Melphalan flufenamide hydrochloride - Generic Drug Details

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

Melphalan flufenamide hydrochloride is the generic ingredient in one branded drug marketed by Oncopeptides Ab and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Melphalan flufenamide hydrochloride has one hundred and eight patent family members in thirty-one countries.

Summary for melphalan flufenamide hydrochloride

International Patents:	108
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Clinical Trials:	8
DailyMed Link:	melphalan flufenamide hydrochloride at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for melphalan flufenamide hydrochloride

Dosage:

POWDER;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for melphalan flufenamide hydrochloride

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

Sponsor	Phase
PRA Health Sciences	Phase 1/Phase 2
Oncopeptides AB	Phase 3
Precision Oncology	Phase 2

See all melphalan flufenamide hydrochloride clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for melphalan flufenamide hydrochloride

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

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

US Patents and Regulatory Information for melphalan flufenamide hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Oncopeptides Ab	PEPAXTO	melphalan flufenamide hydrochloride	POWDER;INTRAVENOUS	214383-001	Feb 26, 2021		DISCN	Yes	No			Y
Oncopeptides Ab	PEPAXTO	melphalan flufenamide hydrochloride	POWDER;INTRAVENOUS	214383-001	Feb 26, 2021		DISCN	Yes	No
Oncopeptides Ab	PEPAXTO	melphalan flufenamide hydrochloride	POWDER;INTRAVENOUS	214383-001	Feb 26, 2021		DISCN	Yes	No			Y
Oncopeptides Ab	PEPAXTO	melphalan flufenamide hydrochloride	POWDER;INTRAVENOUS	214383-001	Feb 26, 2021		DISCN	Yes	No
Oncopeptides Ab	PEPAXTO	melphalan flufenamide hydrochloride	POWDER;INTRAVENOUS	214383-001	Feb 26, 2021		DISCN	Yes	No
Oncopeptides Ab	PEPAXTO	melphalan flufenamide hydrochloride	POWDER;INTRAVENOUS	214383-001	Feb 26, 2021		DISCN	Yes	No
Oncopeptides Ab	PEPAXTO	melphalan flufenamide hydrochloride	POWDER;INTRAVENOUS	214383-001	Feb 26, 2021		DISCN	Yes	No			Y

International Patents for melphalan flufenamide hydrochloride

Country	Patent Number	Title	Estimated Expiration
Japan	6042412
Mexico	365205	PREPARACIONES LIOFILIZADAS DE MELFALÁN FLUFENAMIDA. (LYOPHILIZED PREPARATIONS OF MELPHALAN FLUFENAMIDE.)
South Africa	201308765	LYOPHILIZED PREPARATION OF CYTOTOXIC DIPEPTIDES
European Patent Office	4122482	PRÉPARATION LYOPHILISÉE DE DIPEPTIDES CYTOTOXIQUES (LYOPHILIZED PREPARATION OF CYTOTOXIC DIPEPTIDES)
Serbia	56462	LIOFILIZOVANI PREPARAT CITOTOKSIČNIH DIPEPTIDA (LYOPHILIZED PREPARATION OF CYTOTOXIC DIPEPTIDES)
South Korea	20200084890	세포독성 디펩티드의 동결건조 제제 (Lyophilized preparation of cytotoxic dipeptides)
Hungary	E051690

Supplementary Protection Certificates for melphalan flufenamide hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2701720	122023000007	Germany		PRODUCT NAME: MELPHALANFLUFENAMID HYDROCHLORID; REGISTRATION NO/DATE: EU/1/22/1669 20220817
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
2701720	2023C/504	Belgium		PRODUCT NAME: MELFALANFLUFENAMIDEHYDROCHLORIDE; AUTHORISATION NUMBER AND DATE: EU/1/22/1669 20220818
2701720	CA 2022 00054	Denmark		PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; REG. NO/DATE: EU/1/22/1669 20220818
2701720	PA2022529	Lithuania		PRODUCT NAME: MELFALANO FLUFENAMIDAS; REGISTRATION NO/DATE: EU/1/22/1669 20220817
2701720	C202330006	Spain		PRODUCT NAME: CLORHIDRATO DE MELFALAN FLUFENAMIDA; NATIONAL AUTHORISATION NUMBER: EU/1/22/1669; DATE OF AUTHORISATION: 20220817; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/22/1669; DATE OF FIRST AUTHORISATION IN EEA: 20220817