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Last Updated: April 19, 2024

AZELASTINE HYDROCHLORIDE - Generic Drug Details

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What are the generic 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.

Summary for AZELASTINE HYDROCHLORIDE

International Patents:	50
US Patents:	5
Tradenames:	8
Applicants:	20
NDAs:	30
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	21
Raw Ingredient (Bulk) Api Vendors:	114
Clinical Trials:	43
Patent Applications:	3,210
Formulation / Manufacturing:	see details
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
Sandoz	Phase 1
Johanna Maria Vermeulen	N/A
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
⤷ Try a Trial	⤷ Try a Trial	205.5MCG	SPRAY;NASAL
⤷ Try a Trial	⤷ Try a Trial	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

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	022203-001	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

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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

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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

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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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