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Last Updated: August 8, 2020

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Mechanism of Action: Cytochrome P450 3A4 Inducers

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Drugs with Mechanism of Action: Cytochrome P450 3A4 Inducers

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astellas XTANDI enzalutamide CAPSULE;ORAL 203415-001 Aug 31, 2012 RX Yes Yes   Start Trial   Start Trial   Start Trial
Astellas XTANDI enzalutamide CAPSULE;ORAL 203415-001 Aug 31, 2012 RX Yes Yes   Start Trial   Start Trial   Start Trial
Astellas XTANDI enzalutamide CAPSULE;ORAL 203415-001 Aug 31, 2012 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Astellas XTANDI enzalutamide CAPSULE;ORAL 203415-001 Aug 31, 2012 RX Yes Yes   Start Trial   Start Trial   Start Trial
Astellas XTANDI enzalutamide CAPSULE;ORAL 203415-001 Aug 31, 2012 RX Yes Yes   Start Trial   Start Trial   Start Trial
Supernus Pharms TROKENDI XR topiramate CAPSULE, EXTENDED RELEASE;ORAL 201635-002 Aug 16, 2013 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Supernus Pharms TROKENDI XR topiramate CAPSULE, EXTENDED RELEASE;ORAL 201635-004 Aug 16, 2013 BC RX Yes Yes   Start Trial   Start Trial Y   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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Serving leading biopharmaceutical companies globally:

McKinsey
Moodys
Mallinckrodt
Colorcon
Express Scripts
Johnson and Johnson

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