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Last Updated: October 7, 2022

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 two 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. Two 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:Jul 3, 2022
Regulatory Exclusivity Use:INFORMATION ADDED TO THE LABELING TO DESCRIBE CARMELINA TRIAL TO FULFILL POSTMARKETING COMMITMENT 1766-4
Patent:See Plans and PricingPatent Expiration:Aug 5, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT AND FOR WHOM METFORMIN THERAPY IS INAPPROPRIATE BY ADMINISTERING LINAGLIPTIN WITHOUT DOSE ADJUSTMENT

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 See Plans and Pricing See Plans and Pricing
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 See Plans and Pricing See Plans and Pricing
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 See Plans and Pricing See Plans and Pricing
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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