Generic Arcapta Availability

Arcapta is a brand name of indacaterol, approved by the FDA in the following formulation(s):

ARCAPTA NEOHALER (indacaterol maleate - powder;inhalation)

  • Manufacturer: NOVARTIS
    Approval date: July 1, 2011
    Strength(s): EQ 75MCG BASE [RLD]

Has a generic version of Arcapta been approved?

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

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

  • Beta2-adrenoceptor agonists
    Patent 6,878,721
    Issued: April 12, 2005
    Inventor(s): Cuenoud; Bernard & Bruce; Ian & Fairhurst; Robin Alec & Beattie; David
    Assignee(s): Novartis AG
    Compounds of formula in free or salt or solvate form, where Ar is a group of formula Y is carbon or nitrogen and R1, R2, R3, R4, R5, R6, R7, R8, R9, R10, X, n, p, q and r are as defined in the specification, their preparation and their use as pharmaceuticals, particularly for the treatment of obstructive or inflammatory airways diseases.
    Patent expiration dates:
    • October 10, 2020
      ✓ 
      Patent use: THE LONG TERM, ONCE-DAILY MAINTENANCE BROCHODILATOR TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • Beta-2-adrenoreceptor agonists
    Patent 8,067,437
    Issued: November 29, 2011
    Inventor(s): Cuenoud; Bernard & Bruce; Ian & Fairhurst; Robin A & Beattie; David
    Assignee(s): Novartis AG
    Compounds of formula in free or salt or solvate form, where Ar is a group of formula Y is carbon or nitrogen and R1, R2, R3, R4, R5, R6, R7, R8, R9, R10, X, n, p, q and r are as defined in the specification, their preparation and their use as pharmaceuticals, particularly for the treatment of obstructive or inflammatory airways diseases.
    Patent expiration dates:
    • June 2, 2020
      ✓ 
      Patent use: THE LONG TERM, ONCE-DAILY MAINTENANCE BROCHODILATOR TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA
  • Inhaler device
    Patent 8,479,730
    Issued: July 9, 2013
    Assignee(s): Novartis AG
    An inhaler device (1) for powdered medicaments. The device (1) has a body (5) that has a recess (50) for holding a capsule containing a powdered medicament to be inhaled, at least one air passage (90) that is tangentially disposed to the recess (50) , and a mouthpiece (30) that includes a coaxially disposed inhalation passage (70) that communicates with the recess (50) of the body (5). The body (5) has a pair of opposed spring (105) biased push-buttons (40) that each include at least one piercing element (95) for piercing the capsule when loaded in the recess (50). The medicament is released from the pierced capsule when air is drawn through the air passage(s) (90) into the recess (50) and swirled about therein. The mouthpiece (30) is pivotally attached to the edge of the body (5) so that it is pivotable between an open loading position and a closed dispensing position about an axis that is perpendicular to the longitudinal axis of the inhaler (1).
    Patent expiration dates:
    • October 11, 2028
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      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:
    • July 1, 2016 -

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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