You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: June 18, 2024

Details for New Drug Application (NDA): 207155

✉ Email this page to a colleague

« Back to Dashboard

NDA 207155 describes EVOMELA, which is a drug marketed by Acrotech Biopharma and is included in one NDA. It is available from one supplier. There are seven 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. Fifteen suppliers are listed for this compound. Additional details are available on the melphalan hydrochloride profile page.
Summary for 207155
Applicant:Acrotech Biopharma
Ingredient:melphalan hydrochloride
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 Acrotech Biopharma Inc 72893-001 72893-001-01 1 VIAL in 1 CARTON (72893-001-01) / 20 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrengthEQ 50MG BASE/VIAL
Approval Date:Mar 10, 2016TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Jan 30, 2034Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:May 28, 2030Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:Jun 14, 2030Product Flag?YSubstance Flag?Delist Request?

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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 data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. 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.