DrugPatentWatch Alpha Signals Regulatory Exclusivity

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Regulatory Exclusivity: Orphan Drug

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Drugs with Orphan Drug Regulatory Exclusivity

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		FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S).AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
Astellas	CRESEMBA	isavuconazonium sulfate	CAPSULE;ORAL	207500-001	Mar 6, 2015		RX	Yes	Yes		TREATMENT OF INVASIVE ASPERGILLOSIS
Astellas	CRESEMBA	isavuconazonium sulfate	CAPSULE;ORAL	207500-001	Mar 6, 2015		RX	Yes	Yes		TREATMENT OF INVASIVE MUCORMYCOSIS IN PATIENTS 18 YEARS OF AGE AND OLDER
Astellas	CRESEMBA	isavuconazonium sulfate	POWDER;INTRAVENOUS	207501-001	Mar 6, 2015		RX	Yes	Yes		TREATMENT OF INVASIVE ASPERGILLOSIS
Astellas	CRESEMBA	isavuconazonium sulfate	POWDER;INTRAVENOUS	207501-001	Mar 6, 2015		RX	Yes	Yes		TREATMENT OF INVASIVE MUCORMYCOSIS IN PATIENTS 18 YEARS OF AGE AND OLDER
Eisai Inc	LENVIMA	lenvatinib mesylate	CAPSULE;ORAL	206947-001	Feb 13, 2015		RX	Yes	No		INDICATED FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH UNRESECTABLE HEPATOCELLULAR CARCINOMA (HCC)

Regulatory Exclusivity

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Competitive Generic Therapy
New Chemical Entity
New Dosing Schedule
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Orphan Drug
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Pediatric Exclusivity
RX to OTC Switch

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