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Generic Duaklir Pressair Availability

Last updated on Sep 8, 2022.

Duaklir Pressair is a brand name of aclidinium/formoterol, approved by the FDA in the following formulation(s):

DUAKLIR PRESSAIR (aclidinium bromide; formoterol fumarate - powder, metered;inhalation)

  • Manufacturer: COVIS
    Approval date: March 29, 2019
    Strength(s): 0.4MG/INH;0.012MG/INH [RLD]

Has a generic version of Duaklir Pressair been approved?

No. There is currently no therapeutically equivalent version of Duaklir Pressair available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Duaklir Pressair. 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 FAQ.

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.

  • Dosage and formulation
    Patent 10,085,974
    Issued: October 2, 2018
    Assignee(s): Almirall, S.A.

    The present disclosure relates to pharmaceutical compositions for inhalation comprising aclidinium in the form of a dry powder of a pharmaceutically acceptable salt in admixture with a pharmaceutically acceptable dry powder carrier, providing a metered nominal dose of aclidinium equivalent to about 400 micrograms aclidinium bromide.

    Patent expiration dates:

    • March 13, 2029
      ✓ 
      Patent use: MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
      ✓ 
      Drug product
  • Patent 11,000,517

    Patent expiration dates:

    • March 13, 2029
      ✓ 
      Patent use: MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
      ✓ 
      Drug product
  • Powder formulation disintegrating system and method for dry powder inhalers
    Patent 6,681,768
    Issued: January 27, 2004
    Inventor(s): Anne; Haaije de Boer & Henderik Willem; Frijlink & Doetie; Gjaltema & Joachim; Goede & Paul; Hagedoorn
    Assignee(s): Sofotec GmbH & Co. KG

    A disperser for dry powders which can be used with different dose systems, dose weights ranging from 2 to 25 mg and different types of powder formulation. In one embodiment, the disperser acts both as a de-agglomeration (disintegration; aerosolization) means and as an air classifier for especially adhesive mixtures. Only fine drug particles are emitted whereas the larger agglomerates and carrier crystals are retained by the disperser. Another embodiment enables time controlled release of carrier crystals in these mixtures. Yet another embodiment has optimized performance with spherical pellets, containing no carrier crystals. Other possible embodiments of the invention make it possible to control the total inhaler resistance and the powder deposition in the upper respiratory tract by means of the addition of a so-called sheath flow of clean air. Modifications also enable carrier retainment in the mouthpiece and elimination of the tangential flow component of the discharge cloud.

    Patent expiration dates:

    • August 7, 2022
      ✓ 
      Drug product
  • Inhaler for the administration of powdered pharmaceuticals, and a powder cartridge system for use with this inhaler
    Patent 8,051,851
    Issued: November 8, 2011
    Inventor(s): Herder; Martin & Mett; Ingo & Goede; Joachim
    Assignee(s): Sofotec GmbH & Co. KG

    In order to improve the security and reliability of administration of powdered pharmaceuticals through dry powder inhalers, the invention proposes an inhaler (1) for powdered medicaments, comprising an activating device (4) for manual engagement by the patient for repeatedly metering a dose of medicament to be administered to the patient, and further comprising an advancing mechanism (25) for advancing a counter or indexing means (8) each time the activating device (4) has been engaged by the patient so that a dose of medicament has been released for administration to the patient, wherein the counter or indexing means (8) comprises an index (9), the index (9) being detectable by a detection means (10) of the inhaler, and the detection means (10) being coupled to a locking mechanism (12), the locking mechanism (12) blocking the activating device (4) and/or any transportation mechanism (5) of the inhaler (1) delayed by a predetermined number of metering cycles since detection of the index (9), and a cartridge (3).

    Patent expiration dates:

    • April 22, 2027
      ✓ 
      Drug product
  • Quinuclidine derivatives and their use as muscarinic M3 receptor ligands
    Patent RE46417
    Issued: May 30, 2017
    Assignee(s): Almirall, S.A.

    A compound according to formula (I) wherein: © is a phenyl ring, a C4 to C9 heteroaromatic compound containing one or more heteroatoms, or a naphthalenyl, 5,6,7,8-tetrahydronaphthalenyl or biphenyl group; which shows high affinity for muscarinic M3 receptors (Hm3).

    Patent expiration dates:

    • February 10, 2025
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      Patent use: MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
      ✓ 
      Drug substance
      ✓ 
      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 29, 2022 - NEW COMBINATION

More about Duaklir Pressair (aclidinium / formoterol)

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Glossary

Term Definition
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.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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