Orange Book product · Brand (NDA)

EVOMELA

MELPHALAN HYDROCHLORIDE

Brand (NDA)NDA 207155RX ACROTECH BIOPHARMA

Mar 10, 2016

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Mar 10, 2016
10 yr 5 mo ago
Today
Patent 8410077 expires
Listed drug product patent expiration.
Mar 13, 2029
in 2 yr 9 mo
Patent 9200088 expires
Listed drug product patent expiration.
Mar 13, 2029
in 2 yr 9 mo
Patent 10864183 expires
Listed drug product patent expiration.
May 28, 2030
in 4 yr
Patent 11020363 expires
Listed drug product patent expiration.
May 28, 2030
in 4 yr
Patent 10940128 expires
Listed drug product patent expiration.
Jun 14, 2030
in 4 yr 1 mo
Patent 9493582 expires
Listed drug product patent expiration.
Feb 27, 2033
in 6 yr 10 mo
Patent 10040872 expires
Listed drug product patent expiration.
Jan 30, 2034
in 7 yr 9 mo

Active ingredient

MELPHALAN HYDROCHLORIDE

Strength

EQ 50MG BASE/VIAL

Dosage form

POWDER

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 207155

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8410077	Mar 13, 2029	in 2 yr 9 mo	Product
9200088	Mar 13, 2029	in 2 yr 9 mo	Product
10864183	May 28, 2030	in 4 yr	Product
11020363	May 28, 2030	in 4 yr	Product
10940128	Jun 14, 2030	in 4 yr 1 mo	ProductU-3086
9493582	Feb 27, 2033	in 6 yr 10 mo	Product
10040872	Jan 30, 2034	in 7 yr 9 mo	Product