Regulatory Exclusivity Expiring in 2030

Drugs with Regulatory Exclusivity Expiring in 2030

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Exclusivity Expiration	Patented / Exclusive Use
Beigene	BRUKINSA	zanubrutinib	CAPSULE;ORAL	213217-001	Nov 14, 2019		RX	Yes	Yes		INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL)
Seagen	TUKYSA	tucatinib	TABLET;ORAL	213411-001	Apr 17, 2020		RX	Yes	No		TREATMENT OF ADULT PATIENTS WITH RAS WILD-TYPE, HER2-POSITIVE UNRESECTABLE OR METASTATIC COLORECTAL CANCER THAT HAS PROGRESSED FOLLOWING TREATMENT WITH FLUOROPYRIMIDINE-, OXALIPLATIN-, AND IRINOTECAN-BASED CHEMOTHERAPY
Seagen	TUKYSA	tucatinib	TABLET;ORAL	213411-002	Apr 17, 2020		RX	Yes	Yes		TREATMENT OF ADULT PATIENTS WITH RAS WILD-TYPE, HER2-POSITIVE UNRESECTABLE OR METASTATIC COLORECTAL CANCER THAT HAS PROGRESSED FOLLOWING TREATMENT WITH FLUOROPYRIMIDINE-, OXALIPLATIN-, AND IRINOTECAN-BASED CHEMOTHERAPY
Medexus	GRAFAPEX	treosulfan	POWDER;INTRAVENOUS	214759-001	Jan 21, 2025		RX	Yes	Yes		NEW CHEMICAL ENTITY
Medexus	GRAFAPEX	treosulfan	POWDER;INTRAVENOUS	214759-002	Jan 21, 2025		RX	Yes	Yes		NEW CHEMICAL ENTITY
Loxo Oncol	JAYPIRCA	pirtobrutinib	TABLET;ORAL	216059-001	Jan 27, 2023		RX	Yes	No		TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY MANTLE CELL LYMPHOMA (MCL) AFTER AT LEAST TWO LINES OF SYSTEMIC THERAPY, INCLUDING A BTK INHIBITOR
Loxo Oncol	JAYPIRCA	pirtobrutinib	TABLET;ORAL	216059-002	Jan 27, 2023		RX	Yes	Yes		TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY MANTLE CELL LYMPHOMA (MCL) AFTER AT LEAST TWO LINES OF SYSTEMIC THERAPY, INCLUDING A BTK INHIBITOR