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
Astrazeneca Ab	WAINUA (AUTOINJECTOR)	eplontersen sodium	SOLUTION;SUBCUTANEOUS	217388-001	Dec 21, 2023		RX	Yes	Yes		TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS
Calliditas	TARPEYO	budesonide	CAPSULE, DELAYED RELEASE;ORAL	215935-001	Dec 15, 2021		RX	Yes	Yes		TO REDUCE THE LOSS OF KIDNEY FUNCTION IN ADULTS WITH PRIMARY IMMUNOGLOBULIN A NEPHROPATHY (IGAN) WHO ARE AT RISK FOR DISEASE PROGRESSION, EXCLUDING THE USE PROVIDED FOR IN THE INDICATION APPROVED ON DECEMBER 15, 2021
Chiesi	FILSUVEZ	birch triterpenes	GEL;TOPICAL	215064-001	Dec 18, 2023		RX	Yes	Yes		TREATMENT OF WOUNDS ASSOCIATED WITH DYSTROPHIC AND JUNCTIONAL EPIDERMOLYSIS BULLOSA (EB) IN ADULT AND PEDIATRIC PATIENTS 6 MONTHS OF AGE AND OLDER
Uswm	IWILFIN	eflornithine hydrochloride	TABLET;ORAL	215500-001	Dec 13, 2023		RX	Yes	Yes		TO REDUCE THE RISK OF RELAPSE IN ADULT AND PEDIATRIC PATIENTS WITH HIGH-RISK NEUROBLASTOMA (HRNB) WHO HAVE DEMONSTRATED AT LEAST A PARTIAL RESPONSE TO PRIOR MULTIAGENT, MULTIMODALITY THERAPY INCLUDING ANTI-GD2 IMMUNOTHERAPY
Astellas	CRESEMBA	isavuconazonium sulfate	CAPSULE;ORAL	207500-002	Nov 22, 2022		RX	Yes	No		TREATMENT OF INVASIVE ASPERGILLOSIS IN PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER WHO WEIGH 16 KILOGRAMS (KG) AND GREATER
Astellas	CRESEMBA	isavuconazonium sulfate	CAPSULE;ORAL	207500-002	Nov 22, 2022		RX	Yes	No		TREATMENT OF INVASIVE MUCORMYCOSIS IN PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER WHO WEIGH 16 KG AND GREATER
Astellas	CRESEMBA	isavuconazonium sulfate	CAPSULE;ORAL	207500-001	Mar 6, 2015		RX	Yes	Yes		TREATMENT OF INVASIVE ASPERGILLOSIS IN PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER WHO WEIGH 16 KILOGRAMS (KG) AND GREATER