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Last Updated: June 16, 2021

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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. Four suppliers are listed for this compound. Additional details are available on the azelastine hydrochloride; fluticasone propionate profile page.

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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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   Get Started Free   Get Started Free Y   Get Started Free
Mylan Speciality Lp DYMISTA azelastine hydrochloride; fluticasone propionate SPRAY, METERED;NASAL 202236-001 May 1, 2012 AB RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
Mylan Speciality Lp DYMISTA azelastine hydrochloride; fluticasone propionate SPRAY, METERED;NASAL 202236-001 May 1, 2012 AB RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
Mylan Speciality Lp DYMISTA azelastine hydrochloride; fluticasone propionate SPRAY, METERED;NASAL 202236-001 May 1, 2012 AB RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
>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 PA2013023 Lithuania   Get Started Free PRODUCT NAME: AZELASTINUM HYDROCHLORICUM + FLUTICASONUM PROPIONICUM; REGISTRATION NO/DATE: LT/1/13/3227/001 - LT/1 3/3227/004
1519731 C300740 Netherlands   Get Started Free PRODUCT NAME: AZELASTINE OF EEN; NAT. REGISTRATION NO/DATE: RVG114215 20141125; FIRST REGISTRATION: 2011/07125-REG 20130215
1519731 92269 Luxembourg   Get Started Free PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
1519731 CA 2013 00023 Denmark   Get Started Free PRODUCT NAME: AZELASTIN, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF OG EN FARMACEUTISK ACCEPTABEL ESTER AF FLUTICASON, HERUNDER AZELASTIN HYDROCHLORID OG FLUTICASON PROPIONAT; NAT. REG. NO/DATE: MT49785 20130219; FIRST REG. NO/DATE: SK 24/0055/13-S 20130215
1519731 C01519731/01 Switzerland   Get Started Free PRODUCT NAME: AZELASTIN + FLUTICASON; REGISTRATION NO/DATE: SWISSMEDIC 62675 06.05.2013
1519731 122013000059 Germany   Get Started Free 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 175 5006-2013 Slovakia   Get Started Free PRODUCT NAME: AZELASTIN ALEBO JEHO FARMACEUTICKY PRIJATE LNE SOLI A FARMACEUTICKY PRIJATEL NY ESTER FLUTIKAZONU; REGISTRATION NO/DATE: 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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