Generic Xopenex HFA Availability

See also: Generic Xopenex

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

XOPENEX HFA (levalbuterol tartrate - aerosol, metered;inhalation)

  • Manufacturer: SUNOVION
    Approval date: March 11, 2005
    Strength(s): EQ 0.045MG BASE/INH [RLD]

Has a generic version of Xopenex HFA been approved?

No. There is currently no therapeutically equivalent version of Xopenex HFA available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Xopenex HFA. 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 OR ASTHMATIC SYMPTOMS
  • Medicinal aerosol formulations
    Patent 5,605,674
    Issued: February 25, 1997
    Inventor(s): Purewal; Tarlochan S. & Greenleaf; David J.
    Assignee(s): Riker Laboratories, Inc.
    A self-propelling aerosol formulation which may be free from CFC's which comprises a medicament, 1,1,1,2-tetrafluoroethane, a surface active agent and at least one compound having a higher polarity than 1,1,1,2-tetrafluoroethane.
    Patent expiration dates:
    • February 25, 2014
      ✓ 
      Drug product
  • Seals for use in an aerosol delivery device
    Patent 5,836,299
    Issued: November 17, 1998
    Inventor(s): Kwon; Oh-Seung
    Assignee(s): Minnesota Mining & Manufacturing Co.
    A device for delivering an aerosol, comprising: a casing member, a valve stem, and a diaphragm. The diaphragm is made of an ethylene-propylene-diene rubber ("EPDM") and is stable to dimensional change when exposed to 1,1,1,2-tetrafluoroethane or 1,1,1,2,3,3,3-heptafluoroethane.
    Patent expiration dates:
    • November 17, 2015
      ✓ 
      Drug product
  • Levalbuterol salt
    Patent 7,256,310
    Issued: August 14, 2007
    Inventor(s): McGlynn; Paul & Bakale; Roger & Sturge; Craig
    Assignee(s): Sepracor Inc.
    Levalbuterol L-tartrate affords crystals possessing properties desirable for use in a metered dose inhaler.
    Patent expiration dates:
    • October 8, 2024
      ✓ 
      Patent use: TREATMENT OR PREVENTION OF BRONCHOSPASM OR ASTHMATIC SYMPTOMS
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • Levalbuterol salt
    Patent 8,765,153
    Issued: July 1, 2014
    Levalbuterol L-tartrate affords crystals possessing properties desirable for use in a metered dose inhaler.
    Patent expiration dates:
    • December 8, 2023
      ✓ 
      Drug product

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.
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