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Generated: May 23, 2017

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Melphalan - Generic Drug Details

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What are the generic drug sources for melphalan and what is the scope of melphalan patent protection?

is the generic ingredient in four branded drugs marketed by Alvogen Malta, Apotex Inc, West-ward Pharms Int, Actavis Llc, Spectrum Pharms, Mylan Institutional, Par Sterile Products, and Sagent Pharms, and is included in ten NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for melphalan. Two suppliers are listed for this compound.

Summary for Generic Name: melphalan

Drug Master File Entries: see list12
Suppliers / Packagers: see list2
Bulk Api Vendors: see list42
Clinical Trials: see list338
Patent Applications: see list9,878
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:melphalan at DailyMed

Pharmacology for Ingredient: melphalan

Drug ClassAlkylating Drug
Mechanism of ActionAlkylating Activity
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Par Sterile Products
melphalan hydrochloride
INJECTABLE;INJECTION204773-001Aug 22, 2016APRXNoNo► Subscribe► Subscribe
West-ward Pharms Int
melphalan hydrochloride
INJECTABLE;INJECTION090303-001Oct 28, 2010APRXNoNo► Subscribe► Subscribe
Spectrum Pharms
melphalan hydrochloride
POWDER;IV (INFUSION)207155-001Mar 10, 2016RXNoNo9,200,088► SubscribeY ► Subscribe
Apotex Inc
TABLET;ORAL014691-002Approved Prior to Jan 1, 1982ABRXYesYes► Subscribe► Subscribe
Spectrum Pharms
melphalan hydrochloride
POWDER;IV (INFUSION)207155-001Mar 10, 2016RXNoNo► Subscribe► Subscribe
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