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Last Updated: August 15, 2020

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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 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.

Recent Clinical Trials for FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

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

SponsorPhase
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

US Patents and Regulatory Information for FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

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 RESPICLICK fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 208799-003 Jan 27, 2017 RX Yes Yes   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
>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

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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

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 LUC00077 Luxembourg   Start Trial 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
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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