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Last Updated: December 7, 2019

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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 patent protection?

Melphalan is the generic ingredient in four branded drugs marketed by Apotex Inc, Alvogen, Actavis Llc, Alvogen Inc, Dr Reddys Labs Ltd, Fresenius Kabi Usa, Gland Pharma Ltd, Mylan Institutional, Noratech, Par Sterile Products, Sagent Pharms Inc, Us Worldmeds Llc, West-ward Pharms Int, and Acrotech, and is included in sixteen 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.

Drug Prices for melphalan

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Recent Clinical Trials for melphalan

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
PRA Health SciencesPhase 1/Phase 2
Dutch Cancer SocietyPhase 2
Omar AljitawiEarly Phase 1

See all melphalan clinical trials

Pharmacology for melphalan
Drug ClassAlkylating Drug
Mechanism of ActionAlkylating Activity
Medical Subject Heading (MeSH) Categories for melphalan
Synonyms for melphalan
(2s)-2-amino-3-(4-[bis(2-chloroethyl)amino]phenyl)propanoic acid
(2S)-2-amino-3-[4-[bis(2-chloroethyl)amino]phenyl]propanoic acid
(2S)-2-amino-3-{4-[bis(2-chloroethyl)amino]phenyl}propanoic acid
(2S)-2-azanyl-3-[4-[bis(2-chloroethyl)amino]phenyl]propanoic acid
(S)-2-amino-3-(4-(bis(2-chloroethyl)amino)phenyl)propanoic acid
(S)-2-Amino-3-{4-[bis-(2-chloro-ethyl)-amino]-phenyl}-propionic acid
148-82-3
148M823
2-amino-3-[4-[bis(2-chloroethyl)amino]phenyl]-propanoic acid
2-amino-3-[4-bis(2-chloroethyl)amino]phenylpropanoic acid
2-Amino-3-{4-[bis-(2-chloro-ethyl)-amino]-phenyl}-propionic acid
2-Amino-3-{4-[bis-(2-chloro-ethyl)-amino]-phenyl}-propionic acid (Melphalan)
2-Amino-3-{4-[bis-(2-chloro-ethyl)-amino]-phenyl}-propionic acid(L-PAM)
2-Amino-3-{4-[bis-(2-chloro-ethyl)-amino]-phenyl}-propionic acid(Melphalan)
3-(p-(Bis(2-chloroethyl)amino)phenyl)-L-alanine
3-(p-(Bis(2-chloroethyl)amino)phenyl)alanine
3-p-(Di(2-chloroethyl)amino)-phenyl-L-alanine
3025 c.b
3025 C.B.
4-(Bis(2-chloroethyl)amino)-L-phenylalanine
4-(Bis(2-chloroethyl)amino)phenylalanine
4-[Bis-(2-chloroethyl)amino]-L-phenylalanine
4-[bis(2-chloroethyl)-amino]-l-phenyl-alanine
4-[bis(2-chloroethyl)-amino]-L-phenylalanine
4-[bis(2-chloroethyl)amino]-(L)-phenylalanine
4-[Bis(2-chloroethyl)amino]-L-phenylalanine
4-[Bis(2-chloroethyl)amino]phenylalanine
4-14-00-01689 (Beilstein Handbook Reference)
8057-25-8
A808810
AB0005221
AB00053282_09
AB00053282-07
AB00053282-08
AB2000419
AC1LA2OE
AKOS015895374
Alanine Nitrogen Mustard
Alanine, 3-(p-(bis(2-chloroethyl)amino)phenyl)-
Alanine, 3-(p-(bis(2-chloroethyl)amino)phenyl)-, L-
Alanine, 3-[p-[bis(2-chloroethyl)amino]phenyl]-, L-
Alkeran
ALKERAN (TN)
Alkeran;L-Phenylalanine mustard;L-PAM
AN-976
API0003288
AS-13314
AY33600000
BDBM50025837
BIDD:GT0044
BRD-K87827419-001-02-8
BRN 2816456
BSPBio_002407
C-19011
C07122
CAS-148-82-3
CB 3025
CB-3025
CC-30199
CCG-39704
CCRIS 374
CHEBI:28876
CHEMBL852
CS-3120
CTK5E7915
D00369
DB01042
DivK1c_000653
DL-442
DL-Melphalan hydrochloride
DSSTox_CID_804
DSSTox_GSID_20804
DSSTox_RID_75797
DTXSID6020804
EINECS 205-726-3
Epitope ID:141802
Evomela
FT-0603357
GTPL7620
H877
HMS2090B09
HMS2091B16
HMS2235D21
HMS502A15
HSDB 3234
HY-17575
IDI1_000653
K-4728
KBio1_000653
KBio2_000877
KBio2_003445
KBio2_006013
KBio3_001627
KBioGR_001284
KBioSS_000877
KS-00001D9Q
L-3-(p-(Bis(2-chloroethyl)amino)phenyl)alanine
L-3-(para-(Bis(2-chloroethyl)amino)phenyl)alanine
L-PAM
L-Phenylalanine mustard
L-phenylalanine mustard (L-PAM)
L-Phenylalanine, 4-(bis(2-chloroethyl)amino)-
L-Phenylalanine, 4-[bis(2-chloroethyl)amino]-
L-Sarcolysin
L-Sarcolysine
L-Sarkolysin
Levofalan
Levofolan
Levopholan
LS-15868
LS-865
Melfalan
Melfalano
Melfalano [INN-Spanish]
Melphalan (JP17/USP/INN)
MELPHALAN (SEE ALSO TRANSGENIC MODEL EVALUATION (MELPHALAN))
Melphalan [USAN:INN:BAN:JAN]
Melphalan [USAN:USP:INN:BAN:JAN]
Melphalan-d8 Dihydrochloride
Melphalan, 94%
Melphalan, powder
Melphalanum
Melphalanum [INN-Latin]
MLS001333666
MLS002153368
MolPort-003-665-535
NCGC00090757-01
NCGC00090757-02
NCGC00090757-03
NCGC00090757-04
NCGC00090757-05
NCGC00090757-06
NCGC00260071-01
NCI-C04853
NINDS_000653
NIOSH/AY3360000
NSC 241286
NSC 8806
NSC-757098
NSC-8806
NSC241286
NSC757098
NSC8806
p-Bis(beta-chloroethyl)aminophenylalanine
p-Di-(2-chloroethyl)amino-L-phenylalanine
p-L-Sarcolysin
p-L-sarcolysine
p-N-Bis(2-chloroethyl)amino-L-phenylalanine
p-N-di(chloroethyl)aminophenylala nine
p-N-Di(chloroethyl)aminophenylalanine
p-N,N-bis(2-chloroethyl)amino-L-phenylalanine
Pharmakon1600-01500382
Phenylalanine mustard
phenylalanine nitrogen mu stard
Phenylalanine nitrogen mustard
Phenylalanine, 4-[bis(2-chloroethyl)amino]-
Prestwick_1006
Q41OR9510P
RCRA waste no. U150
Rcra waste number U150
s8266
Sarcolysinum
SBI-0052787.P003
SCHEMBL5872
SGDBTWWWUNNDEQ-LBPRGKRZSA-N
SK-15673
SMP2_000174
SMR000058720
SPBio_000287
Spectrum_000397
SPECTRUM1500382
Spectrum2_000074
Spectrum3_000684
Spectrum4_000882
Spectrum5_001601
SR-05000001667
SR-05000001667-1
TL8001065
Tox21_111010
Tox21_111010_1
Tox21_202522
TRANSGENIC LEP (MELPHALAN) (SEE ALSO MELPHALAN)
TRANSGENIC MODEL EVALUATION (MELPHALAN)
UNII-A960M0G5TP component SGDBTWWWUNNDEQ-LBPRGKRZSA-N
UNII-Q41OR9510P
W-108096
ZINC1673

US Patents and Regulatory Information for melphalan

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Acrotech EVOMELA melphalan hydrochloride POWDER;INTRAVENOUS 207155-001 Mar 10, 2016 RX Yes Yes   Start Trial   Start Trial   Start Trial
Par Sterile Products MELPHALAN HYDROCHLORIDE melphalan hydrochloride INJECTABLE;INJECTION 204773-001 Aug 22, 2016 AP RX No No   Start Trial   Start Trial   Start Trial
Mylan Institutional MELPHALAN HYDROCHLORIDE melphalan hydrochloride INJECTABLE;INJECTION 090270-001 Jun 9, 2009 AP RX No Yes   Start Trial   Start Trial   Start Trial
Mylan Institutional MELPHALAN HYDROCHLORIDE melphalan hydrochloride INJECTABLE;INJECTION 090299-001 Oct 27, 2009 DISCN No No   Start Trial   Start Trial   Start 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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