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Empagliflozin - Generic Drug Details

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

Empagliflozin is the generic ingredient in four branded drugs marketed by Boehringer Ingelheim and is included in four NDAs. There are sixteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Empagliflozin has one hundred and thirty-four patent family members in thirty-six countries.

There are three drug master file entries for empagliflozin. Two suppliers are listed for this compound.

Summary for Generic Name: empagliflozin

Tradenames:4
Patents:16
Applicants:1
NDAs:4
Drug Master File Entries: see list3
Suppliers / Packagers: see list2
Bulk Api Vendors: see list31
Clinical Trials: see list20
Patent Applications: see list99
Drug Prices:see low prices
DailyMed Link:empagliflozin at DailyMed

Pharmacology for Ingredient: empagliflozin

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Boehringer Ingelheim
SYNJARDY XR
empagliflozin; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL208658-004Dec 9, 2016RXYesYes► Subscribe► Subscribe
Boehringer Ingelheim
GLYXAMBI
empagliflozin; linagliptin
TABLET;ORAL206073-001Jan 30, 2015RXYesNo7,713,938► SubscribeYY ► Subscribe
Boehringer Ingelheim
SYNJARDY XR
empagliflozin; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL208658-002Dec 9, 2016RXYesNo6,488,962► SubscribeY ► Subscribe
Boehringer Ingelheim
GLYXAMBI
empagliflozin; linagliptin
TABLET;ORAL206073-001Jan 30, 2015RXYesNo8,673,927► SubscribeY ► Subscribe
Boehringer Ingelheim
SYNJARDY XR
empagliflozin; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL208658-004Dec 9, 2016RXYesYes7,579,449► SubscribeY ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: empagliflozin

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
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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

Country Document Number Estimated Expiration
Cyprus1109870► Subscribe
European Patent Office1730131► Subscribe
Denmark1730131► Subscribe
Uruguay28807► Subscribe
Japan2008208127► 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

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90061-7Sweden► SubscribePRODUCT NAME: EMPAGLIFLOZIN AND SALTS THEREOF, IN PARTICULAR EMPAGLIFLOZIN; REG. NO/DATE: EU/1/14/930 20140522
2014035Lithuania► SubscribePRODUCT NAME: EMPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/14/930 20140522
00696Netherlands► SubscribePRODUCT NAME: EMPAGLIFLOZINE EN ZOUTEN DAARVAN, IN HET BIJZONDER EMPAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/14/930/001-009 20140522
2014 00054Denmark► SubscribePRODUCT NAME: EMPAGLIFLOZIN OG SALTE DERAF, SAERLIGT EMPAGLIFLOZIN; REG. NO/DATE: EU1/14/930/001/018 20140522
0140033 00134Estonia► SubscribePRODUCT NAME: EMPAGLIFLOSIIN;REG NO/DATE: EU/1/14/930 27.05.2014
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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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