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Last Updated: November 26, 2020

DrugPatentWatch Database Preview

ASTEPRO Drug Profile

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When do Astepro patents expire, and what generic alternatives are available?

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

This drug has fifty patent family members in twenty-four countries.

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

Drug patent expirations by year for ASTEPRO
Drug Prices for ASTEPRO

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Drug Sales Revenue Trends for ASTEPRO

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Recent Clinical Trials for ASTEPRO

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Novella ClinicalPhase 4
Meda PharmaceuticalsPhase 4
Meda PharmaceuticalsPhase 3

See all ASTEPRO clinical trials

Pharmacology for ASTEPRO
Paragraph IV (Patent) Challenges for ASTEPRO
Tradename Dosage Ingredient NDA Submissiondate
ASTEPRO SPRAY, METERED;NASAL azelastine hydrochloride 022203 2011-12-15

US Patents and Regulatory Information for 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;NASAL 022203-001 Oct 15, 2008 DISCN No No   Start Trial   Start Trial   Start Trial
Mylan Speciality Lp ASTEPRO azelastine hydrochloride SPRAY, METERED;NASAL 022203-002 Aug 31, 2009 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Mylan Speciality Lp ASTEPRO azelastine hydrochloride SPRAY, METERED;NASAL 022203-001 Oct 15, 2008 DISCN No No   Start Trial   Start Trial Y   Start Trial
Mylan Speciality Lp ASTEPRO azelastine hydrochloride SPRAY, METERED;NASAL 022203-002 Aug 31, 2009 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for ASTEPRO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1519731 13C0067 France   Start Trial 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   Start Trial PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
1519731 C300740 Netherlands   Start Trial PRODUCT NAME: AZELASTINE OF EEN; NAT. REGISTRATION NO/DATE: RVG114215 20141125; FIRST REGISTRATION: 2011/07125-REG 20130215
0316633 99C0012 Belgium   Start Trial PRODUCT NAME: AZELASTINE HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: 31 IS 113 F 13 19981021; FIRST REGISTRATION: GB PL 08336/0083 19980218
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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