MELPHALAN Drug Patent Profile

When do Melphalan patents expire, and what generic alternatives are available?

Melphalan is a drug marketed by Alvogen, 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, and Apotex. and is included in eighteen NDAs. There is one patent protecting this drug.

The generic ingredient in MELPHALAN is melphalan hydrochloride. There are twelve drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the melphalan hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Melphalan

A generic version of MELPHALAN was approved as melphalan hydrochloride by MYLAN INSTITUTIONAL on June 9^th, 2009.

Summary for MELPHALAN

US Patents:	0
Applicants:	16
NDAs:	18
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	71
Clinical Trials:	861
Patent Applications:	3,229
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for MELPHALAN
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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alvogen	MELPHALAN	melphalan	TABLET;ORAL	207809-001	Mar 22, 2017		RX	No	Yes
Apotex	MELPHALAN HYDROCHLORIDE	melphalan hydrochloride	SOLUTION;INTRAVENOUS	217110-001	Aug 18, 2023		RX	Yes	Yes			Y
Fresenius Kabi Usa	MELPHALAN HYDROCHLORIDE	melphalan hydrochloride	INJECTABLE;INJECTION	203393-001	Dec 22, 2017	AP	RX	No	No
Arthur Grp	MELPHALAN HYDROCHLORIDE	melphalan hydrochloride	INJECTABLE;INJECTION	211463-001	Sep 13, 2019	AP	RX	No	No
Mylan Institutional	MELPHALAN HYDROCHLORIDE	melphalan hydrochloride	INJECTABLE;INJECTION	090270-001	Jun 9, 2009	AP	RX	No	Yes
Gland Pharma Ltd	MELPHALAN HYDROCHLORIDE	melphalan hydrochloride	INJECTABLE;INJECTION	209826-001	May 28, 2019	AP	RX	No	No
Uswm	MELPHALAN HYDROCHLORIDE	melphalan hydrochloride	INJECTABLE;INJECTION	207032-001	May 3, 2019		DISCN	No	No

EU/EMA Drug Approvals for MELPHALAN

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