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FDA Orange Book · active-ingredient family

Terazosin hydrochloride

Terazosin hydrochloride is approved as 3 brand and 13 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:TEZRULY · NDA 218139

3

Brand (NDA)

13

Generics (ANDA)

2

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule, solution, tablet

ProductApplicantApplicationTEApproved
TEZRULYRLDNOVITIUM PHARMANDA 218139—Jul 29, 2024
HYTRINRLD×4ABBOTTNDA 020347—Dec 14, 1994
HYTRIN×4ABBOTTNDA 019057—Aug 07, 1987

Generic (ANDA) products (13)

ProductApplicantApplicationTEApproved
TERAZOSIN HYDROCHLORIDE×4AJANTA PHARMA LTDANDA 219482ABMay 12, 2025
TERAZOSIN HYDROCHLORIDE×4JUBILANT CADISTAANDA 075317ABDec 20, 2004
TERAZOSIN HYDROCHLORIDE×4RANBAXY LABS LTDANDA 076021—Aug 22, 2002
TERAZOSIN HYDROCHLORIDE×4HIKMAANDA 075498—Apr 12, 2001
TERAZOSIN HYDROCHLORIDE×4HERITAGE PHARMA AVETANDA 075614ABJan 30, 2001
TERAZOSIN HYDROCHLORIDE×4PHARMOBEDIENTANDA 075384—Dec 01, 2000
TERAZOSIN HYDROCHLORIDE×4BIONPHARMAANDA 075667ABJul 28, 2000
TERAZOSIN HYDROCHLORIDE×4TEVAANDA 074446—May 18, 2000
TERAZOSIN HYDROCHLORIDE×4CHARTWELL RXANDA 074657—Apr 28, 2000
TERAZOSIN HYDROCHLORIDE×4IVAX SUB TEVA PHARMSANDA 074530—Apr 21, 2000
TERAZOSIN HYDROCHLORIDE×4PHARMOBEDIENTANDA 075140—Feb 11, 2000
TERAZOSIN HYDROCHLORIDE×4SANDOZANDA 074315—Dec 31, 1998
TERAZOSIN HYDROCHLORIDE×4SENORES PHARMSANDA 074823ABMar 30, 1998

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
12427108Feb 01, 2041in 14 yr 10 mo
ProductU-3990
11224572Feb 01, 2041in 14 yr 10 mo
ProductU-3990

Terazosin hydrochloride — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

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