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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 208026


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NDA 208026 describes JENTADUETO XR, which is a drug marketed by Boehringer Ingelheim and is included in one NDA. It is available from one supplier. There are nine patents protecting this drug and one Paragraph IV challenge. Additional details are available on the JENTADUETO XR profile page.

The generic ingredient in JENTADUETO XR 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 208026
Pharmacology for NDA: 208026
Suppliers and Packaging for NDA: 208026
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
JENTADUETO XR linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208026 NDA Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0270 0597-0270-12 1 BOTTLE in 1 CARTON (0597-0270-12) / 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
JENTADUETO XR linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208026 NDA Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0270 0597-0270-73 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0597-0270-73)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength2.5MG;1GM
Approval Date:May 27, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 20, 2026
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Regulatory Exclusivity Expiration:Jun 20, 2026
Regulatory Exclusivity Use:REVISIONS TO THE PEDIATRIC USE SUBSECTION OF LABELING TO INCLUDE THE RESULTS FROM CLINICAL STUDY 1218-0091, CONDUCTED TO FULFILL A PEDIATRIC WRITTEN REQUEST
Patent:⤷  Sign UpPatent Expiration:Oct 2, 2029Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 208026

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim JENTADUETO XR linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208026-002 May 27, 2016 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim JENTADUETO XR linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208026-001 May 27, 2016 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim JENTADUETO XR linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208026-002 May 27, 2016 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim JENTADUETO XR linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208026-002 May 27, 2016 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim JENTADUETO XR linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208026-002 May 27, 2016 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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