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Last Updated: January 15, 2021

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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 nine 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:9
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 201280
Generic Entry Date for 201280*:
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: 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
Paragraph IV (Patent) Challenges for 201280
Tradename Dosage Ingredient NDA Submissiondate
TRADJENTA TABLET;ORAL linagliptin 201280 2015-05-04

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:May 2, 2011TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 3, 2022
Regulatory Exclusivity Use:
Regulatory Exclusivity Expiration:Mar 30, 2023
Regulatory Exclusivity Use:
Patent:  Start TrialPatent Expiration:Aug 5, 2029Product Flag?Substance Flag?Delist 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   Start Trial   Start Trial
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011   Start Trial   Start Trial
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011   Start Trial   Start Trial
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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