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Last Updated: September 30, 2023

Fluticasone propionate; salmeterol xinafoate - Generic Drug Details

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What are the generic drug sources for fluticasone propionate; salmeterol xinafoate and what is the scope of patent protection?

Fluticasone propionate; salmeterol xinafoate is the generic ingredient in eight branded drugs marketed by Glaxo Grp Ltd, Teva Pharm, Hikma, Teva Pharms Usa, and Mylan, and is included in six NDAs. There are thirty patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Fluticasone propionate; salmeterol xinafoate has five hundred and eighty-three patent family members in thirty-seven countries.

Twelve suppliers are listed for this compound.

Summary for fluticasone propionate; salmeterol xinafoate

International Patents:	583
US Patents:	30
Tradenames:	8
Applicants:	5
NDAs:	6
Finished Product Suppliers / Packagers:	12
Clinical Trials:	43
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for fluticasone propionate; salmeterol xinafoate
DailyMed Link:	fluticasone propionate; salmeterol xinafoate at DailyMed

Recent Clinical Trials for fluticasone propionate; salmeterol xinafoate

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

Sponsor	Phase
Novartis Pharmaceuticals	Phase 3
Imperial College London	Phase 4
European Research Council	Phase 4

See all fluticasone propionate; salmeterol xinafoate clinical trials

Pharmacology for fluticasone propionate; salmeterol xinafoate

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

Anatomical Therapeutic Chemical (ATC) Classes for fluticasone propionate; salmeterol xinafoate

US Patents and Regulatory Information for fluticasone propionate; salmeterol xinafoate

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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
Teva Pharm	AIRDUO DIGIHALER	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-004	Jul 12, 2019		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Teva Pharm	AIRDUO DIGIHALER	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-006	Jul 12, 2019		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Teva Pharm	AIRDUO RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-002	Jan 27, 2017		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Teva Pharm	AIRDUO DIGIHALER	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-004	Jul 12, 2019		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Teva Pharm	AIRDUO DIGIHALER	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-006	Jul 12, 2019		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ 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 fluticasone propionate; salmeterol xinafoate

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxo Grp Ltd	ADVAIR HFA	fluticasone propionate; salmeterol xinafoate	AEROSOL, METERED;INHALATION	021254-003	Jun 8, 2006	⤷ Try a Trial	⤷ Try a Trial
Glaxo Grp Ltd	ADVAIR HFA	fluticasone propionate; salmeterol xinafoate	AEROSOL, METERED;INHALATION	021254-002	Jun 8, 2006	⤷ Try a Trial	⤷ Try a Trial
Glaxo Grp Ltd	ADVAIR HFA	fluticasone propionate; salmeterol xinafoate	AEROSOL, METERED;INHALATION	021254-002	Jun 8, 2006	⤷ Try a Trial	⤷ Try a Trial
Glaxo Grp Ltd	ADVAIR DISKUS 100/50	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	021077-001	Aug 24, 2000	⤷ Try a Trial	⤷ Try a Trial
Glaxo Grp Ltd	ADVAIR HFA	fluticasone propionate; salmeterol xinafoate	AEROSOL, METERED;INHALATION	021254-003	Jun 8, 2006	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for fluticasone propionate; salmeterol xinafoate

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for fluticasone propionate; salmeterol xinafoate

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	1516283	INDICATEUR D'ACTIONNEMENT POUR DISPOSITIF DISTRIBUTEUR (ACTUATION INDICATOR FOR A DISPENSING DEVICE)	⤷ Try a Trial
Japan	7015168		⤷ Try a Trial
Japan	5933607		⤷ Try a Trial
San Marino	T201500026	Contatori di dosi per inalatori inalatori e steli degli stessi	⤷ Try a Trial
Japan	2017525511	吸入器のためのコンプライアンス支援モジュール	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for fluticasone propionate; salmeterol xinafoate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2506844	SPC/GB18/020	United Kingdom	⤷ Try a Trial	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	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
2506844	132018000000341	Italy	⤷ Try a Trial	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
1305329	08C0014	France	⤷ Try a Trial	PRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 20080111
2506844	18C1022	France	⤷ Try a Trial	PRODUCT NAME: COMBINAISON COMPRENANT UN SEL PHARMACEUTIQUEMENT ACCEPTABLE D'UMECLIDINIUM (EN PARTICULIER LE BROMURE D'UMECLIDINIUM), DU VILANTEROL OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (EN PARTICULIER LE TRIFENATATE DE VILANTEROL), ET DU FUROATE DE FLUTICASONE; REGISTRATION NO/DATE: EU/1/17/1236 20171117
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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