Skip to Content

Generic Dymista Availability

Dymista is a brand name of azelastine/fluticasone nasal, approved by the FDA in the following formulation(s):

DYMISTA (azelastine hydrochloride; fluticasone propionate - spray, metered;nasal)

  • Manufacturer: MEDA PHARMS
    Approval date: May 1, 2012
    Strength(s): EQ 0.125MG BASE/SPRAY;0.05MG/SPRAY [RLD]

Has a generic version of Dymista been approved?

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

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

  • Combination of azelastine and steroids
    Patent 8,163,723
    Issued: April 24, 2012
    Inventor(s): Lulla; Amar & Malhotra; Geena
    Assignee(s): CIPLA Limited
    A pharmaceutical product or formulation, which comprises azelastine or a pharmaceutically acceptable salt, solvate or physiologically functional derivative thereof, and a steroid, or a pharmaceutical acceptable salt, solvate or physiologically functional derivative thereof, preferably the product or formulation being in a form suitable for nasal or ocular administration.
    Patent expiration dates:
    • August 29, 2023
      ✓ 
      Patent use: ALLERGIC RHINITIS
    • August 29, 2023
      ✓ 
      Patent use: TREATMENT OF SEASONAL ALLERGIC RHINITIS
    • August 29, 2023
      ✓ 
      Patent use: TREATMENT OF SYMPTOMS OF SEASONAL ALLERGIC RHINITIS
    • August 29, 2023
      ✓ 
      Patent use: TREATMENT OF ALLERGIC RHINITIS, INCLUDING SEASONAL ALLERGIC RHINITIS
    • August 29, 2023
      ✓ 
      Patent use: RELIEF OF SYMPTOMS ASSOCIATED WITH SEASONAL ALLERGIC RHINITIS
    • February 29, 2024
      ✓ 
      Pediatric exclusivity
  • Combination of azelastine and steroids
    Patent 8,168,620
    Issued: May 1, 2012
    Inventor(s): Lulla; Amar & Malhotra; Geena
    Assignee(s): CIPLA Limited
    A pharmaceutical product or formulation, which comprises azelastine or a pharmaceutically acceptable salt, solvate or physiologically functional derivative thereof, and a steroid, or a pharmaceutically acceptable salt, solvate or physiologically functional derivative thereof, preferably the product or formulation being in a form suitable for nasal or ocular administration.
    Patent expiration dates:
    • February 24, 2026
      ✓ 
      Drug product
    • August 24, 2026
      ✓ 
      Pediatric exclusivity
  • Combination of azelastine and fluticasone for nasal administration
    Patent 9,259,428
    Issued: February 16, 2016
    Assignee(s): Cipla Limited
    A pharmaceutical product or formulation, which comprises azelastine or a pharmaceutically acceptable salt, solvate or physiologically functional derivative thereof, and a steroid, or a pharmaceutical acceptable salt, solvate or physiologically functional derivative thereof, preferably the product or formulation being in a form suitable for nasal or ocular administration.
    Patent expiration dates:
    • June 13, 2023
      ✓ 
      Patent use: TREATMENT OF SEASONAL ALLERGIC RHINITIS
    • December 13, 2023
      ✓ 
      Pediatric exclusivity

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:
    • February 20, 2018 - NEW PATIENT POPULATION
    • August 20, 2018 - 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.
Hide