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Last Updated: July 16, 2024

DYMISTA Drug Patent 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 two patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-seven 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. Five suppliers are listed for this compound. Additional details are available on the azelastine hydrochloride; fluticasone propionate profile page.

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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
St. Paul's Sinus CentrePhase 4
MEDA Pharma GmbH & Co. KGPhase 4
MEDA Pharma GmbH & Co. KGPhase 3

See all DYMISTA clinical trials

Paragraph IV (Patent) Challenges for DYMISTA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
DYMISTA Nasal Spray azelastine hydrochloride; fluticasone propionate 137 mcg/50 mcg per spray 202236 1 2014-06-13

US Patents and Regulatory Information for DYMISTA

DYMISTA is protected by two US patents.

Patents protecting DYMISTA

Combination of azelastine and steroids
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Combination of azelastine and steroids
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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 No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mylan Speciality Lp DYMISTA azelastine hydrochloride; fluticasone propionate SPRAY, METERED;NASAL 202236-001 May 1, 2012 AB RX Yes No ⤷  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

Expired US Patents for DYMISTA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mylan Speciality Lp DYMISTA azelastine hydrochloride; fluticasone propionate SPRAY, METERED;NASAL 202236-001 May 1, 2012 ⤷  Sign Up ⤷  Sign Up
Mylan Speciality Lp DYMISTA azelastine hydrochloride; fluticasone propionate SPRAY, METERED;NASAL 202236-001 May 1, 2012 ⤷  Sign Up ⤷  Sign Up
Mylan Speciality Lp DYMISTA azelastine hydrochloride; fluticasone propionate SPRAY, METERED;NASAL 202236-001 May 1, 2012 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for DYMISTA

See the table below for patents covering DYMISTA around the world.

Country Patent Number Title Estimated Expiration
South Korea 101119895 ⤷  Sign Up
Australia 2003244799 COMBINATION OF AZELASTINE AND STEROIDS ⤷  Sign Up
European Patent Office 2072051 Combinaison d'azĂ©lastine et de momĂ©tasone (Combination of azelastine and mometasone) ⤷  Sign Up
South Africa 200500331 Combination of azelastine and steroids ⤷  Sign Up
Mexico PA04012666 COMBINACION DE AZELASTINA Y ESTEROIDES. (COMBINATION OF AZELASTINE AND STEROIDS.) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for DYMISTA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1519731 CA 2013 00023 Denmark ⤷  Sign Up 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 122013000059 Germany ⤷  Sign Up 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 ⤷  Sign Up PRODUCT NAME: AZELASTIN ALEBO JEHO FARMACEUTICKY PRIJATE LNE SOLI A FARMACEUTICKY PRIJATEL NY ESTER FLUTIKAZONU; REGISTRATION NO/DATE: 24/0055/13-S 20130215
1519731 1390033-7 Sweden ⤷  Sign Up 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
1519731 C20130025 00090 Estonia ⤷  Sign Up PRODUCT NAME: FLUTIKASOON; ASELASTIIN;REG NO/DATE: EE 808513 04.03.2013
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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