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Last Updated: May 19, 2022

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 twenty-four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

Nine suppliers are listed for this compound.

Summary for fluticasone propionate; salmeterol xinafoate
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 DIGIHALER fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 208799-005 Jul 12, 2019 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Teva Pharm AIRDUO RESPICLICK fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 208799-002 Jan 27, 2017 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Teva Pharm AIRDUO RESPICLICK fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 208799-003 Jan 27, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Glaxo Grp Ltd ADVAIR HFA fluticasone propionate; salmeterol xinafoate AEROSOL, METERED;INHALATION 021254-002 Jun 8, 2006 See Plans and Pricing See Plans and Pricing
Teva Pharm AIRDUO RESPICLICK fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 208799-002 Jan 27, 2017 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for fluticasone propionate; salmeterol xinafoate

Country Patent Number Title Estimated Expiration
Eurasian Patent Organization 201291267 СЧЕТЧИКИ ДОЗ ДЛЯ ИНГАЛЯТОРОВ, ИНГАЛЯТОРЫ И ИХ РАБОЧИЕ ОСИ See Plans and Pricing
South Africa 201601960 DRY POWDER INHALER See Plans and Pricing
Australia 2015308424 Compliance-assisting module for an inhaler See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for fluticasone propionate; salmeterol xinafoate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1519731 92269 Luxembourg See Plans and Pricing PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
2506844 LUC00077 Luxembourg See Plans and Pricing 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
1305329 SPC/GB08/026 United Kingdom See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Baxter
Dow
Johnson and Johnson
McKinsey
Moodys

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.