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.
Summary for AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE
International Patents: | 57 |
US Patents: | 2 |
Tradenames: | 2 |
Applicants: | 3 |
NDAs: | 3 |
Finished Product Suppliers / Packagers: | 5 |
Clinical Trials: | 15 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE |
DailyMed Link: | AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE at DailyMed |
Recent Clinical Trials for AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Zheng Liu ENT | Phase 4 |
The People's Hospital of Hebei Province | Phase 4 |
Zhongnan Hospital | Phase 4 |
See all AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE clinical trials
Pharmacology for AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE
Drug Class | Corticosteroid Histamine-1 Receptor Antagonist |
Mechanism of Action | Corticosteroid Hormone Receptor Agonists Histamine H1 Receptor Antagonists |
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
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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