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Last Updated: October 22, 2021

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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, Bayer Hlthcare, Alkem Labs Ltd, Amneal, Aurobindo Pharma Ltd, Breckenridge, Hikma Pharms, 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 twelve drug master file entries for azelastine hydrochloride. Twenty-one suppliers are listed for this compound.

Recent Clinical Trials for azelastine hydrochloride

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

SponsorPhase
Pharmactive Ilac Sanayi ve Tic A.S.Phase 1/Phase 2
Istanbul UniversityPhase 3
Antalya Training and Research HospitalPhase 3

See all azelastine hydrochloride clinical trials

Pharmacology for azelastine hydrochloride
Paragraph IV (Patent) Challenges for AZELASTINE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
ASTEPRO ALLERGY SPRAY, METERED;NASAL azelastine hydrochloride 213872 2021-07-12
CHILDREN'S ASTEPRO ALLERGY SPRAY, METERED;NASAL azelastine hydrochloride 213872 2021-07-12
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
Upsher Smith Labs AZELASTINE HYDROCHLORIDE azelastine hydrochloride SPRAY, METERED;NASAL 202609-001 Mar 17, 2017 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Hikma Pharms AZELASTINE HYDROCHLORIDE azelastine hydrochloride SPRAY, METERED;NASAL 207243-001 Sep 22, 2017 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Mylan Speciality Lp ASTEPRO azelastine hydrochloride SPRAY, METERED;NASAL 022203-001 Oct 15, 2008 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever 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 Speciality Lp OPTIVAR azelastine hydrochloride SOLUTION/DROPS;OPHTHALMIC 021127-001 May 22, 2000 ⤷  Free Forever Trial ⤷  Free Forever Trial
Mylan Speciality Lp ASTELIN azelastine hydrochloride SPRAY, METERED;NASAL 020114-001 Nov 1, 1996 ⤷  Free Forever Trial ⤷  Free Forever Trial
Mylan Speciality Lp OPTIVAR azelastine hydrochloride SOLUTION/DROPS;OPHTHALMIC 021127-001 May 22, 2000 ⤷  Free Forever Trial ⤷  Free Forever Trial
>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 ⤷  Free Forever Trial PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
1519731 C300740 Netherlands ⤷  Free Forever Trial PRODUCT NAME: AZELASTINE OF EEN; NAT. REGISTRATION NO/DATE: RVG114215 20141125; FIRST REGISTRATION: 2011/07125-REG 20130215
0316633 99C0012 Belgium ⤷  Free Forever Trial PRODUCT NAME: AZELASTINE HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: 31 IS 113 F 13 19981021; FIRST REGISTRATION: GB PL 08336/0083 19980218
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Harvard Business School
AstraZeneca
Mallinckrodt
Boehringer Ingelheim
Express Scripts
Moodys

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