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

1 trial from ClinicalTrials.gov, 1 active

Trial	Phase	Status	Sponsor	Enrollment	Dates
Endothelin Role In COronary Microcirculation NCT07670091	N/A	Active	Liverpool University Hospitals NHS Foundation Trust	45	2023-07-01 → 2026-08-01

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

Medicare Part D Spending

CMS annual spending data for Tracleer (2023)

Total Spending

$15.1M

Total Claims

1,192

Beneficiaries

128

Avg Cost/Unit

$209.75

Spending Trend

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

YoY Change:+4.5%

5yr CAGR:+1.4%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain18 active DMFs2 inactive

18 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 PHARMOVA LTDBOSENTAN MONOHYDRATE

DMF 285982014

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