Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: October 22, 2019

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 two suppliers. There are fourteen patents protecting this drug and one Paragraph IV challenge. Additional details are available on the GLYXAMBI profile page.

The generic ingredient in GLYXAMBI is empagliflozin; linagliptin. There are twenty-two drug master file entries for this compound. Two suppliers are 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:14
Generic Entry Opportunity Date for 206073
Generic Entry Date for 206073*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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 0597-0164-07 1 BOTTLE in 1 CARTON (0597-0164-07) > 7 TABLET, FILM COATED in 1 BOTTLE
GLYXAMBI empagliflozin; linagliptin TABLET;ORAL 206073 NDA Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0164 0597-0164-30 30 TABLET, FILM COATED in 1 BOTTLE (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: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
Patent:  Start TrialPatent Expiration:Apr 3, 2034Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2

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

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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.