ALKERAN Drug Patent Profile

Which patents cover Alkeran, and when can generic versions of Alkeran launch?

Alkeran is a drug marketed by Apotex and is included in two NDAs.

The generic ingredient in ALKERAN is melphalan. There are twelve drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the melphalan profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Alkeran

A generic version of ALKERAN was approved as melphalan by ALVOGEN on March 22^nd, 2017.

Summary for ALKERAN

US Patents:	0
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	71
Clinical Trials:	183
Patent Applications:	3,229
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ALKERAN
What excipients (inactive ingredients) are in ALKERAN?	ALKERAN excipients list
DailyMed Link:	ALKERAN at DailyMed

See drug prices for ALKERAN

Recent Clinical Trials for ALKERAN

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

Sponsor	Phase
Baptist Health South Florida	Phase 2
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	Phase 2
Baptist Health South Florida	Phase 1/Phase 2

See all ALKERAN clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for ALKERAN

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

US Patents and Regulatory Information for ALKERAN

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
Apotex	ALKERAN	melphalan	TABLET;ORAL	014691-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Expired US Patents for ALKERAN

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

EU/EMA Drug Approvals for ALKERAN

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

International Patents for ALKERAN

See the table below for patents covering ALKERAN around the world.

Country	Patent Number	Title	Estimated Expiration
Hungary	T48198
Portugal	89028	PROCESSO PARA A PREPARACAO DE DERIVADOS DE 4-{BIS(2-CLORO-ETIL)AMINO}-L-FENILALANINA (MELFALAN) E DE COMPOSICOES FARMACEUTICAS QUE OS CONTEM
Austria	83922

Supplementary Protection Certificates for ALKERAN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2701720	301206	Netherlands		PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/22/1669 20220818
2701720	23C1000	France		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		PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; REG. NO/DATE: EU/1/22/1669 20220818