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EVOMELA Drug Profile

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When do Evomela patents expire, and when can generic versions of Evomela launch?

Evomela is a drug marketed by Spectrum Pharms and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-seven patent family members in fourteen countries.

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

Summary for EVOMELA

International Patents:	37
US Patents:	3
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	54
Clinical Trials:	6
Patent Applications:	4,594
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EVOMELA
DailyMed Link:	EVOMELA at DailyMed

Pharmacology for EVOMELA

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

US Patents and Regulatory Information for EVOMELA

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

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Paragraph IV (Patent) Challenges for EVOMELA

Drugname	Dosage	Strength	RLD	Submissiondate
	Injection	50 mg/vial		2017-09-08

Non-Orange Book US Patents for EVOMELA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
7,635,773	Sulfoalkyl ether cyclodextrin compositions
9,750,822	Sulfoalkyl ether cyclodextrin compositions

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International Patents for EVOMELA

Country	Document Number	Estimated Expiration
Hong Kong	1219883
Japan	4923144
Mexico	2010004900
Japan	2012072160