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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: MYLAN SPECIALITY LP
    Approval date: May 1, 2012
    Strength(s): EQ 0.125MG BASE/SPRAY;0.05MG/SPRAY [RLD] [AB]

Has a generic version of Dymista been approved?

A generic version of Dymista has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Dymista and have been approved by the FDA:

AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE (azelastine hydrochloride; fluticasone propionate spray, metered;nasal)

  • Manufacturer: APOTEX INC
    Approval date: April 28, 2017
    Strength(s): EQ 0.125MG BASE/SPRAY;0.05MG/SPRAY [AB]

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: RELIEF OF SYMPTOMS ASSOCIATED WITH SEASONAL ALLERGIC RHINITIS
    • August 29, 2023
      ✓ 
      Patent use: TREATMENT OF ALLERGIC RHINITIS, INCLUDING SEASONAL ALLERGIC RHINITIS
    • August 29, 2023
      ✓ 
      Patent use: TREATMENT OF SYMPTOMS OF SEASONAL ALLERGIC RHINITIS
    • August 29, 2023
      ✓ 
      Patent use: TREATMENT OF SEASONAL ALLERGIC RHINITIS
    • August 29, 2023
      ✓ 
      Patent use: 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.
ABProducts meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (i.e., identical active ingredients(s), dosage form, and route(s) of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (i.e., AB1, AB2, AB3, etc.). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.
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