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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, Alvogen Inc, Dr Reddys Labs Ltd, Fresenius Kabi Usa, Gland Pharma Ltd, Mylan Institutional, Par Sterile Products, Sagent Pharms, Us Worldmeds Llc, West-ward Pharms Int, and Acrotech, and is included in thirteen NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Melphalan hydrochloride has sixty-nine patent family members in seventeen countries.

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

International Patents:	69
US Patents:	4
Tradenames:	3
Applicants:	12
NDAs:	13
Drug Master File Entries:	12
Suppliers / Packagers:	12
Bulk Api Vendors:	15
Clinical Trials:	762
Patent Applications:	689
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

(2S)-2-amino-3-[4-[bis(2-chloroethyl)amino]phenyl]propanoic acid;hydrochloride
(S)-2-amino-3-(4-(bis(2-chloroethyl)amino)phenyl)propanoic acid hydrochloride
1VXP4V453T
223M072
3223-07-2
4-[Bis(2-chloroethyl)-amino]-L-phenylalanine hydrochloride
4-[bis(2-chloroethyl)-amino]-phenylalanine hydrochloride
AC-25549
AI3-26377
AKOS025401785
Alanine nitrogen mustard hydrochloride
ALANINE, 3-(p-(BIS(2-CHLOROETHYL)AMINO)PHENYL)-, MONOHYDROCHLORIDE, L-
Alkeran (GlaxoSmith)
ALKERAN (TN)
Alkeran hydrochloride
BC208857
CB 3025 hydrochloride
CHEMBL1200863
CTK8G0783
D08173
DTXSID60872785
Evomela (TN)
FT-0773182
L-3-(p-(Bis(2-chloroethyl)amino)phenyl)alanine monohydrochloride
L-Alanine, 3-(p-(bis(2-chloroethyl)amino)phenyl)-, hydrochloride
L-Alanine, hydrochloride
L-Phenylalanine mustard hydrochloride
L-Phenylalanine, 4-(bis(2-chloroethyl)amino)-, monohydrochloride (9CI)
L-Phenylalanine, monohydrochloride
L-Sarcolysine hydrochloride
Melfalan hydrochloride
Melphalan HCl
NSC8806
OUUYBRCCFUEMLH-YDALLXLXSA-N
Phenylalanine mustard hydrochloride
SCHEMBL41335
SK 15673
UNII-1VXP4V453T
UNII-GEG3Q4FC64 component OUUYBRCCFUEMLH-YDALLXLXSA-N
WLN: QVYZ1R DN2G2G &GH

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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
Gland Pharma Ltd	MELPHALAN HYDROCHLORIDE	melphalan hydrochloride	INJECTABLE;INJECTION	209826-001	May 28, 2019	AP	RX	No	No	Try a Free Trial	Try a Free Trial				Try a Free Trial
Acrotech	EVOMELA	melphalan hydrochloride	POWDER;INTRAVENOUS	207155-001	Mar 10, 2016		RX	Yes	Yes	Try a Free Trial	Try a Free Trial	Y			Try a Free Trial
Apotex Inc	ALKERAN	melphalan hydrochloride	INJECTABLE;INJECTION	020207-001	Nov 18, 1992	AP	RX	Yes	No	Try a Free Trial	Try a Free Trial				Try a Free Trial
Acrotech	EVOMELA	melphalan hydrochloride	POWDER;INTRAVENOUS	207155-001	Mar 10, 2016		RX	Yes	Yes	Try a Free Trial	Try a Free Trial	Y			Try a Free Trial
Mylan Institutional	MELPHALAN HYDROCHLORIDE	melphalan hydrochloride	INJECTABLE;INJECTION	090270-001	Jun 9, 2009	AP	RX	No	Yes	Try a Free Trial	Try a Free Trial				Try a Free Trial
Us Worldmeds Llc	MELPHALAN HYDROCHLORIDE	melphalan hydrochloride	INJECTABLE;INJECTION	207032-001	May 3, 2019	AP	RX	No	No	Try a Free Trial	Try a Free Trial				Try a Free Trial
Alvogen Inc	MELPHALAN HYDROCHLORIDE	melphalan hydrochloride	INJECTABLE;INJECTION	204817-001	May 17, 2019	AP	RX	No	No	Try a Free Trial	Try a Free Trial				Try a Free Trial
>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	Try a Free Trial	Try a Free Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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Country	Patent Number	Estimated Expiration
Japan	2018052991	Try a Free Trial
World Intellectual Property Organization (WIPO)	2014066274	Try a Free Trial
Chile	2016003320	Try a Free Trial
Canada	2865950	Try a Free Trial
Russian Federation	2016140391	Try a Free Trial
Japan	2012072160	Try a Free Trial
Russian Federation	2014136206	Try a Free Trial
>Country	>Patent Number	>Estimated Expiration