Unlock all Features See Plans and Pricing

Serving leading biopharmaceutical companies globally:

Express Scripts
Mallinckrodt
Medtronic
Merck
Dow
Baxter

Last Updated: August 8, 2022

DYMISTA Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


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-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

See drug sales revenues for DYMISTA

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 four US patents.

Patents protecting DYMISTA

Combination of azelastine and steroids
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Combination of azelastine and steroids
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Combination of azelastine and fluticasone for nasal administration
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Combination of azelastine and fluticasone for nasal administration
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Mylan Speciality Lp DYMISTA azelastine hydrochloride; fluticasone propionate SPRAY, METERED;NASAL 202236-001 May 1, 2012 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Mylan Speciality Lp DYMISTA azelastine hydrochloride; fluticasone propionate SPRAY, METERED;NASAL 202236-001 May 1, 2012 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for DYMISTA

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

Country Patent Number Title Estimated Expiration
South Korea 20110113781 COMBINATION OF AZELASTINE AND STEROIDS See Plans and Pricing
Spain 2456822 See Plans and Pricing
Canada 2489427 ASSOCIATION D'AZELASTINE ET DE STEROIDES (COMBINATION OF AZELASTINE AND STEROIDS) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for DYMISTA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1519731 1390033-7 Sweden See Plans and Pricing 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 C300740 Netherlands See Plans and Pricing PRODUCT NAME: AZELASTINE OF EEN; NAT. REGISTRATION NO/DATE: RVG114215 20141125; FIRST REGISTRATION: 2011/07125-REG 20130215
1519731 175 5006-2013 Slovakia See Plans and Pricing 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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Medtronic
Baxter
Moodys
Dow
McKinsey

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.