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Serving leading biopharmaceutical companies globally:

Fuji
Express Scripts
Fish and Richardson
US Army
US Department of Justice
Citi
Covington
Cipla
Federal Trade Commission
Harvard Business School

Generated: October 23, 2017

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Salmeterol xinafoate - Generic Drug Details

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

Salmeterol xinafoate
is the generic ingredient in one branded drug marketed by Glaxosmithkline and is included in two NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

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

There are eighteen drug master file entries for salmeterol xinafoate. Two suppliers are listed for this compound.

Summary for Generic Name: salmeterol xinafoate

US Patents:1
Tradenames:1
Applicants:1
NDAs:2
Drug Master File Entries: see list18
Suppliers / Packagers: see list2
Bulk Api Vendors: see list54
Clinical Trials: see list285
Patent Applications: see list3,236
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:salmeterol xinafoate at DailyMed

Pharmacology for Ingredient: salmeterol xinafoate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline
SEREVENT
salmeterol xinafoate
POWDER;INHALATION020692-001Sep 19, 1997RXYesYes► Subscribe► Subscribe ► Subscribe
Glaxosmithkline
SEREVENT
salmeterol xinafoate
AEROSOL, METERED;INHALATION020236-001Feb 4, 1994DISCNNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: salmeterol xinafoate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline
SEREVENT
salmeterol xinafoate
POWDER;INHALATION020692-001Sep 19, 1997► Subscribe► Subscribe
Glaxosmithkline
SEREVENT
salmeterol xinafoate
AEROSOL, METERED;INHALATION020236-001Feb 4, 1994► Subscribe► Subscribe
Glaxosmithkline
SEREVENT
salmeterol xinafoate
POWDER;INHALATION020692-001Sep 19, 1997► Subscribe► Subscribe
Glaxosmithkline
SEREVENT
salmeterol xinafoate
POWDER;INHALATION020692-001Sep 19, 1997► Subscribe► Subscribe
Glaxosmithkline
SEREVENT
salmeterol xinafoate
POWDER;INHALATION020692-001Sep 19, 1997► Subscribe► Subscribe
Glaxosmithkline
SEREVENT
salmeterol xinafoate
POWDER;INHALATION020692-001Sep 19, 1997► Subscribe► Subscribe
Glaxosmithkline
SEREVENT
salmeterol xinafoate
POWDER;INHALATION020692-001Sep 19, 1997► Subscribe► Subscribe
Glaxosmithkline
SEREVENT
salmeterol xinafoate
POWDER;INHALATION020692-001Sep 19, 1997► Subscribe► Subscribe
Glaxosmithkline
SEREVENT
salmeterol xinafoate
POWDER;INHALATION020692-001Sep 19, 1997► Subscribe► Subscribe
Glaxosmithkline
SEREVENT
salmeterol xinafoate
POWDER;INHALATION020692-001Sep 19, 1997► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: 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
2,006,107,948► Subscribe
7,389,775Inhalation device► Subscribe
6,536,427 Inhalation device► Subscribe
6,032,666 Inhalation device► Subscribe
5,590,645 Inhalation device► Subscribe
6,378,519 Inhalation device► Subscribe
6,792,945 Inhalation device► Subscribe
2,007,107,724► Subscribe
5,860,419 Inhalation device► Subscribe
7,225,808Inhalation device► 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 Ingredient: salmeterol xinafoate

Country Document Number Estimated Expiration
Ireland910698► Subscribe
Slovakia280968► Subscribe
Czech Republic283168► Subscribe
Norway302929► Subscribe
Yugoslavia36791► Subscribe
Norway980033► Subscribe
Ireland64503► Subscribe
Norway305786► Subscribe
Australia7202591► Subscribe
Hungary910696► 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: SALMETEROL XINAFOATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/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
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
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

McKinsey
Farmers Insurance
Boehringer Ingelheim
Merck
Colorcon
QuintilesIMS
US Army
Argus Health
Queensland Health
Medtronic

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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