Terazosin Hydrochloride Patent Expiration

Terazosin Hydrochloride is Used for treating hypertension and symptomatic benign prostatic hyperplasia. It was first introduced by Abbott Laboratories Pharmaceutical Products Div in its drug Hytrin on Aug 7, 1987. Another drug containing Terazosin Hydrochloride is Tezruly. 14 different companies have introduced drugs containing Terazosin Hydrochloride.


Terazosin Hydrochloride Patents

Given below is the list of patents protecting Terazosin Hydrochloride, along with the drug name that holds that patent and the company name owning that drug.

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Tezruly US11224572 Stable oral liquid composition of terazosin Feb 01, 2041 Novitium Pharma
Tezruly US12427108 Stable Oral Liquid Composition Of Terazosin Feb 01, 2041 Novitium Pharma
Hytrin US5294615 Terazosin polymorph and pharmaceutical composition Apr 29, 2013

(Expired)

Abbott
Hytrin US5412095 Terazosin monohydrochloride and processes and intermediate for its production Apr 29, 2013

(Expired)

Abbott



Terazosin Hydrochloride's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Terazosin Hydrochloride:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Terazosin And Metabolic Engagement in Alzheimer's Disease Qiang Zhang NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE2
Terazosin for Dementia With Lewy Bodies Qiang Zhang NA NOT YET RECRUITING
(Mar 1, 2026)
PHASE1, PHASE2


Terazosin Hydrochloride Generic API Manufacturers

Several generic applications have been filed for Terazosin Hydrochloride. The first generic version for Terazosin Hydrochloride was by Pharmazone and was approved on Mar 30, 1998. And the latest generic version is by Ajanta Pharma Ltd and was approved on May 12, 2025.

Given below is the list of companies who have filed for Terazosin Hydrochloride generic, along with the locations of their manufacturing plants worldwide.