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Azelastine hydrochloride - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for azelastine hydrochloride?

Azelastine hydrochloride is the generic ingredient in five branded drugs marketed by Meda Pharms, Sandoz Inc, Apotex Inc, Sun Pharma Global, Perrigo Israel, West-ward Pharms Int, Akorn, and Breckenridge Pharm, and is included in fourteen NDAs. There are five patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has twenty-three patent family members in fifteen countries.

There are twelve drug master file entries for azelastine hydrochloride. Twelve suppliers are listed for this compound.

Summary for Generic Name: azelastine hydrochloride

Tradenames:5
Patents:6
Applicants:8
NDAs:14
Drug Master File Entries: see list12
Suppliers / Packagers: see list12
Bulk Api Vendors: see list92
Clinical Trials: see list993
Patent Applications: see list3,528
Therapeutic Class:Ophthalmic Agents
Respiratory Tract Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:azelastine hydrochloride at DailyMed

Pharmacology for Ingredient: azelastine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Meda Pharms
ASTEPRO
azelastine hydrochloride
SPRAY, METERED;NASAL022203-002Aug 31, 2009RXYesYes► Subscribe► Subscribe
Meda Pharms
DYMISTA
azelastine hydrochloride; fluticasone propionate
SPRAY, METERED;NASAL202236-001May 1, 2012RXYesYes► Subscribe► Subscribe
Apotex Inc
AZELASTINE HYDROCHLORIDE
azelastine hydrochloride
SPRAY, METERED;NASAL077954-001Apr 30, 2009RXNoNo► Subscribe► Subscribe
Meda Pharms
ASTEPRO
azelastine hydrochloride
SPRAY, METERED;NASAL022203-002Aug 31, 2009RXYesYes8,071,073► SubscribeY ► Subscribe
Meda Pharms
ASTEPRO
azelastine hydrochloride
SPRAY, METERED;NASAL022203-001Oct 15, 2008DISCNNoNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: azelastine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Meda Pharms
OPTIVAR
azelastine hydrochloride
SOLUTION/DROPS;OPHTHALMIC021127-001May 22, 20005,164,194*PED► Subscribe
Meda Pharms
ASTELIN
azelastine hydrochloride
SPRAY, METERED;NASAL020114-001Nov 1, 19965,164,194*PED► Subscribe
Meda Pharms
OPTIVAR
azelastine hydrochloride
SOLUTION/DROPS;OPHTHALMIC021127-001May 22, 20005,164,194► Subscribe
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Non-Orange Book Patents for Generic Ingredient: azelastine hydrochloride

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,758,816Compositions comprising azelastine and methods of use thereof► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: azelastine hydrochloride

Country Document Number Estimated Expiration
Japan5677397► Subscribe
World Intellectual Property Organization (WIPO)2006058022► Subscribe
Hong Kong1113310► Subscribe
Australia2012203343► Subscribe
BrazilPI0517891► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: AZELASTINE HYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00740Netherlands► SubscribePRODUCT NAME: AZELASTINE OF EEN; NAT. REGISTRATION NO/DATE: RVG114215 20141125; FIRST REGISTRATION: 2011/07125-REG 20130215
269Luxembourg► SubscribePRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
C0067France► SubscribePRODUCT 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
C0012Belgium► SubscribePRODUCT NAME: AZELASTINE HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: 31 IS 113 F 13 19981021; FIRST REGISTRATION: GB PL 08336/0083 19980218
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