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Last Updated: February 25, 2021

DrugPatentWatch Database Preview

AZELASTINE HYDROCHLORIDE Drug Profile

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

Azelastine Hydrochloride is a drug marketed by Akorn, Alembic Pharms Ltd, Apotex Inc, Gland Pharma Ltd, Sandoz Inc, Somerset Theraps Llc, Sun Pharm, Alkem Labs Ltd, Amneal, Aurobindo Pharma Ltd, Breckenridge, Hikma, Perrigo Israel, Upsher Smith Labs, Zydus Pharms, and Apotex. and is included in twenty-four NDAs.

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

Drug patent expirations by year for AZELASTINE HYDROCHLORIDE
Recent Clinical Trials for AZELASTINE HYDROCHLORIDE

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SponsorPhase
Istanbul Training and Research HospitalPhase 3
Uludag UniversityPhase 3
Ankara City Hospital BilkentPhase 3

See all AZELASTINE HYDROCHLORIDE clinical trials

Pharmacology for AZELASTINE HYDROCHLORIDE
Paragraph IV (Patent) Challenges for AZELASTINE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
ASTEPRO SPRAY, METERED;NASAL azelastine hydrochloride 022203 2011-12-15
OPTIVAR SOLUTION/DROPS;OPHTHALMIC azelastine hydrochloride 021127 2006-12-13
ASTELIN SPRAY, METERED;NASAL azelastine hydrochloride 020114 2005-11-14

US Patents and Regulatory Information for AZELASTINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Akorn AZELASTINE HYDROCHLORIDE azelastine hydrochloride SOLUTION/DROPS;OPHTHALMIC 203660-001 Nov 8, 2016 AT RX No No   Start Trial   Start Trial   Start Trial
Hikma AZELASTINE HYDROCHLORIDE azelastine hydrochloride SPRAY, METERED;NASAL 091444-001 Oct 24, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Apotex AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE azelastine hydrochloride; fluticasone propionate SPRAY, METERED;NASAL 207712-001 Apr 28, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Sun Pharm AZELASTINE HYDROCHLORIDE azelastine hydrochloride SOLUTION/DROPS;OPHTHALMIC 078738-001 Jun 21, 2010 AT RX No No   Start Trial   Start Trial   Start Trial
Gland Pharma Ltd AZELASTINE HYDROCHLORIDE azelastine hydrochloride SOLUTION/DROPS;OPHTHALMIC 210092-001 Feb 25, 2020 AT RX No No   Start Trial   Start Trial   Start Trial
Amneal AZELASTINE HYDROCHLORIDE azelastine hydrochloride SPRAY, METERED;NASAL 208199-001 Dec 15, 2017 AB RX 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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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Baxter
Express Scripts
Harvard Business School
Mallinckrodt
Colorcon

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