Remove trial restrictions ▶ Start for $1

Serving leading biopharmaceutical companies globally:

McKesson
Baxter
Dow
AstraZeneca
Boehringer Ingelheim
Colorcon

Last Updated: November 30, 2022

Melphalan hydrochloride - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


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, Almaject, Arthur Grp, Bpi Labs, Dr Reddys, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Ingenus Pharms Llc, Meitheal, Mylan Institutional, Par Sterile Products, Sagent Pharms Inc, Uswm, and Acrotech, and is included in eighteen NDAs. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Melphalan hydrochloride has one hundred and one patent family members in twenty-two countries.

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

Recent Clinical Trials for melphalan hydrochloride

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

SponsorPhase
Alice BertainaPhase 1/Phase 2
ADC TherapeuticsPhase 1
Sichuan UniversityPhase 3

See all melphalan hydrochloride clinical trials

Pharmacology for melphalan hydrochloride
Drug Class Alkylating Drug
Mechanism of ActionAlkylating Activity
Paragraph IV (Patent) Challenges for MELPHALAN HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
EVOMELA Injection melphalan hydrochloride 50 mg/vial 207155 1 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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Uswm MELPHALAN HYDROCHLORIDE melphalan hydrochloride INJECTABLE;INJECTION 207032-001 May 3, 2019 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Dr Reddys MELPHALAN HYDROCHLORIDE melphalan hydrochloride INJECTABLE;INJECTION 203655-001 Dec 8, 2017 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Actavis Llc MELPHALAN HYDROCHLORIDE melphalan hydrochloride INJECTABLE;INJECTION 206018-001 Dec 19, 2016 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bpi Labs MELPHALAN HYDROCHLORIDE melphalan hydrochloride INJECTABLE;INJECTION 209197-001 May 8, 2020 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Acrotech EVOMELA melphalan hydrochloride POWDER;INTRAVENOUS 207155-001 Mar 10, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Almaject MELPHALAN HYDROCHLORIDE melphalan hydrochloride INJECTABLE;INJECTION 204817-001 May 17, 2019 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for melphalan hydrochloride

Country Patent Number Title Estimated Expiration
European Patent Office 2909239 COMPOSITIONS DE CYCLODEXTRINE ALKYLÉE ET PROCÉDÉS DE PRÉPARATION ET D'UTILISATION DE CELLES-CI (ALKYLATED CYCLODEXTRIN COMPOSITIONS AND PROCESSES FOR PREPARING AND USING THE SAME) See Plans and Pricing
Spain 2767880 See Plans and Pricing
Mexico 2018008597 COMPOSICIONES INYECTABLES DE MELFALAN QUE COMPRENDEN UN DERIVADO DE CICLODEXTRINA Y METODOS DE FABRICACION Y USO DE LAS MISMAS. (INJECTABLE MELPHALAN COMPOSITIONS COMPRISING A CYCLODEXTRIN DERIVATIVE AND METHODS OF MAKING AND USING THE SAME.) See Plans and Pricing
Japan 2010539193 See Plans and Pricing
European Patent Office 2748205 COMPOSITIONS DE CYCLODEXTRINE ALKYLÉE ET PROCÉDÉS POUR LEUR PRÉPARATION ET LEUR UTILISATION (ALKYLATED CYCLODEXTRIN COMPOSITIONS AND PROCESSES FOR PREPARING AND USING THE SAME) See Plans and Pricing
Mexico 360192 COMPOSICIONES DE CICLODEXTRINAS ALQUILADAS Y PROCESOS PARA PREPARAR Y USAR LAS MISMAS. (ALKYLATED CYCLODEXTRIN COMPOSITIONS AND PROCESSES FOR PREPARING AND USING THE SAME.) See Plans and Pricing
Hong Kong 1213585 烷基化環糊精組合物及其製備和使用方法 (ALKYLATED CYCLODEXTRIN COMPOSITIONS AND PROCESSES FOR PREPARING AND USING THE SAME) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Medtronic
Dow
Baxter
Merck
Mallinckrodt
AstraZeneca

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.