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Last Updated: April 19, 2024

Melphalan - Generic Drug Details

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

Melphalan is the generic ingredient in six branded drugs marketed by Apotex, Alvogen, Oncopeptides Ab, 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-three NDAs. There are twenty-four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for melphalan. One supplier is listed for this compound.

Summary for melphalan

US Patents:	24
Tradenames:	6
Applicants:	19
NDAs:	23
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	71
Clinical Trials:	861
Patent Applications:	3,304
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for melphalan
What excipients (inactive ingredients) are in melphalan?	melphalan excipients list
DailyMed Link:	melphalan at DailyMed

See drug prices for melphalan

Recent Clinical Trials for melphalan

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 clinical trials

Pharmacology for melphalan

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

Medical Subject Heading (MeSH) Categories for melphalan

Antineoplastic Agents, Alkylating
Myeloablative Agonists

Anatomical Therapeutic Chemical (ATC) Classes for melphalan

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

US Patents and Regulatory Information for melphalan

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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
Apotex	ALKERAN	melphalan hydrochloride	INJECTABLE;INJECTION	020207-001	Nov 18, 1992		DISCN	Yes	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				⤷ 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	090299-001	Oct 27, 2009		DISCN	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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

EU/EMA Drug Approvals for melphalan

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
ADIENNE S.r.l. S.U.	Phelinun	melphalan	EMEA/H/C/005173 High-dose of Phelinun used alone or in combination with other cytotoxic medicinal products and/or total body irradiation is indicated in the treatment of:multiple myeloma,malignant lymphoma (Hodgkin, non-Hodgkin lymphoma),acute lymphoblastic and myeloblastic leukemia,childhood neuroblastoma,ovarian cancer,mammary adenocarcinoma.Phelinun in combination with other cytotoxic medicinal products is indicated as reduced intensity conditioning (RIC) treatment prior to allogeneic haematopoietic stem cell transplantation (allo-HSCT) in malignant haematological diseases in adults.Phelinun in combination with other cytotoxic medicinal products is indicated as conditioning regimen prior to allogeneic haematopoietic stem cell transplantation in haematological diseases in the paediatric population as:Myeloablative conditioning (MAC) treatment in case of malignant haematological diseasesRIC treatment in case of non-malignant haematological diseases.	Authorised	no	no	no	2020-11-16
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

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