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Last Updated: October 17, 2021

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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-one suppliers are listed for this compound. Additional details are available on the azelastine hydrochloride profile page.

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 ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Bayer Hlthcare ASTEPRO ALLERGY azelastine hydrochloride SPRAY, METERED;NASAL 213872-001 Jun 17, 2021 OTC Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Mylan Speciality Lp ASTEPRO azelastine hydrochloride SPRAY, METERED;NASAL 022203-002 Aug 31, 2009 DISCN Yes No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Bayer Hlthcare ASTEPRO ALLERGY azelastine hydrochloride SPRAY, METERED;NASAL 213872-001 Jun 17, 2021 OTC Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Mylan Speciality Lp ASTEPRO azelastine hydrochloride SPRAY, METERED;NASAL 022203-001 Oct 15, 2008 DISCN No No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
>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 C300740 Netherlands ⤷  Try it Free PRODUCT NAME: AZELASTINE OF EEN; NAT. REGISTRATION NO/DATE: RVG114215 20141125; FIRST REGISTRATION: 2011/07125-REG 20130215
1519731 92269 Luxembourg ⤷  Try it Free PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
0316633 99C0012 Belgium ⤷  Try it Free PRODUCT NAME: AZELASTINE HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: 31 IS 113 F 13 19981021; FIRST REGISTRATION: GB PL 08336/0083 19980218
1519731 13C0067 France ⤷  Try it Free 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
Merck
Baxter
Boehringer Ingelheim
Express Scripts
Harvard Business School

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