Orange Book product · Brand (NDA)

DRIZALMA SPRINKLE

DULOXETINE HYDROCHLORIDE

Brand (NDA)NDA 212516RX SUN PHARM

Jul 19, 2019

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jul 19, 2019
7 yr ago
Today
Patent 10413525 expires
Listed drug product patent expiration.
Apr 13, 2037
in 11 yr
Patent 10959982 expires
Listed drug product patent expiration.
Apr 13, 2037
in 11 yr
Patent 11202772 expires
Listed drug product patent expiration.
Apr 13, 2037
in 11 yr
Patent 12171742 expires
Listed drug product patent expiration.
Apr 13, 2037
in 11 yr
Patent 9839626 expires
Listed drug product patent expiration.
Apr 13, 2037
in 11 yr

Active ingredient

DULOXETINE HYDROCHLORIDE

Strength

EQ 40MG BASE

Dosage form

CAPSULE, DELAYED REL PELLETS

Route

ORAL

TE code

Not listed

Application

NDA 212516

Product number

003

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

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
10413525	Apr 13, 2037	in 11 yr	Product
10959982	Apr 13, 2037	in 11 yr	Product
11202772	Apr 13, 2037	in 11 yr	Product
12171742	Apr 13, 2037	in 11 yr	Product
9839626	Apr 13, 2037	in 11 yr	Product