Generic AccuNeb Availability
ACCUNEB (albuterol sulfate - solution;inhalation)
Manufacturer: MYLAN SPECLT
Approval date: April 30, 2001
Strength(s): EQ 0.021% BASE [RLD] [AN], EQ 0.042% BASE [RLD] [AN]
Has a generic version of AccuNeb been approved?
A generic version of AccuNeb 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 AccuNeb and have been approved by the FDA:
Approval date: June 28, 2004
Strength(s): EQ 0.042% BASE [AN]
Approval date: March 31, 2010
Strength(s): EQ 0.021% BASE [AN]
Manufacturer: WATSON LABS
Approval date: September 25, 2007
Strength(s): EQ 0.021% BASE [AN], EQ 0.042% BASE [AN]
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of AccuNeb. 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.
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 inhalation solution, system, kit and method for relieving symptoms of pediatric asthma
Issued: March 9, 2004
Inventor(s): Imtiaz; Chaudry & Partha; Banerjee
Assignee(s): Dey, L.P.
The present invention relates to an albuterol inhalation solution, system, kit and method for relieving bronchospasm in children suffering from asthma. In one alternative embodiment, the solution of the present invention is a sterile, premixed, premeasured single unit dose of albuterol for asthmatic patients 2 to 12 years of age. The present solution may be free of anti-microbial preservatives, such as benzalkonium chloride. In another alternative embodiment, the solution of the present invention comprises about 0.63 mg or about 1.25 mg albuterol.Patent expiration dates:
- December 28, 2021✓
- December 28, 2021
More about AccuNeb (albuterol)
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|Drug Patent||A 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 Exclusivity||Exclusivity 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.|
|RLD||A 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.|
|AN||Solutions 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.|