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Last Updated: January 27, 2023

ASTEPRO ALLERGY Drug Patent Profile


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

Astepro Allergy is a drug marketed by Bayer Hlthcare and is included in one NDA. There are three patents protecting this drug.

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

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Astepro Allergy

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

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Summary for ASTEPRO ALLERGY
Drug patent expirations by year for ASTEPRO ALLERGY
Recent Clinical Trials for ASTEPRO ALLERGY

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

SponsorPhase
Novella ClinicalPhase 4
Meda PharmaceuticalsPhase 4
Meda PharmaceuticalsPhase 3

See all ASTEPRO ALLERGY clinical trials

Pharmacology for ASTEPRO ALLERGY

US Patents and Regulatory Information for ASTEPRO ALLERGY

ASTEPRO ALLERGY is protected by three US patents.

Patents protecting ASTEPRO ALLERGY

Compositions comprising azelastine and methods of use thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compositions comprising azelastine and methods of use thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: OTC USE: ALLERGY SYMPTOM RELIEVER; TEMPORARY RELIEF OF THESE SYMPTOMS DUE TO HAY FEVER OR OTHER UPPER RESPIRATORY ALLERGIES: NASAL CONGESTION, RUNNY NOSE, SNEEZING AND ITCHY NOSE

Compositions comprising azelastine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Hlthcare ASTEPRO ALLERGY azelastine hydrochloride SPRAY, METERED;NASAL 213872-001 Jun 17, 2021 OTC Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bayer Hlthcare ASTEPRO ALLERGY azelastine hydrochloride SPRAY, METERED;NASAL 213872-001 Jun 17, 2021 OTC Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Bayer Hlthcare ASTEPRO ALLERGY azelastine hydrochloride SPRAY, METERED;NASAL 213872-001 Jun 17, 2021 OTC Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 ALLERGY

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

Country Patent Number Title Estimated Expiration
Spain 2704482 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2006058022 See Plans and Pricing
Poland 2522365 See Plans and Pricing
Israel 238308 תכשירי רוקחות המכילים אזלאסטין (Pharmaceutical compositions containing azelastine) See Plans and Pricing
Slovenia 2522365 See Plans and Pricing
Cyprus 1121330 See Plans and Pricing
Lithuania 2486942 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ASTEPRO ALLERGY

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1519731 92269 Luxembourg See Plans and Pricing PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
1519731 13C0067 France See Plans and Pricing 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
0316633 99C0012 Belgium See Plans and Pricing PRODUCT NAME: AZELASTINE HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: 31 IS 113 F 13 19981021; FIRST REGISTRATION: GB PL 08336/0083 19980218
1519731 C300740 Netherlands See Plans and Pricing PRODUCT NAME: AZELASTINE OF EEN; NAT. REGISTRATION NO/DATE: RVG114215 20141125; FIRST REGISTRATION: 2011/07125-REG 20130215
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Mallinckrodt
McKinsey
Johnson and Johnson
Dow

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.