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Last Updated: March 19, 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.

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 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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Combination of azelastine and steroids
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan Speciality Lp DYMISTA azelastine hydrochloride; fluticasone propionate SPRAY, METERED;NASAL 202236-001 May 1, 2012 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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 ⤷  Try a Trial ⤷  Try a Trial
Mylan Speciality Lp DYMISTA azelastine hydrochloride; fluticasone propionate SPRAY, METERED;NASAL 202236-001 May 1, 2012 ⤷  Try a Trial ⤷  Try a Trial
Mylan Speciality Lp DYMISTA azelastine hydrochloride; fluticasone propionate SPRAY, METERED;NASAL 202236-001 May 1, 2012 ⤷  Try a Trial ⤷  Try a Trial
>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
New Zealand 574658 Combination of azelastine and steroids such as fluticasone and mometasone for nasal and ocular use ⤷  Try a Trial
United Kingdom 0213739 ⤷  Try a Trial
Denmark 1519731 ⤷  Try a Trial
Israel 216931 הרכב רוקחות המכיל אזלסטין ואסטר של מומטסון (Pharmaceutical formulation comprising azelastine and a mometasone ester) ⤷  Try a Trial
Brazil 122014030154 ⤷  Try a Trial
Brazil 0312128 Formulação, produto farmacêutico, embalagem de pressão. mdi, pulverizador nasal, processos para preparar um produto farmacêutico e uma formulação e métodos para profilaxia ou tratamento em um mamìfero tal como um humano, de condições para as quais a administração de um ou mais anti-histamìnico e/ou um ou mais esteróides é indicada e para tratamento de irritação do distúrbios do nariz ou do olho e de distúrbios das vias aéreas ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for DYMISTA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1519731 13C0067 France ⤷  Try a 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
1519731 C01519731/01 Switzerland ⤷  Try a Trial PRODUCT NAME: AZELASTIN + FLUTICASON; REGISTRATION NO/DATE: SWISSMEDIC 62675 06.05.2013
1519731 C300740 Netherlands ⤷  Try a Trial PRODUCT NAME: AZELASTINE OF EEN; NAT. REGISTRATION NO/DATE: RVG114215 20141125; FIRST REGISTRATION: 2011/07125-REG 20130215
1519731 122013000059 Germany ⤷  Try a 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 ⤷  Try a Trial 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 40/2013 Austria ⤷  Try a Trial PRODUCT NAME: WIRKSTOFFKOMBINATION AUS AZELASTINHYDROCHLORID UND FLUTICASONPROPRIONAT; NAT. REGISTRATION NO/DATE: 1-31812 20130226; FIRST REGISTRATION: SK 24/0055/13-S 20130215
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.