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Last Updated: April 25, 2024

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
Viiv Hlthcare SELZENTRY maraviroc SOLUTION;ORAL 208984-001 Nov 4, 2016 RX Yes Yes ⤷  Try a Trial NEW PATIENT POPULATION
Pacira Pharms Inc EXPAREL bupivacaine INJECTABLE, LIPOSOMAL;INJECTION 022496-001 Oct 28, 2011 RX Yes Yes ⤷  Try a Trial NEW PATIENT POPULATION
Pacira Pharms Inc EXPAREL bupivacaine INJECTABLE, LIPOSOMAL;INJECTION 022496-002 Oct 28, 2011 RX Yes Yes ⤷  Try a Trial NEW PATIENT POPULATION
Celator Pharms VYXEOS cytarabine; daunorubicin POWDER;INTRAVENOUS 209401-001 Aug 3, 2017 RX Yes Yes ⤷  Try a Trial NEW PATIENT POPULATION
Novartis DIOVAN valsartan TABLET;ORAL 021283-004 Aug 14, 2002 AB RX Yes No ⤷  Try a Trial NEW PATIENT POPULATION
Novartis DIOVAN valsartan TABLET;ORAL 021283-001 Jul 18, 2001 AB RX Yes No ⤷  Try a Trial NEW PATIENT POPULATION
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Exclusivity Expiration >Patented / Exclusive Use

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