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Last Updated: May 28, 2024

ASTEPRO Drug Patent 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 Bayer Hlthcare and is included in two NDAs. 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.

DrugPatentWatch® Litigation and Generic Entry Outlook for Astepro

A generic version of ASTEPRO was approved as azelastine hydrochloride by APOTEX INC on April 30th, 2009.

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Paragraph IV (Patent) Challenges for ASTEPRO
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ASTEPRO Nasal Spray azelastine hydrochloride 205.5 mcg/spray 022203 2011-12-15

US Patents and Regulatory Information for ASTEPRO

ASTEPRO is protected by three US patents.

Patents protecting ASTEPRO

Compositions comprising azelastine and methods of use thereof
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Compositions comprising azelastine and methods of use thereof
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ALLERGIC RHINITIS, INCLUDING SEASONAL AND PERENNIAL ALLERGIC RHINITIS

Compositions comprising azelastine
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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 Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bayer Hlthcare ASTEPRO ALLERGY azelastine hydrochloride SPRAY, METERED;NASAL 213872-001 Jun 17, 2021 OTC Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Mylan Speciality Lp ASTEPRO azelastine hydrochloride SPRAY, METERED;NASAL 022203-002 Aug 31, 2009 DISCN No No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Bayer Hlthcare ASTEPRO ALLERGY azelastine hydrochloride SPRAY, METERED;NASAL 213872-001 Jun 17, 2021 OTC Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Mylan Speciality Lp ASTEPRO azelastine hydrochloride SPRAY, METERED;NASAL 022203-001 Oct 15, 2008 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Mylan Speciality Lp ASTEPRO azelastine hydrochloride SPRAY, METERED;NASAL 022203-002 Aug 31, 2009 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bayer Hlthcare ASTEPRO ALLERGY azelastine hydrochloride SPRAY, METERED;NASAL 213872-001 Jun 17, 2021 OTC Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for ASTEPRO

See the table below for patents covering ASTEPRO around the world.

Country Patent Number Title Estimated Expiration
European Patent Office 1827499 COMPOSITIONS COMPORTANT DE L'AZELASTINE ET LEURS PROCEDES D'UTILISATION (COMPOSITIONS COMPRISING AZELASTINE AND METHODS OF USE THEREOF) ⤷  Sign Up
Lithuania 2522365 ⤷  Sign Up
China 101098714 Compositions comprising azelastine and methods of use thereof ⤷  Sign Up
Australia 2012201428 Compositions comprising azelastine and methods of use thereof ⤷  Sign Up
Lithuania 2486942 ⤷  Sign Up
Spain 2617253 ⤷  Sign Up
Lithuania 2377557 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ASTEPRO

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

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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 verification 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.