Orange Book product · Brand (NDA)

PRADAXA

DABIGATRAN ETEXILATE MESYLATE

Brand (NDA)NDA 022512TE ABRX BOEHRINGER INGELHEIM

Oct 19, 2010

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Oct 19, 2010
15 yr 11 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
Patent 9034822 expires
Listed method-of-use patent (U-1759) expiration.
Jan 20, 2031
in 4 yr 8 mo
Patent 9034822*PED expires
Listed listed patent expiration.
Jul 20, 2031
in 5 yr 2 mo

Active ingredient

DABIGATRAN ETEXILATE MESYLATE

Strength

EQ 75MG BASE

Dosage form

CAPSULE

Route

ORAL

TE code

Application

NDA 022512

Product number

001

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
9034822	Jan 20, 2031	in 4 yr 8 mo	U-1759
9034822*PED	Jul 20, 2031	in 5 yr 2 mo