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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

Tradenames:3
Patents:4
Applicants:7
NDAs:9
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
EVOMELA
melphalan hydrochloride
POWDER;IV (INFUSION)207155-001Mar 10, 2016RXNoNo9,200,088► SubscribeY ► Subscribe
Actavis Llc
MELPHALAN HYDROCHLORIDE
melphalan hydrochloride
INJECTABLE;INJECTION206018-001Dec 19, 2016RXNoNo► Subscribe► Subscribe
Mylan Institutional
MELPHALAN HYDROCHLORIDE
melphalan hydrochloride
INJECTABLE;INJECTION090299-001Oct 27, 2009DISCNNoNo► Subscribe► Subscribe
Apotex Inc
ALKERAN
melphalan hydrochloride
INJECTABLE;INJECTION020207-001Nov 18, 1992RXYesYes► Subscribe► Subscribe
Apotex Inc
ALKERAN
melphalan
TABLET;ORAL014691-002Approved Prior to Jan 1, 1982RXYesYes► Subscribe► Subscribe
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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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