azelastine hydrochloride; fluticasone propionate - Profile
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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, Teva Pharms Usa Inc, and Mylan Speciality Lp, and is included in four NDAs. There is one patent 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.
Summary for azelastine hydrochloride; fluticasone propionate
| International Patents: | 57 |
| US Patents: | 1 |
| Tradenames: | 2 |
| Applicants: | 4 |
| NDAs: | 4 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases 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
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 | ⤷ Start Trial | ⤷ Start 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 |
|---|---|---|---|
| Mexico | PA04012666 | COMBINACION DE AZELASTINA Y ESTEROIDES. (COMBINATION OF AZELASTINE AND STEROIDS.) | ⤷ Start Trial |
| Spain | 2545205 | ⤷ Start Trial | |
| Hungary | S1300032 | ⤷ Start Trial | |
| Cyprus | 1115386 | ⤷ Start Trial | |
| Portugal | 1519731 | ⤷ Start 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 | 92269 | Luxembourg | ⤷ Start Trial | PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE |
| 1519731 | C01519731/01 | Switzerland | ⤷ Start Trial | PRODUCT NAME: AZELASTIN + FLUTICASON; REGISTRATION NO/DATE: SWISSMEDIC 62675 06.05.2013 |
| 1519731 | 40/2013 | Austria | ⤷ Start Trial | PRODUCT NAME: WIRKSTOFFKOMBINATION AUS AZELASTINHYDROCHLORID UND FLUTICASONPROPRIONAT; NAT. REGISTRATION NO/DATE: 1-31812 20130226; FIRST REGISTRATION: SK 24/0055/13-S 20130215 |
| 1519731 | 122013000059 | Germany | ⤷ Start Trial | PRODUCT NAME: AZELASTIN ODER EIN PHARMAZEUTISCH UNBEDENKLICHES SALZ DAVON UND EIN PHARMAZEUTISCH UNBEDENKLICHER ESTER VON FLUTICASON; NAT. REGISTRATION NO/DATE: 85237.00.00 20130318; FIRST REGISTRATION: SLOWAKEI 24/0055/13-S 20130215 |
| 1519731 | CA 2013 00023 | Denmark | ⤷ Start 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
