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Last Updated: September 16, 2021

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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 ⤷  Free Forever Trial 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 ⤷  Free Forever Trial 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
Recordati Rare CARBAGLU carglumic acid TABLET, FOR SUSPENSION;ORAL 022562-001 Mar 18, 2010 RX Yes Yes ⤷  Free Forever Trial 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)
Emd Serono Inc TEPMETKO tepotinib hydrochloride TABLET;ORAL 214096-001 Feb 3, 2021 RX Yes Yes ⤷  Free Forever Trial TREATMENT OF ADULT PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) HARBORING MESENCHYMAL-EPITHELIAL TRANSITION (MET) EXON 14 SKIPPING ALTERATIONS
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Exclusivity Expiration >Patented / Exclusive Use

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Serving leading biopharmaceutical companies globally:

Dow
Colorcon
Moodys
McKinsey
Baxter
AstraZeneca

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