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Last Updated: June 21, 2024

Regulatory Exclusivity Expiring in 2028


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Drugs with Regulatory Exclusivity Expiring in 2028

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Exclusivity Expiration Patented / Exclusive Use
Pf Prism Cv XALKORI crizotinib CAPSULE;ORAL 202570-001 Aug 26, 2011 RX Yes No ⤷  Sign Up TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER AND YOUNG ADULTS WITH RELAPSED OR REFRACTORY, SYSTEMIC ANAPLASTIC LARGE CELL LYMPHOMA (ALCL) THAT IS ALK-POSITIVE
Pf Prism Cv XALKORI crizotinib CAPSULE;ORAL 202570-002 Aug 26, 2011 RX Yes Yes ⤷  Sign Up TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER AND YOUNG ADULTS WITH RELAPSED OR REFRACTORY, SYSTEMIC ANAPLASTIC LARGE CELL LYMPHOMA (ALCL) THAT IS ALK-POSITIVE
Theracosbio BRENZAVVY bexagliflozin TABLET;ORAL 214373-001 Jan 20, 2023 RX Yes Yes ⤷  Sign Up NEW CHEMICAL ENTITY
Recordati Rare CARBAGLU carglumic acid TABLET, FOR SUSPENSION;ORAL 022562-001 Mar 18, 2010 AB RX Yes Yes ⤷  Sign Up IN PEDIATRIC AND ADULT PATIENTS AS ADJUNCTIVE THERAPY TO STANDARD OF CARE FOR THE TREATMENT OF ACUTE HYPERAMMONEMIA DUE TO PROPIONIC ACIDEMIA (PA) OR METHYLMALONIC ACIDEMIA (MMA)
Loxo Oncol JAYPIRCA pirtobrutinib TABLET;ORAL 216059-001 Jan 27, 2023 RX Yes No ⤷  Sign Up NEW CHEMICAL ENTITY
Loxo Oncol JAYPIRCA pirtobrutinib TABLET;ORAL 216059-002 Jan 27, 2023 RX Yes Yes ⤷  Sign Up NEW CHEMICAL ENTITY
Stemline Therap ORSERDU elacestrant dihydrochloride TABLET;ORAL 217639-001 Jan 27, 2023 RX Yes No ⤷  Sign Up NEW CHEMICAL ENTITY
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Exclusivity Expiration >Patented / Exclusive Use

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