Generic Pulmicort Flexhaler Availability

See also: Generic Pulmicort Respules

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

PULMICORT FLEXHALER (budesonide - powder, metered;inhalation)

  • Manufacturer: ASTRAZENECA
    Approval date: July 12, 2006
    Strength(s): 0.08MG/INH, 0.16MG/INH [RLD]

Has a generic version of Pulmicort Flexhaler been approved?

No. There is currently no therapeutically equivalent version of Pulmicort Flexhaler available in the United States.

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

  • Formulation for inhalation
    Patent 6,027,714
    Issued: February 22, 2000
    Inventor(s): Trofast; Jan
    Assignee(s): Astra Aktiebolag
    A dry powder composition comprising budesonide and a carrier substance, both of which are in finely divided form, wherein the formulation has a poured bulk density of from 0.28 to 0.38 g/ml is useful in the treatment of respiratory disorders.
    Patent expiration dates:
    • January 9, 2018
      ✓ 
      Patent use: MAINTENANCE TREATMENT OF ASTHMA AS PROPHYLACTIC THERAPY IN ADULT AND PEDIATRIC PATIENTS SIX YEARS OF AGE OR OLDER, INCLUDING PATIENTS REQUIRING ORAL CORTICOSTEROID THERAPY FOR ASTHMA
      ✓ 
      Drug product
  • Inhalation device
    Patent 6,142,145
    Issued: November 7, 2000
    Inventor(s): Dagsland; Allan & Malmqvist-Granlund; Karin & Virtanen; Risto
    Assignee(s): Astra Aktiebolag
    An inhaler for administering powder by inhalation, including an inhaler body having two ends and a peripheral wall therebetween; an inhalation unit disposed in the inhaler body, the inhalation unit comprising an inhalation channel, the inhalation channel having an air inlet and an outlet; a dosing unit disposed in the inhaler body for providing a dose of powder to the inhalation channel such that a stream of air containing powder may be drawn from the outlet of the inhalation channel on inhalation by a user; a divider having a first surface bounded by a periphery and which substantially closes one end of the inhaler body; a mouthpiece attached to the periphery of the divider, the mouthpiece having a substantially radially directed flange which provides a second surface and which, together with the first surface, defines an air chamber; a first inlet for the air chamber provided in the first surface within the periphery of the divider and in fluid communication with the outlet of the inhalation channel; a second inlet for the air chamber disposed in the first surface within the periphery of the divider and adjacent the first inlet, a stream of supplementary air in use being drawn through the second inlet on inhalation by the user; and a discrete opening in peripheral wall of the inhaler body which is in fluid communication with the second inlet of the air chamber.
    Patent expiration dates:
    • May 8, 2018
      ✓ 
      Drug product
  • Formulation for inhalation
    Patent 6,287,540
    Issued: September 11, 2001
    Inventor(s): Trofast; Jan
    Assignee(s): Astra Aktiebolag
    A dry powder composition comprising one more potent pharmaceutically active substances and a carrier substance, all of which are in finely divided form, wherein the formulation has a poured bulk density of from 0.28 to 0.38 g/ml is useful in the treatment of respiratory disorders.
    Patent expiration dates:
    • January 9, 2018
      ✓ 
      Drug product
  • Inhalation device
    Patent 7,143,764
    Issued: December 5, 2006
    Inventor(s): Dagsland; Allan & Virtanen; Risto
    Assignee(s): AstraZeneca AB
    A powder inhaler for administering powder by inhalation which includes: an inhaler body having an opening therein; an inhalation unit disposed in the inhaler body, the inhalation unit including an inhalation channel through which powder is in use inhaled; a dosing unit for providing a dose of powder to the inhalation channel disposed in the inhaler body so as to be rotatable about the central axis thereof, wherein the dosing unit includes a central shaft which is co-axial with the central axis of the inhaler body and has a spiral groove or protrusion on the end face thereof; and an indicating wheel for providing an indication as to the usage of the inhaler disposed in the inhaler body, the indicating wheel having a toothed periphery for engaging the spiral groove or protrusion on the shaft and being disposed such that at least a part thereof is visible through the opening and so as to be rotatable within a diametrical plane containing the central axis of the inhaler body. One side surface of the indicating wheel includes at least one indication which is representative of the usage of the inhaler. In addition, the inhaler body includes a recess in which the opening is provided. The opening allows at least a part of the one side surface of the indicating wheel to be viewed.
    Patent expiration dates:
    • March 13, 2018
      ✓ 
      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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