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Last Updated: April 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. Fifteen suppliers are listed for this compound.

Summary for melphalan hydrochloride

International Patents:	128
US Patents:	18
Tradenames:	4
Applicants:	17
NDAs:	20
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	15
Raw Ingredient (Bulk) Api Vendors:	24
Clinical Trials:	861
Patent Applications:	1,550
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for melphalan hydrochloride
What excipients (inactive ingredients) are in melphalan hydrochloride?	melphalan hydrochloride excipients list
DailyMed Link:	melphalan hydrochloride at DailyMed

Recent Clinical Trials for melphalan hydrochloride

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

Sponsor	Phase
University Hospital Heidelberg	Phase 1
University Hospital Dresden	Phase 1
German Cancer Research Center	Phase 1

See all melphalan hydrochloride clinical trials

Pharmacology for melphalan hydrochloride

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

Anatomical Therapeutic Chemical (ATC) Classes for melphalan hydrochloride

L01AA	Nitrogen mustard analogues
L01A	ALKYLATING AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
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
Apotex	ALKERAN	melphalan hydrochloride	INJECTABLE;INJECTION	020207-001	Nov 18, 1992		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ 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
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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for melphalan hydrochloride

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apotex	ALKERAN	melphalan hydrochloride	INJECTABLE;INJECTION	020207-001	Nov 18, 1992	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for melphalan hydrochloride

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Country	Patent Number	Title	Estimated Expiration
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)	⤷ Try a Trial
Spain	2757557		⤷ Try a Trial
South Korea	101314803		⤷ Try a Trial
Hungary	E046954		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for melphalan hydrochloride

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2701720	301206	Netherlands	⤷ Try a Trial	PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/22/1669 20220818
2701720	23C1000	France	⤷ Try a Trial	PRODUCT NAME: MELPHALAN FLUFENAMIDE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, TELS QUE LE CHLORHYDRATE; REGISTRATION 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	CA 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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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.