ADVAIR DISKUS 100/50 Drug Patent Profile

When do Advair Diskus 100/50 patents expire, and when can generic versions of Advair Diskus 100/50 launch?

Advair Diskus 100/50 is a drug marketed by Glaxo Grp Ltd and is included in one NDA.

The generic ingredient in ADVAIR DISKUS 100/50 is fluticasone propionate; salmeterol xinafoate. There are twenty-nine drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the fluticasone propionate; salmeterol xinafoate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Advair Diskus 100/50

A generic version of ADVAIR DISKUS 100/50 was approved as fluticasone propionate; salmeterol xinafoate by HIKMA on December 17^th, 2020.

Summary for ADVAIR DISKUS 100/50

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	7
Clinical Trials:	59
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ADVAIR DISKUS 100/50
DailyMed Link:	ADVAIR DISKUS 100/50 at DailyMed

Recent Clinical Trials for ADVAIR DISKUS 100/50

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Becro Ltd.	Phase 3
Teva Pharmaceuticals USA	Phase 3
Becro Ltd.	Phase 1

See all ADVAIR DISKUS 100/50 clinical trials

Pharmacology for ADVAIR DISKUS 100/50

Drug Class	Corticosteroid beta2-Adrenergic Agonist
Mechanism of Action	Adrenergic beta2-Agonists Corticosteroid Hormone Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for ADVAIR DISKUS 100/50

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

R03AC	Selective beta-2-adrenoreceptor agonists
R03A	ADRENERGICS, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
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 ADVAIR DISKUS 100/50

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxo Grp Ltd	ADVAIR DISKUS 100/50	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	021077-001	Aug 24, 2000	AB	RX	Yes	Yes

Expired US Patents for ADVAIR DISKUS 100/50

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxo Grp Ltd	ADVAIR DISKUS 100/50	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	021077-001	Aug 24, 2000
Glaxo Grp Ltd	ADVAIR DISKUS 100/50	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	021077-001	Aug 24, 2000
Glaxo Grp Ltd	ADVAIR DISKUS 100/50	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	021077-001	Aug 24, 2000
Glaxo Grp Ltd	ADVAIR DISKUS 100/50	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	021077-001	Aug 24, 2000
Glaxo Grp Ltd	ADVAIR DISKUS 100/50	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	021077-001	Aug 24, 2000
Glaxo Grp Ltd	ADVAIR DISKUS 100/50	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	021077-001	Aug 24, 2000

EU/EMA Drug Approvals for ADVAIR DISKUS 100/50

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Teva B.V.	Airexar Spiromax	salmeterol xinafoate, fluticasone propionate	EMEA/H/C/004267 Airexar Spiromax is indicated for use in adults aged 18 years and older only.AsthmaAirexar Spiromax is indicated for the regular treatment of patients with severe asthma where use of a combination product (inhaled corticosteroid and long-acting β2 agonist) is appropriate:- patients not adequately controlled on a lower strength corticosteroid combination productor- patients already controlled on a high dose inhaled corticosteroid and long-acting β2 agonist.Chronic Obstructive Pulmonary Disease (COPD)Airexar Spiromax is indicated for the symptomatic treatment of patients with COPD, with a FEV1	Withdrawn	no	no	no	2016-08-18

International Patents for ADVAIR DISKUS 100/50

See the table below for patents covering ADVAIR DISKUS 100/50 around the world.

Country	Patent Number	Title	Estimated Expiration
Bulgaria	61490
United Kingdom	2088877	ANDROSTANE 17 CARBOTHIOATES
Spain	8502447
Japan	H0569817
United Kingdom	8329568
Switzerland	644615	ANDROSTAN-CARBOTHIOATE, VERFAHREN ZU DEREN HERSTELLUNG UND DIESE ENTHALTENDE PHARMAZEUTISCHE ZUSAMMENSETZUNGEN.

Supplementary Protection Certificates for ADVAIR DISKUS 100/50

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2506844	SPC/GB18/020	United Kingdom		PRODUCT NAME: A PHARMACEUTICAL COMBINATION PRODUCT COMPRISING A PHARMACEUTICALLY ACCEPTABLE SALT OF UMECLIDINIUM (E.G. UMECLIDINIUM BROMIDE), VILANTEROL OR A PHARMACEUTICALLY ACCETPABLE SALT THEREOF (E.G. VILANTEROL TRIFENATATE), AND FLUTICASONE FUROATE; REGISTERED: UK EU/1/17/1236/001(NI) 20171117; UK EU/1/17/1236/002(NI) 20171117; UK EU/1/17/1236/003(NI) 20171117; UK PLGB 19494/0287 20171117
1519731	92269	Luxembourg		PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
1305329	SPC/GB08/026	United Kingdom		PRODUCT NAME: FLUTICASONE FUROATE AND SOLVATES THEREOF; REGISTERED: UK EU/1/07/434/001 20080116; UK EU/1/07/434/002 20080116; UK EU/1/07/434/003 20080116
2506844	2018C/022	Belgium		PRODUCT NAME: EEN FARMACEUTISCH COMBINATIEPRODUCT DAT EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN UMECLIDINIUM (BV. UMECLIDINIUMBROMIDE), VILANTEROL OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN (BV. VILANTEROLTRIFENATAAT) EN FLUTICASONEFUROAAT OMVAT; AUTHORISATION NUMBER AND DATE: EU/1/17/1236 20171117
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
0416951	12/1999	Austria		PRODUCT NAME: SALMETEROL, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, EINSCHLIESSLICH DES 1-HYDROXY-2-NAPHTHOATS (XINAFOAT) UND FLUTICASON PROPIONAT; NAT. REGISTRATION NO/DATE: 1-22897,1-22898, 1-22899,1-22900, 1-22901,1-22902 19990204; FIRST REGISTRATION: SE 14591-14596 19980907