CARDURA XL Drug Patent Profile

Which patents cover Cardura Xl, and what generic alternatives are available?

Cardura Xl is a drug marketed by Viatris and is included in one NDA.

The generic ingredient in CARDURA XL is doxazosin mesylate. There are fourteen drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the doxazosin mesylate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Cardura Xl

A generic version of CARDURA XL was approved as doxazosin mesylate by APOTEX on October 18^th, 2000.

Summary for CARDURA XL

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	106
Clinical Trials:	11
Drug Prices:	Drug price information for CARDURA XL
DailyMed Link:	CARDURA XL at DailyMed

See drug prices for CARDURA XL

See drug sales revenues for CARDURA XL

Recent Clinical Trials for CARDURA XL

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

Sponsor	Phase
The University of Texas Health Science Center, Houston	Phase 1
Brown University	Phase 2
University of California, Los Angeles	Phase 3

See all CARDURA XL clinical trials

Pharmacology for CARDURA XL

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

US Patents and Regulatory Information for CARDURA XL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Viatris	CARDURA XL	doxazosin mesylate	TABLET, EXTENDED RELEASE;ORAL	021269-001	Feb 22, 2005		RX	Yes	No
Viatris	CARDURA XL	doxazosin mesylate	TABLET, EXTENDED RELEASE;ORAL	021269-002	Feb 22, 2005		RX	Yes	Yes

Expired US Patents for CARDURA XL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viatris	CARDURA XL	doxazosin mesylate	TABLET, EXTENDED RELEASE;ORAL	021269-002	Feb 22, 2005

International Patents for CARDURA XL

See the table below for patents covering CARDURA XL around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	H01242528	PERMEABLE ADMINISTRATION FORM
Japan	2729072
Ireland	890142
Denmark	135389
Austria	96308
Denmark	175637

CARDURA XL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for CARDURA XL

Introduction to CARDURA XL

CARDURA XL, containing the active ingredient doxazosin mesylate, is an extended-release tablet designed for the treatment of hypertension and benign prostatic hyperplasia (BPH). It utilizes the innovative Gastrointestinal Therapeutic System (GITS) technology, allowing for once-daily administration and a stable serum drug concentration throughout the day[3][4].

Therapeutic Indications and Market Need

CARDURA XL is indicated for the treatment of hypertension and BPH, making it a versatile drug in the cardiovascular and urological markets. Its ability to treat both conditions effectively, especially in patients with comorbidities such as dyslipidaemia and diabetes mellitus type 2, positions it as a valuable option for clinicians[3][4].

Pharmacological Advantages

The GITS technology in CARDURA XL ensures a slow and systematic release of doxazosin, independent of gastrointestinal pH and peristalsis. This results in a stable daily serum drug concentration, reducing the risk of side effects like orthostatic hypotension. The drug's pharmacokinetic profile, with a peak/trough ratio less than half that of immediate-release doxazosin, enhances patient compliance and safety[3][4].

Market Competition

In the hypertension and BPH treatment markets, CARDURA XL competes with other alpha-1 adrenergic blockers and various antihypertensive drugs. However, its unique GITS technology and favorable metabolic effects give it a competitive edge, particularly in treating patients with multiple comorbidities[3][4].

Clinical Efficacy and Safety

Clinical studies have demonstrated the efficacy of CARDURA XL in reducing blood pressure and improving urodynamic parameters in patients with BPH. The drug has shown significant reductions in blood pressure and improvement in symptoms, with a low incidence of adverse events leading to discontinuation[1][3].

Patient Population and Demographics

CARDURA XL is primarily used in adult males aged 50-80 years with symptomatic BPH and hypertension. The patient population is diverse, although the majority are Caucasian. The drug's efficacy and safety have been established across various demographic groups, including elderly patients[1][3].

Dosage and Administration

The recommended dosage of CARDURA XL is 4-8 mg once daily, with the option to titrate the dose based on patient response. The initial dose is typically 4 mg, which can be increased to 8 mg if necessary. This flexible dosing regimen helps in managing both hypertension and BPH effectively[1][4].

Financial Performance and Market Trends

The financial performance of CARDURA XL is influenced by several factors, including market demand, competition, and regulatory environments. Here are some key financial and market trends:

Revenue and Sales

CARDURA XL generates significant revenue due to its widespread use in treating hypertension and BPH. The drug's unique formulation and therapeutic benefits contribute to its market share and revenue growth.

Manufacturing and Production Costs

Setting up a manufacturing plant for CARDURA XL involves substantial capital investment, including costs for raw materials, machinery, and infrastructure. The IMARC Group report provides detailed insights into the project economics, including capital expenditures, operating expenses, and expected ROI[5].

Market Size and Growth

The global market for antihypertensive and BPH drugs is substantial and growing, driven by increasing prevalence of these conditions. CARDURA XL benefits from this growth, particularly in regions with aging populations and rising healthcare expenditures.

Regulatory Environment

Regulatory approvals and compliance are crucial for the financial trajectory of CARDURA XL. Manufacturers must adhere to stringent quality assurance criteria and obtain necessary certifications, which can impact production costs and timelines[5].

Competitive Landscape

The competitive landscape for CARDURA XL includes other alpha-1 adrenergic blockers and antihypertensive medications. However, its unique GITS technology and favorable metabolic profile make it a preferred choice for many clinicians.

Future Outlook

The future outlook for CARDURA XL is promising, given the increasing demand for effective treatments for hypertension and BPH. As the global population ages and the prevalence of these conditions rises, the market for CARDURA XL is expected to grow.

Key Takeaways

• Therapeutic Versatility: CARDURA XL is effective in treating both hypertension and BPH.
• Pharmacological Advantages: GITS technology ensures stable serum drug concentrations and reduces side effects.
• Market Demand: Growing demand driven by increasing prevalence of hypertension and BPH.
• Financial Performance: Significant revenue generation with substantial capital investment in manufacturing.
• Regulatory Compliance: Adherence to quality assurance criteria and regulatory approvals is crucial.

FAQs

Q: What is the primary indication for CARDURA XL?

A: CARDURA XL is primarily indicated for the treatment of hypertension and benign prostatic hyperplasia (BPH).

Q: How does the GITS technology in CARDURA XL work?

A: The GITS technology ensures a slow and systematic release of doxazosin, independent of gastrointestinal pH and peristalsis, providing a stable daily serum drug concentration.

Q: What are the common adverse events associated with CARDURA XL?

A: Common adverse events include dizziness, dyspnea, asthenia, headache, hypotension, postural hypotension, and somnolence[1].

Q: Can CARDURA XL be used in patients with multiple comorbidities?

A: Yes, CARDURA XL is particularly suitable for patients with comorbidities such as dyslipidaemia, diabetes mellitus type 2, and BPH[3].

Q: What is the recommended dosage for CARDURA XL?

A: The recommended dosage is 4-8 mg once daily, with the option to titrate the dose based on patient response[1][4].

Cited Sources

1. CARDURA XL - accessdata.fda.gov
2. Pfizer Form 10K - pfizer.com
3. Cardura XL--a unique drug formulation--doxazosine administered ... - PubMed
4. Cardura XL 4mg tablet - Summary of Product Characteristics (SmPC) - medicines.org.uk
5. Doxazosin (Cardura) Manufacturing Plant Project Report 2024 - imarcgroup.com