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Last Updated: April 10, 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, Ingenus Pharms Llc, Mylan Institutional, Par Sterile Products, Sagent Pharms Inc, Twi Pharms, Us Worldmeds Llc, West-ward Pharms Int, and Acrotech, and is included in sixteen 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. Thirteen suppliers are listed for this compound.

Recent Clinical Trials for melphalan hydrochloride

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SponsorPhase
Baptist Health South FloridaPhase 2
Second Affiliated Hospital of Xi'an Jiaotong UniversityEarly Phase 1
920th Hospital of Joint Logistics Support ForceEarly Phase 1

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
Alanine nitrogen mustard hydrochloride
ALANINE, 3-(p-(BIS(2-CHLOROETHYL)AMINO)PHENYL)-, MONOHYDROCHLORIDE, L-
Alkeran (GlaxoSmith)
ALKERAN (TN)
Alkeran hydrochloride
CB 3025 hydrochloride
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
Q27252967
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
Par Sterile Products MELPHALAN HYDROCHLORIDE melphalan hydrochloride INJECTABLE;INJECTION 204773-001 Aug 22, 2016 DISCN No No   Start Trial   Start Trial   Start Trial
Actavis Llc MELPHALAN HYDROCHLORIDE melphalan hydrochloride POWDER;INTRAVENOUS 209323-001 Mar 6, 2020 AP RX No No   Start Trial   Start Trial   Start Trial
Acrotech EVOMELA melphalan hydrochloride POWDER;INTRAVENOUS 207155-001 Mar 10, 2016 AP RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Sagent Pharms Inc MELPHALAN HYDROCHLORIDE melphalan hydrochloride INJECTABLE;INJECTION 201379-001 Feb 28, 2017 AP RX No No   Start Trial   Start Trial   Start Trial
Apotex ALKERAN melphalan hydrochloride INJECTABLE;INJECTION 020207-001 Nov 18, 1992 AP RX Yes 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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Serving leading biopharmaceutical companies globally:

McKinsey
McKesson
AstraZeneca
Merck
Baxter
Johnson and Johnson

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 verification 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.