Generic Xopenex Availability

See also: Generic Xopenex HFA

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

XOPENEX (levalbuterol hydrochloride - solution;inhalation)

  • Manufacturer: SUNOVION
    Approval date: March 25, 1999
    Strength(s): EQ 0.021% BASE [RLD] [AN], EQ 0.042% BASE [RLD] [AN]
  • Manufacturer: SUNOVION
    Approval date: January 30, 2002
    Strength(s): EQ 0.0103% BASE [RLD] [AN]
  • Manufacturer: SUNOVION
    Approval date: July 18, 2003
    Strength(s): EQ 0.25% BASE [RLD] [AN]

Has a generic version of Xopenex been approved?

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

levalbuterol hydrochloride solution;inhalation

  • Manufacturer: CIPLA LTD
    Approval date: December 13, 2013
    Strength(s): EQ 0.021% BASE [AN], EQ 0.042% BASE [AN], EQ 0.0103% BASE [AN]
  • Manufacturer: MYLAN SPECLT
    Approval date: March 20, 2009
    Strength(s): EQ 0.25% BASE [AN]
  • Manufacturer: MYLAN SPECLT
    Approval date: March 15, 2013
    Strength(s): EQ 0.0103% BASE [AN], EQ 0.021% BASE [AN], EQ 0.042% BASE [AN]
  • Manufacturer: TEVA PARENTERAL
    Approval date: September 11, 2014
    Strength(s): EQ 0.25% BASE [AN]
  • Manufacturer: TEVA PHARMS USA
    Approval date: April 26, 2013
    Strength(s): EQ 0.0103% BASE [AN], EQ 0.021% BASE [AN], EQ 0.042% BASE [AN]
  • Manufacturer: WATSON LABS INC
    Approval date: April 9, 2008
    Strength(s): EQ 0.0103% BASE [AN], EQ 0.021% BASE [AN], EQ 0.042% BASE [AN]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Xopenex. 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 asthma using optically pure R(-) albuterol
    Patent 5,547,994
    Issued: August 20, 1996
    Inventor(s): Barberich; Timothy J. & Young; James W.
    Assignee(s): Sepracor, Inc.
    The optically pure R(-) isomer of albuterol, which is substantially free of the S(+) isomer, is a potent bronchodilator for relieving the symptoms associated with asthma in individuals. A method is disclosed utilizing the optically pure R(-) isomer of albuterol for treating asthma while minimizing the side effects associated with albuterol.
    Patent expiration dates:
    • August 20, 2013
      ✓ 
      Patent use: TREATMENT OR PREVENTION OF BRONCHOSPASM
  • Albuterol formulations
    Patent 6,451,289
    Issued: September 17, 2002
    Inventor(s): Robert J.; Wherry, III & Stewart H.; Mueller
    Assignee(s): Sepracor Inc.
    Albuterol formulations packaged in an oxygen-permeable plastic container have a long shelf life at room temperature. The formulations consist essentially of albuterol or a pharmaceutically acceptable salt thereof, sodium chloride, and water, have a pH of about 4, and contain less than 0.08% by weight of albuterol aldehyde and less than 1 ppm dissolved oxygen.
    Patent expiration dates:
    • March 21, 2021
      ✓ 
      Drug product
    • March 21, 2021

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.
ANSolutions and powders for aerosolization. Uncertainty regarding the therapeutic equivalence of aerosolized products arises primarily because of differences in the drug delivery system. Solutions and powders intended for aerosolization that are marketed for use in any of several delivery systems are considered to be pharmaceutically and therapeutically equivalent and are coded AN. Those products that are compatible only with a specific delivery system or those products that are packaged in and with a specific delivery system are coded BN, unless they have met an appropriate bioequivalence standard. Solutions or suspensions in a specific delivery system will be coded AN if the bioequivalence standard is based upon in vitro methodology, if bioequivalence needs to be demonstrated by in vivo methodology then the drug products will be coded AB.
Hide
(web2)