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Last Updated: March 28, 2024

AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE - Generic Drug Details


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What are the generic drug sources for azelastine hydrochloride; fluticasone propionate and what is the scope of freedom to operate?

Azelastine hydrochloride; fluticasone propionate is the generic ingredient in two branded drugs marketed by Apotex, Padagis Israel, and Mylan Speciality Lp, and is included in three NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Azelastine hydrochloride; fluticasone propionate has fifty-seven patent family members in twenty-seven countries.

Five suppliers are listed for this compound.

Recent Clinical Trials for AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Zheng Liu ENTPhase 4
The People's Hospital of Hebei ProvincePhase 4
Zhongnan HospitalPhase 4

See all AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE clinical trials

Pharmacology for AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE
Paragraph IV (Patent) Challenges for AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE
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 AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE

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
Padagis Israel AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE azelastine hydrochloride; fluticasone propionate SPRAY, METERED;NASAL 208111-001 Feb 18, 2021 AB RX No 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
Apotex AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE azelastine hydrochloride; fluticasone propionate SPRAY, METERED;NASAL 207712-001 Apr 28, 2017 AB RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  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 AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE

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 AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE

Country Patent Number Title Estimated Expiration
Denmark 2075000 ⤷  Try a Trial
Cyprus 1116693 ⤷  Try a Trial
South Korea 101119895 ⤷  Try a Trial
Denmark 1519731 ⤷  Try a Trial
Canada 2779633 ASSOCIATION D'AZELASTINE ET DE STEROIDES (COMBINATION OF AZELASTINE AND STEROIDS) ⤷  Try a Trial
Slovenia 1519731 ⤷  Try a Trial
Morocco 27285 COMBINAISON D'AZELASTINE ET DE STEROiDES ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1519731 C20130025 00090 Estonia ⤷  Try a Trial PRODUCT NAME: FLUTIKASOON; ASELASTIIN;REG NO/DATE: EE 808513 04.03.2013
1519731 92269 Luxembourg ⤷  Try a Trial PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
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 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 C300740 Netherlands ⤷  Try a Trial PRODUCT NAME: AZELASTINE OF EEN; NAT. REGISTRATION NO/DATE: RVG114215 20141125; FIRST REGISTRATION: 2011/07125-REG 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
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
>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.