FDA Orange Book · active-ingredient family

Azelastine hydrochloride

Azelastine hydrochloride: 4 brands, 27 generics; first approved Nov 01, 1996; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 27 ANDA applications approved.

Earliest patent expiry Jun 04, 2028

Brands (NDA)

4

Generics (ANDA)

27

Listed patents

1

Next patent expiry

Jun 04, 2028

in 1 yr 11 mo

Originator applications

Brand (NDA) products

ASTEPRO ALLERGYRLDRS

BAYER HLTHCARENDA 21387220212 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.2055MG/SPRAY	SPRAY, METERED	NASAL	OTC	—
0.2055MG/SPRAY	SPRAY, METERED	NASAL	OTC	—

VIATRISNDA 02220320082 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.137MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED	NASAL	Discontinued	—
0.2055MG/SPRAY	SPRAY, METERED	NASAL	Discontinued	—

RISINGNDA 0211272000

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS	OPHTHALMIC	Discontinued	—

RISINGNDA 0201141996

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.137MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED	NASAL	Discontinued	—

Abbreviated applications

Generic (ANDA) products (27)

AZELASTINE HYDROCHLORIDE ALLERGY

AUROBINDO PHARMAANDA 2165612025

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.2055MG/SPRAY	SPRAY, METERED	NASAL	OTC	—

AZELASTINE HYDROCHLORIDE

AMNEALANDA 2165762024

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.2055MG/SPRAY	SPRAY, METERED	NASAL	Discontinued	—

AZELASTINE HYDROCHLORIDE ALLERGY

APOTEXANDA 21642120242 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.2055MG/SPRAY	SPRAY, METERED	NASAL	OTC	—
0.2055MG/SPRAY	SPRAY, METERED	NASAL	OTC	—

AZELASTINE HYDROCHLORIDE

PADAGIS ISRAELANDA 2168012024

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.2055MG/SPRAY	SPRAY, METERED	NASAL	Discontinued	—

AZELASTINE HYDROCHLORIDE

AUROBINDO PHARMA LTDANDA 2127752020

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.2055MG/SPRAY	SPRAY, METERED	NASAL	Discontinued	—

AZELASTINE HYDROCHLORIDE

AUROBINDO PHARMA LTDANDA 2122892020

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.137MG/SPRAY	SPRAY, METERED	NASAL	Rx	AB

AZELASTINE HYDROCHLORIDE

GLANDANDA 2100922020

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	SOLUTION/DROPS	OPHTHALMIC	Rx	AT

AZELASTINE HYDROCHLORIDE

SCIEGEN PHARMSANDA 2100322019

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.2055MG/SPRAY	SPRAY, METERED	NASAL	Discontinued	—

AZELASTINE HYDROCHLORIDE

EPIC PHARMA LLCANDA 2076102019

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.137MG/SPRAY	SPRAY, METERED	NASAL	Rx	AB

AZELASTINE HYDROCHLORIDE

SOMERSET THERAPS LLCANDA 2074112019

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	SOLUTION/DROPS	OPHTHALMIC	Rx	AT

AZELASTINE HYDROCHLORIDE

ALEMBICANDA 2096202019

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	SOLUTION/DROPS	OPHTHALMIC	Rx	AT

AZELASTINE HYDROCHLORIDE

AMNEALANDA 2081992017

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.2055MG/SPRAY	SPRAY, METERED	NASAL	Discontinued	—

AZELASTINE HYDROCHLORIDE

HIKMAANDA 2072432017

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.2055MG/SPRAY	SPRAY, METERED	NASAL	Discontinued	—

AZELASTINE HYDROCHLORIDE

AMNEALANDA 2046602017

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.137MG/SPRAY	SPRAY, METERED	NASAL	Rx	AB

AZELASTINE HYDROCHLORIDE

ALKEM LABS LTDANDA 2081562017

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.137MG/SPRAY	SPRAY, METERED	NASAL	Rx	AB

AZELASTINE HYDROCHLORIDE

ZYDUS PHARMSANDA 0914092017

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.137MG/SPRAY	SPRAY, METERED	NASAL	Rx	AB

AZELASTINE HYDROCHLORIDE

PADAGIS USANDA 2026092017

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.137MG/SPRAY	SPRAY, METERED	NASAL	Discontinued	—

AZELASTINE HYDROCHLORIDE

EPIC PHARMA LLCANDA 2036602016

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	SOLUTION/DROPS	OPHTHALMIC	Discontinued	—

AZELASTINE HYDROCHLORIDE

BIONPHARMAANDA 0901762015

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.137MG/SPRAY	SPRAY, METERED	NASAL	Discontinued	—

AZELASTINE HYDROCHLORIDE

HIKMAANDA 0914442014

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.137MG/SPRAY	SPRAY, METERED	NASAL	Discontinued	—

AZELASTINE HYDROCHLORIDE

PADAGIS ISRAELANDA 2027432014

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.2055MG/SPRAY	SPRAY, METERED	NASAL	Discontinued	—

AZELASTINE HYDROCHLORIDE

APOTEX INCANDA 2018462012

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.2055MG/SPRAY	SPRAY, METERED	NASAL	Discontinued	—

AZELASTINE HYDROCHLORIDERS

SANDOZANDA 2023052012

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	SOLUTION/DROPS	OPHTHALMIC	Rx	AT

AZELASTINE HYDROCHLORIDE

SUN PHARMANDA 0904232012

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.137MG/SPRAY	SPRAY, METERED	NASAL	Discontinued	—

AZELASTINE HYDROCHLORIDE

SUN PHARMANDA 0787382010

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	SOLUTION/DROPS	OPHTHALMIC	Discontinued	—

AZELASTINE HYDROCHLORIDE

APOTEXANDA 0786212009

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	SOLUTION/DROPS	OPHTHALMIC	Rx	AT

AZELASTINE HYDROCHLORIDERS

APOTEX INCANDA 0779542009

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.137MG/SPRAY	SPRAY, METERED	NASAL	Rx	AB

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

Orange Book patent file

Listed patents

Listed patents (1)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8071073	Jun 04, 2028	in 1 yr 11 mo	Product

FDA approval span

Approval history

First approval

Nov 01, 1996

30 yr 1 mo ago

Most recent approval

Jan 27, 2025

1 yr 6 mo ago

Approvals span 1996–2025 across 31 FDA applications.

Brand (NDA) 413%

Generic (ANDA) 2787%

Azelastine hydrochloride — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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