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Melphalan - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for melphalan?

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

There are twelve drug master file entries for melphalan. One supplier is listed for this compound.

Summary for Generic Name: melphalan

Drug Master File Entries: see list12
Suppliers / Packagers: see list1
Bulk Api Vendors: see list42
Clinical Trials: see list338
Patent Applications: see list25,935
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 Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Spectrum Pharms
melphalan hydrochloride
POWDER;IV (INFUSION)207155-001Mar 10, 2016RXNoNo9,200,088► SubscribeY ► Subscribe
Actavis Llc
melphalan hydrochloride
INJECTABLE;INJECTION206018-001Dec 19, 2016RXNoNo► Subscribe► Subscribe
Mylan Institutional
melphalan hydrochloride
INJECTABLE;INJECTION090299-001Oct 27, 2009DISCNNoNo► Subscribe► Subscribe
Apotex Inc
melphalan hydrochloride
INJECTABLE;INJECTION020207-001Nov 18, 1992RXYesYes► Subscribe► Subscribe
Apotex Inc
TABLET;ORAL014691-002Approved Prior to Jan 1, 1982RXYesYes► Subscribe► Subscribe
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