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Last Updated: February 19, 2020

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Melphalan hydrochloride - Generic Drug Details

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

Melphalan hydrochloride is the generic ingredient in three branded drugs marketed by Apotex, 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 fourteen 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 seventy-one patent family members in seventeen countries.

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

Recent Clinical Trials for melphalan hydrochloride

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SponsorPhase
General Oncology, Inc.Phase 2
PRA Health SciencesPhase 1/Phase 2
Dutch Cancer SocietyPhase 2

See all melphalan hydrochloride clinical trials

Recent Litigation for melphalan hydrochloride

Identify potential future generic entrants

District Court Litigation
Case NameDate
CyDex Pharmaceuticals, Inc. v. Alembic Global Holding SA2019-05-23
MERCK SHARP & DOHME CORP. v. MYLAN LABORATORIES LIMITED2018-03-29
CyDex Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc.2017-12-20

See all melphalan hydrochloride litigation

Pharmacology for melphalan hydrochloride
Drug ClassAlkylating Drug
Mechanism of ActionAlkylating Activity
Synonyms for melphalan hydrochloride
(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
Paragraph IV (Patent) Challenges for MELPHALAN HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
EVOMELA POWDER;INTRAVENOUS melphalan hydrochloride 207155 2017-09-08

US Patents and Regulatory Information for melphalan hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Institutional MELPHALAN HYDROCHLORIDE melphalan hydrochloride INJECTABLE;INJECTION 090299-001 Oct 27, 2009 DISCN No No   Start Trial   Start Trial   Start Trial
Noratech MELPHALAN HYDROCHLORIDE melphalan hydrochloride INJECTABLE;INJECTION 211463-001 Sep 13, 2019 AP RX No No   Start Trial   Start Trial   Start Trial
Us Worldmeds Llc MELPHALAN HYDROCHLORIDE melphalan hydrochloride INJECTABLE;INJECTION 207032-001 May 3, 2019 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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