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Last Updated: March 3, 2024

Details for New Drug Application (NDA): 201280


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NDA 201280 describes TRADJENTA, which is a drug marketed by Boehringer Ingelheim and is included in one NDA. It is available from three suppliers. There are ten patents protecting this drug and one Paragraph IV challenge. Additional details are available on the TRADJENTA profile page.

The generic ingredient in TRADJENTA is linagliptin. There are nineteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the linagliptin profile page.
Summary for 201280
Tradename:TRADJENTA
Applicant:Boehringer Ingelheim
Ingredient:linagliptin
Patents:10
Formulation / Manufacturing:see details
Pharmacology for NDA: 201280
Medical Subject Heading (MeSH) Categories for 201280
Suppliers and Packaging for NDA: 201280
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRADJENTA linagliptin TABLET;ORAL 201280 NDA Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0140 0597-0140-30 30 TABLET, FILM COATED in 1 BOTTLE (0597-0140-30)
TRADJENTA linagliptin TABLET;ORAL 201280 NDA Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0140 0597-0140-61 100 BLISTER PACK in 1 CARTON (0597-0140-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:May 2, 2011TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Mar 30, 2023
Regulatory Exclusivity Use:ADDITION OF INFORMATION TO CLINICAL STUDIES SECTION REGARDING CARDIOVASCULAR OUTCOME
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

Expired US Patents for NDA 201280

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 ⤷  Try a Trial ⤷  Try a 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 verification 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.