Terazosin hydrochloride - Generic Drug Details

What are the generic sources for terazosin hydrochloride and what is the scope of patent protection?

Terazosin hydrochloride is the generic ingredient in three branded drugs marketed by Abbott, Apnar Pharma Lp, Bionpharma, Heritage Pharma Avet, Hikma, Jubilant Cadista, Norvium Bioscience, Ranbaxy Labs Ltd, Novitium Pharma, Chartwell Rx, Ivax Sub Teva Pharms, Sandoz, and Teva, and is included in fifteen NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

There are sixteen drug master file entries for terazosin hydrochloride. Twenty suppliers are listed for this compound.

Summary for terazosin hydrochloride

US Patents:	1
Tradenames:	3
Applicants:	13
NDAs:	15
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	20
Raw Ingredient (Bulk) Api Vendors:	85
Clinical Trials:	24
Patent Applications:	2,390
What excipients (inactive ingredients) are in terazosin hydrochloride?	terazosin hydrochloride excipients list
DailyMed Link:	terazosin hydrochloride at DailyMed

Recent Clinical Trials for terazosin hydrochloride

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

Sponsor	Phase
I.R.C.C.S. Fondazione Santa Lucia	Phase 4
Università Foro Italico Roma	Phase 4
CNR Pisa	Phase 4

See all terazosin hydrochloride clinical trials

Pharmacology for terazosin hydrochloride

Drug Class	alpha-Adrenergic Blocker
Mechanism of Action	Adrenergic alpha-Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for terazosin hydrochloride

G04CA	Alpha-adrenoreceptor antagonists
G04C	DRUGS USED IN BENIGN PROSTATIC HYPERTROPHY
G04	UROLOGICALS
G	Genito-urinary system and sex hormones

US Patents and Regulatory Information for terazosin hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Heritage Pharma Avet	TERAZOSIN HYDROCHLORIDE	terazosin hydrochloride	CAPSULE;ORAL	075614-003	Jan 30, 2001	AB	RX	No	No
Heritage Pharma Avet	TERAZOSIN HYDROCHLORIDE	terazosin hydrochloride	CAPSULE;ORAL	075614-001	Jan 30, 2001	AB	RX	No	No
Abbott	HYTRIN	terazosin hydrochloride	CAPSULE;ORAL	020347-004	Dec 14, 1994		DISCN	Yes	No
Jubilant Cadista	TERAZOSIN HYDROCHLORIDE	terazosin hydrochloride	CAPSULE;ORAL	075317-001	Dec 20, 2004	AB	RX	No	Yes
Heritage Pharma Avet	TERAZOSIN HYDROCHLORIDE	terazosin hydrochloride	CAPSULE;ORAL	075614-002	Jan 30, 2001	AB	RX	No	No
Abbott	HYTRIN	terazosin hydrochloride	TABLET;ORAL	019057-004	Aug 7, 1987		DISCN	No	No
Norvium Bioscience	TERAZOSIN HYDROCHLORIDE	terazosin hydrochloride	CAPSULE;ORAL	075384-001	Dec 1, 2000		DISCN	No	No

Expired US Patents for terazosin hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbott	HYTRIN	terazosin hydrochloride	TABLET;ORAL	019057-001	Aug 7, 1987
Abbott	HYTRIN	terazosin hydrochloride	TABLET;ORAL	019057-004	Aug 7, 1987
Abbott	HYTRIN	terazosin hydrochloride	CAPSULE;ORAL	020347-002	Dec 14, 1994
Abbott	HYTRIN	terazosin hydrochloride	CAPSULE;ORAL	020347-004	Dec 14, 1994
Abbott	HYTRIN	terazosin hydrochloride	TABLET;ORAL	019057-003	Aug 7, 1987
Abbott	HYTRIN	terazosin hydrochloride	TABLET;ORAL	019057-003	Aug 7, 1987
Abbott	HYTRIN	terazosin hydrochloride	TABLET;ORAL	019057-001	Aug 7, 1987

Terazosin hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Terazosin Hydrochloride

Introduction to Terazosin Hydrochloride

Terazosin hydrochloride is a medication primarily used to treat benign prostatic hyperplasia (BPH) and hypertension. It functions as an alpha 1 receptor antagonist, relaxing muscle fibers in the bladder and prostate, thereby easing urinary symptoms and reducing blood pressure.

Market Drivers

Several factors are driving the growth of the terazosin hydrochloride market:

• Growing Awareness and Diagnosis Rates: Increasing awareness and diagnosis rates of BPH and hypertension are contributing to higher adoption of terazosin hydrochloride. This is particularly significant in regions with aging populations, where these conditions are more prevalent[1].
• Advancements in Drug Formulation: Improvements in drug formulations, such as extended-release formulations and better patient compliance options, are enhancing the market share of terazosin hydrochloride[1].
• Boost in Internet and Telemedicine Services: The rise of internet and telemedicine services has improved access to prescription medications, including terazosin hydrochloride, making it easier for patients to obtain and adhere to treatment plans[1].
• Pharmaceutical Partnerships and Collaborations: Partnerships and collaborations among pharmaceutical companies are driving research and development, leading to better drug formulations and increased market penetration[1].

Market Restraints

Despite the growth drivers, there are several restraints affecting the market:

• Side Effects and Interactions: Terazosin hydrochloride is associated with side effects such as dizziness, postural hypotension, and potential interactions with other medications, which can limit its widespread adoption[1][3].
• Regulatory and Ethical Challenges: Navigating ethical challenges in marketing to diverse patient demographics and addressing patient awareness and prescription challenges are significant hurdles[1].
• Fluctuating Raw Material Prices: Changes in raw material prices can impact the cost structure of terazosin hydrochloride, affecting its marketability and distribution efficiency[1].

Market Opportunities

There are several opportunities for growth and expansion in the terazosin hydrochloride market:

• Patient-Centric Educational Campaigns: Developing educational campaigns to boost awareness of the benefits of terazosin hydrochloride can increase patient adherence and market share[1].
• Regulatory Support: Capitalizing on regulatory support for antihypertensive drugs can enhance the accessibility of terazosin hydrochloride[1].
• Product Formulation Enhancements: Improving product formulations to enhance patient adherence and compliance can further expand the market share of terazosin hydrochloride[1].

Market Challenges

The market faces several challenges that need to be addressed:

• Navigating Ethical Challenges: Marketing terazosin hydrochloride to diverse patient demographics while adhering to ethical standards is a significant challenge[1].
• Addressing Patient Awareness: Overcoming patient awareness and prescription challenges is crucial for the widespread adoption of terazosin hydrochloride[1].
• Fluctuating Raw Material Costs: Managing the impact of fluctuating raw material prices on the cost structure of the drug is essential for maintaining profitability[1].

Financial Trajectory

Historical Sales and Revenue

Terazosin hydrochloride, marketed under the brand name Hytrin by Abbott Laboratories, has generated significant revenue. In the late 1990s, total U.S. sales of terazosin HCL amounted to approximately $540 million per year[2].

Impact of Generic Competition

The entry of generic versions of terazosin hydrochloride has significantly impacted the market. For instance, Geneva's generic terazosin HCL was expected to eliminate over $185 million in Hytrin sales in just six months if it had entered the market in 1998. This led to a settlement where Abbott paid Geneva $4.5 million per month to delay the launch of the generic version[2].

Pharmacoeconomic Evaluations

Economic evaluations have shown that terazosin is cost-effective compared to other treatments for BPH. For example, a study found that the total direct treatment costs for terazosin were similar to those for placebo but significantly lower than for transurethral resection of the prostate (TURP) and finasteride[3].

Current Market Forecast

The market for oral terazosin hydrochloride is expected to grow, driven by an aging global population and increasing prevalence of BPH and hypertension. Emerging economies with improving healthcare infrastructure are also contributing to this growth. The market is forecasted to expand not only for BPH but also for off-label uses such as treating ureteral stones and certain bladder dysfunctions[1].

Porter’s Five Forces Analysis

Understanding the competitive landscape through Porter’s Five Forces Analysis is crucial for businesses in the terazosin hydrochloride market:

• Threat of New Entrants: The entry of new generic competitors can significantly impact the market, as seen with Geneva's generic terazosin HCL. However, regulatory barriers and the need for FDA approval can limit new entrants[1][2].
• Bargaining Power of Suppliers: Fluctuations in raw material prices can affect the cost structure of terazosin hydrochloride, giving suppliers some bargaining power[1].
• Bargaining Power of Buyers: Patients and healthcare providers have some bargaining power due to the availability of alternative treatments and the impact of side effects on patient adherence[1][3].
• Threat of Substitute Products: Other alpha 1 receptor antagonists and treatments like finasteride and TURP pose a threat, but terazosin hydrochloride's efficacy and cost-effectiveness maintain its market position[1][3].
• Competitive Rivalry Among Existing Competitors: The market is competitive, with both branded and generic versions available. Pharmaceutical companies must innovate and improve formulations to maintain market share[1].

Market Segmentation and Coverage

The terazosin hydrochloride market can be segmented based on various factors:

• Indication: BPH, hypertension, and off-label uses such as treating ureteral stones and bladder dysfunctions[1].
• Dosage Form: Capsules, extended-release formulations, and tablets[1].
• Distribution Channel: Retail pharmacies, hospitals, and online platforms[1].
• Patient Demographics: Age, gender, and geographic location[1].

Key Takeaways

• The terazosin hydrochloride market is driven by growing awareness and diagnosis rates of BPH and hypertension.
• Advancements in drug formulations and increased access through telemedicine services are boosting market growth.
• Side effects and regulatory challenges are significant restraints.
• Patient-centric educational campaigns and regulatory support can enhance market share.
• The financial trajectory is influenced by generic competition and pharmacoeconomic evaluations.

Frequently Asked Questions (FAQs)

1. What are the primary indications for terazosin hydrochloride?

Terazosin hydrochloride is primarily used to treat benign prostatic hyperplasia (BPH) and hypertension.

2. How does terazosin hydrochloride work?

It functions as an alpha 1 receptor antagonist, relaxing muscle fibers in the bladder and prostate, thereby easing urinary symptoms and reducing blood pressure.

3. What are the common side effects of terazosin hydrochloride?

Common side effects include dizziness, postural hypotension, asthenia, somnolence, headache, peripheral edema, nasal congestion/rhinitis, and syncope[3].

4. How has the entry of generic versions impacted the market?

The entry of generic versions has significantly reduced the market share of branded terazosin hydrochloride, as seen with the impact on Abbott's Hytrin sales[2].

5. What are the future growth prospects for the terazosin hydrochloride market?

The market is expected to grow driven by an aging global population, increasing prevalence of BPH and hypertension, and improving healthcare infrastructure in emerging economies[1].

Sources:

1. 360iResearch: Oral Terazosin Hydrochloride Market Size & Share 2025-2030.
2. Federal Trade Commission: Abbott Laboratories - CMP.
3. PubMed: Terazosin. A pharmacoeconomic evaluation of its use in benign prostatic hyperplasia.
4. Wicz: Terazosin Hydrochloride Market 2024: Industry Overview, Competitiveness.
5. FDA: HYTRIN - terazosin hydrochloride tablet Abbott Laboratories.