CARDURA Drug Patent Profile

Which patents cover Cardura, and when can generic versions of Cardura launch?

Cardura is a drug marketed by Viatris and is included in two NDAs.

The generic ingredient in CARDURA 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

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

Summary for CARDURA

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	106
Clinical Trials:	11
Patent Applications:	1,789
Drug Prices:	Drug price information for CARDURA
What excipients (inactive ingredients) are in CARDURA?	CARDURA excipients list
DailyMed Link:	CARDURA at DailyMed

See drug prices for CARDURA

See drug sales revenues for CARDURA

Recent Clinical Trials for CARDURA

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 clinical trials

Pharmacology for CARDURA

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

US Patents and Regulatory Information for CARDURA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Viatris	CARDURA	doxazosin mesylate	TABLET;ORAL	019668-001	Nov 2, 1990	AB	RX	Yes	Yes
Viatris	CARDURA	doxazosin mesylate	TABLET;ORAL	019668-004	Nov 2, 1990	AB	RX	Yes	No
Viatris	CARDURA	doxazosin mesylate	TABLET;ORAL	019668-002	Nov 2, 1990	AB	RX	Yes	No

Expired US Patents for CARDURA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viatris	CARDURA	doxazosin mesylate	TABLET;ORAL	019668-001	Nov 2, 1990
Viatris	CARDURA	doxazosin mesylate	TABLET;ORAL	019668-004	Nov 2, 1990
Viatris	CARDURA	doxazosin mesylate	TABLET;ORAL	019668-003	Nov 2, 1990

International Patents for CARDURA

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

Country	Patent Number	Title	Estimated Expiration
Czechoslovakia	207672	METHOD OF MAKING THE PIPERAZINYLCHINAZOLINE DERIVATIVES
U.S.S.R.	816403	METHOD OF PREPARING 4-AMINO-2-(PIPERAZIN-1-YL)-OR 4-AMINO-2-(HOMOPIPERAZIN-1-YL)QUI
Poland	210681

CARDURA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for CARDURA (Doxazosin Mesylate)

Introduction

CARDURA, also known as doxazosin mesylate, is a medication primarily used to treat benign prostatic hyperplasia (BPH) and hypertension. Here, we will delve into the market dynamics and financial trajectory of this drug.

Mechanism of Action and Clinical Use

CARDURA works by selectively inhibiting the alpha1 subtype of alpha-adrenergic receptors, which are predominantly found in the prostatic stroma, prostatic capsule, and bladder neck. This action reduces urethral resistance, relieving symptoms of BPH and improving urinary flow rates[1].

Market Size and Growth

The global doxazosin mesylate market is anticipated to experience significant growth. According to HTF Market Intelligence, the market is expected to grow at a rate of 10.2% and reach a size of USD 2,487.21 million by 2030, up from USD 1,298.45 million in the current period[3].

Regional Market Breakdown

• North America: This region is a significant market for doxazosin mesylate, with the United States, Canada, and Mexico contributing substantially to the overall market size.
• Europe: Countries such as Germany, France, Italy, the UK, and others in the Benelux and Nordic regions also form a crucial part of the European market.
• Asia Pacific: This region is expected to see considerable growth due to increasing healthcare expenditure and a rising population.
• South America: Countries like Brazil, Argentina, and Chile are key markets in this region[3].

Financial Performance of Key Players

Companies involved in the production and distribution of CARDURA have seen varying financial performances.

Petros Pharmaceuticals

Petros Pharmaceuticals, which is involved in the distribution of CARDURA among other products, reported a decline in net sales for the first quarter of 2022 compared to the same period in 2021. The net sales dropped from $4,075,606 to $2,465,169. However, the company's gross profit remained substantial, though lower than the previous year, at $1,992,829 compared to $3,432,220. Operating expenses, including selling, general, and administrative costs, as well as research and development expenses, impacted the company's overall financial performance[2].

Other Biopharmaceutical Companies

Other biopharmaceutical companies, such as Veru Inc., have also been involved in advancing urology products, including those related to BPH treatment. These companies have reported solid revenue growth from their existing commercial products and anticipate continued growth in the urology segment[4].

Clinical Efficacy and Market Impact

The clinical efficacy of CARDURA has been extensively evaluated in multiple double-blind, placebo-controlled trials. These studies have shown that CARDURA significantly improves BPH symptoms and urinary flow rates. For instance, in one study, CARDURA-treated patients showed a significant increase in maximum flow rate of 0.8 mL/sec compared to a decrease of 0.5 mL/sec in the placebo group. Such clinical efficacy has contributed to the drug's market success and patient preference[1].

Adverse Reactions and Safety Profile

While CARDURA is generally well-tolerated, common adverse reactions include fatigue, malaise, hypotension, and dizziness. Postmarketing reports have also included other adverse reactions such as leukopenia, thrombocytopenia, and allergic reactions. However, these do not significantly impact the drug's market trajectory due to its overall safety profile and effectiveness[5].

Competitive Landscape

The market for BPH treatments is competitive, with several other medications available. However, CARDURA's selective inhibition of alpha1 adrenergic receptors and its proven efficacy in clinical trials have maintained its position in the market.

Future Outlook

Given the growing prevalence of BPH and the aging population, the demand for effective treatments like CARDURA is expected to increase. The projected market growth rate of 10.2% underscores the potential for continued financial success for companies involved in the production and distribution of this drug[3].

Key Takeaways

• Market Growth: The global doxazosin mesylate market is expected to grow at a rate of 10.2% and reach USD 2,487.21 million by 2030.
• Clinical Efficacy: CARDURA has shown significant improvement in BPH symptoms and urinary flow rates in clinical trials.
• Financial Performance: Companies like Petros Pharmaceuticals have seen varying financial performances, but the overall market for CARDURA remains strong.
• Safety Profile: While there are adverse reactions, CARDURA's safety profile supports its continued use and market presence.
• Competitive Landscape: CARDURA maintains a strong position in the market for BPH treatments due to its efficacy and safety.

FAQs

What is the primary use of CARDURA?

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

How does CARDURA work?

CARDURA works by selectively inhibiting the alpha1 subtype of alpha-adrenergic receptors, reducing urethral resistance and relieving BPH symptoms.

What is the expected market size of doxazosin mesylate by 2030?

The global doxazosin mesylate market is expected to reach USD 2,487.21 million by 2030[3].

What are the common adverse reactions associated with CARDURA?

Common adverse reactions include fatigue, malaise, hypotension, and dizziness[5].

How has the financial performance of companies like Petros Pharmaceuticals been for CARDURA?

Petros Pharmaceuticals reported a decline in net sales but maintained substantial gross profit for the first quarter of 2022 compared to the previous year[2].

Sources

1. CARDURA® - accessdata.fda.gov
2. Petros Pharmaceuticals Reports First Quarter 2022 Financial Results and Provides Corporate Update - globenewswire.com
3. Global Doxazosin Mesylate Market Growing High for Next Decade Return - htfmarketintelligence.com
4. 2018 ANNUAL REPORT - annualreports.co.uk
5. CARDURA (doxazosin) Label - accessdata.fda.gov