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Serving leading biopharmaceutical companies globally:

QuintilesIMS
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US Army
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Generated: December 17, 2017

DrugPatentWatch Database Preview

ADVAIR DISKUS 500/50 Drug Profile

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Which patents cover Advair Diskus 500/50, and what generic alternatives are available?

Advair Diskus 500/50 is a drug marketed by Glaxo Grp Ltd and is included in one NDA. There is one patent protecting this drug.

This drug has seventy-eight patent family members in forty-one countries and four supplementary protection certificates in three countries.

The generic ingredient in ADVAIR DISKUS 500/50 is fluticasone propionate; salmeterol xinafoate. There are twenty-five drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the fluticasone propionate; salmeterol xinafoate profile page.

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxo Grp LtdADVAIR DISKUS 500/50fluticasone propionate; salmeterol xinafoatePOWDER;INHALATION021077-003Aug 24, 2000RXYesYes► Subscribe► Subscribe► Subscribe
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Expired Patents for Tradename: ADVAIR DISKUS 500/50

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxo Grp LtdADVAIR DISKUS 500/50fluticasone propionate; salmeterol xinafoatePOWDER;INHALATION021077-003Aug 24, 2000► Subscribe► Subscribe
Glaxo Grp LtdADVAIR DISKUS 500/50fluticasone propionate; salmeterol xinafoatePOWDER;INHALATION021077-003Aug 24, 2000► Subscribe► Subscribe
Glaxo Grp LtdADVAIR DISKUS 500/50fluticasone propionate; salmeterol xinafoatePOWDER;INHALATION021077-003Aug 24, 2000► Subscribe► Subscribe
Glaxo Grp LtdADVAIR DISKUS 500/50fluticasone propionate; salmeterol xinafoatePOWDER;INHALATION021077-003Aug 24, 2000► Subscribe► Subscribe
Glaxo Grp LtdADVAIR DISKUS 500/50fluticasone propionate; salmeterol xinafoatePOWDER;INHALATION021077-003Aug 24, 2000► Subscribe► Subscribe
Glaxo Grp LtdADVAIR DISKUS 500/50fluticasone propionate; salmeterol xinafoatePOWDER;INHALATION021077-003Aug 24, 2000► Subscribe► Subscribe
Glaxo Grp LtdADVAIR DISKUS 500/50fluticasone propionate; salmeterol xinafoatePOWDER;INHALATION021077-003Aug 24, 2000► Subscribe► Subscribe
Glaxo Grp LtdADVAIR DISKUS 500/50fluticasone propionate; salmeterol xinafoatePOWDER;INHALATION021077-003Aug 24, 2000► Subscribe► Subscribe
Glaxo Grp LtdADVAIR DISKUS 500/50fluticasone propionate; salmeterol xinafoatePOWDER;INHALATION021077-003Aug 24, 2000► Subscribe► Subscribe
Glaxo Grp LtdADVAIR DISKUS 500/50fluticasone propionate; salmeterol xinafoatePOWDER;INHALATION021077-003Aug 24, 2000► Subscribe► Subscribe
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Non-Orange Book Patents for Tradename: ADVAIR DISKUS 500/50

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
6,536,427 Inhalation device► Subscribe
2,006,107,948► Subscribe
6,792,945 Inhalation device► Subscribe
7,225,808Inhalation device► Subscribe
6,378,519 Inhalation device► Subscribe
5,860,419 Inhalation device► Subscribe
7,389,775Inhalation device► Subscribe
6,032,666 Inhalation device► Subscribe
5,590,645 Inhalation device► Subscribe
2,007,107,724► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: ADVAIR DISKUS 500/50

Country Document Number Estimated Expiration
Australia675825► Subscribe
Austria401007► Subscribe
Slovakia280967► Subscribe
Taiwan197380► Subscribe
Sweden9100582► Subscribe
Singapore169094► Subscribe
China1066036► Subscribe
Hungary910696► Subscribe
Belgium1003798► Subscribe
CroatiaP940631► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: ADVAIR DISKUS 500/50

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB08/026United Kingdom► SubscribePRODUCT 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
C0067France► SubscribePRODUCT 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
C0014France► SubscribePRODUCT NAME: FLUTICASONE FLUORATE; REG. NO/DATE: EU/1/07/434/001 20080111
269Luxembourg► SubscribePRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
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For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Deloitte
UBS
Dow
Boehringer Ingelheim
Harvard Business School
Fish and Richardson
Cipla
QuintilesIMS
Julphar
Chinese Patent Office

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.

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