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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
McKinsey
Fuji
Chubb
Mallinckrodt
McKesson
Cipla
Merck
Johnson and Johnson

Generated: April 26, 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 twenty-nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Fluticasone propionate; salmeterol xinafoate has five hundred and fifty-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.
Summary for fluticasone propionate; salmeterol xinafoate
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
Glaxo Grp Ltd ADVAIR DISKUS 500/50 fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 021077-003 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 ➤ 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
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
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 HFA fluticasone propionate; salmeterol xinafoate AEROSOL, METERED;INHALATION 021254-003 Jun 8, 2006 ➤ 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 500/50 fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 021077-003 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
9,649,455 Indicating device ➤ Sign Up
8,505,773 Indicating device ➤ Sign Up
7,073,768 Device and method for setting a frame ➤ Sign Up
9,737,674 Dose counters for inhalers, inhalers and methods of assembly thereof ➤ 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
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
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
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:

Covington
Julphar
Teva
Boehringer Ingelheim
Mallinckrodt
Citi
Cerilliant
McKinsey
Dow

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.