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Serving leading biopharmaceutical companies globally:

Harvard Business School
Johnson and Johnson
Boehringer Ingelheim
US Army
Queensland Health
Chinese Patent Office
Cantor Fitzgerald

Generated: December 14, 2017

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 five 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

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 0597-0164-90 90 TABLET, FILM COATED in 1 BOTTLE (0597-0164-90)
GLYXAMBI empagliflozin; linagliptin TABLET;ORAL 206073 NDA Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0164 0597-0164-39 30 BLISTER PACK in 1 CARTON (0597-0164-39) > 1 TABLET, FILM COATED in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG;5MG
Approval Date:Jan 30, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 2, 2019
Regulatory Exclusivity Use:
Regulatory Exclusivity Expiration:Aug 1, 2019
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Jan 30, 2018
Regulatory Exclusivity Use:NEW COMBINATION

Expired Orange Book Patents for NDA: 206073

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer IngelheimGLYXAMBIempagliflozin; linagliptinTABLET;ORAL206073-001Jan 30, 2015► Subscribe► Subscribe
Boehringer IngelheimGLYXAMBIempagliflozin; linagliptinTABLET;ORAL206073-002Jan 30, 2015► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
US Army
Chinese Patent Office
Fish and Richardson
Argus Health

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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