Fluticasone propionate; salmeterol xinafoate - Generic Drug Details

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

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 seven branded drugs marketed by Glaxo Grp Ltd, Teva Pharm, and Mylan, and is included in four NDAs. There are twenty-six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Fluticasone propionate; salmeterol xinafoate has five hundred patent family members in thirty-six countries.

There are twenty-nine drug master file entries for fluticasone propionate; salmeterol xinafoate. Seven suppliers are listed for this compound.

Summary for fluticasone propionate; salmeterol xinafoate

International Patents:	500
US Patents:	26
Tradenames:	7
Applicants:	3
NDAs:	4
Drug Master File Entries:	29
Suppliers / Packagers:	7
Clinical Trials:	33
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
Respirent Pharmaceuticals Co Ltd.	Phase 1
BECRO Ltd.	Phase 1
Shanghai Biomabs Pharmaceutical Co., Ltd.	Phase 3

See all fluticasone propionate; salmeterol xinafoate clinical trials

Pharmacology for fluticasone propionate; salmeterol xinafoate

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

US Patents and Regulatory Information for fluticasone propionate; salmeterol xinafoate

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Start Trial
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 RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-002	Jan 27, 2017		RX	Yes	No	Start Trial	Start Trial	Y			Start Trial
Teva Pharm	AIRDUO DIGIHALER	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-005	Jul 12, 2019		RX	Yes	No	Start Trial	Start Trial	Y			Start Trial
Teva Pharm	AIRDUO DIGIHALER	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-005	Jul 12, 2019		RX	Yes	No	Start Trial	Start Trial	Y			Start Trial
Teva Pharm	AIRDUO RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-002	Jan 27, 2017		RX	Yes	No	Start Trial	Start Trial				Start Trial
Teva Pharm	AIRDUO DIGIHALER	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-005	Jul 12, 2019		RX	Yes	No	Start Trial	Start Trial	Y			Start 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

Subscribe to access the full database, or Start Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxo Grp Ltd	ADVAIR HFA	fluticasone propionate; salmeterol xinafoate	AEROSOL, METERED;INHALATION	021254-001	Jun 8, 2006	Start Trial	Start Trial
Glaxo Grp Ltd	ADVAIR DISKUS 500/50	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	021077-003	Aug 24, 2000	Start Trial	Start Trial
Glaxo Grp Ltd	ADVAIR DISKUS 500/50	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	021077-003	Aug 24, 2000	Start Trial	Start Trial
Glaxo Grp Ltd	ADVAIR HFA	fluticasone propionate; salmeterol xinafoate	AEROSOL, METERED;INHALATION	021254-002	Jun 8, 2006	Start Trial	Start Trial
Glaxo Grp Ltd	ADVAIR DISKUS 500/50	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	021077-003	Aug 24, 2000	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for fluticasone propionate; salmeterol xinafoate

Subscribe to access the full database, or Start Trial
Country	Patent Number	Estimated Expiration
Spain	2707498	Start Trial
Eurasian Patent Organization	201300233	Start Trial
Australia	2003278236	Start Trial
Spain	2233659	Start Trial
European Patent Office	2496294	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for fluticasone propionate; salmeterol xinafoate

Subscribe to access the full database, or Start Trial
Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1305329	SPC/GB08/026	United Kingdom	Start Trial	PRODUCT NAME: FLUTICASONE FUROATE AND SOLVATES THEREOF; REGISTERED: UK EU/1/07/434/001 20080111; UK EU/1/07/434/002 20080111; UK EU/1/07/434/003 20080111
2506844	1890025-8	Sweden	Start Trial	PRODUCT NAME: COMBINATION OF A PHARMACEUTICALLY ACCEPTABLE SALT OF UMECLIDINIUM (E.G. UMECLIDINIUM BROMIDE), VILANTEROL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF (E.G. VILANTEROL TRIFENATATE) AND FLUTICASONE FUROATE.; REG. NO/DATE: EU/1/17/1236 20171117
1519731	13C0067	France	Start Trial	PRODUCT NAME: AZELASTINE OU SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE; NAT. REGISTRATION NO/DATE: NL41755 20130925; FIRST REGISTRATION: SK - 24/0055/13-S 20130215
1519731	132013902182575	Italy	Start 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	2018C/022	Belgium	Start Trial	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

By using our website you are consenting to our use of cookies in accordance with our privacy policy.