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 |
---|---|
The People's Hospital of Hebei Province | Phase 4 |
Zhongnan Hospital | Phase 4 |
Wuhan Union Hospital, China | 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 |
Anatomical Therapeutic Chemical (ATC) Classes 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 | Y | ⤷ 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 | ⤷ 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 |
---|---|---|---|
Hungary | S1300032 | ⤷ Try a Trial | |
China | 1674910 | Combination of azelastine and steroids | ⤷ Try a Trial |
Canada | 2779630 | ASSOCIATION D'AZELASTINE ET DE STEROIDES (COMBINATION OF AZELASTINE AND STEROIDS) | ⤷ Try a Trial |
South Korea | 20050024362 | Combination of azelastine and steroids | ⤷ Try a Trial |
Spain | 2456822 | ⤷ Try a Trial | |
Slovenia | 2072051 | ⤷ Try a Trial | |
Australia | 2009243420 | Combination of azelastine and steroids | ⤷ 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 | 132013902182575 | Italy | ⤷ Try a Trial | PRODUCT NAME: AZELASTINA CLORIDRATO/FLUTICASONE PROPIONATO(DYMISTA); AUTHORISATION NUMBER(S) AND DATE(S): 2011/07125-REG, 20111024;041808015/M-027/M-039/M-041/M, 20130527 |
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 | PA2013023 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: AZELASTINUM HYDROCHLORICUM + FLUTICASONUM PROPIONICUM; REGISTRATION NO/DATE: LT/1/13/3227/001 - LT/1 3/3227/004 |
1519731 | 13C0067 | France | ⤷ Try a Trial | PRODUCT NAME: AZELASTINE OU SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE; NAT. REGISTRATION NO/DATE: NL41755 20130925; FIRST REGISTRATION: SK - 24/0055/13-S 20130215 |
1519731 | C20130025 00090 | Estonia | ⤷ Try a Trial | PRODUCT NAME: FLUTIKASOON; ASELASTIIN;REG NO/DATE: EE 808513 04.03.2013 |
1519731 | 40/2013 | Austria | ⤷ Try a Trial | PRODUCT NAME: WIRKSTOFFKOMBINATION AUS AZELASTINHYDROCHLORID UND FLUTICASONPROPRIONAT; NAT. REGISTRATION NO/DATE: 1-31812 20130226; FIRST REGISTRATION: SK 24/0055/13-S 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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