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Last Updated: February 3, 2023

Azelastine hydrochloride - Generic Drug Details


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What are the generic sources for azelastine hydrochloride and what is the scope of patent protection?

Azelastine hydrochloride is the generic ingredient in eight branded drugs marketed by Akorn, Alembic Pharms Ltd, Apotex Inc, Gland Pharma Ltd, Sandoz Inc, Somerset Theraps Llc, Sun Pharm, Mylan Speciality Lp, Mylan Spclt Viatris, Bayer Hlthcare, Alkem Labs Ltd, Amneal, Aurobindo Pharma Ltd, Breckenridge, Hikma, Padagis Israel, Upsher Smith Labs, Zydus Pharms, and Apotex, and is included in thirty NDAs. There are seven patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Azelastine hydrochloride has fifty patent family members in twenty-four countries.

There are nine drug master file entries for azelastine hydrochloride. Twenty-one suppliers are listed for this compound. There is one tentative approval for this compound.

Recent Clinical Trials for azelastine hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
NorthShore University HealthSystemPhase 4
SandozPhase 3
Zhongnan HospitalPhase 4

See all azelastine hydrochloride clinical trials

Generic filers with tentative approvals for AZELASTINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing205.5MCGSPRAY;NASAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for azelastine hydrochloride
Paragraph IV (Patent) Challenges for AZELASTINE HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
CHILDREN'S ASTEPRO ALLERGY Nasal Spray azelastine hydrochloride 205.5 mcg/spray 213872 1 2021-07-12
ASTEPRO Nasal Spray azelastine hydrochloride 205.5 mcg/spray 022203 2011-12-15
OPTIVAR Ophthalmic Solution azelastine hydrochloride 0.05% 021127 1 2006-12-13
ASTELIN Nasal Spray azelastine hydrochloride 0.125 mg base/spray 020114 1 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
Bayer Hlthcare ASTEPRO ALLERGY azelastine hydrochloride SPRAY, METERED;NASAL 213872-001 Jun 17, 2021 OTC Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Apotex Inc AZELASTINE HYDROCHLORIDE azelastine hydrochloride SPRAY, METERED;NASAL 077954-001 Apr 30, 2009 AB RX No Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bayer Hlthcare ASTEPRO ALLERGY azelastine hydrochloride SPRAY, METERED;NASAL 213872-001 Jun 17, 2021 OTC Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Zydus Pharms AZELASTINE HYDROCHLORIDE azelastine hydrochloride SPRAY, METERED;NASAL 091409-001 Aug 14, 2017 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hikma AZELASTINE HYDROCHLORIDE azelastine hydrochloride SPRAY, METERED;NASAL 207243-001 Sep 22, 2017 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Aurobindo Pharma Ltd AZELASTINE HYDROCHLORIDE azelastine hydrochloride SPRAY, METERED;NASAL 212289-001 May 8, 2020 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for azelastine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mylan Speciality Lp OPTIVAR azelastine hydrochloride SOLUTION/DROPS;OPHTHALMIC 021127-001 May 22, 2000 See Plans and Pricing See Plans and Pricing
Mylan Speciality Lp OPTIVAR azelastine hydrochloride SOLUTION/DROPS;OPHTHALMIC 021127-001 May 22, 2000 See Plans and Pricing See Plans and Pricing
Mylan Spclt Viatris ASTELIN azelastine hydrochloride SPRAY, METERED;NASAL 020114-001 Nov 1, 1996 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for azelastine hydrochloride

Country Patent Number Title Estimated Expiration
Poland 2486942 See Plans and Pricing
European Patent Office 2522365 Compositions comprenant de l'azélastine et leurs procédés d'utilisation (Compositions comprising azelastine and methods of use thereof) See Plans and Pricing
European Patent Office 1827499 COMPOSITIONS COMPORTANT DE L'AZELASTINE ET LEURS PROCEDES D'UTILISATION (COMPOSITIONS COMPRISING AZELASTINE AND METHODS OF USE THEREOF) See Plans and Pricing
Slovenia 2522365 See Plans and Pricing
Israel 238308 תכשירי רוקחות המכילים אזלאסטין (Pharmaceutical compositions containing azelastine) See Plans and Pricing
Turkey 201820559 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for azelastine hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1519731 C300740 Netherlands See Plans and Pricing PRODUCT NAME: AZELASTINE OF EEN; NAT. REGISTRATION NO/DATE: RVG114215 20141125; FIRST REGISTRATION: 2011/07125-REG 20130215
0316633 99C0012 Belgium See Plans and Pricing PRODUCT NAME: AZELASTINE HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: 31 IS 113 F 13 19981021; FIRST REGISTRATION: GB PL 08336/0083 19980218
1519731 13C0067 France See Plans and Pricing PRODUCT NAME: AZELASTINE OU SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE; NAT. REGISTRATION NO/DATE: NL41755 20130925; FIRST REGISTRATION: SK - 24/0055/13-S 20130215
1519731 92269 Luxembourg See Plans and Pricing PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.