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Last Updated: April 1, 2023

Regulatory Exclusivity: NEW PATIENT POPULATION

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Drugs with New Patient Population Regulatory Exclusivity

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Exclusivity Expiration	Patented / Exclusive Use
Pf Prism Cv	VFEND	voriconazole	FOR SUSPENSION;ORAL	021630-001	Dec 19, 2003	AB	RX	Yes	Yes	⤷ Sign Up	NEW PATIENT POPULATION
Pf Prism Cv	VFEND	voriconazole	INJECTABLE;INTRAVENOUS	021267-001	May 24, 2002	AP	RX	Yes	Yes	⤷ Sign Up	NEW PATIENT POPULATION
Pf Prism Cv	VFEND	voriconazole	TABLET;ORAL	021266-001	May 24, 2002	AB	RX	Yes	No	⤷ Sign Up	NEW PATIENT POPULATION
Pf Prism Cv	VFEND	voriconazole	TABLET;ORAL	021266-002	May 24, 2002	AB	RX	Yes	Yes	⤷ Sign Up	NEW PATIENT POPULATION
Vertex Pharms Inc	KALYDECO	ivacaftor	GRANULE;ORAL	207925-003	Apr 29, 2019		RX	Yes	No	⤷ Sign Up	NEW PATIENT POPULATION
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Exclusivity Expiration	>Patented / Exclusive Use

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Serving leading biopharmaceutical companies globally:

Colorcon

Harvard Business School

Medtronic

Mallinckrodt

Baxter

Merck

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