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Profile for Tradename: EMEND

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Emend is a drug marketed by Merck and Merck And Co Inc and is included in two NDAs. It is available from three suppliers. There are five patents protecting this drug and three Paragraph IV challenges.

This drug has two hundred and nine patent family members in fifty-two countries.

The generic ingredient in EMEND is fosaprepitant dimeglumine. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the fosaprepitant dimeglumine profile page.

Summary for Tradename: EMEND

Patents:5
Applicants:2
NDAs:2
Suppliers: see list3

Clinical Trials for: EMEND

Re-examination Study of EMEND (Aprepitant) (MK-0869-184)
Status: Completed Condition: Chemotherapy-induced Nausea and Vomiting

Efficacy of Aprepitant (Emend®) in Children
Status: Recruiting Condition: Nausea; Vomiting; Childhood Cancer

Pharmacokinetic (PK) Characteristics and Anti-Inflammatory Effects of the NK-1R Antagonist, Aprepitant, In HIV-Infected Subjects With Undetectable Viral Load Receiving Atazanavir/Ritonavir Or Darunavir/Ritonavir-Containing Antiretroviral Therapy
Status: Recruiting Condition: HIV Infection

Study Assessing Fosaprepitant in Advanced NSCLC Patients Treated With Carboplatin Based Chemotherapy
Status: Not yet recruiting Condition: Non-small Cell Lung Cancer; Vomiting; Nausea; Emesis

A Study of MK-0869 (Aprepitant) and MK-0517 (Fosaprepitant) in Pediatric Participants Receiving Chemotherapy (MK-0869-134)
Status: Terminated Condition: Chemotherapy-Induced Nausea and Vomiting

Study of the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Fosaprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Children (MK-0517-029)
Status: Recruiting Condition: Chemotherapy-induced Nausea and Vomiting

Comparison of Adding EMEND to PONV/PDNV Treatment Regimen
Status: Not yet recruiting Condition: Postoperative Nausea and Vomiting

Aprepitant's Effect on Drug Metabolism in Multi-Day Combination (CHOP/R-CHOP) Chemotherapy Regimen in Lymphoma Patients
Status: Completed Condition: Lymphoma

Emend and Ondansetron Compared to Ondansetron Alone to Prevent CINV in Glioma Patients Receiving Temozolomide
Status: Recruiting Condition: Nausea; Vomiting; Glioma

Fosaprepitant for Nausea and Vomiting During High-dose Interleukin-2 (HD IL-2) for Metastatic Melanoma and Renal Cell Carcinoma
Status: Recruiting Condition: Chemotherapy-induced Nausea and Vomiting

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck
EMEND
aprepitant
CAPSULE;ORAL021549-002Mar 26, 2003RXYes5,719,147<disabled>YY<disabled>
Merck
EMEND
aprepitant
CAPSULE;ORAL021549-001Mar 26, 2003RXNo8,258,132<disabled>Y<disabled>
Merck
EMEND
aprepitant
CAPSULE;ORAL021549-003Jun 30, 2006RXNo8,258,132<disabled>Y<disabled>
Merck And Co Inc
EMEND
fosaprepitant dimeglumine
POWDER;INTRAVENOUS022023-002Nov 12, 2010RXYes5,716,942<disabled><disabled>
Merck
EMEND
aprepitant
CAPSULE;ORAL021549-003Jun 30, 2006RXNo5,719,147<disabled>YY<disabled>
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Paragraph IV activity for: EMEND

Drugname Dosage Strength RLD Submissiondate
fosaprepitant dimeglumineInjection115 mg/vialEmend1/25/2012
fosaprepitant dimeglumineInjection150 mg/vialEmend1/25/2012
aprepitantCapsule40 mg, 80 mg and 125 mgEmend11/3/2008

Non-Orange Book Patents for Tradename: EMEND

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
6,229,010 Polymorphic form of a tachykinin receptor antagonist<disabled in preview>
6,583,142 Polymorphic form of a tachykinin receptor antagonist<disabled in preview>
6,048,859 Morpholine and thiomorpholine tachykinin receptor antagonists<disabled in preview>
5,922,706 Morpholine and thiomorpholine tachykinin receptor antagonists<disabled in preview>
6,638,930 Morpholine and thiomorpholine tachykinin receptor antagonists<disabled in preview>
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International Patent Family for Tradename: EMEND

Country Document Number Publication Date
Poland191496May 31, 2006
Brazil9810360Jan 30, 2001
Hungary224014Apr 28, 2005
Portugal734381Dec 29, 2000
Czech Republic295381Jul 13, 2005
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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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