Orange Book product · Brand (NDA)

TEZRULY

TERAZOSIN HYDROCHLORIDE

Brand (NDA)NDA 218139DISCN NOVITIUM PHARMA

Jul 29, 2024

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jul 29, 2024
1 yr 11 mo ago
Today
Patent 11224572 expires
Listed drug product patent expiration.
Feb 01, 2041
in 14 yr 10 mo
Patent 11224572 expires
Listed drug product patent expiration.
Feb 01, 2041
in 14 yr 10 mo
Patent 12427108 expires
Listed drug product patent expiration.
Feb 01, 2041
in 14 yr 10 mo
Patent 12427108 expires
Listed drug product patent expiration.
Feb 01, 2041
in 14 yr 10 mo

Active ingredient

TERAZOSIN HYDROCHLORIDE

Strength

EQ 1MG BASE/ML

Dosage form

SOLUTION

Route

ORAL

TE code

Not listed

Application

NDA 218139

Product number

001

Marketing status

DISCN

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
11224572	Feb 01, 2041	in 14 yr 10 mo	ProductU-3990
11224572	Feb 01, 2041	in 14 yr 10 mo	ProductU-3991
12427108	Feb 01, 2041	in 14 yr 10 mo	ProductU-3990
12427108	Feb 01, 2041	in 14 yr 10 mo	ProductU-3991