ARMONAIR DIGIHALER Drug Patent Profile

When do Armonair Digihaler patents expire, and when can generic versions of Armonair Digihaler launch?

Armonair Digihaler is a drug marketed by Teva Pharm and is included in one NDA. There are twenty-five patents protecting this drug.

This drug has five hundred and seven patent family members in thirty-four countries.

The generic ingredient in ARMONAIR DIGIHALER is fluticasone propionate. There are twenty-nine drug master file entries for this compound. Seventy-eight suppliers are listed for this compound. Additional details are available on the fluticasone propionate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Armonair Digihaler

A generic version of ARMONAIR DIGIHALER was approved as fluticasone propionate by FOUGERA PHARMS on May 14^th, 2004.

Summary for ARMONAIR DIGIHALER

International Patents:	507
US Patents:	25
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	86
Patent Applications:	4,474
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ARMONAIR DIGIHALER
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ARMONAIR DIGIHALER
What excipients (inactive ingredients) are in ARMONAIR DIGIHALER?	ARMONAIR DIGIHALER excipients list
DailyMed Link:	ARMONAIR DIGIHALER at DailyMed

See drug prices for ARMONAIR DIGIHALER

Pharmacology for ARMONAIR DIGIHALER

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for ARMONAIR DIGIHALER

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

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

US Patents and Regulatory Information for ARMONAIR DIGIHALER

ARMONAIR DIGIHALER is protected by twenty-six US patents and two FDA Regulatory Exclusivities.

Patents protecting ARMONAIR DIGIHALER

FDA Regulatory Exclusivity protecting ARMONAIR DIGIHALER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Pharm	ARMONAIR DIGIHALER	fluticasone propionate	POWDER;INHALATION	208798-005	Feb 20, 2020		RX	Yes	No					Y
Teva Pharm	ARMONAIR DIGIHALER	fluticasone propionate	POWDER;INHALATION	208798-006	Feb 20, 2020		RX	Yes	Yes					Y
Teva Pharm	ARMONAIR DIGIHALER	fluticasone propionate	POWDER;INHALATION	208798-004	Feb 20, 2020		RX	Yes	No					Y
Teva Pharm	ARMONAIR DIGIHALER	fluticasone propionate	POWDER;INHALATION	208798-004	Feb 20, 2020		RX	Yes	No					Y
Teva Pharm	ARMONAIR DIGIHALER	fluticasone propionate	POWDER;INHALATION	208798-006	Feb 20, 2020		RX	Yes	Yes					Y

Expired US Patents for ARMONAIR DIGIHALER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Pharm	ARMONAIR DIGIHALER	fluticasone propionate	POWDER;INHALATION	208798-006	Feb 20, 2020
Teva Pharm	ARMONAIR DIGIHALER	fluticasone propionate	POWDER;INHALATION	208798-004	Feb 20, 2020
Teva Pharm	ARMONAIR DIGIHALER	fluticasone propionate	POWDER;INHALATION	208798-005	Feb 20, 2020
Teva Pharm	ARMONAIR DIGIHALER	fluticasone propionate	POWDER;INHALATION	208798-005	Feb 20, 2020
Teva Pharm	ARMONAIR DIGIHALER	fluticasone propionate	POWDER;INHALATION	208798-006	Feb 20, 2020

International Patents for ARMONAIR DIGIHALER

See the table below for patents covering ARMONAIR DIGIHALER around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	2314336
China	114306839	呼吸驱动吸入器的依从性监控模块 (Compliance monitoring module for breath-driven inhaler)
China	110167619	具有电子元件的药物递送装置 (DRUG DELIVERY DEVICE WITH ELECTRONICS)
Portugal	2502644
Japan	2007521844

Supplementary Protection Certificates for ARMONAIR DIGIHALER

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2506844	LUC00077	Luxembourg		PRODUCT NAME: PRODUIT DE COMBINAISON PHARMACEUTIQUE COMPRENANT UN SEL PHARMACEUTIQUEMENT ACCEPTABLE D'UMECLIDINIUM (PAR EXEMPLE LE BROMURE D'UMECLIDINIUM), LE VILANTEROL OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE (PAR EXEMPLE LE TRIFENATATE DE VILANTEROL) ET LE FUROATE DE FLUTICASONE; AUTHORISATION NUMBER AND DATE: EU/1/17/1236 20171117
1305329	08C0014	France		PRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 20080111
1519731	132013902182575	Italy		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
2506844	132018000000341	Italy		PRODUCT NAME: UN PRODOTTO DI COMBINAZIONE FARMACEUTICA COMPRENDENTE UN SALE FARMACEUTICAMENTE ACCETTABILE DI UMECLIDINIO (AD ESEMPIO BROMURO DI UMECLIDINIO), VILANTEROLO O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE (AD ESEMPIO VILANTEROLO TRIFENATATO) E UN FUROATO(TRELEGY ELLIPTA - FLUTICASONE FUROATO/UMECLIDINIO/VILANTEROLO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1236, 20171117
1519731	92269	Luxembourg		PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE