HYTRIN Drug Patent Profile

When do Hytrin patents expire, and what generic alternatives are available?

Hytrin is a drug marketed by Abbott and is included in two NDAs.

The generic ingredient in HYTRIN is terazosin hydrochloride. There are twenty-four drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the terazosin hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Hytrin

A generic version of HYTRIN was approved as terazosin hydrochloride by APNAR PHARMA LP on March 30^th, 1998.

Summary for HYTRIN

US Patents:	0
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	82
Clinical Trials:	4
Patent Applications:	3,476
DailyMed Link:	HYTRIN at DailyMed

Recent Clinical Trials for HYTRIN

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Iowa	Phase 1
Michael J. Fox Foundation for Parkinson's Research	Phase 1
Jordan Schultz	Phase 1/Phase 2

See all HYTRIN clinical trials

US Patents and Regulatory Information for HYTRIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbott	HYTRIN	terazosin hydrochloride	CAPSULE;ORAL	020347-001	Dec 14, 1994		DISCN	Yes	No
Abbott	HYTRIN	terazosin hydrochloride	TABLET;ORAL	019057-003	Aug 7, 1987		DISCN	No	No
Abbott	HYTRIN	terazosin hydrochloride	CAPSULE;ORAL	020347-004	Dec 14, 1994		DISCN	Yes	No
Abbott	HYTRIN	terazosin hydrochloride	TABLET;ORAL	019057-004	Aug 7, 1987		DISCN	No	No
Abbott	HYTRIN	terazosin hydrochloride	CAPSULE;ORAL	020347-002	Dec 14, 1994		DISCN	Yes	No

Expired US Patents for HYTRIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbott	HYTRIN	terazosin hydrochloride	CAPSULE;ORAL	020347-004	Dec 14, 1994	5,412,095
Abbott	HYTRIN	terazosin hydrochloride	CAPSULE;ORAL	020347-004	Dec 14, 1994	5,212,176
Abbott	HYTRIN	terazosin hydrochloride	CAPSULE;ORAL	020347-002	Dec 14, 1994	5,212,176
Abbott	HYTRIN	terazosin hydrochloride	TABLET;ORAL	019057-001	Aug 7, 1987	4,026,894
Abbott	HYTRIN	terazosin hydrochloride	TABLET;ORAL	019057-003	Aug 7, 1987	4,251,532

International Patents for HYTRIN

See the table below for patents covering HYTRIN around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	136779
Japan	S5543474
Sweden	431208	FORFARANDE FOR FRAMSTELLNING AV 2-(4-(TETRAHYDROPYRAN-2-KARBONYL)PIPERAZINYL)-4-AMINO-6,7-DIMETOXIKINAZOLIN
Australia	1655776
Israel	98562	R(+)-2- [4-[(tetrahydro-2-furanyl) carbonyl]-1-piperazinyl] 6-7-dimethoxy-4-quinazolinamine and pharmaceutical compositions containing it

Market Dynamics and Financial Trajectory for Hytrin (Terazosin)

Last updated: July 29, 2025

Introduction

Hytrin (generic name: terazosin) is an alpha-1 adrenergic receptor blocker primarily prescribed for treating benign prostatic hyperplasia (BPH) and hypertension. Since its launch in the late 1980s, Hytrin has maintained a significant position in the U.S. and global markets through its efficacy and established safety profile. This analysis explores current market dynamics, competitive landscapes, regulatory influences, and the future financial trajectory of Hytrin.

Market Overview

Historical Market Performance

Hytrin has historically enjoyed steady demand driven by the aging global population and the increasing prevalence of BPH and hypertension. As of 2022, the global BPH drug market was valued at approximately USD 3.4 billion, with alpha-blockers like Hytrin constituting a significant share, thanks to their effective symptom management and tolerability. U.S. sales alone accounted for approximately half of this figure, reflecting the drug’s entrenched position (MarketResearch.com, 2022).

Key Indications and Patient Demographics

Hytrin's primary indications include:

• Benign Prostatic Hyperplasia (BPH): Affects approximately 50% of men over 50, with increased incidence in older age groups.
• Hypertension: Often comorbid with BPH; effective management in hypertensive patients further broadens its use.

The aging demographic, especially in developed markets, sustains demand, while awareness and improved diagnostics boost prescription rates. However, the emergence of newer therapies and changing treatment guidelines influence its growth trajectory.

Market Dynamics

Competitive Landscape

Hytrin faces significant competition from several classes of medications:

• Other Alpha-Blockers: Tamsulosin (Flomax), alfuzosin (Uroxatral), doxazosin (Cardura). These often offer more selective receptor targeting, leading to fewer systemic side effects.
• 5-Alpha Reductase Inhibitors: Drugs like finasteride impact prostate size but are used in different treatment contexts.
• Emerging Medications: Phosphodiesterase-5 inhibitors and minimally invasive surgical procedures also influence traditional drug markets toward surgical management or combination therapy.

Tamsulosin has been particularly disruptive, capturing a substantial market share owing to its selective alpha-1A adrenergic receptor activity, which reduces side effects like orthostatic hypotension associated with Hytrin.

Regulatory and Patent Environment

• Patent status: Hytrin’s primary patents expired in the early 2000s, enabling generic manufacturers to enter the market. As a result, generic terazosin accounts for the majority of sales, significantly reducing Novartis' (original manufacturer) pricing power.
• Regulatory approvals: Hytrin, as a generic, faces standard regulatory scrutiny. Still, newer formulations, if developed, would require regulatory pathways that could alter its market positioning.

Pricing Trends and Reimbursement Policies

Pricing has declined owing to generic competition, with average retail prices for terazosin dropping by over 70% since patent expiry. Reimbursement rates in the U.S. remain favorable, supported by formulary placements due to cost-effectiveness and clinical familiarity.

Market Challenges

Key barriers include:

• Brand erosion: Generic proliferation diminishes brand loyalty.
• Safety profile: While well-tolerated, newer drugs with better side effect profiles challenge Hytrin’s dominance.
• Patient adherence: Adherence rates are impacted by side effect profiles and phased titration requirements.

Future Financial Trajectory

Market Penetration and Growth Opportunities

Despite fierce generic competition, Hytrin remains a staple due to its established efficacy, especially for long-term management of BPH and hypertension. Opportunities include:

• Line Extension and Fixed-Dose Combinations: Developing combination therapies with other antihypertensives or BPH medications could sustain interest.
• Geographic Expansion: Emerging markets in Asia, Latin America, and Eastern Europe present growth avenues, driven by demographic shifts and healthcare infrastructure improvements.
• Pharmacogenomic Personalization: Tailoring treatment based on genetic markers could optimize therapy, opening niche markets.

Forecasted Revenue Trends

Projections suggest a declining revenue trend in the U.S. due to generics, with global markets expected to stabilize or slightly grow driven by demographic changes in developing regions.

A conservative estimate indicates a compound annual decline rate (CAGR) of approximately 4-6% over the next five years for Hytrin, primarily due to market share erosion. However, niche markets and geographic expansion could offset some declines.

Impact of New Therapeutics

• Emergence of novel therapies: The introduction of more selective or multifunctional agents (e.g., PDE-5 inhibitors with BPH benefits) could further erode Hytrin's market share.
• Surgical alternatives: Minimally invasive procedures and laser therapies are increasingly preferred, limiting pharmacological growth.

Regulatory and Market Considerations

Continued patent challenges and biosimilar entries could further compress pricing and margins. Conversely, patent extensions or new formulation approvals might temporarily buoy revenues.

Conclusion

Hytrin's financial trajectory reflects the classic lifecycle of a longstanding generic drug: initially high sales, plateauing due to generic competition, and eventual decline with regional expansion potential. Its future success hinges on strategic positioning in emerging markets, potential line extensions, and adapting to therapeutic innovations.

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Key Takeaways

• Hytrin remains a globally recognized treatment for BPH and hypertension but faces steep competition from selective alpha-blockers like tamsulosin.
• Patent expirations and the proliferation of generics have significantly reduced pricing power and revenue in mature markets.
• Emerging markets and population aging present growth opportunities, particularly through geographic expansion.
• Market challenges include new therapeutic alternatives, surgical procedures, and evolving treatment guidelines favoring newer agents.
• Strategic diversification, such as combination therapies or formulations, could mitigate revenue declines.
• The future landscape demands vigilance toward innovation, regulatory developments, and shifting treatment paradigms to sustain profitability.

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FAQs

1. How does Hytrin compare to newer alpha-blockers like tamsulosin?
Hytrin is less selective, resulting in broader receptor blockade and potentially more systemic side effects such as orthostatic hypotension. Tamsulosin's selectivity affords better tolerability, which has led to its increased market share over Hytrin.

2. What is the current status of Hytrin's patent protection?
Primary patents expired in the early 2000s, allowing generic manufacturers to produce terazosin, leading to significant price reductions and market erosion for brand-name versions.

3. Are there any upcoming formulations or line extensions for Hytrin?
Currently, no major new formulations or line extensions are under development. Focus remains on generic manufacturing and geographical expansion.

4. What are the key factors influencing the decline in Hytrin's sales?
Patent expiration, the rise of more selective alpha-blockers, shifting treatment guidelines favoring minimally invasive procedures, and patient preference for drugs with fewer side effects drive sales decline.

5. How might emerging markets influence Hytrin's future revenues?
Growing healthcare infrastructure and increasing prevalence of BPH and hypertension in emerging economies offer opportunities for market expansion, potentially offsetting declines in mature markets.

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References:

[1] MarketResearch.com. (2022). Global Benign Prostatic Hyperplasia (BPH) Drugs Market.
[2] IQVIA. (2022). US Prescription Sales Data.
[3] FDA. (2021). Regulatory Status of Terazosin.