You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 28, 2024

Melphalan hydrochloride - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


What are the generic 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. 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
Acrotech Biopharma EVOMELA melphalan hydrochloride POWDER;INTRAVENOUS 207155-001 Mar 10, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  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
Delcath Systems Inc HEPZATO melphalan hydrochloride POWDER;INTRA-ARTERIAL 201848-001 Aug 14, 2023 RX Yes Yes ⤷  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
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
Dr Reddys MELPHALAN HYDROCHLORIDE melphalan hydrochloride INJECTABLE;INJECTION 203655-001 Dec 8, 2017 AP RX 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
Canada 2865950 COMPOSITIONS DE CYCLODEXTRINE ALKYLEE ET PROCEDES POUR LEUR PREPARATION ET LEUR UTILISATION (ALKYLATED CYCLODEXTRIN COMPOSITIONS AND PROCESSES FOR PREPARING AND USING THE SAME) ⤷  Try a Trial
Singapore 11201503089W ALKYLATED CYCLODEXTRIN COMPOSITIONS AND PROCESSES FOR PREPARING AND USING THE SAME ⤷  Try a Trial
Japan 2018048350 アルキル化シクロデキストリン組成物ならびにその調製方法および使用方法 (ALKYLATED CYCLODEXTRIN COMPOSITION AS WELL AS PREPARATION METHOD AND USE METHOD THEREOF) ⤷  Try a Trial
Malaysia 181829 ALKYLATED CYCLODEXTRIN COMPOSITIONS AND PROCESSES FOR PREPARING AND USING THE SAME ⤷  Try a Trial
Japan 2016166368 アルキル化シクロデキストリン組成物ならびにその調製方法および使用方法 (ALKYLATED CYCLODEXTRIN COMPOSITION AS WELL AS PREPARATION METHOD AND USE METHOD THEREOF) ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2013070809 ⤷  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 3/2023 Austria ⤷  Try a Trial PRODUCT NAME: MELPHALANFLUFENAMID-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/22/1669 (MITTEILUNG) 20220818
2701720 CA 2022 00054 Denmark ⤷  Try a Trial PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; REG. NO/DATE: EU/1/22/1669 20220818
2701720 CR 2022 00054 Denmark ⤷  Try a Trial PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; REG. NO/DATE: EU/1/22/1669 20220818
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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

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.