Last Updated: June 22, 2026

AZELASTINE Drug Patent Profile


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Which patents cover Azelastine, and when can generic versions of Azelastine launch?

Azelastine is a drug marketed by Alembic, Apotex, Epic Pharma Llc, Gland, Sandoz, Somerset Theraps Llc, Sun Pharm, Alkem Labs Ltd, Amneal, Apotex Inc, Aurobindo Pharma Ltd, Bionpharma, Hikma, Padagis Israel, Padagis Us, Sciegen Pharms, Zydus Pharms, Aurobindo Pharma, and Teva Pharms Usa Inc. and is included in thirty NDAs.

The generic ingredient in AZELASTINE is azelastine hydrochloride; fluticasone propionate. There are twelve drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the azelastine hydrochloride; fluticasone propionate profile page.

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US Patents and Regulatory Information for AZELASTINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apotex AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE azelastine hydrochloride; fluticasone propionate SPRAY, METERED;NASAL 207712-001 Apr 28, 2017 AB RX No Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Padagis Israel AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE azelastine hydrochloride; fluticasone propionate SPRAY, METERED;NASAL 208111-001 Feb 18, 2021 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Alembic AZELASTINE HYDROCHLORIDE azelastine hydrochloride SOLUTION/DROPS;OPHTHALMIC 209620-001 Mar 20, 2019 AT RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Hikma AZELASTINE HYDROCHLORIDE azelastine hydrochloride SPRAY, METERED;NASAL 091444-001 Oct 24, 2014 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Sun Pharm AZELASTINE HYDROCHLORIDE azelastine hydrochloride SPRAY, METERED;NASAL 090423-001 May 23, 2012 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Sun Pharm AZELASTINE HYDROCHLORIDE azelastine hydrochloride SOLUTION/DROPS;OPHTHALMIC 078738-001 Jun 21, 2010 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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