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Details for Generic Name: gemtuzumab ozogamicin

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Gemtuzumab ozogamicin is the generic ingredient in one branded drug marketed by Wyeth Pharms Inc and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

Summary for Generic Name: gemtuzumab ozogamicin

Tradenames:1
Patents:4
Applicants:1
NDAs:1
Drug Master File Entries: 0

Clinical Trials for: gemtuzumab ozogamicin

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

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

Phase I/II Study of Mitoxantrone, Etoposide and Gemtuzumab Ozogamicin for Acute Myeloid Leukemia
Status: Recruiting Condition: Acute Myeloid Leukemia

Acute Promyelocytic Leukemia (APL) Treated With ATRA, Arsenic Trioxide and Gemtuzumab Ozogamicin
Status: Recruiting Condition: Leukemia

Gemtuzumab Ozogamicin in Treating Patients With Acute Myeloid Leukemia
Status: Withdrawn Condition: Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Del(5q); Adult Acute Myeloid Leukemia With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); Recurrent Adult Acute Myeloid Leukemia

Azacitidine and Gemtuzumab Ozogamicin in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia
Status: Active, not recruiting Condition: Adult Acute Megakaryoblastic Leukemia; Adult Acute Monoblastic Leukemia; Adult Acute Monocytic Leukemia; Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11; Adult Acute Myeloid Leukemia With Maturation; Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11; Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); RUNX1-RUNX1T1; Adult Acute Myeloid Leukemia With t(9;11)(p22;q23); MLLT3-MLL; Adult Acute Myeloid Leukemia Without Maturation; Adult Acute Myelomonocytic Leukemia; Adult Erythroleukemia; Adult Pure Erythroid Leukemia; Secondary Acute Myeloid Leukemia; Untreated Adult Acute Myeloid Leukemia

Arsenic Trioxide and Gemtuzumab Ozogamicin in Treating Patients With Advanced Myelodysplastic Syndromes
Status: Completed Condition: Leukemia; Myelodysplastic Syndromes

Vorinostat and Gemtuzumab Ozogamicin in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia
Status: Terminated Condition: Adult Acute Megakaryoblastic Leukemia (M7); Adult Acute Minimally Differentiated Myeloid Leukemia (M0); Adult Acute Monoblastic Leukemia (M5a); Adult Acute Monocytic Leukemia (M5b); Adult Acute Myeloblastic Leukemia With Maturation (M2); Adult Acute Myeloblastic Leukemia Without Maturation (M1); 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(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Adult Acute Myelomonocytic Leukemia (M4); Adult Erythroleukemia (M6a); Adult Pure Erythroid Leukemia (M6b); Untreated Adult Acute Myeloid Leukemia

Combination 5-azacitidine and Gemtuzumab Ozogamicin Therapy for Treatment of Relapsed Acute Myeloid Leukemia (AML)
Status: Active, not recruiting 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, 2000DISCNNo5,739,116<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>
Wyeth Pharms Inc
MYLOTARG
gemtuzumab ozogamicin
INJECTABLE;INJECTION021174-001May 17, 2000DISCNNo5,773,001<disabled><disabled>
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Non-Orange Book Patents for Generic Ingredient: gemtuzumab ozogamicin

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 Ingredient: gemtuzumab ozogamicin

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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