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Details for Generic Name: caspofungin acetate

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Caspofungin acetate is the generic ingredient in one branded drug marketed by Merck and is included in one NDA. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for caspofungin acetate. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: caspofungin acetate

Tradenames:1
Patents:3
Applicants:1
NDAs:1
Drug Master File Entries: see list6
Suppliers / Packaging: see list2
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details

Pharmacology for Ingredient: caspofungin acetate

Ingredient-typeLipopeptides
Drug ClassEchinocandin Antifungal

Tentative approvals for CASPOFUNGIN ACETATE

Applicant Application No. Form Dosage
<disabled><disabled>INJECTABLE; INJECTION70MG/VIAL
<disabled><disabled>INJECTABLE; INJECTION50MG/VIAL

Clinical Trials for: caspofungin acetate

Open, Pharmacokinetic Study of Caspofungin Acetate in Immunocompromised Young Children With Febrile Neutropenia (0991-042)
Status: Completed Condition: Fungal Infection

Caspofungin Acetate, Fluconazole, or Voriconazole in Preventing Fungal Infections in Patients Following Donor Stem Cell Transplant
Status: Recruiting Condition: Fungal Infection; Hematopoietic/Lymphoid Cancer

Caspofungin Acetate or Fluconazole in Preventing Invasive Fungal Infections in Patients With Acute Myeloid Leukemia Who Are Undergoing Chemotherapy
Status: Recruiting 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 in Remission; 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); Childhood Acute Erythroleukemia (M6); Childhood Acute Megakaryocytic Leukemia (M7); Childhood Acute Minimally Differentiated Myeloid Leukemia (M0); Childhood Acute Monoblastic Leukemia (M5a); Childhood Acute Monocytic Leukemia (M5b); Childhood Acute Myeloblastic Leukemia With Maturation (M2); Childhood Acute Myeloblastic Leukemia Without Maturation (M1); Childhood Acute Myeloid Leukemia in Remission; Childhood Acute Myelomonocytic Leukemia (M4); Fungal Infection; Neutropenia; Recurrent Adult Acute Myeloid Leukemia; Recurrent Childhood Acute Myeloid Leukemia; Secondary Acute Myeloid Leukemia; Untreated Adult Acute Myeloid Leukemia; Untreated Childhood Acute Myeloid Leukemia and Other Myeloid Malignancies

Pharmacokinetics of Caspofungin (Cancidas ®) Given Intravenously as Therapy to Patients With an Invasive Fungal Infection in the Intensive Care Unit - a Search for Co-variates
Status: Completed Condition: Invasive Fungal Infection

A Study of Caspofungin Acetate (MK0991) for the Treatment of Esophageal Candidiasis or Invasive Candidiasis in Chinese Adults (MK-0991-066)
Status: Completed Condition: Fungal Infection

Pilot Feasibility Study With Patients Who Are at High Risk For Developing Invasive Candidiasis in a Critical Care Setting (MK-0991-067)
Status: Terminated Condition: Invasive Candidiasis

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
Merck
CANCIDAS
caspofungin acetate
INJECTABLE;IV (INFUSION)021227-002Jan 26, 2001RXYes5,514,650*PED<disabled>Y<disabled>
Merck
CANCIDAS
caspofungin acetate
INJECTABLE;IV (INFUSION)021227-001Jan 26, 2001RXYes6,136,783*PED<disabled>Y<disabled>
Merck
CANCIDAS
caspofungin acetate
INJECTABLE;IV (INFUSION)021227-001Jan 26, 2001RXYes5,514,650*PED<disabled>Y<disabled>
Merck
CANCIDAS
caspofungin acetate
INJECTABLE;IV (INFUSION)021227-002Jan 26, 2001RXYes6,136,783*PED<disabled>Y<disabled>
Merck
CANCIDAS
caspofungin acetate
INJECTABLE;IV (INFUSION)021227-002Jan 26, 2001RXYes5,952,300*PED<disabled>Y<disabled>
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Non-Orange Book Patents for Generic Ingredient: caspofungin acetate

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
5,378,804 Aza cyclohexapeptide compounds<disabled in preview>
5,792,746 Aza cyclohexapeptide compounds<disabled in preview>
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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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