Orange Book product · Brand (NDA)

MULPLETA

LUSUTROMBOPAG

Brand (NDA)NDA 210923RX VANCOCIN ITALIA

Jul 31, 2018

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jul 31, 2018
8 yr ago
Today
Patent 8889722 expires
Listed drug substance patent expiration.
Jul 29, 2028
in 2 yr 2 mo
Patent 8530668 expires
Listed drug substance patent expiration.
Jan 21, 2030
in 3 yr 8 mo
Patent 9427402 expires
Listed drug product patent expiration.
Sep 29, 2031
in 5 yr 4 mo

Active ingredient

LUSUTROMBOPAG

Strength

3MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 210923

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
8889722	Jul 29, 2028	in 2 yr 2 mo	SubstanceProduct
8530668	Jan 21, 2030	in 3 yr 8 mo	SubstanceProduct
9427402	Sep 29, 2031	in 5 yr 4 mo	Product