EVOMELA Drug Patent Profile

Which patents cover Evomela, and what generic alternatives are available?

Evomela is a drug marketed by Acrotech Biopharma and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and one patent family members in twenty-two countries.

The generic ingredient in EVOMELA 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 Evomela

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

Summary for EVOMELA

International Patents:	101
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	25
Clinical Trials:	20
Patent Applications:	1,006
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for EVOMELA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EVOMELA
What excipients (inactive ingredients) are in EVOMELA?	EVOMELA excipients list
DailyMed Link:	EVOMELA at DailyMed

See drug prices for EVOMELA

Recent Clinical Trials for EVOMELA

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

Sponsor	Phase
Ehsan Malek	Early Phase 1
Washington University School of Medicine	Phase 1
Spectrum Pharmaceuticals, Inc	Phase 1/Phase 2

See all EVOMELA clinical trials

Pharmacology for EVOMELA

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

Anatomical Therapeutic Chemical (ATC) Classes for EVOMELA

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

Paragraph IV (Patent) Challenges for EVOMELA

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 EVOMELA

EVOMELA is protected by seven US patents.

Patents protecting EVOMELA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Acrotech Biopharma	EVOMELA	melphalan hydrochloride	POWDER;INTRAVENOUS	207155-001	Mar 10, 2016		RX	Yes	Yes			Y
Acrotech Biopharma	EVOMELA	melphalan hydrochloride	POWDER;INTRAVENOUS	207155-001	Mar 10, 2016		RX	Yes	Yes			Y
Acrotech Biopharma	EVOMELA	melphalan hydrochloride	POWDER;INTRAVENOUS	207155-001	Mar 10, 2016		RX	Yes	Yes			Y
Acrotech Biopharma	EVOMELA	melphalan hydrochloride	POWDER;INTRAVENOUS	207155-001	Mar 10, 2016		RX	Yes	Yes			Y
Acrotech Biopharma	EVOMELA	melphalan hydrochloride	POWDER;INTRAVENOUS	207155-001	Mar 10, 2016		RX	Yes	Yes			Y
Acrotech Biopharma	EVOMELA	melphalan hydrochloride	POWDER;INTRAVENOUS	207155-001	Mar 10, 2016		RX	Yes	Yes			Y
Acrotech Biopharma	EVOMELA	melphalan hydrochloride	POWDER;INTRAVENOUS	207155-001	Mar 10, 2016		RX	Yes	Yes			Y

International Patents for EVOMELA

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

Country	Patent Number	Title	Estimated Expiration
Brazil	112015008954	composições de ciclodextrina alquilatada e processos para preparação e uso das mesmas
Canada	2888822	COMPOSITIONS DE CYCLODEXTRINE ALKYLEE ET PROCEDES DE PREPARATION ET D'UTILISATION DE CELLES-CI (ALKYLATED CYCLODEXTRIN COMPOSITIONS AND PROCESSES FOR PREPARING AND USING THE SAME)
Japan	2016117748	シクロデキストリン誘導体を含む注射用メルファラン組成物並びにその製造及び使用方法 (INJECTABLE MELPHALAN COMPOSITIONS COMPRISING CYCLODEXTRIN DERIVATIVE AND METHODS OF PRODUCING AND USING THE SAME)
China	104704007	Alkylated cyclodextrin compositions and processes for preparing and using the same
Canada	2771879	COMPOSITIONS DE CYCLODEXTRINE A GROUPEMENTS ETHER SULFOALKYLIQUE (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS)
Israel	216405	תכשיר רוקחי המכיל מלפלן ונגזרת ציקלודקסטרין ושימוש בו להכנת תרופות (Pharmaceutical composition comprising melphalan and a cyclodextrin derivative and its use in the manufacture of medicaments)
Japan	6444548

Supplementary Protection Certificates for EVOMELA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2701720	3/2023	Austria		PRODUCT NAME: MELPHALANFLUFENAMID-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/22/1669 (MITTEILUNG) 20220818
2701720	CR 2022 00054	Denmark		PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; REG. NO/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	122023000007	Germany		PRODUCT NAME: MELPHALANFLUFENAMID HYDROCHLORID; REGISTRATION NO/DATE: EU/1/22/1669 20220817
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