Last Updated: June 25, 2026

Mechanism of Action: Cytochrome P450 3A4 Inhibitors

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Drugs with Mechanism of Action: Cytochrome P450 3A4 Inhibitors

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-003	Jul 9, 2010	AB	RX	Yes	No	9,006,224	⤷ Start Trial				⤷ Start Trial
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-003	Jul 9, 2010	AB	RX	Yes	No	8,410,131*PED	⤷ Start Trial			Y	⤷ Start Trial
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-001	Mar 30, 2009	AB	RX	Yes	Yes	9,006,224	⤷ Start Trial				⤷ Start Trial
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-001	Mar 30, 2009	AB	RX	Yes	Yes	8,410,131*PED	⤷ Start Trial			Y	⤷ Start Trial
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-004	Mar 30, 2012	AB	RX	Yes	No	9,006,224	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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