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Last Updated: July 21, 2024

MELPHALAN HYDROCHLORIDE - Generic Drug Details


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What are the generic drug sources for melphalan hydrochloride and what is the scope of patent protection?

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. Fifteen suppliers are listed for this compound.

Recent Clinical Trials for MELPHALAN HYDROCHLORIDE

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

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

See all MELPHALAN HYDROCHLORIDE clinical trials

Pharmacology for MELPHALAN HYDROCHLORIDE
Drug ClassAlkylating Drug
Mechanism of ActionAlkylating Activity
Anatomical Therapeutic Chemical (ATC) Classes for MELPHALAN HYDROCHLORIDE
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
Gland Pharma Ltd MELPHALAN HYDROCHLORIDE melphalan hydrochloride INJECTABLE;INJECTION 209826-001 May 28, 2019 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Delcath Systems Inc HEPZATO melphalan hydrochloride POWDER;INTRA-ARTERIAL 201848-001 Aug 14, 2023 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Delcath Systems Inc HEPZATO melphalan hydrochloride POWDER;INTRA-ARTERIAL 201848-001 Aug 14, 2023 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Delcath Systems Inc HEPZATO melphalan hydrochloride POWDER;INTRA-ARTERIAL 201848-001 Aug 14, 2023 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Delcath Systems Inc HEPZATO melphalan hydrochloride POWDER;INTRA-ARTERIAL 201848-001 Aug 14, 2023 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Mylan Institutional MELPHALAN HYDROCHLORIDE melphalan hydrochloride INJECTABLE;INJECTION 090299-001 Oct 27, 2009 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Acrotech Biopharma EVOMELA melphalan hydrochloride POWDER;INTRAVENOUS 207155-001 Mar 10, 2016 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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
Mexico 2010004900 COMPOSICIONES DE ETER-SULFOALQUILICO-CICLODEXTRINA. (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS.) ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2013130666 ⤷  Sign Up
China 104704007 Alkylated cyclodextrin compositions and processes for preparing and using the same ⤷  Sign Up
Chile 2016003320 Composiciones y procesos para la preparación de ciclodextrina alquiladas y uso de la mismas (solicitud divisional 1016-2015) ⤷  Sign Up
China 102458114 Injectable melphalan compositions comprising a cyclodextrin derivative and methods of making and using the same ⤷  Sign Up
Japan 2018052991 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) ⤷  Sign Up
Spain 2950585 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for MELPHALAN HYDROCHLORIDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2701720 3/2023 Austria ⤷  Sign Up PRODUCT NAME: MELPHALANFLUFENAMID-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/22/1669 (MITTEILUNG) 20220818
2701720 CA 2022 00054 Denmark ⤷  Sign Up PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; REG. NO/DATE: EU/1/22/1669 20220818
2701720 122023000007 Germany ⤷  Sign Up PRODUCT NAME: MELPHALANFLUFENAMID HYDROCHLORID; REGISTRATION NO/DATE: EU/1/22/1669 20220817
2701720 23C1000 France ⤷  Sign Up PRODUCT NAME: MELPHALAN FLUFENAMIDE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, TELS QUE LE CHLORHYDRATE; REGISTRATION NO/DATE: EU/1/22/1669 20220818
2701720 301206 Netherlands ⤷  Sign Up PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/22/1669 20220818
2701720 CR 2022 00054 Denmark ⤷  Sign Up 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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