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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

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

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

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Status: Withdrawn Condition: Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Del(5q); Adult Acute Myeloid Leukemia With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

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: Completed Condition: 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

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, 2000DISCNNo5,767,285<disabled> <disabled>
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>
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Expired Orange Book Patents for Generic Ingredient: gemtuzumab ozogamicin

These historical archives are available as an add-on to one-year subscriptions

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Wyeth Pharms Inc
MYLOTARG
gemtuzumab ozogamicin
INJECTABLE;INJECTION021174-001May 17, 20004,970,198<disabled>
Wyeth Pharms Inc
MYLOTARG
gemtuzumab ozogamicin
INJECTABLE;INJECTION021174-001May 17, 20005,773,001<disabled>
Wyeth Pharms Inc
MYLOTARG
gemtuzumab ozogamicin
INJECTABLE;INJECTION021174-001May 17, 20005,767,285<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
5,877,296 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>
7,022,500Humanized immunoglobulins<disabled in preview>
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International Patent Family for Ingredient: gemtuzumab ozogamicin

Country Document Number Publication Date
Netherlands300173May 01, 2006
Germany68925536Nov 22, 2012
Norway2009026Nov 30, 2009
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Copyright 2002-2016 thinkBiotech LLC
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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