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Last Updated: November 21, 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 ten branded drugs marketed by Alembic, Apotex Inc, Epic Pharma Llc, Gland Pharma Ltd, Sandoz, Somerset Theraps Llc, Sun Pharm, Norvium Bioscience, Mylan Speciality Lp, Bayer Hlthcare, Alkem Labs Ltd, Amneal, Aurobindo Pharma Ltd, Bionpharma, Hikma, Padagis Israel, Sciegen Pharms Inc, Upsher Smith Labs, Zydus Pharms, and Apotex, and is included in thirty-three 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 is one tentative approval for this compound.

Summary for AZELASTINE HYDROCHLORIDE
Recent Clinical Trials for AZELASTINE HYDROCHLORIDE

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

SponsorPhase
MEDA Pharma GmbH & Co. KGPhase 2
SandozPhase 1
Nanjing University of Chinese MedicineN/A

See all AZELASTINE HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for AZELASTINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up205.5MCGSPRAY;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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mylan Speciality Lp DYMISTA azelastine hydrochloride; fluticasone propionate SPRAY, METERED;NASAL 202236-001 May 1, 2012 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Padagis Israel AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE azelastine hydrochloride; fluticasone propionate SPRAY, METERED;NASAL 208111-001 Feb 18, 2021 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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
Norvium Bioscience OPTIVAR azelastine hydrochloride SOLUTION/DROPS;OPHTHALMIC 021127-001 May 22, 2000 ⤷  Sign Up ⤷  Sign Up
Norvium Bioscience ASTELIN azelastine hydrochloride SPRAY, METERED;NASAL 020114-001 Nov 1, 1996 ⤷  Sign Up ⤷  Sign Up
Norvium Bioscience OPTIVAR azelastine hydrochloride SOLUTION/DROPS;OPHTHALMIC 021127-001 May 22, 2000 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for AZELASTINE HYDROCHLORIDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1519731 92269 Luxembourg ⤷  Sign Up PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
1519731 C300740 Netherlands ⤷  Sign Up PRODUCT NAME: AZELASTINE OF EEN; NAT. REGISTRATION NO/DATE: RVG114215 20141125; FIRST REGISTRATION: 2011/07125-REG 20130215
1519731 13C0067 France ⤷  Sign Up 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
>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.