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Empagliflozin; metformin hydrochloride - Generic Drug Details

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

This ingredient has ninety-seven patent family members in thirty-three countries.

There are two drug master file entries for empagliflozin; metformin hydrochloride. One supplier is listed for this compound.

Summary for Generic Name: empagliflozin; metformin hydrochloride

Tradenames:1
Patents:2
Applicants:1
NDAs:1
Drug Master File Entries: see list2
Suppliers / Packaging: see list1
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: empagliflozin; metformin hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Boehringer Ingelheim
SYNJARDY
empagliflozin; metformin hydrochloride
TABLET;ORAL206111-003Aug 26, 2015RXNo► subscribe► subscribe
Boehringer Ingelheim
SYNJARDY
empagliflozin; metformin hydrochloride
TABLET;ORAL206111-003Aug 26, 2015RXNo7,579,449► subscribeY ► subscribe
Boehringer Ingelheim
SYNJARDY
empagliflozin; metformin hydrochloride
TABLET;ORAL206111-002Aug 26, 2015RXNo7,713,938► subscribeYY ► subscribe
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Non-Orange Book Patents for Generic Ingredient: empagliflozin; metformin hydrochloride

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; metformin hydrochloride

Country Document Number Estimated Expiration
South Korea20060133021► subscribe
Peru13742006► subscribe
Ukraine91546► 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; METFORMIN HYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00696Netherlands► subscribePRODUCT NAME: EMPAGLIFLOZINE EN ZOUTEN DAARVAN, IN HET BIJZONDER EMPAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/14/930/001-009 20140522
0140033 00134Estonia► subscribePRODUCT NAME: EMPAGLIFLOSIIN;REG NO/DATE: EU/1/14/930 27.05.2014
90061-7Sweden► subscribePRODUCT NAME: EMPAGLIFLOZIN AND SALTS THEREOF, IN PARTICULAR EMPAGLIFLOZIN; REG. NO/DATE: EU/1/14/930 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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