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Last Updated: July 12, 2020

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DYMISTA Drug Profile


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Which patents cover Dymista, 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. Three suppliers are 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
University Hospital, GhentN/A

See all DYMISTA clinical trials

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 CA 2013 00023 Denmark   Start Trial
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 40/2013 Austria   Start Trial PRODUCT NAME: WIRKSTOFFKOMBINATION AUS AZELASTINHYDROCHLORID UND FLUTICASONPROPRIONAT; NAT. REGISTRATION NO/DATE: 1-31812 20130226; FIRST REGISTRATION: SK 24/0055/13-S 20130215
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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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Medtronic
Baxter
Moodys
Dow
McKinsey

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