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Melphalan hydrochloride - Generic Drug Details

What are the generic sources for melphalan hydrochloride and what is the scope of melphalan hydrochloride freedom to operate?

Melphalan hydrochloride is the generic ingredient in three branded drugs marketed by Apotex Inc, Actavis Llc, Dr Reddys Labs Ltd, Fresenius Kabi Usa, Mylan Institutional, Par Sterile Products, Sagent Pharms, West-ward Pharms Int, and Spectrum Pharms, and is included in ten NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

US Patents:	4
Tradenames:	3
Applicants:	9
NDAs:	10
Drug Master File Entries:	12
Suppliers / Packagers:	9
Bulk Api Vendors:	14
Clinical Trials:	713
Patent Applications:	584
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for melphalan hydrochloride
DailyMed Link:	melphalan hydrochloride at DailyMed

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Fresenius Kabi Usa	MELPHALAN HYDROCHLORIDE	melphalan hydrochloride	INJECTABLE;INJECTION	203393-001	Dec 22, 2017	AP	RX	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Spectrum Pharms	EVOMELA	melphalan hydrochloride	POWDER;IV (INFUSION)	207155-001	Mar 10, 2016		RX	Yes	Yes	➤ Sign Up	➤ Sign Up				➤ Sign Up
Spectrum Pharms	EVOMELA	melphalan hydrochloride	POWDER;IV (INFUSION)	207155-001	Mar 10, 2016		RX	Yes	Yes	➤ Sign Up	➤ Sign Up	Y			➤ Sign Up
West-ward Pharms Int	MELPHALAN HYDROCHLORIDE	melphalan hydrochloride	INJECTABLE;INJECTION	090303-001	Oct 28, 2010	AP	RX	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apotex Inc	ALKERAN	melphalan hydrochloride	INJECTABLE;INJECTION	020207-001	Nov 18, 1992	➤ Sign Up	➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration