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NDA

BOSENTAN | N209279 | ACTELION PHARMACEUTICALS US INC

1 strength2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Expired (1)Active (1)Today

2027

2028

Today

7959945

Dec. 28, 2027

8309126

May. 15, 2026

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 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	—
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).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

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

11 letters from Drugs@FDA

Date	Submission	Document
Mar 4, 2026	SUPPL -17	View Letter (PDF)
Nov 6, 2025	SUPPL -15	View Letter (PDF)
Aug 1, 2025	SUPPL -14	View Letter (PDF)
Sep 19, 2024	SUPPL -11	View Letter (PDF)
Feb 9, 2024	SUPPL -10	View Letter (PDF)
Nov 2, 2022	SUPPL -8	View Letter (PDF)
May 3, 2022	SUPPL -9	View Letter (PDF)
May 17, 2019	SUPPL -5	View Letter (PDF)
Apr 30, 2019	SUPPL -4	View Letter (PDF)
Oct 30, 2018	SUPPL -2	View Letter (PDF)
Dec 29, 2017	SUPPL -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 32MG

RLDAB

2 patents0 exclusivities▴

TABLET, FOR SUSPENSION;ORAL | Approved: Sep 5, 2017

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7959945	Dec 28, 2027	—	—	Yes	—	—
8309126	May 15, 2026	—	—	Yes	—	—