ASTEPRO Drug Patent Profile

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.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Astepro

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

Summary for ASTEPRO

International Patents:	50
US Patents:	3
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	114
Clinical Trials:	5
Patent Applications:	1,692
Drug Prices:	Drug price information for ASTEPRO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ASTEPRO
DailyMed Link:	ASTEPRO at DailyMed

See drug prices for ASTEPRO

See drug sales revenues for ASTEPRO

Recent Clinical Trials for ASTEPRO

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

Sponsor	Phase
University of Chicago	Phase 4
Meda Pharmaceuticals	Phase 4
Novella Clinical	Phase 4

See all ASTEPRO clinical trials

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

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
Bayer Hlthcare	ASTEPRO ALLERGY	azelastine hydrochloride	SPRAY, METERED;NASAL	213872-001	Jun 17, 2021		OTC	Yes	Yes			Y
Mylan Speciality Lp	ASTEPRO	azelastine hydrochloride	SPRAY, METERED;NASAL	022203-002	Aug 31, 2009		DISCN	No	No			Y
Bayer Hlthcare	ASTEPRO ALLERGY	azelastine hydrochloride	SPRAY, METERED;NASAL	213872-001	Jun 17, 2021		OTC	Yes	Yes			Y

International Patents for ASTEPRO

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

Country	Patent Number	Title	Estimated Expiration
Denmark	2486942
European Patent Office	1827499	COMPOSITIONS COMPORTANT DE L'AZELASTINE ET LEURS PROCEDES D'UTILISATION (COMPOSITIONS COMPRISING AZELASTINE AND METHODS OF USE THEREOF)
Israel	238308	תכשירי רוקחות המכילים אזלאסטין (Pharmaceutical compositions containing azelastine)
Japan	5677397

Supplementary Protection Certificates for ASTEPRO

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