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:	16
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
Humanis Saglık Anonim Sirketi	Phase 1
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

Anatomical Therapeutic Chemical (ATC) Classes for azelastine hydrochloride; fluticasone propionate

D07AC	Corticosteroids, potent (group III)
D07A	CORTICOSTEROIDS, PLAIN
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

R01AC	Antiallergic agents, excl. corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R01AD	Corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R03BA	Glucocorticoids
R03B	OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

R06AX	Other antihistamines for systemic use
R06A	ANTIHISTAMINES FOR SYSTEMIC USE
R06	ANTIHISTAMINES FOR SYSTEMIC USE
R	Respiratory system

S01GX	Other antiallergics
S01G	DECONGESTANTS AND ANTIALLERGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Padagis Israel	AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	azelastine hydrochloride; fluticasone propionate	SPRAY, METERED;NASAL	208111-001	Feb 18, 2021	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mylan Speciality Lp	DYMISTA	azelastine hydrochloride; fluticasone propionate	SPRAY, METERED;NASAL	202236-001	May 1, 2012	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Apotex	AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	azelastine hydrochloride; fluticasone propionate	SPRAY, METERED;NASAL	207712-001	Apr 28, 2017	AB	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mylan Speciality Lp	DYMISTA	azelastine hydrochloride; fluticasone propionate	SPRAY, METERED;NASAL	202236-001	May 1, 2012	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
>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

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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	⤷ Sign Up	⤷ Sign Up
Mylan Speciality Lp	DYMISTA	azelastine hydrochloride; fluticasone propionate	SPRAY, METERED;NASAL	202236-001	May 1, 2012	⤷ Sign Up	⤷ Sign Up
Mylan Speciality Lp	DYMISTA	azelastine hydrochloride; fluticasone propionate	SPRAY, METERED;NASAL	202236-001	May 1, 2012	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for azelastine hydrochloride; fluticasone propionate

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Country	Patent Number	Title	Estimated Expiration
Brazil	PI0312128	formulação farmacêutica compreendendo azelastina e éster de fluticasona	⤷ Sign Up
Canada	2489427	ASSOCIATION D'AZELASTINE ET DE STEROIDES (COMBINATION OF AZELASTINE AND STEROIDS)	⤷ Sign Up
European Patent Office	2072051	Combinaison d'azélastine et de mométasone (Combination of azelastine and mometasone)	⤷ Sign Up
Spain	2324910		⤷ Sign Up
Costa Rica	7654	UNA COMBINACION DE AZELATINA Y ESTEROIDES	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for azelastine hydrochloride; fluticasone propionate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1519731	C01519731/01	Switzerland	⤷ Sign Up	PRODUCT NAME: AZELASTIN + FLUTICASON; REGISTRATION NO/DATE: SWISSMEDIC 62675 06.05.2013
1519731	122013000059	Germany	⤷ Sign Up	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	132013902182575	Italy	⤷ Sign Up	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	C300740	Netherlands	⤷ Sign Up	PRODUCT NAME: AZELASTINE OF EEN; NAT. REGISTRATION NO/DATE: RVG114215 20141125; FIRST REGISTRATION: 2011/07125-REG 20130215
1519731	CA 2013 00023	Denmark	⤷ Sign Up	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

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