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Generic Astepro Availability

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

ASTEPRO (azelastine hydrochloride - spray, metered;nasal)

  • Manufacturer: MEDA PHARMS
    Approval date: October 15, 2008
    Strength(s): EQ 0.125MG BASE/SPRAY
  • Manufacturer: MEDA PHARMS
    Approval date: August 31, 2009
    Strength(s): EQ 0.1876MG BASE/SPRAY [RLD] [AB]

Has a generic version of Astepro been approved?

A generic version of Astepro 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 Astepro and have been approved by the FDA:

azelastine hydrochloride spray, metered;nasal

  • Manufacturer: APOTEX INC
    Approval date: August 31, 2012
    Strength(s): EQ 0.1876MG BASE/SPRAY [AB]
  • Manufacturer: PERRIGO ISRAEL
    Approval date: May 8, 2014
    Strength(s): EQ 0.1876MG BASE/SPRAY [AB]

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

  • Compositions comprising azelastine and methods of use thereof
    Patent 8,071,073
    Issued: December 6, 2011
    Inventor(s): Dang; Phuong Grace & Lawrence; Brian D. & Balwani; Gul & D'Addio; Alexander D.
    Assignee(s): MEDA Pharmaceuticals Inc.
    The present invention provides pharmaceutical compositions comprising azelastine, or a pharmaceutically acceptable salt or ester thereof including azelastine hydrochloride, and optionally one or more additional active agents. Preferred such compositions further comprise one or more pharmaceutically acceptable carriers or excipients that reduce the amount of post-nasal drip, and/or that minimize or mask the unpleasant bitter taste associated with post-nasal drip, of the compositions into the oral cavity, upon intranasal or ocular administration of the compositions. Especially effective excipients used in the compositions of the present invention are hypromellose as a viscosity modifier and sucralose as a taste-masking agent. The invention also provides methods of treating or preventing certain disorders, or symptomatic relief therefrom, by administering the compositions of the invention to a patient, e.g., for the symptomatic relief of allergic rhinitis, non-allergic vasomotor rhinitis, allergic conjunctivitis, as well as other disorders. The compositions and methods of the present invention provide significant value in terms of patient acceptability, convenience, and compliance.
    Patent expiration dates:
    • June 4, 2028
      ✓ 
      Drug product
  • Compositions comprising azelastine and methods of use thereof
    Patent 8,518,919
    Issued: August 27, 2013
    Assignee(s): MEDA Pharmaceuticals Inc.
    The present invention provides pharmaceutical compositions comprising azelastine, or a pharmaceutically acceptable salt or ester thereof including azelastine hydrochloride, and optionally one or more additional active agents. Preferred such compositions further comprise one or more pharmaceutically acceptable carriers or excipients that reduce the amount of post-nasal drip, and/or that minimize or mask the unpleasant bitter taste associated with post-nasal drip, of the compositions into the oral cavity, upon intranasal or ocular administration of the compositions. Especially effective excipients used in the compositions of the present invention are hypromellose as a viscosity modifier and sucralose as a taste-masking agent. The invention also provides methods of treating or preventing certain disorders, or symptomatic relief therefrom, by administering the compositions of the invention to a patient, e.g., for the symptomatic relief of allergic rhinitis, non-allergic vasomotor rhinitis, allergic conjunctivitis, as well as other disorders.
    Patent expiration dates:
    • November 22, 2025
      ✓ 
      Patent use: TREATMENT OF ALLERGIC RHINITIS, INCLUDING SEASONAL AND PERENNIAL ALLERGIC RHINITIS

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:
    • August 30, 2016 - NEW PATIENT POPULATION
    • August 30, 2016 - RESULTS OF A CLINICAL STUDY REPORT WHICH ASSESSES THE SAFETY AND EFFICACY IN CHILDREN AGES 6 TO 12 YEARS OF AGE
    • February 20, 2018 - NEW PATIENT POPULATION

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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