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Serving leading biopharmaceutical companies globally:

Argus Health
Johnson and Johnson
Farmers Insurance
Chinese Patent Office
US Department of Justice
US Army

Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207155

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NDA 207155 describes EVOMELA, which is a drug marketed by Spectrum Pharms and is included in one NDA. It is available from one supplier. There are three 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. Seven suppliers are listed for this compound. Additional details are available on the melphalan hydrochloride profile page.

Summary for 207155

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;IV (INFUSION) 207155 NDA Spectrum Pharmaceuticals, Inc. 68152-109 68152-109-00 1 VIAL in 1 CARTON (68152-109-00) > 20 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;IV (INFUSION)StrengthEQ 50MG BASE/VIAL
Approval Date:Mar 10, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Mar 10, 2023
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY
Patent:► SubscribePatent Expiration:Mar 13, 2029Product Flag?YSubstance Flag?Delist Request?
Patent:► SubscribePatent Expiration:Mar 13, 2029Product Flag?YSubstance Flag?Delist Request?

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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Chinese Patent Office
Queensland Health

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 verifification 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.

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