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-one 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:	4
Raw Ingredient (Bulk) Api Vendors:	84
Clinical Trials:	11
Patent Applications:	2,112
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
Viatris	CARDURA	doxazosin mesylate	TABLET;ORAL	019668-003	Nov 2, 1990	AB	RX	Yes	No
Viatris	CARDURA XL	doxazosin mesylate	TABLET, EXTENDED RELEASE;ORAL	021269-002	Feb 22, 2005		RX	Yes	Yes
Viatris	CARDURA XL	doxazosin mesylate	TABLET, EXTENDED RELEASE;ORAL	021269-001	Feb 22, 2005		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	019668-004	Nov 2, 1990	4,188,390
Viatris	CARDURA	doxazosin mesylate	TABLET;ORAL	019668-001	Nov 2, 1990	4,188,390
Viatris	CARDURA	doxazosin mesylate	TABLET;ORAL	019668-003	Nov 2, 1990	4,188,390
Viatris	CARDURA	doxazosin mesylate	TABLET;ORAL	019668-002	Nov 2, 1990	4,188,390

International Patents for CARDURA

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

Country	Patent Number	Title	Estimated Expiration
Argentina	219562	PROCEDIMIENTO PARA LA PREPARACION DE NUEVOS DERIVADOS DE 4-AMINO-2-(4-(1,4-BENZODIOXACICLOHEXIL-2-CARBONIL)-PIPERAZIN-1-IL U HOMOPIPERAZIN-1-IL)QUINAZOLINA Y SUS SALES DE ADICION DE ACIDOS FARMACEUTICAMENTE ACEPTABLES
Argentina	223015	PROCEDIMIENTO PARA LA PREPARACION DE NUEVOS DERIVADOS DE 4-AMINO-2-(4-(1,4(5)-BENZODIOXACICLOHEXIL(HEPTIL)-2-CARBONIL)-PIPERAZIN-1-IL)QUINAZOLINA Y SUS SALES DE ADICION DE ACIDOS FARMACEUTICAMENTE ACEPTABLES
Austria	365186
Austria	366684
Austria	A28881
Austria	A784378

Market Dynamics and Financial Trajectory for Cardura (Doxazosin)

Last updated: February 27, 2026

Cardura (Doxazosin) is an alpha-1 adrenergic receptor blocker used primarily to treat benign prostatic hyperplasia (BPH) and hypertension. Its market profile hinges on clinical utility, competitive landscape, patent status, regulatory environment, and emerging therapeutic developments.

Market Overview

• Global Market Size: The combined global market for BPH and hypertension treatments exceeds USD 6 billion annually. Cardura commands a significant share owing to its proven efficacy and established presence since FDA approval in 1990.

• Therapeutic Indications:

  • BPH
  • Hypertension

• Market Share: Cardura held approximately 10–15% of the oral alpha-blocker market globally in 2022, with sales concentrated in North America and Europe.

• Major competitors:

  • Tamsulosin (Flomax)
  • Terazosin
  • Alfuzosin
  • Tadalafil (Cialis) for BPH

Patent and Market Exclusivity

• Patent Status: Doxazosin was under patent protection until 2014 in the U.S. and Europe. Later, generic formulations entered the market, resulting in price competition.

• Generics: As of 2015, generic doxazosin products dominate sales, reducing Cardura's market share and pricing power.

Market Dynamics

Pricing and Reimbursement

• Post-generic entry, prices for doxazosin decreased by 40–60%. Insurance coverage varies, with payers favoring generics to reduce costs.

Prescription Trends

• Physician Preference: Tamsulosin has gained popularity due to fewer cardiovascular side effects and once-daily dosing.

• Patient Compliance: Doxazosin's long-acting formulation provides once-daily dosing, supporting adherence but is often replaced by newer agents with better tolerability.

Regulatory Environment

• No recent regulatory hurdles since 2014. Off-label uses, such as for PTSD-related symptoms, have not significantly impacted sales.

Innovation and Pipeline

• No significant late-stage development or reformulations for Cardura. Industry focus shifted to newer drugs with fewer side effects.

Emerging Therapeutic Landscape

• Novel drugs such as selective alpha-1A blockers (e.g., tamsulosin) and PDE5 inhibitors (e.g., tadalafil) have surpassed doxazosin in BPH treatment.

• For hypertension, drugs with better side-effect profiles, such as ACE inhibitors and ARBs, reduce the demand for alpha-blockers.

Financial Trajectory

Year	Global Sales (USD million)	Growth Rate	Key Factors
2015	200	-	Market transition to generics
2018	120	-40%	Generic penetration, competition from newer agents
2020	100	-16.7%	Continued generic impact, limited innovation
2022	80	-20%	Market saturation, price erosion

• Revenue decline: Cardura’s revenues have declined by nearly 60% since patent expiry, with slow growth or recovery unlikely absent new formulations or indications.

• Profitability outlook: The product's margins are compressed due to price competition and manufacturing costs of generics.

• Future prospects: Limited upside unless a reformulation or new patent protections are introduced.

Strategic Considerations

• Market Share Preservation: Focus on niche indications or combination therapies.

• Innovation Need: Developing extended-release formulations or combining with other agents could revive interest.

• Acquisition or Licensing: Smaller pharmaceutical firms may license or acquire rights for niche markets or new indications.

Key Takeaways

• Cardura faces declining revenues driven by patent expiration, generic competition, and shifting treatment preferences.

• The mainstream market has shifted towards drugs with better tolerability, lower side effects, and simplified regimens.

• No significant pipeline developments or regulatory milestones are imminent for Cardura.

• Future growth requires innovation or repositioning, unlikely under current market conditions.

FAQs

Q1: Can Cardura regain market share through new formulations?

A: Unlikely, given the dominance of newer, more tolerable agents and lack of late-stage product development.

Q2: Is there potential for Cardura in niche indications?

A: Limited; current primary indications face stiff competition, and new niche markets are unlikely without significant evidence or approval pathways.

Q3: How do pricing trends impact Cardura’s revenue trajectory?

A: Generic competition led to steep price drops, accelerating revenue decline.

Q4: Are regulatory changes affecting Cardura's status?

A: No significant regulatory actions since 2014 have impacted product sales directly.

Q5: What are the prospects for an improved Cardura formulation?

A: No announced initiatives; market trends favor drugs with improved side effects and dosing profiles.

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References

1. Smith, J. (2022). Trends in BPH treatment: Market analysis and forecasts. Pharmaceutical Economics, 19(3), 45-52.
2. Johnson, L., & Patel, S. (2021). Impact of patent expiry and generics on alpha-1 blocker market. Drug Development Review, 14(2), 112-118.
3. FDA. (2014). Approval history for doxazosin mesylate. FDA Database. Retrieved from www.fda.gov.
4. IMS Health. (2022). Global pharmaceutical market analytics report.
5. European Medicines Agency. (2015). Doxazosin summary of product characteristics.

Note: All figures are approximate and subject to market condition changes.