Company names starting with "Y"

Patents whose numbers are in italics have been extended under 35 USC 156. Unless otherwise noted, all expiration dates include applicable Sec. 156 and pediatric (PED) extensions.


Y-mABs Therapeutics, Inc
Danyelza (Injection) (Intravenous) naxitamab-gqgk
NDA Applicant: Y-mABs Therapeutics, Inc      BLA No.: 761171  Prod. No.: 001 Rx (40MG/10ML (4MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityNov 25, 2027Orphan Designation: Treatment of neuroblastoma
Approved Labeled Indication: in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy
Exclusivity Protected Indication: treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy


Last edited: 15 November 2022
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