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 patent protection?

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
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

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
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
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
>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
Israel	165771	הרכב רוקחות המכיל אזלסטין ופולטיקאזון ותוצר המכיל אותם כגורם אנטיהיסטמיני ונוגד דלקת (Pharmaceutical formulation that comprisies azelastine and fluticasone and a product comprising these as antihistamine and anti-inflammatory agent)	⤷ Sign Up
Spain	2456822		⤷ Sign Up
Russian Federation	2361593	КОМБИНАЦИЯ АЗЕЛАСТИНА И СТЕРОИДОВ (AXELASTIN AND STEROIDS COMBINATION)	⤷ Sign Up
Denmark	2072051		⤷ Sign Up
Denmark	1519731		⤷ 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	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	PA2013023	Lithuania	⤷ Sign Up	PRODUCT NAME: AZELASTINUM HYDROCHLORICUM + FLUTICASONUM PROPIONICUM; REGISTRATION NO/DATE: LT/1/13/3227/001 - LT/1 3/3227/004
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	C01519731/01	Switzerland	⤷ Sign Up	PRODUCT NAME: AZELASTIN + FLUTICASON; REGISTRATION NO/DATE: SWISSMEDIC 62675 06.05.2013
1519731	C20130025 00090	Estonia	⤷ Sign Up	PRODUCT NAME: FLUTIKASOON; ASELASTIIN;REG NO/DATE: EE 808513 04.03.2013
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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