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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?

An Authorized Generic version of Xopenex HFA has been approved. An Authorized Generic is a prescription drug that is produced by a brand company under a New Drug Application (NDA) and marketed as a generic under a private label. It is identical to the branded product in appearance, and unlike a generic, the Authorized Generic has exactly the same inactive ingredients.

List of authorized generic versions:

  • levalbuterol tartrate ORAL AEROSOL, METERED 45 ug
    Actavis Pharma, Inc.
    NDC Code: 005912927
  • levalbuterol tartrate ORAL AEROSOL, METERED 45 ug
    Proficient Rx LP
    NDC Code: 631870876
  • levalbuterol tartrate ORAL AEROSOL, METERED 45 ug
    Preferred Pharmaceuticals Inc.
    NDC Code: 687886845

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: Generic Drug FAQs.

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.

  • 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

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:
    • March 12, 2018 - UPDATE TO THE LABELING WITH INFORMATION REGARDING A CLINICAL TRIAL IN CHILDREN LESS THAN 4 YEARS OF AGE.
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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