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

International Patents:	50
US Patents:	5
Tradenames:	10
Applicants:	20
NDAs:	33
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	21
Raw Ingredient (Bulk) Api Vendors:	114
Clinical Trials:	46
Patent Applications:	2,988
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AZELASTINE HYDROCHLORIDE
What excipients (inactive ingredients) are in AZELASTINE HYDROCHLORIDE?	AZELASTINE HYDROCHLORIDE excipients list
DailyMed Link:	AZELASTINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for AZELASTINE HYDROCHLORIDE

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

Sponsor	Phase
MEDA Pharma GmbH & Co. KG	Phase 2
Sandoz	Phase 1
Nanjing University of Chinese Medicine	N/A

See all AZELASTINE HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for AZELASTINE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	205.5MCG	SPRAY;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

Drug Class	Histamine-1 Receptor Antagonist
Mechanism of Action	Histamine H1 Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes 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

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Glossary

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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	022203-002	Aug 31, 2009		DISCN	No	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Bayer Hlthcare	ASTEPRO ALLERGY	azelastine hydrochloride	SPRAY, METERED;NASAL	213872-001	Jun 17, 2021		OTC	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Sun Pharm	AZELASTINE HYDROCHLORIDE	azelastine hydrochloride	SPRAY, METERED;NASAL	090423-001	May 23, 2012	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Apotex	AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY	azelastine hydrochloride	SPRAY, METERED;NASAL	216421-002	May 29, 2024		OTC	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Apotex Inc	AZELASTINE HYDROCHLORIDE	azelastine hydrochloride	SPRAY, METERED;NASAL	201846-001	Aug 31, 2012		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bayer Hlthcare	CHILDREN'S ASTEPRO ALLERGY	azelastine hydrochloride	SPRAY, METERED;NASAL	213872-002	Jun 17, 2021		OTC	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ 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

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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

International Patents for AZELASTINE HYDROCHLORIDE

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Country	Patent Number	Title	Estimated Expiration
Denmark	2486942		⤷ Sign Up
European Patent Office	1827499	COMPOSITIONS COMPORTANT DE L'AZELASTINE ET LEURS PROCEDES D'UTILISATION (COMPOSITIONS COMPRISING AZELASTINE AND METHODS OF USE THEREOF)	⤷ Sign Up
Israel	238308	תכשירי רוקחות המכילים אזלאסטין (Pharmaceutical compositions containing azelastine)	⤷ Sign Up
Japan	5677397		⤷ Sign Up
European Patent Office	2522365	Compositions comprenant de l'azélastine et leurs procédés d'utilisation (Compositions comprising azelastine and methods of use thereof)	⤷ Sign Up
South Korea	20180030953	아젤라스틴을 포함하는 조성물 및 이의 사용 방법 (COMPOSITIONS COMPRISING AZELASTINE AND METHODS OF USE THEREOF)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for AZELASTINE HYDROCHLORIDE

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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
0316633	99C0012	Belgium	⤷ Sign Up	PRODUCT NAME: AZELASTINE HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: 31 IS 113 F 13 19981021; FIRST REGISTRATION: GB PL 08336/0083 19980218
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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