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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
McKinsey
Medtronic
AstraZeneca
Express Scripts
Accenture
Farmers Insurance
US Department of Justice
Dow

Generated: June 25, 2018

DrugPatentWatch Database Preview

Fluticasone propionate; salmeterol xinafoate - Generic Drug Details

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What are the generic sources for fluticasone propionate; salmeterol xinafoate and what is the scope of fluticasone propionate; salmeterol xinafoate freedom to operate?

Fluticasone propionate; salmeterol xinafoate
is the generic ingredient in five branded drugs marketed by Glaxo Grp Ltd and Teva Pharm, and is included in three 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 forty-five countries.

There are twenty-six drug master file entries for fluticasone propionate; salmeterol xinafoate. Ten suppliers are listed for this compound.
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 208799-003 Jan 27, 2017 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Teva Pharm AIRDUO RESPICLICK fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 208799-001 Jan 27, 2017 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Glaxo Grp Ltd ADVAIR DISKUS 250/50 fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 021077-002 Aug 24, 2000 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Glaxo Grp Ltd ADVAIR HFA fluticasone propionate; salmeterol xinafoate AEROSOL, METERED;INHALATION 021254-002 Jun 8, 2006 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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

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Non-Orange Book US Patents for fluticasone propionate; salmeterol xinafoate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,191,777 Medicament dispenser ➤ Sign Up
7,661,423 Device housing for an aerosol container ➤ Sign Up
7,819,116 Medicament dispenser ➤ Sign Up
6,142,339 Aerosol dispensing device ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for fluticasone propionate; salmeterol xinafoate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB08/026 United Kingdom ➤ Sign Up 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
269 Luxembourg ➤ Sign Up PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
C0067 France ➤ Sign Up 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
C0014 France ➤ Sign Up PRODUCT NAME: FLUTICASONE FLUORATE; REG. NO/DATE: EU/1/07/434/001 20080111
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Cipla
QuintilesIMS
AstraZeneca
Boehringer Ingelheim
Moodys
Dow
Accenture
US Army
Chubb

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 verifification 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.