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 six branded drugs marketed by Akorn, Alembic Pharms Ltd, Apotex Inc, Gland Pharma Ltd, Sandoz Inc, Somerset Theraps Llc, Sun Pharm, Mylan Speciality Lp, Alkem Labs Ltd, Amneal Pharms Llc, Aurobindo Pharma Ltd, Breckenridge, Hi Tech, Hikma, Perrigo Israel, Upsher Smith Labs, Zydus Pharms, and Apotex, and is included in twenty-seven 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 forty-nine patent family members in twenty-three countries.

There are twelve drug master file entries for azelastine hydrochloride. Twenty-one suppliers are listed for this compound.

Summary for azelastine hydrochloride

International Patents:	49
US Patents:	7
Tradenames:	6
Applicants:	18
NDAs:	27
Drug Master File Entries:	12
Suppliers / Packagers:	21
Bulk Api Vendors:	80
Clinical Trials:	33
Patent Applications:	1,225
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for azelastine hydrochloride
DailyMed Link:	azelastine hydrochloride at DailyMed

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	NDA	Submissiondate
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

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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
Sandoz Inc	AZELASTINE HYDROCHLORIDE	azelastine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	202305-001	May 31, 2012	AT	RX	No	Yes	Start Trial	Start Trial				Start Trial
Mylan Speciality Lp	DYMISTA	azelastine hydrochloride; fluticasone propionate	SPRAY, METERED;NASAL	202236-001	May 1, 2012	AB	RX	Yes	Yes	Start Trial	Start Trial			Y	Start Trial
Hikma	AZELASTINE HYDROCHLORIDE	azelastine hydrochloride	SPRAY, METERED;NASAL	091444-001	Oct 24, 2014	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Mylan Speciality Lp	DYMISTA	azelastine hydrochloride; fluticasone propionate	SPRAY, METERED;NASAL	202236-001	May 1, 2012	AB	RX	Yes	Yes	Start Trial	Start Trial	Y			Start Trial
Zydus Pharms	AZELASTINE HYDROCHLORIDE	azelastine hydrochloride	SPRAY, METERED;NASAL	091409-001	Aug 14, 2017	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Gland Pharma Ltd	AZELASTINE HYDROCHLORIDE	azelastine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	210092-001	Feb 25, 2020	AT	RX	No	No	Start Trial	Start Trial				Start 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 Speciality Lp	OPTIVAR	azelastine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	021127-001	May 22, 2000	Start Trial	Start Trial
Mylan Speciality Lp	ASTELIN	azelastine hydrochloride	SPRAY, METERED;NASAL	020114-001	Nov 1, 1996	Start Trial	Start Trial
Mylan Speciality Lp	OPTIVAR	azelastine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	021127-001	May 22, 2000	Start Trial	Start 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	Estimated Expiration
Australia	2012203343	Start Trial
Israel	238308	Start Trial
Slovenia	2522365	Start Trial
Spain	2617253	Start Trial
Japan	2013047253	Start Trial
Israel	183372	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for azelastine hydrochloride

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1519731	13C0067	France	Start 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
0316633	99C0012	Belgium	Start 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	Start Trial	PRODUCT NAME: AZELASTINE OF EEN; NAT. REGISTRATION NO/DATE: RVG114215 20141125; FIRST REGISTRATION: 2011/07125-REG 20130215
1519731	92269	Luxembourg	Start 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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