Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 17, 2019

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Azelastine hydrochloride; fluticasone propionate - Generic Drug Details

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What are the generic sources for azelastine hydrochloride; fluticasone propionate and what is the scope of patent protection?

Azelastine hydrochloride; fluticasone propionate is the generic ingredient in two branded drugs marketed by Apotex Inc and Mylan Speciality Lp, and is included in two NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Azelastine hydrochloride; fluticasone propionate has fifty-six patent family members in twenty-seven countries.

There are twelve drug master file entries for azelastine hydrochloride; fluticasone propionate. One supplier is listed for this compound.

Recent Clinical Trials for azelastine hydrochloride; fluticasone propionate

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SponsorPhase
MEDA Pharma GmbH & Co. KGPhase 4
University of DundeePhase 4
University of ChicagoPhase 4

See all azelastine hydrochloride; fluticasone propionate clinical trials

Recent Litigation for azelastine hydrochloride; fluticasone propionate

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District Court Litigation
Case NameDate
Meda Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc.2015-09-08

See all azelastine hydrochloride; fluticasone propionate litigation

PTAB Litigation
PetitionerDate
Argentum Pharmaceuticals LLC2017-02-02

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Pharmacology for azelastine hydrochloride; fluticasone propionate
Paragraph IV (Patent) Challenges for AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE
Tradename Dosage Ingredient NDA Submissiondate
DYMISTA SPRAY, METERED;NASAL azelastine hydrochloride; fluticasone propionate 202236 2014-06-13

US Patents and Regulatory Information for azelastine hydrochloride; fluticasone propionate

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 DYMISTA azelastine hydrochloride; fluticasone propionate SPRAY, METERED;NASAL 202236-001 May 1, 2012 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Apotex Inc AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE azelastine hydrochloride; fluticasone propionate SPRAY, METERED;NASAL 207712-001 Apr 28, 2017 DISCN No No   Start Trial   Start Trial   Start Trial
Mylan Speciality Lp DYMISTA azelastine hydrochloride; fluticasone propionate SPRAY, METERED;NASAL 202236-001 May 1, 2012 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Mylan Speciality Lp DYMISTA azelastine hydrochloride; fluticasone propionate SPRAY, METERED;NASAL 202236-001 May 1, 2012 RX Yes Yes   Start Trial   Start Trial Y   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 azelastine hydrochloride; fluticasone propionate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1519731 C01519731/01 Switzerland   Start Trial PRODUCT NAME: AZELASTIN + FLUTICASON; REGISTRATION NO/DATE: SWISSMEDIC 62675 06.05.2013
1519731 1390033-7 Sweden   Start Trial PRODUCT NAME: AZELASTIN, ELLER ETT FARMACEUTISKT GODTAGBART SALT DAERAV, OCH EN FARMACEUTISKT GODTAGBAR ESTER AV FLUTIKASON; NAT. REG. NO/DATE: MTNR 47084 20130221; FIRST REG.: SK 24/0055/13-S 20130215
0316633 99C0012 Belgium   Start Trial PRODUCT NAME: AZELASTINE HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: 31 IS 113 F 13 19981021; FIRST REGISTRATION: GB PL 08336/0083 19980218
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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