Generic Pulmicort Respules Availability

See also: Generic Pulmicort Flexhaler

Pulmicort Respules is a brand name of budesonide, approved by the FDA in the following formulation(s):

PULMICORT RESPULES (budesonide - suspension;inhalation)

  • Manufacturer: ASTRAZENECA
    Approval date: August 8, 2000
    Strength(s): 0.25MG/2ML [AN], 0.5MG/2ML [AN], 1MG/2ML [RLD] [AN]

Has a generic version of Pulmicort Respules been approved?

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

budesonide suspension;inhalation

  • Manufacturer: SANDOZ
    Approval date: September 27, 2013
    Strength(s): 0.25MG/2ML [AN], 0.5MG/2ML [AN], 1MG/2ML [AN]
  • Manufacturer: TEVA PHARMS
    Approval date: November 18, 2008
    Strength(s): 0.25MG/2ML [AN], 0.5MG/2ML [AN]
  • Manufacturer: WATSON LABS INC
    Approval date: July 31, 2012
    Strength(s): 0.25MG/2ML [AN], 0.5MG/2ML [AN]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Pulmicort Respules. 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 respiratory diseases
    Patent 6,598,603
    Issued: July 29, 2003
    Inventor(s): Bertil; Andersson & Thor-Björn; Conradsson & Göran; Eriksson
    Assignee(s): Astra Aktiebolag
    The invention provides a novel method of treating respiratory diseases, e.g., pediatric asthma, in a continuing regimen with not more than one daily dose of the drug budesonide using a nebulizer.
    Patent expiration dates:
    • December 23, 2018
      ✓ 
      Patent use: ONCE DAILY TREATMENT OF ASTHMA WITH NEBULIZED BUDESONIDE
    • June 23, 2019
      ✓ 
      Pediatric exclusivity
  • Method for treating a respiratory disease
    Patent 6,899,099
    Issued: May 31, 2005
    Inventor(s): Andersson; Bertil & Conradsson; Thor-Björn & Eriksson; Göran
    Assignee(s): AstraZeneca AB
    The invention provides a novel method of treating respiratory diseases, e.g., pediatric asthma, in a continuing regimen with not more than one daily dose of the drug budesonide using a nebulizer.
    Patent expiration dates:
    • December 23, 2018
      ✓ 
      Patent use: ONCE DAILY TREATMENT OF ASTHMA WITH NEBULIZED BUDESONIDE
    • June 23, 2019
      ✓ 
      Pediatric exclusivity
  • Sterile powders, formulations, and methods for producing the same
    Patent 7,524,834
    Issued: April 28, 2009
    Inventor(s): Karlsson; Ann-Kristin & Larrivee-Elkins; Cheryl & Molin; Ove
    Assignee(s): AstraZeneca AB
    The invention provides sterile glucocorticosteroids and sterile formulations containing glucocorticosteroid and use thereof in the treatment of an allergic and/or inflammatory condition of the nose or the lungs.
    Patent expiration dates:
    • November 11, 2018
      ✓ 
      Patent use: TREATMENT OF ASTHMA (MAINTENANCE AND PROPHYLACTIC THERAPY)
      ✓ 
      Drug product
    • May 11, 2019
      ✓ 
      Pediatric exclusivity

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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