Generic Oxandrin Availability

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

OXANDRIN (oxandrolone - tablet;oral)

  • Manufacturer: CREALTA PHARMS LLC
    Approved Prior to Jan 1, 1982
    Strength(s): 2.5MG [AB]
  • Manufacturer: CREALTA PHARMS LLC
    Approval date: November 5, 2001
    Strength(s): 10MG [RLD] [AB]

Has a generic version of Oxandrin been approved?

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

oxandrolone tablet;oral

  • Manufacturer: PAR PHARM
    Approval date: June 22, 2007
    Strength(s): 2.5MG [AB], 10MG [AB]
  • Manufacturer: UPSHER SMITH
    Approval date: December 1, 2006
    Strength(s): 2.5MG [AB]
  • Manufacturer: UPSHER SMITH
    Approval date: March 22, 2007
    Strength(s): 10MG [AB]

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

  • Use of oxandrolone in the treatment of chronic obstructive pulmonary disease
    Patent 5,872,147
    Issued: February 16, 1999
    Inventor(s): Bowen; Robert E.
    Assignee(s): Bio-Technology General Corp.
    The subject invention provides a method of treating a symptom associated with chronic obstructive pulmonary disease in a patient suffering from chronic obstructive pulmonary disease which comprises administering a therapeutically effective amount of an oxandrolone to the patient. The subject invention further provides a method of improving functional capacity and/or pulmonary function in a patient suffering from chronic obstructive pulmonary disease which comprises administering a therapeutically effective amount of an oxandrolone to the patient.
    Patent expiration dates:
    • December 5, 2017
      ✓ 
      Patent use: TO PROMOTE WEIGHT GAIN AFTER WEIGHT LOSS IN CERTAIN TYPES OF PATIENTS
  • Method for ameliorating muscle weakness/wasting in a patient infected with human immunodeficiency virus-type 1
    Patent 6,090,799
    Issued: July 18, 2000
    Inventor(s): Berger; Joseph R.
    Assignee(s): BTG Pharmaceuticals Corp.
    A method for attenuating the HIV-associated myopathy and muscle wasting associated with infection by human immunodeficiency virus-Type 1. Administration of oxandrolone in a daily dosage of about 2.5 to about 20 milligrams is described.
    Patent expiration dates:
    • July 18, 2017
      ✓ 
      Patent use: TO PROMOTE WEIGHT GAIN AFTER WEIGHT LOSS IN CERTAIN TYPES OF PATIENTS
  • Use of oxandrolone in the treatment of burns an other wounds
    Patent 6,576,659
    Issued: June 10, 2003
    Inventor(s): Don; Fishbein
    Assignee(s): Bio-Technology General Corp.
    The subject invention provides a method of treating burn-induced weight loss in a burn patient which comprises administering a therapeutically effective amount of an oxandrolone to the patient. The invention also provides a method of treating a wound in a patient suffering from a wound which comprises administering a therapeutically effective amount of an oxandrolone to the patient. The subject invention further provides a method of treating burn-induced weight loss in a burn patient which comprises administering a therapeutically effective amount of an oxandrolone in conjunction with a protein supplement to the patient.
    Patent expiration dates:
    • December 5, 2017
      ✓ 
      Patent use: TO PROMOTE WEIGHT GAIN AFTER WEIGHT LOSS IN CERTAIN TYPES OF PATIENTS
  • Use of oxandrolone in the treatment of burns and other wounds
    Patent 6,828,313
    Issued: December 7, 2004
    Inventor(s): Don; Fishbein
    Assignee(s): Savient Pharmaceuticals, Inc.
    The subject invention provides a method of treating burn-induced weight loss in a burn patient which comprises administering a therapeutically effective amount of an oxandrolone to the patient. The invention also provides a method of treating a wound in a patient suffering from a wound which comprises administering a therapeutically effective amount of an oxandrolone to the patient. The subject invention further provides a method of treating burn-induced weight loss in a burn patient which comprises administering a therapeutically effective amount of an oxandrolone in conjunction with a protein supplement to the patient.
    Patent expiration dates:
    • December 5, 2017
      ✓ 
      Patent use: TO PROMOTE WEIGHT GAIN AFTER WEIGHT LOSS IN CERTAIN TYPES OF PATIENTS

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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