Regulatory Exclusivity Expiring in 2029

Drugs with Regulatory Exclusivity Expiring in 2029

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Exclusivity Expiration	Patented / Exclusive Use
Lnhc	ZELSUVMI	berdazimer sodium	GEL;TOPICAL	217424-001	Jan 5, 2024		RX	Yes	Yes		NEW CHEMICAL ENTITY
Gilead Sciences Inc	DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215-002	Jan 7, 2022		RX	Yes	No		TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS UNDER 12 YEARS OF AGE WEIGHING AT LEAST 14 KG TO LESS THAN 25 KG
Agios Pharms Inc	PYRUKYND	mitapivat sulfate	TABLET;ORAL	216196-001	Feb 17, 2022		RX	Yes	No		TREATMENT OF HEMOLYTIC ANEMIA IN ADULTS WITH PYRUVATE KINASE (PK) DEFICIENCY
Agios Pharms Inc	PYRUKYND	mitapivat sulfate	TABLET;ORAL	216196-002	Feb 17, 2022		RX	Yes	No		TREATMENT OF HEMOLYTIC ANEMIA IN ADULTS WITH PYRUVATE KINASE (PK) DEFICIENCY
Agios Pharms Inc	PYRUKYND	mitapivat sulfate	TABLET;ORAL	216196-003	Feb 17, 2022		RX	Yes	Yes		TREATMENT OF HEMOLYTIC ANEMIA IN ADULTS WITH PYRUVATE KINASE (PK) DEFICIENCY
Allecra Theraps	EXBLIFEP	cefepime hydrochloride; enmetazobactam	POWDER;INTRAVENOUS	216165-001	Feb 22, 2024		DISCN	Yes	No		NEW CHEMICAL ENTITY
Sobi	VONJO	pacritinib citrate	CAPSULE;ORAL	208712-001	Feb 28, 2022		RX	Yes	Yes		TREATMENT OF ADULTS WITH INTERMEDIATE OR HIGH-RISK PRIMARY OR SECONDARY (POST-POLYCYTHEMIA VERA OR POST-ESSENTIAL THROMBOCYTHEMIA) MYELOFIBROSIS (MF) WITH A PLATELET COUNT BELOW 50 X 10^9/L