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Last Updated: April 24, 2024

Regulatory Exclusivity: ORPHAN DRUG EXCLUSIVITY


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Drugs with Orphan Drug Exclusivity Regulatory Exclusivity

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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 ⤷  Try a Trial 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 ⤷  Try a Trial TREATMENT OF INVASIVE MUCORMYCOSIS IN PATIENTS 18 YEARS OF AGE AND OLDER
Astellas CRESEMBA isavuconazonium sulfate CAPSULE;ORAL 207500-001 Mar 6, 2015 RX Yes Yes ⤷  Try a Trial TREATMENT OF INVASIVE ASPERGILLOSIS
Astellas CRESEMBA isavuconazonium sulfate POWDER;INTRAVENOUS 207501-001 Mar 6, 2015 RX Yes Yes ⤷  Try a Trial 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 ⤷  Try a Trial TREATMENT OF INVASIVE ASPERGILLOSIS
Adienne Sa TEPADINA thiotepa POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL 208264-001 Jan 26, 2017 AP RX Yes Yes ⤷  Try a Trial INDICATED FOR REDUCING THE RISK OF GRAFT REJECTION WHEN USED IN CONJUNCTION WITH HIGH-DOSE BUSULFAN & CYCLOPHOSPHAMIDE AS A PREPARATIVE REGIMEN FOR ALLOGENIC HEMATOPOIETIC PROGENITOR CELL TRANSPLANTATION FOR PEDS. PATIENTS WITH CLASS 3 BETA-THALASSEMIA
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Exclusivity Expiration >Patented / Exclusive Use

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