Melphalan hydrochloride - Generic Drug Details

What are the generic sources for melphalan hydrochloride and what is the scope of freedom to operate?

Melphalan hydrochloride is the generic ingredient in three 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, and Acrotech, and is included in eighteen NDAs. There are seven 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 one patent family members in twenty-two countries.

There are nine drug master file entries for melphalan hydrochloride. Nine suppliers are listed for this compound.

Summary for melphalan hydrochloride

International Patents:	101
US Patents:	7
Tradenames:	3
Applicants:	16
NDAs:	18
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	23
Clinical Trials:	847
Patent Applications:	1,582
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
Alice Bertaina	Phase 1/Phase 2
ADC Therapeutics	Phase 1
Sichuan University	Phase 3

See all melphalan hydrochloride clinical trials

Pharmacology for melphalan hydrochloride

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating 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
Par Sterile Products	MELPHALAN HYDROCHLORIDE	melphalan hydrochloride	INJECTABLE;INJECTION	204773-001	Aug 22, 2016		DISCN	No	No
Uswm	MELPHALAN HYDROCHLORIDE	melphalan hydrochloride	INJECTABLE;INJECTION	207032-001	May 3, 2019		DISCN	No	No
Dr Reddys	MELPHALAN HYDROCHLORIDE	melphalan hydrochloride	INJECTABLE;INJECTION	203655-001	Dec 8, 2017	AP	RX	No	No
Actavis Llc	MELPHALAN HYDROCHLORIDE	melphalan hydrochloride	INJECTABLE;INJECTION	206018-001	Dec 19, 2016	AP	RX	No	No
Bpi Labs	MELPHALAN HYDROCHLORIDE	melphalan hydrochloride	INJECTABLE;INJECTION	209197-001	May 8, 2020	AP	RX	No	No
Acrotech	EVOMELA	melphalan hydrochloride	POWDER;INTRAVENOUS	207155-001	Mar 10, 2016		RX	Yes	Yes			Y
Almaject	MELPHALAN HYDROCHLORIDE	melphalan hydrochloride	INJECTABLE;INJECTION	204817-001	May 17, 2019	AP	RX	No	No

Expired US Patents for melphalan hydrochloride

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

International Patents for melphalan hydrochloride

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2909239	COMPOSITIONS DE CYCLODEXTRINE ALKYLÉE ET PROCÉDÉS DE PRÉPARATION ET D'UTILISATION DE CELLES-CI (ALKYLATED CYCLODEXTRIN COMPOSITIONS AND PROCESSES FOR PREPARING AND USING THE SAME)
Spain	2767880
Mexico	2018008597	COMPOSICIONES INYECTABLES DE MELFALAN QUE COMPRENDEN UN DERIVADO DE CICLODEXTRINA Y METODOS DE FABRICACION Y USO DE LAS MISMAS. (INJECTABLE MELPHALAN COMPOSITIONS COMPRISING A CYCLODEXTRIN DERIVATIVE AND METHODS OF MAKING AND USING THE SAME.)
Japan	2010539193
European Patent Office	2748205	COMPOSITIONS DE CYCLODEXTRINE ALKYLÉE ET PROCÉDÉS POUR LEUR PRÉPARATION ET LEUR UTILISATION (ALKYLATED CYCLODEXTRIN COMPOSITIONS AND PROCESSES FOR PREPARING AND USING THE SAME)
Mexico	360192	COMPOSICIONES DE CICLODEXTRINAS ALQUILADAS Y PROCESOS PARA PREPARAR Y USAR LAS MISMAS. (ALKYLATED CYCLODEXTRIN COMPOSITIONS AND PROCESSES FOR PREPARING AND USING THE SAME.)
Hong Kong	1213585	烷基化環糊精組合物及其製備和使用方法 (ALKYLATED CYCLODEXTRIN COMPOSITIONS AND PROCESSES FOR PREPARING AND USING THE SAME)