ASTEPRO ALLERGY Drug Patent Profile

Which patents cover Astepro Allergy, and when can generic versions of Astepro Allergy launch?

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 30^th, 2009.

Summary for ASTEPRO ALLERGY

International Patents:	50
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	114
Clinical Trials:	4
Patent Applications:	1,793
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ASTEPRO ALLERGY
What excipients (inactive ingredients) are in ASTEPRO ALLERGY?	ASTEPRO ALLERGY excipients list
DailyMed Link:	ASTEPRO ALLERGY at DailyMed

Recent Clinical Trials for ASTEPRO ALLERGY

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

Sponsor	Phase
Novella Clinical	Phase 4
Meda Pharmaceuticals	Phase 4
Meda Pharmaceuticals	Phase 3

See all ASTEPRO ALLERGY clinical trials

Pharmacology for ASTEPRO ALLERGY

Drug Class	Histamine-1 Receptor Antagonist
Mechanism of Action	Histamine H1 Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for ASTEPRO ALLERGY

R01AC	Antiallergic agents, excl. corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R06AX	Other antihistamines for systemic use
R06A	ANTIHISTAMINES FOR SYSTEMIC USE
R06	ANTIHISTAMINES FOR SYSTEMIC USE
R	Respiratory system

S01GX	Other antiallergics
S01G	DECONGESTANTS AND ANTIALLERGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for ASTEPRO ALLERGY

ASTEPRO ALLERGY is protected by three US patents.

Patents protecting ASTEPRO ALLERGY

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
Bayer Hlthcare	ASTEPRO ALLERGY	azelastine hydrochloride	SPRAY, METERED;NASAL	213872-001	Jun 17, 2021		OTC	Yes	Yes			Y
Bayer Hlthcare	ASTEPRO ALLERGY	azelastine hydrochloride	SPRAY, METERED;NASAL	213872-001	Jun 17, 2021		OTC	Yes	Yes			Y

International Patents for ASTEPRO ALLERGY

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

Country	Patent Number	Title	Estimated Expiration
Mexico	344036	COMPOSICIONES QUE COMPRENDEN AZELASTINA Y METODOS DE USO DE LA MISMA. (COMPOSITIONS COMPRISING AZELASTINE AND METHODS OF USE THEREOF.)
European Patent Office	2377557	Compositions comprenant de l'azélastine et leurs procédés d'utilisation (Compositions comprising azelastine and methods of use thereof)
Denmark	2377557
Slovenia	2486942

Supplementary Protection Certificates for ASTEPRO ALLERGY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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