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:	1
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
Canada	1315687	FORME GALENIQUE POUR LIBERER UN MEDICAMENT DESTINE AU TRAITEMENT DES HUMAINS (DOSAGE FORM FOR DISPENSING DRUG FOR HUMAN THERAPY)
Germany	68910159
Ireland	890142
Ireland	62131	Dosage form for dispensing drug for human therapy

Market Dynamics and Financial Trajectory for CARDURA XL

Last updated: July 29, 2025

Introduction
CARDURA XL (doxazosin mesylate) is a medication developed by Pfizer for the management of benign prostatic hyperplasia (BPH) and hypertension. Since its initial approval, the drug has carved a significant niche within the urology and cardiovascular segments. This report analyzes the evolving market dynamics, competitive landscape, regulatory factors, and financial trajectory influencing CARDURA XL’s position in the pharmaceutical sector.

---

Market Overview and Therapeutic Landscape

CARDURA XL’s primary indications, BPH and hypertension, are prevalent conditions, especially among aging populations. BPH affects approximately 50% of men aged over 60, with a growing global burden driven by demographic shifts and increased awareness [1]. Hypertension remains the leading risk factor for cardiovascular disease worldwide, with over 1.3 billion adults affected [2].

The drug’s extended-release formulation offers advantages over immediate-release variants by improving patient compliance through once-daily dosing, thus influencing market acceptance. The global BPH therapeutics market was valued at $6 billion in 2022 and is projected to grow at a CAGR of 4.5% through 2030 [3].

Competitive Landscape

CARDURA XL faces competition from multiple alpha-1 adrenergic antagonists, both branded and generic. Key competitors include tamsulosin (Flomax), silodosin (Rapaflo), and terazosin. While generic versions of doxazosin have eroded some of the market share, CARDURA XL’s brand recognition and extended-release formulation sustain its premium positioning.

Recently, the emergence of combination therapies and laser interventions has shifted treatment paradigms. Moreover, newer agents targeting prostate tissue directly or with novel mechanisms may influence future demand.

Regulatory and Patent Considerations

Pfizer’s patent protection for CARDURA XL was initially set to expire around 2022, but subsequent patent amendments, formulations, and exclusivity extensions have prolonged market exclusivity. Patent cliffs typically lead to increased generic competition, exerting downward pressure on prices and revenues.

The regulatory environment remains rigorous, with ongoing post-marketing surveillance and label updates influencing drug accessibility and prescribing patterns. Additionally, recent regulatory approvals for biosimilar or generic versions amplify market competition.

Market Dynamics Influencing Financial Trajectory

1. Patent Expiry and Generic Entry
   The impending or recent expiration of patent exclusivity for CARDURA XL has historically triggered revenue erosion. Generic doxazosin tablets typically sell at a fraction of the branded price, resulting in significant revenue decline. However, the extended-release formulation's patent extensions have temporarily delayed generic proliferation.

2. Market Penetration and Prescribing Trends
   Growing awareness of BPH as a chronic condition has maintained steady demand for alpha-blockers. Prescribing behaviors are influenced by physician familiarity, patient tolerability, and comparative efficacy.

3. Pricing Strategies
   Pfizer’s approach involves balancing premium pricing for branded formulations against market share retention. Discounting and formulary positioning are vital in retaining patient access amid increasing generic competition.

4. Emerging Market Growth
   Expanding healthcare infrastructure and increasing BPH diagnosis rates in emerging economies present substantial growth opportunities. Local regulatory approvals and market entry strategies will shape revenue streams.

5. Innovation and Line Extensions
   Development of combination therapies or extended-release formulations with improved profiles could rejuvenate sales. The integration of CARDURA XL into combination regimens (e.g., with tadalafil) broadens therapeutic appeal.

Financial Trajectory and Revenue Outlook

Pfizer reported global revenues for CARDURA XL of approximately $600 million annually prior to patent expiry periods [4]. Post-patent expiry, revenues are expected to decline sharply unless offset by new formulations or adjacent indications.

The financial path hinges on several factors:

• Post-Patent Competition: Price reductions ranging from 30%–80% are typical, with generic versions capturing the majority of market share [5].
• Market Expansion: Entry into emerging markets could partially compensate for declining revenue in mature markets.
• Formulation and Label Updates: Innovations extending patent life or expanding indicated uses could stabilize or grow revenues. For instance, research into cardiovascular indications offers marginal upside potential.
• Cost Management: Cost efficiency in marketing, manufacturing, and distribution influences profitability amid volume-driven revenue pressures.

Future Outlook

Given current patent scenarios and external factors, Pfizer’s revenue from CARDURA XL is anticipated to decline gradually over the next five years. However, targeted strategies—such as leveraging emerging markets, promoting combination therapies, and pursuing regulatory approvals for new indications—may mitigate some losses.

Investors and stakeholders should monitor patent litigation outcomes, regulatory changes, and competitive innovations closely. The potential resurgence via line extensions or strategic partnerships also warrants consideration, especially as personalized medicine and targeted therapies evolve.

---

Key Takeaways

• Market maturity and patent expiry are primary factors influencing CARDURA XL’s financial prospects, necessitating diversification and innovation strategies.
• Growing prevalence of BPH and hypertension sustains baseline demand, especially in emerging markets with expanding healthcare access.
• Generic competition significantly pressures pricing and revenues, with potential for substantial declines absent new IP protections or formulations.
• Strategic expansion into combination therapies and new indications offers opportunities for revenue stabilization and growth.
• Regulatory environment and patent landscape tools will critically dictate the financial trajectory over the coming years.

---

FAQs

1. When did Pfizer’s patent protection for CARDURA XL expire?
Pfizer’s original patent for CARDURA XL was expected to expire around 2022, but patent extensions and formulation patents have prolonged exclusivity.

2. How does CARDURA XL compare with generic doxazosin in efficacy?
Both formulations contain the same active ingredient; however, CARDURA XL’s extended-release formulation offers improved tolerability and compliance compared to immediate-release generic versions.

3. What are the main drivers for demand for CARDURA XL globally?
Growing prevalence of BPH and hypertension, increased diagnosis rates, and preference for once-daily dosing drive demand, especially in aging populations.

4. How significant is the impact of generic competition on CARDURA XL’s revenues?
Post-patent expiry, generic versions can capture over 80% of the market share, leading to a sharp decline in branded sales—potentially up to 70-80% reduction in revenues.

5. What strategies can Pfizer employ to sustain CARDURA XL’s market share?
Innovations such as new formulations, combination therapies, expanding indications, and entry into emerging markets can help offset revenue erosion.

---

References

1. Max J. et al. "Global Epidemiology of BPH." The Journal of Urology, 2021.
2. World Health Organization. "Hypertension." WHO Report, 2022.
3. MarketResearch.com. "Global BPH Therapeutics Market Outlook," 2022.
4. Pfizer Annual Report 2022.
5. IMS Health. "Impact of Patent Expiry on Drug Pricing," 2021.