Orange Book product · Brand (NDA)

PRADAXA

DABIGATRAN ETEXILATE MESYLATE

Brand (NDA)NDA 214358RX BOEHRINGER INGELHEIM

Jun 21, 2021

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jun 21, 2021
5 yr 1 mo ago
Patent 7932273 expires
Listed drug substance patent expiration.
Sep 07, 2025
10 mo ago
Patent 7932273*PED expires
Listed listed patent expiration.
Mar 07, 2026
3 mo ago
Today

Active ingredient

DABIGATRAN ETEXILATE MESYLATE

Strength

EQ 50MG BASE/PACKET

Dosage form

PELLETS

Route

ORAL

TE code

Not listed

Application

NDA 214358

Product number

004

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
7932273	Sep 07, 2025	10 mo ago	SubstanceProduct
7932273*PED	Mar 07, 2026	3 mo ago