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BOSENTAN

ANDA

BOSENTAN | A213154 | NATCO PHARMA LTD

1 strength0 unique patents1 unique exclusivity

Reference Listed Drug: TRACLEER(TE code: AB)

Patent Timeline

0 unique patents, 1 exclusivity by expiration date

TodayExclusivity

Today

Feb. 14, 2026

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
ACTELION PHARMACEUTICALS LTD. et al v. NATCO PHARMA LIMITED et al 3:2019cv12984 1 patentANDA 213154bosentan	D.N.J.	2019-05-28	Terminated 2019-11-26	—

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

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

1 letter from Drugs@FDA

Date	Submission	Document
Mar 6, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 32MG

0 patents1 exclusivity▴

TABLET, FOR SUSPENSION;ORAL | Approved: Feb 5, 2025

Exclusivities (1)

Code	Date	Status
PC	Feb 14, 2026	Expired