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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Citi
Chinese Patent Office
Daiichi Sankyo
McKesson
Johnson and Johnson
Farmers Insurance
Moodys
Fuji

Generated: May 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206073

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NDA 206073 describes GLYXAMBI, which is a drug marketed by Boehringer Ingelheim and is included in one NDA. It is available from one supplier. There are thirteen patents protecting this drug. Additional details are available on the GLYXAMBI profile page.

The generic ingredient in GLYXAMBI is empagliflozin; linagliptin. There are fourteen 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 206073
Tradename:GLYXAMBI
Applicant:Boehringer Ingelheim
Ingredient:empagliflozin; linagliptin
Patents:13
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 206073
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLYXAMBI empagliflozin; linagliptin TABLET;ORAL 206073 NDA Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0164 N 0597-0164-07
GLYXAMBI empagliflozin; linagliptin TABLET;ORAL 206073 NDA Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0164 N 0597-0164-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG;5MG
Approval Date:Jan 30, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 1, 2019
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Jan 30, 2018
Regulatory Exclusivity Use:NEW COMBINATION
Regulatory Exclusivity Expiration:Dec 2, 2019
Regulatory Exclusivity Use:TO REDUCE THE RISK OF CARDIOVASCULAR DEATH IN ADULT PATIENTS WITH TYPE 2 DIABETES MELLITUS AND ESTABLISHED CARDIOVASCULAR DISEASE

Expired US Patents for NDA 206073

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim GLYXAMBI empagliflozin; linagliptin TABLET;ORAL 206073-001 Jan 30, 2015 ➤ Try a Free Trial ➤ Try a Free Trial
Boehringer Ingelheim GLYXAMBI empagliflozin; linagliptin TABLET;ORAL 206073-002 Jan 30, 2015 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Dow
Johnson and Johnson
Chinese Patent Office
Colorcon
Federal Trade Commission
McKesson
Citi
Merck
Cipla

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