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Serving 500+ biopharmaceutical companies globally:

Farmers Insurance
Medtronic
Citi
Teva
McKinsey
AstraZeneca
Colorcon
Cerilliant
Novartis
Queensland Health

Generated: August 24, 2017

DrugPatentWatch Database Preview

ASTEPRO Drug Profile

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Which patents cover Astepro, and what generic Astepro alternatives are available?

Astepro is a drug marketed by Mylan Speciality Lp and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-five patent family members in nineteen countries.

The generic ingredient in ASTEPRO is azelastine hydrochloride. There are twelve drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the azelastine hydrochloride profile page.

Summary for Tradename: ASTEPRO

Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
Bulk Api Vendors: see list80
Clinical Trials: see list4
Patent Applications: see list3,679
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:ASTEPRO at DailyMed

Pharmacology for Tradename: ASTEPRO

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;NASAL022203-001Oct 15, 2008DISCNNoNo► Subscribe► SubscribeY ► Subscribe
Mylan Speciality Lp
ASTEPRO
azelastine hydrochloride
SPRAY, METERED;NASAL022203-002Aug 31, 2009ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Mylan Speciality Lp
ASTEPRO
azelastine hydrochloride
SPRAY, METERED;NASAL022203-002Aug 31, 2009ABRXYesYes► Subscribe► Subscribe ► Subscribe
Mylan Speciality Lp
ASTEPRO
azelastine hydrochloride
SPRAY, METERED;NASAL022203-001Oct 15, 2008DISCNNoNo► Subscribe► Subscribe ► Subscribe
Mylan Speciality Lp
ASTEPRO
azelastine hydrochloride
SPRAY, METERED;NASAL022203-001Oct 15, 2008DISCNNoNo► Subscribe► Subscribe► Subscribe
Mylan Speciality Lp
ASTEPRO
azelastine hydrochloride
SPRAY, METERED;NASAL022203-001Oct 15, 2008DISCNNoNo► Subscribe► Subscribe► Subscribe
Mylan Speciality Lp
ASTEPRO
azelastine hydrochloride
SPRAY, METERED;NASAL022203-002Aug 31, 2009ABRXYesYes► Subscribe► Subscribe► Subscribe
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Paragraph IV activity for: ASTEPRO

Drugname Dosage Strength RLD Submissiondate
azelastine hydrochlorideNasal Spray205.5 mcg/sprayAstepro12/15/2011

Non-Orange Book Patents for Tradename: ASTEPRO

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 Tradename: ASTEPRO

Country Document Number Estimated Expiration
Australia2012203343► Subscribe
European Patent Office1827499► Subscribe
Portugal2377557► Subscribe
Japan2013047253► Subscribe
European Patent Office2486942► Subscribe
Japan5677397► Subscribe
Portugal2522365► Subscribe
World Intellectual Property Organization (WIPO)2006058022► Subscribe
BrazilPI0517891► Subscribe
European Patent Office2522365► 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: ASTEPRO

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
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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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Johnson and Johnson
Boehringer Ingelheim
US Army
McKinsey
Covington
Harvard Business School
Baxter
Daiichi Sankyo
QuintilesIMS
US Department of Justice

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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