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Azelastine hydrochloride - Generic Drug Details

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Azelastine hydrochloride is the generic ingredient in five branded drugs marketed by Meda Pharms, Alcon Pharma, Apotex Inc, Sun Pharma Global, Perrigo Israel, Roxane, Akorn, and Breckenridge Pharms, 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 thirteen countries.

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

Summary for Generic Name: azelastine hydrochloride

Tradenames:5
Patents:5
Applicants:8
NDAs:14
Drug Master File Entries: see list12
Suppliers / Packaging: see list11
Therapeutic Class:Ophthalmic Agents
Respiratory Tract Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: azelastine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Meda Pharms
DYMISTA
azelastine hydrochloride; fluticasone propionate
SPRAY, METERED;NASAL202236-001May 1, 2012RXYes9,259,428*PED► subscribeY► subscribe
Alcon Pharma
AZELASTINE HYDROCHLORIDE
azelastine hydrochloride
SOLUTION/DROPS;OPHTHALMIC202305-001May 31, 2012RXNo► subscribe► subscribe
Apotex Inc
AZELASTINE HYDROCHLORIDE
azelastine hydrochloride
SOLUTION/DROPS;OPHTHALMIC078621-001Aug 3, 2009RXNo► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: azelastine hydrochloride

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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
OPTIVAR
azelastine hydrochloride
SOLUTION/DROPS;OPHTHALMIC021127-001May 22, 20005,164,194► subscribe
Meda Pharms
ASTELIN
azelastine hydrochloride
SPRAY, METERED;NASAL020114-001Nov 1, 19965,164,194*PED► 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
South Korea20140048349► subscribe
Canada2588338► subscribe
Japan5607291► 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
269Luxembourg► subscribePRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
00740Netherlands► subscribePRODUCT NAME: AZELASTINE OF EEN; NAT. REGISTRATION NO/DATE: RVG114215 20141125; FIRST REGISTRATION: 2011/07125-REG 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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