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GLYXAMBI Drug Profile

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Glyxambi is a drug marketed by Boehringer Ingelheim and is included in one NDA. It is available from one supplier. There are fourteen patents protecting this drug.

This drug has four hundred and thirteen patent family members in forty-five countries.

The generic ingredient in GLYXAMBI is empagliflozin; linagliptin. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the empagliflozin; linagliptin profile page.

Summary for Tradename: GLYXAMBI

Patents:14
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Formulation / Manufacturing:see details
Drug Prices:see details
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Boehringer Ingelheim
GLYXAMBI
empagliflozin; linagliptin
TABLET;ORAL206073-002Jan 30, 2015RXYes7,407,955► subscribeYY ► subscribe
Boehringer Ingelheim
GLYXAMBI
empagliflozin; linagliptin
TABLET;ORAL206073-002Jan 30, 2015RXYes7,078,381► subscribe ► subscribe
Boehringer Ingelheim
GLYXAMBI
empagliflozin; linagliptin
TABLET;ORAL206073-002Jan 30, 2015RXYes8,883,805► subscribeY ► subscribe
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Non-Orange Book Patents for Tradename: GLYXAMBI

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
8,513,190Method of regulating glucose metabolism, and reagents related thereto► subscribe
6,803,357 Method of regulating glucose metabolism, and reagents related thereto► subscribe
7,687,469Glucopyranosyl-substituted benzene derivatives, medicaments containing such compounds, their use and process for their manufacture► 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: GLYXAMBI

Country Document Number Estimated Expiration
Singapore157371► subscribe
Luxembourg92612► subscribe
Norway20050069► 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: GLYXAMBI

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0074France► subscribePRODUCT NAME: EMPAGLIFLOZINE ET SES SELS,EN PARTICULIER L'EMPAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/14/930 20140522
C/GB14/085United Kingdom► subscribePRODUCT NAME: SAXAGLIPTIN; REGISTERED: UK EU/1/09/545/001-010 20091005
00696Netherlands► subscribePRODUCT NAME: EMPAGLIFLOZINE EN ZOUTEN DAARVAN, IN HET BIJZONDER EMPAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/14/930/001-009 20140522
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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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