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 30^th, 2009.

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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:	5
Patent Applications:	1,692
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

Drug patent expirations by year for ASTEPRO ALLERGY

Recent Clinical Trials for ASTEPRO ALLERGY

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 ALLERGY clinical trials

Pharmacology for ASTEPRO ALLERGY

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

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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Compositions comprising azelastine and methods of use thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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
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Patent Expiration: ⤷ Sign Up

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Glossary

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

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Country	Patent Number	Title	Estimated Expiration
China	101098714	Compositions comprising azelastine and methods of use thereof	⤷ Sign Up
Lithuania	2522365		⤷ Sign Up
Lithuania	2486942		⤷ Sign Up
Slovenia	2377557		⤷ Sign Up
Poland	2486942		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ASTEPRO ALLERGY

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