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Last Updated: February 29, 2020

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DYMISTA Drug Profile


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When do Dymista patents expire, and when can generic versions of Dymista launch?

Dymista is a drug marketed by Mylan Speciality Lp and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-six patent family members in twenty-seven countries.

The generic ingredient in DYMISTA is azelastine hydrochloride; fluticasone propionate. There are twelve drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the azelastine hydrochloride; fluticasone propionate profile page.

US ANDA Litigation and Generic Entry Outlook for Dymista

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for DYMISTA
Drug Prices for DYMISTA

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Drug Sales Revenue Trends for DYMISTA

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Recent Clinical Trials for DYMISTA

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SponsorPhase
MEDA Pharma GmbH & Co. KGPhase 3
University of DundeePhase 4
MEDA Pharma GmbH & Co. KGN/A

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Recent Litigation for DYMISTA

Identify potential future generic entrants

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

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PTAB Litigation
PetitionerDate
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC2020-01-31
2017-02-02

See all DYMISTA litigation

Synonyms for DYMISTA
1417803-89-4
Azelastine / fluticasone propionate
Azelastine hydrochloride / fluticasone propionate
Azelastine hydrochloride mixture with fluticasone propionate
Azelastine hydrochloride/fluticasone propionate
DTXSID40161821
MP 29-02
MP29-02
S900005920
Paragraph IV (Patent) Challenges for DYMISTA
Tradename Dosage Ingredient NDA Submissiondate
DYMISTA SPRAY, METERED;NASAL azelastine hydrochloride; fluticasone propionate 202236 2014-06-13

US Patents and Regulatory Information for DYMISTA

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 AB 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 AB 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 AB 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 AB 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 DYMISTA

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 C20130025 00090 Estonia   Start Trial PRODUCT NAME: FLUTIKASOON; ASELASTIIN;REG NO/DATE: EE 808513 04.03.2013
1519731 92269 Luxembourg   Start Trial PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
1519731 C300740 Netherlands   Start Trial PRODUCT NAME: AZELASTINE OF EEN; NAT. REGISTRATION NO/DATE: RVG114215 20141125; FIRST REGISTRATION: 2011/07125-REG 20130215
1519731 PA2013023 Lithuania   Start Trial PRODUCT NAME: AZELASTINUM HYDROCHLORICUM + FLUTICASONUM PROPIONICUM; REGISTRATION NO/DATE: LT/1/13/3227/001 - LT/1 3/3227/004
1519731 122013000059 Germany   Start Trial PRODUCT NAME: AZELASTIN ODER EIN PHARMAZEUTISCH UNBEDENKLICHES SALZ DAVON UND EIN PHARMAZEUTISCH UNBEDENKLICHER ESTER VON FLUTICASON; NAT. REGISTRATION NO/DATE: 85237.00.00 20130318; FIRST REGISTRATION: SLOWAKEI 24/0055/13-S 20130215
1519731 CA 2013 00023 Denmark   Start Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
Baxter
Harvard Business School
Express Scripts
Dow
Mallinckrodt

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