Viewing data from:

PRADAXA

NDA

DABIGATRAN ETEXILATE MESYLATE | N022512 | BOEHRINGER INGELHEIM PHARMACEUTICALS INC

3 strengths2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Expired (1)Active (1)TodayPED (+6 mo)

2026

2027

2028

2029

2030

2031

Today

7932273

Mar. 7, 2026

9034822

Jul. 20, 2031

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

2 cases on OB patents (1 active) from PACER

Case	Court	Filed	Status	Judge
Breckenridge Pharmaceutical, Inc. v. Hetero USA Inc. et al 1:2024cv00571 2 patentsdabigatran etexilate mesylate	D. Del.	2024-05-10	Active	—
Boehringer Ingelheim Pharma GmbH & Co. KG et al v. Teva Pharmaceuticals USA Inc. et al 1:2015cv00048 1 patentANDA 208057dabigatran etexilate mesylate	D. Del.	2015-01-16	Terminated 2015-04-22	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

47 trials from ClinicalTrials.gov, 3 active, 31 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Dabigatran for Mitral Stenosis Atrial Fibrillation NCT04045093	Phase 4	Active	The University of Hong Kong	370	2020-10-22 → 2027-09-30
The Danish Non-vitamin K Antagonist Oral Anticoagulation Study in Patients With Atrial Fibrillation NCT03129490	Phase 4	Active	Herlev and Gentofte Hospital	11,000	2023-04-01 → 2027-10-30
The Danish Non-vitamin K Antagonist Oral Anticoagulation Study in Patients With Venous Thromboembolism (DANNOAC-VTE)NCT03129555	Phase 4	Active	Herlev and Gentofte Hospital	5,000	2023-04-01 → 2029-03-31
A Study in Healthy Men to Test the Influence of BI 1358894 on the Amount of the Medicines Rosuvastatin and Dabigatran in the Blood NCT04099732	Phase 1	Completed	Boehringer Ingelheim	26	2019-10-07 → 2019-12-10
Relative Bioavailability of Dabigatran and Digoxin in Healthy Male and Female Volunteers NCT02171052	Phase 1	Completed	Boehringer Ingelheim	24	2006-06
Relative Bioavailability of Dabigatran and Diclofenac After Dabigatran Etexilate and Diclofenac Single Dose Alone or Following Concomitant Multiple Oral Administrations in Healthy Male and Female Volunteers NCT02171507	Phase 1	Completed	Boehringer Ingelheim	24	2006-05
Dabigatran Etexilate in Extended Venous Thromboembolism (VTE) Prevention After Hip Replacement Surgery NCT00168818	Phase 3	Completed	Boehringer Ingelheim	3,494	2004-11
A Pharmacokinetic Interaction Study Between Odalasvir, Given as a Single Agent or in Combination With Simeprevir, and Dabigatran Etexilate Mesylate in Healthy Participants NCT02945020	Phase 1	Completed	Janssen Research & Development, LLC	15	2016-11-10 → 2017-01-20
Relative Bioavailability of Single Doses of Dabigatran Etexilate in Healthy Volunteers NCT02173717	Phase 1	Completed	Boehringer Ingelheim	24	2009-06
RE-MODEL Dabigatran Etexilate 150mg or 220mg Once Daily (o.d.) Versus (v.s.) Enoxaparin 40mg o.d. for Prevention of Thrombosis After Knee Surgery NCT00168805	Phase 3	Completed	Boehringer Ingelheim	2,101	2004-11

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 6 NDCs

Highest NADAC/Unit

$3.17

per ea

Lowest NADAC/Unit

$3.16

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00597010854PRADAXA 110 MG CAPSULE	$3.17	EA	Brand	$0.9198	2026-06-17
00597010860PRADAXA 110 MG CAPSULE	$3.17	EA	Brand	$0.9198	2026-06-17
00597036055PRADAXA 150 MG CAPSULE	$3.16	EA	Brand	$0.8569	2026-06-17
00597036082PRADAXA 150 MG CAPSULE	$3.16	EA	Brand	$0.8569	2026-06-17
00597035509PRADAXA 75 MG CAPSULE	$3.16	EA	Brand	$0.8983	2026-06-17
00597035556PRADAXA 75 MG CAPSULE	$3.16	EA	Brand	$0.8983	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 12 NDCs (6 FSS, 6 Big4)

Lowest Price

$14.94

Highest Price

$169.49

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00597-0108-54PRADAXA 110MG CAPSULES	$169.49	FSS	Boehringer Ingelheim Pharmaceuticals, Inc.	09/14/2027
00597-0108-54PRADAXA 110MG CAPSULES	$14.94	Big4	Boehringer Ingelheim Pharmaceuticals, Inc.	09/14/2027
00597-0108-60PRADAXA 110MG CAPSULES	$169.49	FSS	Boehringer Ingelheim Pharmaceuticals, Inc.	09/14/2027
00597-0108-60PRADAXA 110MG CAPSULES	$33.82	Big4	Boehringer Ingelheim Pharmaceuticals, Inc.	09/14/2027
00597-0355-09PRADAXA 75MG CAPSULES	$169.49	FSS	Boehringer Ingelheim Pharmaceuticals, Inc.	09/14/2027
00597-0355-09PRADAXA 75MG CAPSULES	$41.16	Big4	Boehringer Ingelheim Pharmaceuticals, Inc.	09/14/2027

Showing 6 of 12 NDCs.

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Pradaxa (2024)

Total Spending

$123.2M

Total Claims

481,836

Beneficiaries

139,514

Avg Cost/Unit

$1.82

Spending Trend

$627.0M(2019)→$599.6M(2020)→$571.0M(2021)→$469.9M(2022)→$176.2M(2023)→$123.2M(2024)

YoY Change:-25.4%

5yr CAGR:-26.3%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain33 active DMFs5 inactive

31 active API suppliers hold Drug Master Files for this ingredient.

MSN LABORATORIES PRIVATE LTDDABIGATRAN ETEXILATE MESYLATE [ROUTE CODE - "DE"]

DMF 270372013

ALEMBIC PHARMACEUTICALS LTDDABIGATRAN ETEXILATE MESYLATE

DMF 277812013

DR REDDYS LABORATORIES LTDDABIGATRAN ETEXILATE MESYLATE

DMF 279602014

APOTEX INCDABIGATRAN ETEXILATE MESYLATE

DMF 280292014

LUPIN MANUFACTURING SOLUTIONS LTDDABIGATRAN ETEXILATE MESYLATE

DMF 280392014

TAPI NL BVDABIGATRAN ETEXILATE MESYLATE

DMF 281182014

HETERO DRUGS LTDDABIGATRAN ETEXILATE MESYLATE

DMF 281772014

ALKEM LABORATORIES LTDDABIGATRAN ETEXILATE MESYLATE

DMF 282312014

ZYDUS LIFESCIENCES LTDDABIGATRAN ETEXILATE MESYLATE

DMF 282852014

NEULAND LABORATORIES LTDDABIGATRAN ETEXILATE MESYLATE (FORM-I)

DMF 283522014

SUN PHARMACEUTICAL INDUSTRIES LTDDABIGATRAN ETEXILATE MESYLATE

DMF 283952014

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDDABIGATRAN ETEXILATE MESYLATE

DMF 284192014

APITORIA PHARMA PRIVATE LTDDABIGATRAN ETEXILATE MESYLATE

DMF 284422014

MICRO LABS LTDDABIGATRAN ETEXILATE MESYLATE

DMF 296682015

PIRAMAL PHARMA LTDDABIGATRAN ETEXILATE MESYLATE

DMF 304042016

SOLARA ACTIVE PHARMA SCIENCES LTDDABIGATRAN ETEXILATE MESYLATE

DMF 304602016

JUBILANT BIOSYS LTDDABIGATRAN ETEXILATE MESYLATE

DMF 313832017

JIANGXI SYNERGY PHARMACEUTICAL CO LTDDABIGATRAN ETEXILATE MESYLATE

DMF 327822018

HISUN PHARMACEUTICAL NANTONG CO LTDDABIGATRAN ETEXILATE MESYLATE

DMF 329412018

BIOCON LTDDABIGATRAN ETEXILATE MESYLATE

DMF 331122018

OPTIMUS DRUGS PRIVATE LTDDABIGATRAN ETEXILATE MESYLATE

DMF 351322020

YABAO PHARMACEUTICAL GROUP CO LTDDABIGATRAN ETEXILATE MESYLATE

DMF 352262020

SRINI PHARMACEUTICALS PRIVATE LTDDABIGATRAN ETEXILATE MESYLATE

DMF 352532020

ACEBRIGHT INDIA PHARMA PRIVATE LTDDABIGATRAN ETEXILATE MESYLATE [DRUG SUBSTANCE (NON-STERILE)]

DMF 353602020

MSN LIFE SCIENCES PRIVATE LTDDABIGATRAN ETEXILATE MESYLATE

DMF 353622021

LEE PHARMA LTDDABIGATRAN ETEXILATE MESYLATE

DMF 361812021

SICHUAN QINGMU PHARMACEUTICAL CO LTDDABIGATRAN ETEXILATE MESYLATE

DMF 365392021

ALIVUS LIFE SCIENCES LTDDABIGATRAN ETEXILATE MESYLATE(PROCESS II)

DMF 367942022

CHANGZHOU PHARMACEUTICAL FACTORYDABIGATRAN ETEXILATE MESYLATE

DMF 375282022

METROCHEM API PRIVATE LTDDABIGATRAN ETEXILATE MESYLATE

DMF 376332022

NEULAND LABORATORIES LTDDABIGATRAN ETEXILATE MESYLATE

DMF 387692025

DR REDDYS LABORATORIES LTDDABIGATRAN ETEXILATE MESYLATE (PROCESS-II)

DMF 405682024

ZHEJIANG JINHUA CONBA BIO-PHARM CO LTDDABIGATRAN ETEXILATE MESYLATE

DMF 435602026

GLENMARK LIFE SCIENCES LTDInactiveDABIGATRAN ETEXILATE MESYLATE

DMF 278922014

INTAS PHARMACEUTICALS LTDInactiveDABIGATRAN ETEXILATE MESYLATE FORM-I

DMF 284752014

ESTEVE QUIMICA SAInactiveDABIGATRAN ETEXILATE MESYLATE

DMF 292702015

HIKAL LTDInactiveDABIGATRAN ETEXILATE MESYLATE

DMF 316132017

SICHUAN RENAN PHARMACEUTICAL CO LTDInactiveDABIGATRAN ETEXILATE MESYLATE (MICRO-POWDER)

DMF 380992023

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

26 letters from Drugs@FDA

Date	Submission	Document
Oct 3, 2025	SUPPL -49	View Letter (PDF)
Nov 20, 2023	SUPPL -47	View Letter (PDF)
Jun 23, 2021	SUPPL -41	View Letter (PDF)
Apr 22, 2021	SUPPL -42	View Letter (PDF)
Jul 6, 2020	SUPPL -39	View Letter (PDF)
Nov 26, 2019	SUPPL -38	View Letter (PDF)
Mar 15, 2018	SUPPL -35	View Letter (PDF)
Nov 23, 2015	SUPPL -28	View Letter (PDF)
Oct 26, 2015	SUPPL -32	View Letter (PDF)
Sep 14, 2015	SUPPL -27	View Letter (PDF)
Aug 28, 2015	SUPPL -31	View Letter (PDF)
Jan 20, 2015	SUPPL -24	View Letter (PDF)
Sep 8, 2014	SUPPL -25	View Letter (PDF)
Aug 15, 2014	SUPPL -23	View Letter (PDF)
Apr 9, 2014	SUPPL -18	View Letter (PDF)
Dec 13, 2013	SUPPL -21	View Letter (PDF)
Apr 30, 2013	SUPPL -17	View Letter (PDF)
Dec 26, 2012	SUPPL -16	View Letter (PDF)
Nov 6, 2012	SUPPL -14	View Letter (PDF)
Jun 5, 2012	SUPPL -11	View Letter (PDF)
May 2, 2012	SUPPL -10	View Letter (PDF)
Jan 19, 2012	SUPPL -9	View Letter (PDF)
Nov 14, 2011	SUPPL -7	View Letter (PDF)
Apr 7, 2011	SUPPL -5	View Letter (PDF)
Mar 8, 2011	SUPPL -4	View Letter (PDF)
Oct 20, 2010	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 75MG BASE

RLDAB

2 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Oct 19, 2010

Patents (2) · 1 use code

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7932273	Sep 7, 2025PED: Mar 7, 2026	PED	Yes	Yes	—	—
9034822	Jan 20, 2031PED: Jul 20, 2031	PED	—	—		—

#002 — EQ 150MG BASE

RLDAB

2 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Oct 19, 2010

#003 — EQ 110MG BASE

RLDAB

2 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Nov 20, 2015