Last Updated: November 8, 2026

Details for New Drug Application (NDA): 211026

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NDA 211026 describes MACITENTAN, which is a drug marketed by Alembic, Amneal, Apotex, Aurobindo Pharma Ltd, Laurus, Lepu Pharm, MSN, Mylan, Sun Pharm, Teva Pharms Usa Inc, Torrent, and Zydus Lifesciences, and is included in twelve NDAs. It is available from fourteen suppliers. Additional details are available on the MACITENTAN profile page.

The generic ingredient in MACITENTAN is macitentan. There is one drug master file entry for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the macitentan profile page.

Summary for 211026

Tradename:	MACITENTAN
Applicant:	Lepu Pharm
Ingredient:	macitentan
Patents:	0

Pharmacology for NDA: 211026

Mechanism of Action	Endothelin Receptor Antagonists

Suppliers and Packaging for NDA: 211026

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MACITENTAN	macitentan	TABLET;ORAL	211026	ANDA	Novugen Pharma (USA) LLC	82293-041	82293-041-10	1 BLISTER PACK in 1 CARTON (82293-041-10) / 15 TABLET, FILM COATED in 1 BLISTER PACK
MACITENTAN	macitentan	TABLET;ORAL	211026	ANDA	Novugen Pharma (USA) LLC	82293-041	82293-041-20	30 TABLET, FILM COATED in 1 BOTTLE (82293-041-20)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Dec 3, 2025	TE:	AB	RLD:	No
Regulatory Exclusivity Expiration:	Dec 3, 2026
Regulatory Exclusivity Use:	PATENT CHALLENGE

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