Drug facts

Brand

Tradjenta (Linagliptin)

No generic linagliptin has an active Orange Book listing (a generic was first approved 08/31/2021); the latest Tradjenta patent or exclusivity in the Orange Book runs to 12/08/2037.

Tradjenta was first approved by the FDA on 05/02/2011 under NDA 201280; the application holder is Boehringer Ingelheim Pharmaceuticals Inc.

The latest NADAC for TRADJENTA 5 MG TABLET is $16.80 per unit (as of 10/28/2026).

Holder Boehringer Ingelheim Pharmaceuticals IncApplication NDA 201280Approved 05/02/2011

01Patents and exclusivity

When competition can legally begin. A generic can launch once both exclusivity and the last listed patent expire, unless a court or settlement says otherwise.

4,056days until the latest patent expires

ExclusivityPatent onlyOpen to generics
Today
Approved05/02/2011
Exclusivity ends12/20/2026
Last patent12/08/2037
2012201620202024202820322036
Latest patent
12/08/2037Tradjenta
Orange Book
Exclusivity
12/20/2026Tradjenta
Orange Book

02Competition

Generics
No active generic listing in the Orange Book
Orange Book
First generic approved
08/31/2021
Orange Book
Every listingEach listing and maker behind the generics count.
Price erosionHow NADAC moves as generics enter.
PrescribersWho prescribes it, from Medicare data.
Available in the full Tradjenta profile.See what is included

03Supply and price

FDA drug shortage
ClearNot on the current shortage list
FDA shortages
NADAC
$16.80 per unitTRADJENTA 5 MG TABLET, as of 10/28/2026
CMS NADAC

04Product

Application holder
Boehringer Ingelheim Pharmaceuticals Inc
Orange Book
Application
NDA 201280
Orange Book
First approved
05/02/2011
Orange Book
Dosage forms
tablet
Routes
oral

Sources: FDA Orange Book, FDA Purple Book, FDA drug shortages, FDA enforcement reports and CMS NADAC, read through QOPE. Not medical or legal advice.