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Serving leading biopharmaceutical companies globally:

Express Scripts
Boehringer Ingelheim
Chubb
Johnson and Johnson
Queensland Health
McKesson
McKinsey
Chinese Patent Office
Colorcon
Accenture

Generated: December 11, 2017

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SEREVENT Drug Profile

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When do Serevent patents expire, and what generic alternatives are available?

Serevent is a drug marketed by Glaxosmithkline and is included in two NDAs. There is one patent protecting this drug.

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

The generic ingredient in SEREVENT is salmeterol xinafoate. There are eighteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the salmeterol xinafoate profile page.
Drug patent expirations by year for SEREVENT

Pharmacology for SEREVENT

Medical Subject Heading (MeSH) Categories for SEREVENT

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
GlaxosmithklineSEREVENTsalmeterol xinafoateAEROSOL, METERED;INHALATION020236-001Feb 4, 1994DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
GlaxosmithklineSEREVENTsalmeterol xinafoatePOWDER;INHALATION020692-001Sep 19, 1997RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
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Expired Patents for Tradename: SEREVENT

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
GlaxosmithklineSEREVENTsalmeterol xinafoatePOWDER;INHALATION020692-001Sep 19, 1997► Subscribe► Subscribe
GlaxosmithklineSEREVENTsalmeterol xinafoatePOWDER;INHALATION020692-001Sep 19, 1997► Subscribe► Subscribe
GlaxosmithklineSEREVENTsalmeterol xinafoatePOWDER;INHALATION020692-001Sep 19, 1997► Subscribe► Subscribe
GlaxosmithklineSEREVENTsalmeterol xinafoatePOWDER;INHALATION020692-001Sep 19, 1997► Subscribe► Subscribe
GlaxosmithklineSEREVENTsalmeterol xinafoatePOWDER;INHALATION020692-001Sep 19, 1997► Subscribe► Subscribe
GlaxosmithklineSEREVENTsalmeterol xinafoateAEROSOL, METERED;INHALATION020236-001Feb 4, 1994► Subscribe► Subscribe
GlaxosmithklineSEREVENTsalmeterol xinafoatePOWDER;INHALATION020692-001Sep 19, 1997► Subscribe► Subscribe
GlaxosmithklineSEREVENTsalmeterol xinafoatePOWDER;INHALATION020692-001Sep 19, 1997► Subscribe► Subscribe
GlaxosmithklineSEREVENTsalmeterol xinafoatePOWDER;INHALATION020692-001Sep 19, 1997► Subscribe► Subscribe
GlaxosmithklineSEREVENTsalmeterol xinafoatePOWDER;INHALATION020692-001Sep 19, 1997► Subscribe► Subscribe
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Non-Orange Book Patents for Tradename: SEREVENT

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: SEREVENT

Country Document Number Estimated Expiration
Cyprus2014► Subscribe
Singapore169094► Subscribe
Norway302929► Subscribe
Finland107883► Subscribe
CroatiaP940631► Subscribe
China1066036► Subscribe
Poland167736► Subscribe
Slovakia280967► Subscribe
Denmark175075► Subscribe
African Regional IP Organization (ARIPO)310► 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: SEREVENT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90012Netherlands► SubscribePRODUCT NAME: SALMETEROL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN FLUTICASONPROPIONAAT,IN HET BIJZONDER SALMETEROLXINAFOAAT EN FLUTICASONPROPIONAAT; NATL REGISTRATION NO/DATE: RVG 23529 - RVG 23534 19990112; FIRST REGISTRATION: SE 14591 - 14596 19980907
/1999Austria► SubscribePRODUCT NAME: SALMETEROL, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, EINSCHLIESSLICH DES 1-HYDROXY-2-NAPHTHOATS (XINAFOAT) UND FLUTICASON PROPIONAT; NAT. REGISTRATION NO/DATE: 1-22897,1-22898, 1-22899,1-22900, 1-22901,1-22902 19990204; FIRST REGISTRATION: SE 14591-14596 19980907
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Serving leading biopharmaceutical companies globally:

Citi
Cerilliant
Cantor Fitzgerald
McKesson
Covington
Mallinckrodt
Daiichi Sankyo
Julphar
Chinese Patent Office
Fuji

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