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Last Updated: October 30, 2020

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Details for New Drug Application (NDA): 201281

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NDA 201281 describes JENTADUETO, which is a drug marketed by Boehringer Ingelheim and is included in two NDAs. It is available from one supplier. There are twelve patents protecting this drug and two Paragraph IV challenges. Additional details are available on the JENTADUETO profile page.

The generic ingredient in JENTADUETO is linagliptin; metformin hydrochloride. There are nineteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the linagliptin; metformin hydrochloride profile page.
Summary for 201281
Tradename:JENTADUETO
Applicant:Boehringer Ingelheim
Ingredient:linagliptin; metformin hydrochloride
Patents:9
Generic Entry Opportunity Date for 201281
Generic Entry Date for 201281*:
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.

Pharmacology for NDA: 201281
Suppliers and Packaging for NDA: 201281
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
JENTADUETO linagliptin; metformin hydrochloride TABLET;ORAL 201281 NDA Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0146 0597-0146-18 180 TABLET, FILM COATED in 1 BOTTLE (0597-0146-18)
JENTADUETO linagliptin; metformin hydrochloride TABLET;ORAL 201281 NDA Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0146 0597-0146-60 60 TABLET, FILM COATED in 1 BOTTLE (0597-0146-60)
Paragraph IV (Patent) Challenges for 201281
Tradename Dosage Ingredient NDA Submissiondate
JENTADUETO TABLET;ORAL linagliptin; metformin hydrochloride 201281 2015-05-04

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG;500MG
Approval Date:Jan 30, 2012TE:RLD:Yes
Regulatory Exclusivity Expiration:Mar 30, 2023
Regulatory Exclusivity Use:ADDITION OF INFORMATION TO CLINICAL STUDIES SECTION REGARDING CARDIOVASCULAR OUTCOME
Regulatory Exclusivity Expiration:Jul 3, 2022
Regulatory Exclusivity Use:INFORMATION ADDED TO THE LABELING TO DESCRIBE CARMELINA TRIAL TO FULFILL POSTMARKETING COMMITMENT 1766-4
Patent:  Start TrialPatent Expiration:Apr 2, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:USE OF A PHARMACEUTICAL COMPOSITION COMPRISING LINAGLIPTIN, METFORMIN AND A BASIC AMINO ACID TO TREAT TYPE 2 DIABETES MELLITUS

Expired US Patents for NDA 201281

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