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Empagliflozin; linagliptin - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for empagliflozin; linagliptin?

Empagliflozin; linagliptin is the generic ingredient in one branded drug marketed by Boehringer Ingelheim and is included in one NDA. There are fourteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has four hundred and twenty-five patent family members in forty-five countries.

There are three drug master file entries for empagliflozin; linagliptin. One supplier is listed for this compound.

Summary for Generic Name: empagliflozin; linagliptin

Tradenames:1
Patents:15
Applicants:1
NDAs:1
Drug Master File Entries: see list3
Suppliers / Packagers: see list1
Clinical Trials: see list42
Drug Prices:see low prices
DailyMed Link:empagliflozin; linagliptin at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Boehringer Ingelheim
GLYXAMBI
empagliflozin; linagliptin
TABLET;ORAL206073-002Jan 30, 2015RXYesYes9,173,859► SubscribeY ► Subscribe
Boehringer Ingelheim
GLYXAMBI
empagliflozin; linagliptin
TABLET;ORAL206073-001Jan 30, 2015RXYesNo► Subscribe► Subscribe
Boehringer Ingelheim
GLYXAMBI
empagliflozin; linagliptin
TABLET;ORAL206073-001Jan 30, 2015RXYesNo8,846,695► Subscribe ► Subscribe
Boehringer Ingelheim
GLYXAMBI
empagliflozin; linagliptin
TABLET;ORAL206073-001Jan 30, 2015RXYesNo► Subscribe► Subscribe
Boehringer Ingelheim
GLYXAMBI
empagliflozin; linagliptin
TABLET;ORAL206073-002Jan 30, 2015RXYesYes8,883,805► SubscribeY ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: empagliflozin; linagliptin

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
7,687,469Glucopyranosyl-substituted benzene derivatives, medicaments containing such compounds, their use and process for their manufacture► Subscribe
8,664,2328-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions► Subscribe
8,232,281Uses of DPP-IV inhibitors► Subscribe
9,499,546Process for the preparation of chiral 8-(3-aminopiperidin-1-yl)-xanthines► Subscribe
9,556,1758-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and thier use as pharmaceutical compositions► 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: empagliflozin; linagliptin

Country Document Number Estimated Expiration
Taiwan201036975► Subscribe
European Patent Office1828216► Subscribe
Spain2387881► Subscribe
Canada2833705► Subscribe
Singapore185967► 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: EMPAGLIFLOZIN; LINAGLIPTIN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2007 00030Denmark► Subscribe
2014043Lithuania► SubscribePRODUCT NAME: SAXAGLIPTINUM; REGISTRATION NO/DATE: EU/1/09/545/001-015 20091001
2014 00063Denmark► SubscribePRODUCT NAME: SITAGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER SITAGLIPTIN PHOSPHAT MONOHYDRAT; REG. NO/DATE: EU/1/07/383/001-024 AND EU/1/07/382/001-024 20070323
2014 00066Denmark► SubscribePRODUCT NAME: ALOGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER ALOGLIPTIN BENZOATE; REG. NO/DATE: EU/1/13/844/001-027 20130923
0280Netherlands► Subscribe300280, 20170424, EXPIRES: 20220320
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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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