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Last Updated: April 19, 2024

Azelastine hydrochloride - Generic Drug Details


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What are the generic drug sources for azelastine hydrochloride and what is the scope of freedom to operate?

Azelastine hydrochloride is the generic ingredient in eight branded drugs marketed by Alembic, Apotex Inc, Epic Pharma Llc, Gland Pharma Ltd, Sandoz, Somerset Theraps Llc, Sun Pharm, Mylan Speciality Lp, Mylan Spclt Viatris, Bayer Hlthcare, Akorn, Alkem Labs Ltd, Amneal, Aurobindo Pharma Ltd, Bionpharma, Hikma, Padagis Israel, Upsher Smith Labs, Zydus Pharms, and Apotex, and is included in thirty NDAs. There are five 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 are two tentative approvals for this compound.

Recent Clinical Trials for azelastine hydrochloride

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

SponsorPhase
SandozPhase 1
Mermaid Medicine®N/A
Johanna Maria VermeulenN/A

See all azelastine hydrochloride clinical trials

Generic filers with tentative approvals for AZELASTINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial205.5MCGSPRAY;NASAL
⤷  Try a Trial⤷  Try a Trial205.5MCGSPRAY;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
Mylan Speciality Lp ASTEPRO azelastine hydrochloride SPRAY, METERED;NASAL 022203-001 Oct 15, 2008 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Padagis Israel AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE azelastine hydrochloride; fluticasone propionate SPRAY, METERED;NASAL 208111-001 Feb 18, 2021 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Padagis Israel AZELASTINE HYDROCHLORIDE azelastine hydrochloride SPRAY, METERED;NASAL 202743-001 May 8, 2014 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Apotex Inc AZELASTINE HYDROCHLORIDE azelastine hydrochloride SPRAY, METERED;NASAL 201846-001 Aug 31, 2012 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 Spclt Viatris ASTELIN azelastine hydrochloride SPRAY, METERED;NASAL 020114-001 Nov 1, 1996 ⤷  Try a Trial ⤷  Try a Trial
Mylan Speciality Lp OPTIVAR azelastine hydrochloride SOLUTION/DROPS;OPHTHALMIC 021127-001 May 22, 2000 ⤷  Try a Trial ⤷  Try a Trial
Mylan Speciality Lp OPTIVAR azelastine hydrochloride SOLUTION/DROPS;OPHTHALMIC 021127-001 May 22, 2000 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for azelastine hydrochloride

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2006058022 ⤷  Try a Trial
South Korea 20070104884 COMPOSITIONS COMPRISING AZELASTINE AND METHODS OF USE THEREOF ⤷  Try a Trial
Hungary E030388 ⤷  Try a Trial
European Patent Office 2522365 Compositions comprenant de l'azélastine et leurs procédés d'utilisation (Compositions comprising azelastine and methods of use thereof) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for azelastine hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0316633 99C0012 Belgium ⤷  Try a Trial PRODUCT NAME: AZELASTINE HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: 31 IS 113 F 13 19981021; FIRST REGISTRATION: GB PL 08336/0083 19980218
1519731 C300740 Netherlands ⤷  Try a Trial PRODUCT NAME: AZELASTINE OF EEN; NAT. REGISTRATION NO/DATE: RVG114215 20141125; FIRST REGISTRATION: 2011/07125-REG 20130215
1519731 13C0067 France ⤷  Try a Trial 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 ⤷  Try a Trial 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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