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)
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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.
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.
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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✓✓✓
- October 10, 2020
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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✓
- June 2, 2020
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 - NEW CHEMICAL ENTITY
See also...
- Arcapta Consumer Information (Drugs.com)
- Arcapta Neohaler Consumer Information (Wolters Kluwer)
- Arcapta Neohaler inhalation Consumer Information (Cerner Multum)
- Arcapta Neohaler Advanced Consumer Information (Micromedex)
- Arcapta Neohaler AHFS DI Monographs (ASHP)
- Indacaterol Consumer Information (Wolters Kluwer)
- Indacaterol inhalation Consumer Information (Cerner Multum)
- Indacaterol Inhalation Advanced Consumer Information (Micromedex)
- Indacaterol Maleate AHFS DI Monographs (ASHP)
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. |


