Viewing data from:

BOSENTAN

ANDA

BOSENTAN | A213981 | ZYDUS PHARMACEUTICALS USA INC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: TRACLEER(TE code: AB)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
ACTELION PHARMACEUTICALS LTD. et al v. ZYDUS PHARMACEUTICALS (USA), INC. et al 3:2019cv22193 1 patentANDA 213981bosentan	D.N.J.	2019-12-31	Terminated 2020-07-10	—

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.

Products (1)

#001 — 32MG

0 patents0 exclusivities▴

TABLET, FOR SUSPENSION;ORAL | Approved: Feb 17, 2026

No patent or exclusivity listings for this strength.