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Last Updated: May 11, 2021

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

Fluticasone propionate; salmeterol xinafoate has four hundred and seventy-seven patent family members in thirty-six countries.

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

Recent Clinical Trials for fluticasone propionate; salmeterol xinafoate

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

SponsorPhase
European Research CouncilPhase 4
Imperial College LondonPhase 4
Respirent Pharmaceuticals Co Ltd.Phase 1

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   Get Started for $10   Get Started for $10 Y   Get Started for $10
Teva Pharm AIRDUO DIGIHALER fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 208799-005 Jul 12, 2019 RX Yes No   Get Started for $10   Get Started for $10 Y   Get Started for $10
Teva Pharm AIRDUO DIGIHALER fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 208799-004 Jul 12, 2019 RX Yes No   Get Started for $10   Get Started for $10 Y   Get Started for $10
>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 DISKUS 250/50 fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 021077-002 Aug 24, 2000   Get Started for $10   Get Started for $10
Glaxo Grp Ltd ADVAIR DISKUS 100/50 fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 021077-001 Aug 24, 2000   Get Started for $10   Get Started for $10
Glaxo Grp Ltd ADVAIR HFA fluticasone propionate; salmeterol xinafoate AEROSOL, METERED;INHALATION 021254-003 Jun 8, 2006   Get Started for $10   Get Started for $10
>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
1519731 92269 Luxembourg   Get Started for $10 PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
2506844 1890025-8 Sweden   Get Started for $10 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
1305329 SPC/GB08/026 United Kingdom   Get Started for $10 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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