Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: October 23, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207155

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NDA 207155 describes EVOMELA, which is a drug marketed by Acrotech and is included in one NDA. It is available from two suppliers. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the EVOMELA profile page.

The generic ingredient in EVOMELA is melphalan hydrochloride. There are twelve drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the melphalan hydrochloride profile page.
Summary for 207155
Tradename:EVOMELA
Applicant:Acrotech
Ingredient:melphalan hydrochloride
Patents:4
Formulation / Manufacturing:see details
Pharmacology for NDA: 207155
Mechanism of ActionAlkylating Activity
Suppliers and Packaging for NDA: 207155
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EVOMELA melphalan hydrochloride POWDER;INTRAVENOUS 207155 NDA Spectrum Pharmaceuticals, Inc. 68152-109 68152-109-00 1 VIAL in 1 CARTON (68152-109-00) > 20 mL in 1 VIAL
EVOMELA melphalan hydrochloride POWDER;INTRAVENOUS 207155 NDA Acrotech Biopharma LLC 72893-001 72893-001-01 1 VIAL in 1 CARTON (72893-001-01) > 20 mL in 1 VIAL
Paragraph IV (Patent) Challenges for 207155
Tradename Dosage Ingredient NDA Submissiondate
EVOMELA POWDER;INTRAVENOUS melphalan hydrochloride 207155 2017-09-08

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrengthEQ 50MG BASE/VIAL
Approval Date:Mar 10, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Mar 10, 2023
Regulatory Exclusivity Use:FOR HIGH-DOSE CONDITIONING TREATMENT PRIOR TO HEMATOPOIETIC PROGENITOR (STEM) CELL TRANSPLANTATION IN PATIENTS WITH MULTIPLE MYELOMA
Patent:  Start TrialPatent Expiration:Jan 30, 2034Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Mar 13, 2029Product Flag?YSubstance Flag?Delist Request?

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