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Profile for Tradename: MYLOTARG

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Mylotarg is a drug marketed by Wyeth Pharms Inc and is included in one NDA. There are four patents protecting this drug.

This drug has one hundred and thirty patent family members in thirty-four countries.

The generic ingredient in MYLOTARG is gemtuzumab ozogamicin. Additional details are available on the gemtuzumab ozogamicin profile page.

Summary for Tradename: MYLOTARG

Patents:4
Applicants:1
NDAs:1

Clinical Trials for: MYLOTARG

Nonmyeloablative Preparative Regimen Using Mylotarg for Patients With High Risk Acute Myeloid Leukemia (AML), Acute Lymphocytic Leukemia (ALL), Chronic Myeloid Leukemia (CML) and Myelodysplastic Syndrome (MDS)
Status: Terminated Condition: Leukemia

Allo Transplantation With Mylotarg, Fludarabine and Melphalan for AML, CML and MDS
Status: Completed Condition: Acute Myelogenous Leukemia; Myelodysplastic Syndrome; Chronic Lymphocytic Leukemia

Efficacy of Gemtuzumab Ozogamycin for Patients Presenting an Acute Myeloid Leukemia (AML) With Intermediate Risk
Status: Active, not recruiting Condition: Acute Myeloid Leukemia

Decitabine and Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (H-R MDS)
Status: Completed Condition: Acute Myelogenous Leukemia; Myelodysplastic Syndrome

Study Evaluating the Effect of Corticosteroids on Mylotarg® Infusion-Related Adverse Events in Patients With Leukemia
Status: Completed Condition: Leukemia, Myelocytic, Acute; Infusions, Intravenous

Gemtuzumab Ozogamicin in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Acute Promyelocytic Leukemia
Status: Recruiting Condition: Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Del(5q); Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(15;17)(q22;q12); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Adult Acute Promyelocytic Leukemia (M3); Childhood Acute Promyelocytic Leukemia (M3); Recurrent Adult Acute Myeloid Leukemia; Recurrent Childhood Acute Myeloid Leukemia

Decitabine and Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia and High-risk Myelodysplastic Syndrome
Status: Completed Condition: Acute Myelogenous Leukemia; Myelodysplastic Syndrome

DNR and AraC Combined to Fractionated Mylotarg® in Patients With First Relapse of AML
Status: Completed Condition: Acute Myeloid Leukemia

Prospective Study of Mylotarg and G-CSF in Acute Myeloid Leukemia Treatment
Status: Active, not recruiting Condition: Novo Acute Myeloid Leukemia

A Randomized Study of Gemtuzumab Ozogamicin (GO) With Daunorubicine and Cytarabine in Untreated Acute Myeloid Leukemia (AML) Aged of 50-70 Years Old
Status: Completed Condition: Acute Myeloid Leukemia

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Wyeth Pharms Inc
MYLOTARG
gemtuzumab ozogamicin
INJECTABLE;INJECTION021174-001May 17, 2000DISCNNo5,773,001<disabled><disabled>
Wyeth Pharms Inc
MYLOTARG
gemtuzumab ozogamicin
INJECTABLE;INJECTION021174-001May 17, 2000DISCNNo5,739,116<disabled><disabled>
Wyeth Pharms Inc
MYLOTARG
gemtuzumab ozogamicin
INJECTABLE;INJECTION021174-001May 17, 2000DISCNNo5,693,762<disabled><disabled>
Wyeth Pharms Inc
MYLOTARG
gemtuzumab ozogamicin
INJECTABLE;INJECTION021174-001May 17, 2000DISCNNo5,767,285<disabled><disabled>
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Non-Orange Book Patents for Tradename: MYLOTARG

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,693,761 Polynucleotides encoding improved humanized immunoglobulins<disabled in preview>
5,877,296 Process for preparing conjugates of methyltrithio antitumor agents<disabled in preview>
6,180,370 Humanized immunoglobulins and methods of making the same<disabled in preview>
5,585,089 Humanized immunoglobulins<disabled in preview>
5,530,101 Humanized immunoglobulins<disabled in preview>
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International Patent Family for Tradename: MYLOTARG

Country Document Number Publication Date
Germany10075038Aug 12, 2004
Japan2007145863Jun 14, 2007
Germany122009000071Mar 25, 2010
European Patent Office0566647Jun 14, 1995
Israel92904Sep 17, 1990
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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