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Last Updated: April 25, 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

See drug prices for DYMISTA

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
Hungary S1300032 ⤷  Try a Trial
China 1674910 Combination of azelastine and steroids ⤷  Try a Trial
Canada 2779630 ASSOCIATION D'AZELASTINE ET DE STEROIDES (COMBINATION OF AZELASTINE AND STEROIDS) ⤷  Try a Trial
South Korea 20050024362 Combination of azelastine and steroids ⤷  Try a Trial
Spain 2456822 ⤷  Try a Trial
Slovenia 2072051 ⤷  Try a Trial
Australia 2009243420 Combination of azelastine and steroids ⤷  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 132013902182575 Italy ⤷  Try a Trial PRODUCT NAME: AZELASTINA CLORIDRATO/FLUTICASONE PROPIONATO(DYMISTA); AUTHORISATION NUMBER(S) AND DATE(S): 2011/07125-REG, 20111024;041808015/M-027/M-039/M-041/M, 20130527
1519731 1390033-7 Sweden ⤷  Try a 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
1519731 PA2013023 Lithuania ⤷  Try a Trial PRODUCT NAME: AZELASTINUM HYDROCHLORICUM + FLUTICASONUM PROPIONICUM; REGISTRATION NO/DATE: LT/1/13/3227/001 - LT/1 3/3227/004
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 C20130025 00090 Estonia ⤷  Try a Trial PRODUCT NAME: FLUTIKASOON; ASELASTIIN;REG NO/DATE: EE 808513 04.03.2013
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
1519731 175 5006-2013 Slovakia ⤷  Try a Trial 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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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.