Generic DuoNeb Availability

DuoNeb is a brand name of albuterol/ipratropium, approved by the FDA in the following formulation(s):

DUONEB (albuterol sulfate; ipratropium bromide - solution;inhalation)

  • Manufacturer: MYLAN SPECLT
    Approval date: March 21, 2001
    Strength(s): EQ 0.083% BASE;0.017% [RLD] [AN]

Has a generic version of DuoNeb been approved?

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

ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE (albuterol sulfate; ipratropium bromide solution;inhalation)

  • Manufacturer: CIPLA LTD
    Approval date: December 31, 2007
    Strength(s): EQ 0.083% BASE;0.017% [AN]
  • Manufacturer: NEPHRON
    Approval date: December 31, 2007
    Strength(s): EQ 0.083% BASE;0.017% [AN]
  • Manufacturer: RITEDOSE CORP
    Approval date: October 1, 2012
    Strength(s): EQ 0.083% BASE;0.017% [AN]
  • Manufacturer: TEVA PHARMS
    Approval date: December 31, 2007
    Strength(s): EQ 0.083% BASE;0.017% [AN]
  • Manufacturer: WATSON LABS
    Approval date: December 31, 2007
    Strength(s): EQ 0.083% BASE;0.017% [AN]

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

  • Albuterol and ipratropium inhalation solution, system, kit and method for relieving symptoms of chronic obstructive pulmonary disease
    Patent 6,632,842
    Issued: October 14, 2003
    Inventor(s): Imtiaz; Chaudry & Partha; Banerjee
    Assignee(s): Dey, L.P.
    The present invention relates to a dual bronchodilator inhalation solution, system, kit and method for relieving bronchospasm in patients suffering from chronic obstructive pulmonary disease (COPD). In one alternative embodiment, the solution of the present invention is a prepackaged, sterile, premixed, premeasured single unit dose of albuterol and ipratropium bromide for patients suffering from COPD. The present solution may be free of antimicrobial preservatives, such as benzalkonium chloride. In another alternative embodiment, the solution of the present invention comprises about 2.50 mg albuterol and about 0.50 mg ipratropium bromide.
    Patent expiration dates:
    • December 28, 2021
      ✓ 
      Patent use: TREATMENT OF BRONCHOSPASM ASSOCIATED WITH COPD IN PATIENTS REQUIRING MORE THAN ONE BRONCHO DILATOR

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.
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