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. 2016 Apr 26;8(5):841–847. doi: 10.1080/19420862.2016.1180491

Table 2.

Correlation between antibody dosage patent and approved dosage of gemtuzumab ozogamicin. The patent is broader than the approved dosage, hence anticipating later factionated dosages that could have given rise to new patent protection.

Approved antibody Patent Priority date Claimed dosage Dosage in the FDA label
Gemtuzumab ozogamicin US7727968B2 (wihdrawn by patentee) Nov. 6, 2002 Method of treating AML consisting essentially of: (a) administering a first course (…) of (…)about 3 to 9 mg/m2 gemtuzumab ozogamicin for one day (plus chemotherapy) (b) administering a second course of (…) of about 3 to 9 mg/m2 gemtuzumab ozogamicin for one day (plus chemotherapy) (…) and (c) administering a third course (chemotherapy) 9 mg/m2, infused over a 2-hour period. The recommended treatment course with Mylotarg is a total of 2 doses with 14 d between the doses