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 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-one 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 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:	8
Applicants:	20
NDAs:	31
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	20
Raw Ingredient (Bulk) Api Vendors:	114
Clinical Trials:	43
Patent Applications:	2,988
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
Nanjing University of Chinese Medicine	N/A
Mermaid 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	022203-001	Oct 15, 2008		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mylan Speciality Lp	ASTEPRO	azelastine hydrochloride	SPRAY, METERED;NASAL	022203-001	Oct 15, 2008		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Zydus Pharms	AZELASTINE HYDROCHLORIDE	azelastine hydrochloride	SPRAY, METERED;NASAL	091409-001	Aug 14, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ 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
Mylan Speciality Lp	OPTIVAR	azelastine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	021127-001	May 22, 2000	⤷ Sign Up	⤷ Sign Up
Mylan Spclt Viatris	ASTELIN	azelastine hydrochloride	SPRAY, METERED;NASAL	020114-001	Nov 1, 1996	⤷ Sign Up	⤷ Sign Up
Mylan Speciality Lp	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
South Africa	200704902	Compositions comprising azelastine and methods of use thereof	⤷ Sign Up
China	101098714	Compositions comprising azelastine and methods of use thereof	⤷ Sign Up
Slovenia	2377557		⤷ 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	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
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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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