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Last Updated: February 26, 2024

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 four 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, Delcath Systems Inc, and Acrotech Biopharma, and is included in twenty NDAs. There are eighteen 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 twenty-eight patent family members in twenty-six countries.

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

Recent Clinical Trials for melphalan hydrochloride

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

SponsorPhase
German Cancer Research CenterPhase 1
University Hospital HeidelbergPhase 1
University Hospital DresdenPhase 1

See all melphalan hydrochloride clinical trials

Pharmacology for melphalan hydrochloride
Drug ClassAlkylating 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
Arthur Grp MELPHALAN HYDROCHLORIDE melphalan hydrochloride INJECTABLE;INJECTION 211463-001 Sep 13, 2019 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Delcath Systems Inc HEPZATO melphalan hydrochloride POWDER;INTRA-ARTERIAL 201848-001 Aug 14, 2023 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Mylan Institutional MELPHALAN HYDROCHLORIDE melphalan hydrochloride INJECTABLE;INJECTION 090270-001 Jun 9, 2009 AP RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Meitheal MELPHALAN HYDROCHLORIDE melphalan hydrochloride INJECTABLE;INJECTION 212960-001 May 28, 2021 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Uswm MELPHALAN HYDROCHLORIDE melphalan hydrochloride INJECTABLE;INJECTION 207032-001 May 3, 2019 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 2748205 COMPOSITIONS DE CYCLODEXTRINE ALKYLÉE ET PROCÉDÉS POUR LEUR PRÉPARATION ET LEUR UTILISATION (ALKYLATED CYCLODEXTRIN COMPOSITIONS AND PROCESSES FOR PREPARING AND USING THE SAME) ⤷  Try a Trial
Spain 2757557 ⤷  Try a Trial
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.) ⤷  Try a Trial
Japan 2015110671 スルホアルキルエーテルシクロデキストリン組成物 (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS) ⤷  Try a Trial
Malaysia 181829 ALKYLATED CYCLODEXTRIN COMPOSITIONS AND PROCESSES FOR PREPARING AND USING THE SAME ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for melphalan hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2701720 122023000007 Germany ⤷  Try a Trial PRODUCT NAME: MELPHALANFLUFENAMID HYDROCHLORID; REGISTRATION NO/DATE: EU/1/22/1669 20220817
2701720 301206 Netherlands ⤷  Try a Trial PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/22/1669 20220818
2701720 CA 2022 00054 Denmark ⤷  Try a Trial PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; REG. NO/DATE: EU/1/22/1669 20220818
2701720 3/2023 Austria ⤷  Try a Trial PRODUCT NAME: MELPHALANFLUFENAMID-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/22/1669 (MITTEILUNG) 20220818
2701720 CR 2022 00054 Denmark ⤷  Try a Trial PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; REG. NO/DATE: EU/1/22/1669 20220818
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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