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McKinsey
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Fish and Richardson
Medtronic
Argus Health
US Department of Justice

Generated: March 21, 2019

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DYMISTA Drug Profile

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When do Dymista patents expire, 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-four 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. Two 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
Synonyms for DYMISTA
1417803-89-4
Azelastine / fluticasone propionate
Azelastine hydrochloride / fluticasone propionate
Azelastine hydrochloride mixture with fluticasone propionate
Azelastine hydrochloride/fluticasone propionate
DTXSID40161821
MP 29-02
MP29-02
S900005920

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

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Paragraph IV (Patent) Challenges for DYMISTA
Drugname Dosage Strength RLD Date
➤ Subscribe Nasal Spray 137 mcg/50 mcg per spray ➤ Subscribe ➤ Sign Up

Supplementary Protection Certificates for DYMISTA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 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 C20130025 00090 Estonia ➤ Sign Up PRODUCT NAME: FLUTIKASOON; ASELASTIIN;REG NO/DATE: EE 808513 04.03.2013
1519731 C01519731/01 Switzerland ➤ Sign Up PRODUCT NAME: AZELASTIN + FLUTICASON; REGISTRATION NO/DATE: SWISSMEDIC 62675 06.05.2013
1519731 92269 Luxembourg ➤ Sign Up PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
1519731 CA 2013 00023 Denmark ➤ Sign Up
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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