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Last Updated: March 18, 2026

DrugPatentWatch Alpha Signals Regulatory Exclusivity

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Regulatory Exclusivity: Pediatric Exclusivity

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Drugs with Pediatric Exclusivity Regulatory Exclusivity

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Exclusivity Expiration	Patented / Exclusive Use
Astellas	CRESEMBA	isavuconazonium sulfate	CAPSULE;ORAL	207500-002	Nov 22, 2022		RX	Yes	No	⤷ Get Started Free	PEDIATRIC EXCLUSIVITY
Astellas	CRESEMBA	isavuconazonium sulfate	CAPSULE;ORAL	207500-001	Mar 6, 2015		RX	Yes	Yes	⤷ Get Started Free	PEDIATRIC EXCLUSIVITY
Astellas	CRESEMBA	isavuconazonium sulfate	POWDER;INTRAVENOUS	207501-001	Mar 6, 2015		RX	Yes	Yes	⤷ Get Started Free	PEDIATRIC EXCLUSIVITY
Incyte Corp	OPZELURA	ruxolitinib phosphate	CREAM;TOPICAL	215309-001	Sep 21, 2021		RX	Yes	Yes	⤷ Get Started Free	PEDIATRIC EXCLUSIVITY
Genentech Inc	COTELLIC	cobimetinib fumarate	TABLET;ORAL	206192-001	Nov 10, 2015		RX	Yes	Yes	⤷ Get Started Free	PEDIATRIC EXCLUSIVITY
Eisai Inc	LENVIMA	lenvatinib mesylate	CAPSULE;ORAL	206947-001	Feb 13, 2015		RX	Yes	No	⤷ Get Started Free	PEDIATRIC EXCLUSIVITY
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Exclusivity Expiration	>Patented / Exclusive Use

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