5MG [AB], 7.5MG [AB]
  • Manufacturer: DR REDDYS LABS LTD
    Approval date: October 24, 2011
    Strength(s): 20MG [AB]
  • Manufacturer: DR REDDYS LABS LTD
    Approval date: April 23, 2012
    Strength(s): 10MG [AB], 15MG [AB], 2.5MG [AB], 5MG [AB], 7.5MG [AB]
  • Manufacturer: MYLAN
    Approval date: April 23, 2012
    Strength(s): 10MG [AB], 15MG [AB], 2.5MG [AB], 20MG [AB], 5MG [AB], 7.5MG [AB]
  • Manufacturer: ORCHID HLTHCARE
    Approval date: April 23, 2012
    Strength(s): 10MG [AB], 15MG [AB], 2.5MG [AB], 20MG [AB], 5MG [AB], 7.5MG [AB]
  • Manufacturer: SUN PHARM INDS
    Approval date: April 23, 2012
    Strength(s): 10MG [AB], 15MG [AB], 2.5MG [AB], 20MG [AB], 5MG [AB], 7.5MG [AB]
  • Manufacturer: TEVA PHARMS
    Approval date: October 24, 2011
    Strength(s): 10MG [AB], 15MG [AB], 2.5MG [AB], 5MG [AB], 7.5MG [AB]
  • Manufacturer: TORRENT PHARMS LTD
    Approval date: April 23, 2012
    Strength(s): 10MG [AB], 15MG [AB], 2.5MG [AB], 20MG [AB], 5MG [AB], 7.5MG [AB]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Zyprexa. 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:
    • December 4, 2012 - NEW PATIENT POPULATION
    • June 4, 2013 - PEDIATRIC EXCLUSIVITY

See also...

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.
APInjectable aqueous solutions and, in certain instances, intravenous non-aqueous solutions. It should be noted that even though injectable (parenteral) products under a specific listing may be evaluated as therapeutically equivalent, there may be important differences among the products in the general category, Injectable; Injection. For example, some injectable products that are rated therapeutically equivalent are labeled for different routes of administration. In addition, some products evaluated as therapeutically equivalent may have different preservatives or no preservatives at all. Injectable products available as dry powders for reconstitution, concentrated sterile solutions for dilution, or sterile solutions ready for injection are pharmaceutical alternative drug products. They are not rated as therapeutically equivalent (AP) to each other even if these pharmaceutical alternative drug products are designed to produce the same concentration prior to injection and are similarly labeled. Consistent with accepted professional practice, it is the responsibility of the prescriber, dispenser, or individual administering the product to be familiar with a product's labeling to assure that it is given only by the route(s) of administration stated in the labeling.

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