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Serving leading biopharmaceutical companies globally:

Dow
Fish and Richardson
Johnson and Johnson
Accenture
Mallinckrodt
Daiichi Sankyo
Argus Health
Novartis
AstraZeneca
Chubb

Generated: December 17, 2017

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Azelastine hydrochloride - Generic Drug Details

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What are the generic sources for azelastine hydrochloride and what is the scope of azelastine hydrochloride freedom to operate?

Azelastine hydrochloride
is the generic ingredient in six branded drugs marketed by Akorn, Apotex Inc, Sandoz Inc, Sun Pharma Global, Mylan Speciality Lp, Alkem Labs Ltd, Amneal Pharms Llc, Breckenridge Pharm, Perrigo Israel, Upsher-smith Labs, West-ward Pharms Int, and Zydus Pharms Usa Inc, and is included in twenty 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 thirty-eight patent family members in twenty countries and four supplementary protection certificates in four countries.

There are twelve drug master file entries for azelastine hydrochloride. Fourteen suppliers are listed for this compound. There is one tentative approval for this compound.

Pharmacology for azelastine hydrochloride

Tentative approvals for AZELASTINE HYDROCHLORIDE

Applicant Application No. Strength Dosage Form
u► SubscribeEQ 0.1876MG BASE/SPRAYSPRAY, METERED;NASAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Speciality LpDYMISTAazelastine hydrochloride; fluticasone propionateSPRAY, METERED;NASAL202236-001May 1, 2012ABRXYesYes► Subscribe► Subscribe► Subscribe
Mylan Speciality LpDYMISTAazelastine hydrochloride; fluticasone propionateSPRAY, METERED;NASAL202236-001May 1, 2012ABRXYesYes► Subscribe► SubscribeY► Subscribe
Apotex IncAZELASTINE HYDROCHLORIDEazelastine hydrochlorideSPRAY, METERED;NASAL077954-001Apr 30, 2009ABRXNoNo► Subscribe► Subscribe► Subscribe
Upsher-smith LabsAZELASTINE HYDROCHLORIDEazelastine hydrochlorideSPRAY, METERED;NASAL202609-001Mar 17, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Breckenridge PharmAZELASTINE HYDROCHLORIDEazelastine hydrochlorideSPRAY, METERED;NASAL090176-001Jul 28, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Sun Pharma GlobalAZELASTINE HYDROCHLORIDEazelastine hydrochlorideSPRAY, METERED;NASAL090423-001May 23, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe
West-ward Pharms IntAZELASTINE HYDROCHLORIDEazelastine hydrochlorideSPRAY, METERED;NASAL091444-001Oct 24, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe
Mylan Speciality LpASTEPROazelastine hydrochlorideSPRAY, METERED;NASAL022203-001Oct 15, 2008DISCNNoNo► Subscribe► Subscribe► Subscribe
Mylan Speciality LpASTEPROazelastine hydrochlorideSPRAY, METERED;NASAL022203-001Oct 15, 2008DISCNNoNo► Subscribe► Subscribe► Subscribe
Mylan Speciality LpASTELINazelastine hydrochlorideSPRAY, METERED;NASAL020114-001Nov 1, 1996ABRXYesYes► Subscribe► 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
Mylan Speciality LpOPTIVARazelastine hydrochlorideSOLUTION/DROPS;OPHTHALMIC021127-001May 22, 2000► Subscribe► Subscribe
Mylan Speciality LpASTELINazelastine hydrochlorideSPRAY, METERED;NASAL020114-001Nov 1, 1996► Subscribe► Subscribe
Mylan Speciality LpOPTIVARazelastine hydrochlorideSOLUTION/DROPS;OPHTHALMIC021127-001May 22, 2000► Subscribe► 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 Africa200704902► Subscribe
Slovenia2377557► Subscribe
Portugal2377557► Subscribe
Denmark2377557► Subscribe
Australia2012201428► Subscribe
Denmark2522365► Subscribe
Lithuania2522365► Subscribe
HungaryE030388► Subscribe
Hong Kong1113310► Subscribe
Israel183372► 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
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
00740Netherlands► SubscribePRODUCT NAME: AZELASTINE OF EEN; NAT. REGISTRATION NO/DATE: RVG114215 20141125; FIRST REGISTRATION: 2011/07125-REG 20130215
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For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Chubb
US Army
Fuji
Moodys
Fish and Richardson
Cerilliant
AstraZeneca
Accenture
Medtronic
Baxter

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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