Viewing data from:

TRACLEER

NDA

BOSENTAN | N021290 | ACTELION PHARMACEUTICALS US INC

2 strengths0 unique patents0 unique exclusivities

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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

85 trials from ClinicalTrials.gov, 1 active, 55 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Endothelin Receptor Function and Acute Stress NCT02116335	N/A	Active	Augusta University	320	2015-06 → 2026-01
Open-label Study With Bosentan in Interstitial Lung Disease NCT00319033	Phase 2/3	Completed	Actelion	132	2004-07 → 2006-02
Effect of Bosentan in Patients With Metastatic Melanoma Treated With Dacarbazine (DTIC)NCT01009177	Phase 2	Completed	Actelion	80	2005-09-30 → 2008-02-29
Bosentan and Pulmonary Endothelial Function NCT01721564	N/A	Completed	Prof David S Celermajer	8	2006-04 → 2009-12
The Clinical And Subclinical Effects on Arterial Stiffness of Bosentan in Patients With Systemic Sclerosis NCT02480335	Phase 4	Completed	University Medical Center Groningen	20	2015-06-26 → 2018-07-30
Influence of Bosentan on the Pharmacokinetics of Nintedanib NCT02667704	Phase 1	Completed	Boehringer Ingelheim	13	2016-02 → 2016-03
Double Blind, Randomized Trial of Bosentan for Sarcoidosis Associated Pulmonary Hypertension NCT00581607	Phase 2/3	Completed	University of Cincinnati	43	2008-04 → 2012-12
Effect of Bosentan on Endothelial Function in Patients With Type 2 Diabetes NCT01357109	Phase 2	Completed	Karolinska Institutet	56	2007-11 → 2011-01
Assess the Efficacy and Safety of Sildenafil When Added to Bosentan in the Treatment of Pulmonary Arterial Hypertension NCT00323297	Phase 4	Completed	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	105	2006-09 → 2013-08
Effect of Bosentan on Skin Fibrosis in Patients With Systemic Sclerosis NCT00318175	Phase 2	Completed	Heinrich-Heine University, Duesseldorf	10	2006-06 → 2007-05

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

VA Federal Supply Schedule

Government-negotiated contract prices | 8 NDCs (4 FSS, 4 Big4)

Lowest Price

$5098.38

Highest Price

$12505.65

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
66215-0101-06TRACLEER 62.5MG TAB	$12505.65	FSS	Actelion Pharmaceuticals, U.S. Inc.	07/31/2029
66215-0101-06TRACLEER 62.5MG TAB	$9844.03	Big4	Actelion Pharmaceuticals, U.S. Inc.	07/31/2029
66215-0102-03TRACLEER 125MG TAB	$6252.82	FSS	Actelion Pharmaceuticals, U.S. Inc.	07/31/2029
66215-0102-03TRACLEER 125MG TAB	$5098.38	Big4	Actelion Pharmaceuticals, U.S. Inc.	07/31/2029
66215-0102-06TRACLEER 125MG TAB	$12505.65	FSS	Actelion Pharmaceuticals, U.S. Inc.	07/31/2029
66215-0102-06TRACLEER 125MG TAB	$10208.81	Big4	Actelion Pharmaceuticals, U.S. Inc.	07/31/2029
66215-0101-03TRACLEER 62.5MG TAB	$6252.82	FSS	Actelion Pharmaceuticals, U.S. Inc.	07/31/2029
66215-0101-03TRACLEER 62.5MG TAB	$5272.85	Big4	Actelion Pharmaceuticals, U.S. Inc.	07/31/2029

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

Medicare Part D Spending

CMS annual spending data for Tracleer (2024)

Total Spending

$13.6M

Total Claims

1,062

Beneficiaries

107

Avg Cost/Unit

$205.54

Spending Trend

$105.1M(2019)→$33.8M(2020)→$25.7M(2021)→$18.5M(2022)→$15.1M(2023)→$13.6M(2024)

YoY Change:-2.0%

5yr CAGR:+1.1%

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

API Supply Chain19 active DMFs2 inactive

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

MSN LABORATORIES PRIVATE LTDBOSENTAN MONOHYDRATE [ROUTE CODE - 'BN']

DMF 232552009

MATRIX PHARMACORP PRIVATE LTDBOSENTAN

DMF 233542009

AMINO CHEMICALS LTDBOSENTAN MONOHYDRATE

DMF 234552010

ALIVUS LIFE SCIENCES LTDBOSENTAN

DMF 241242010

ZACH SYSTEM SABOSENTAN MONOHYDRATE

DMF 249292011

ALEMBIC PHARMACEUTICALS LTDBOSENTAN

DMF 250992011

MEGAFINE PHARMA P LTDBOSENTAN MONOHYDRATE (NON-STERILE DRUG SUBSTANCE)

DMF 253542011

ZYDUS LIFESCIENCES LTDBOSENTAN MONOHYDRATE

DMF 259152012

NEULAND LABORATORIES LTDBOSENTAN MONOHYDRATE

DMF 260382012

PURE AND CURE HEALTHCARE PRIVATE LTDBOSENTAN MONOHYDRATE

DMF 261582012

ZHEJIANG MEDICINE CO LTD XINCHANG PHARMACEUTICAL FACTORYBOSENTAN MONOHYDRATE

DMF 264762012

CADILA PHARMACEUTICALS LTDBOSENTAN MONOHYDRATE

DMF 266322013

APITORIA PHARMA PRIVATE LTDBOSENTAN MONOHYDRATE (NON-STERILE DRUG SUBSTANCE)

DMF 268652013

JUBILANT BIOSYS LTDBOSENTAN MONOHYDRATE

DMF 285982014

CHEMWERTH INCBOSENTAN, NON-STERILE BULK DRUG SUBSTANCE

DMF 290012015

CIPLA LTDBOSENTAN MONOHYDRATE

DMF 290292015

SUN PHARMACEUTICAL INDUSTRIES LTDBOSENTAN MONOHYDRATE

DMF 326722019

RAKS PHARMA PVT LTDBOSENTAN MONOHYDRATE

DMF 327572018

HONOUR LAB LTDBOSENTAN MONOHYDRATE

DMF 360182021

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveBOSENTAN MONOHYDRATE

DMF 238172010

TAI HENG INDUSTRY CO LTDInactiveBOSENTAN MONOHYDRATE

DMF 251692011

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

Approval Letters

32 letters from Drugs@FDA

Date	Submission	Document
Mar 4, 2026	SUPPL -50	View Letter (PDF)
Nov 6, 2025	SUPPL -48	View Letter (PDF)
Aug 1, 2025	SUPPL -47	View Letter (PDF)
Sep 19, 2024	SUPPL -45	View Letter (PDF)
Feb 9, 2024	SUPPL -44	View Letter (PDF)
Jun 7, 2023	SUPPL -42	View Letter (PDF)
May 3, 2022	SUPPL -43	View Letter (PDF)
May 15, 2020	SUPPL -20	View Letter (PDF)
May 17, 2019	SUPPL -39	View Letter (PDF)
Apr 30, 2019	SUPPL -32	View Letter (PDF)
Oct 30, 2018	SUPPL -37	View Letter (PDF)
Dec 29, 2017	SUPPL -35	View Letter (PDF)
Sep 11, 2017	SUPPL -34	View Letter (PDF)
Dec 21, 2016	SUPPL -30	View Letter (PDF)
Oct 21, 2016	SUPPL -33	View Letter (PDF)
Dec 9, 2015	SUPPL -29	View Letter (PDF)
Dec 9, 2015	SUPPL -27	View Letter (PDF)
Jul 5, 2013	SUPPL -25	View Letter (PDF)
Oct 9, 2012	SUPPL -22	View Letter (PDF)
Feb 14, 2011	SUPPL -19	View Letter (PDF)
Feb 25, 2010	SUPPL -18	View Letter (PDF)
Aug 20, 2009	SUPPL -16	View Letter (PDF)
Aug 13, 2009	SUPPL -12	View Letter (PDF)
Mar 24, 2009	SUPPL -15	View Letter (PDF)
Feb 18, 2009	SUPPL -14	View Letter (PDF)
Jun 4, 2007	SUPPL -11	View Letter (PDF)
Feb 23, 2007	SUPPL -10	View Letter (PDF)
Dec 6, 2005	SUPPL -7	View Letter (PDF)
Dec 6, 2005	SUPPL -6	View Letter (PDF)
Dec 2, 2004	SUPPL -4	View Letter (PDF)
Oct 6, 2003	SUPPL -1	View Letter (PDF)
Nov 20, 2001	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 62.5MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Nov 20, 2001

No patent or exclusivity listings for this strength.

#002 — 125MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 20, 2001