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Last Updated: February 25, 2021

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ASTELIN Drug Profile

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

Astelin is a drug marketed by Mylan Speciality Lp and is included in one NDA.

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

Drug patent expirations by year for ASTELIN
Recent Clinical Trials for ASTELIN

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SponsorPhase
ClinResearch, GmbHPhase 1
Prolytic GmbHPhase 1
MEDA Pharma GmbH & Co. KGPhase 1

See all ASTELIN clinical trials

Paragraph IV (Patent) Challenges for ASTELIN
Tradename Dosage Ingredient NDA Submissiondate
ASTELIN SPRAY, METERED;NASAL azelastine hydrochloride 020114 2005-11-14

US Patents and Regulatory Information for ASTELIN

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 ASTELIN azelastine hydrochloride SPRAY, METERED;NASAL 020114-001 Nov 1, 1996 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 ASTELIN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1519731 C300740 Netherlands   Start Trial PRODUCT NAME: AZELASTINE OF EEN; NAT. REGISTRATION NO/DATE: RVG114215 20141125; FIRST REGISTRATION: 2011/07125-REG 20130215
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Colorcon
Mallinckrodt
Boehringer Ingelheim
Baxter
Medtronic

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