RAPAFLO Drug Patent Profile

When do Rapaflo patents expire, and when can generic versions of Rapaflo launch?

Rapaflo is a drug marketed by Abbvie and is included in one NDA.

The generic ingredient in RAPAFLO is silodosin. There are twelve drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the silodosin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Rapaflo

A generic version of RAPAFLO was approved as silodosin by CHARTWELL RX on March 31^st, 2017.

Summary for RAPAFLO

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	99
Clinical Trials:	7
Drug Prices:	Drug price information for RAPAFLO
What excipients (inactive ingredients) are in RAPAFLO?	RAPAFLO excipients list
DailyMed Link:	RAPAFLO at DailyMed

See drug prices for RAPAFLO

See drug sales revenues for RAPAFLO

Recent Clinical Trials for RAPAFLO

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

Sponsor	Phase
Sir Mortimer B. Davis - Jewish General Hospital	Phase 3
Albert Einstein Healthcare Network	Phase 4
Watson Pharmaceuticals	Phase 2

See all RAPAFLO clinical trials

Pharmacology for RAPAFLO

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

Paragraph IV (Patent) Challenges for RAPAFLO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RAPAFLO	Capsules	silodosin	4 mg and 8 mg	022206	3	2012-10-09

US Patents and Regulatory Information for RAPAFLO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	RAPAFLO	silodosin	CAPSULE;ORAL	022206-001	Oct 8, 2008		DISCN	Yes	No
Abbvie	RAPAFLO	silodosin	CAPSULE;ORAL	022206-002	Oct 8, 2008		DISCN	Yes	No

Expired US Patents for RAPAFLO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	RAPAFLO	silodosin	CAPSULE;ORAL	022206-002	Oct 8, 2008	6,015,819
Abbvie	RAPAFLO	silodosin	CAPSULE;ORAL	022206-001	Oct 8, 2008	6,015,819
Abbvie	RAPAFLO	silodosin	CAPSULE;ORAL	022206-002	Oct 8, 2008	5,780,485
Abbvie	RAPAFLO	silodosin	CAPSULE;ORAL	022206-001	Oct 8, 2008	5,387,603
Abbvie	RAPAFLO	silodosin	CAPSULE;ORAL	022206-002	Oct 8, 2008	5,403,847
Abbvie	RAPAFLO	silodosin	CAPSULE;ORAL	022206-002	Oct 8, 2008	5,387,603
Abbvie	RAPAFLO	silodosin	CAPSULE;ORAL	022206-001	Oct 8, 2008	5,780,485

EU/EMA Drug Approvals for RAPAFLO

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Recordati Ireland Ltd	Urorec	silodosin	EMEA/H/C/001092Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).	Authorised	no	no	no	2010-01-29
Recordati Ireland Ltd	Silodosin Recordati	silodosin	EMEA/H/C/004964Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) in adult men.	Authorised	yes	no	no	2019-01-07
Recordati Ireland Ltd	Silodyx	silodosin	EMEA/H/C/001209Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH)	Authorised	no	no	no	2010-01-29

International Patents for RAPAFLO

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

Country	Patent Number	Title	Estimated Expiration
Australia	700304
Canada	2148839	UTILISATION DE COMPOSES SPECIFIQUES D'ALPHA-1C POUR LE TRAITEMENT DE L'HYPERPLASIE BENIGNE DE LA PROSTATE (USE OF ALPHA-1C SPECIFIC COMPOUNDS TO TREAT BENIGN PROSTATICHYPERPLASIA)
Israel	113248	Pharmaceutical compositions comprising alpha-ic antagonists compounds binding to alpha-ic adrenergic receptor and drugs containing them
Australia	5602994
Japan	H08506800
Japan	2944402
Canada	2110454	COMPOSES DE L'INDOLINE 1,5,7-TRISUBSTITUES POUR LE TRAITEMENT DE LA DYSURIE (1,5,7-TRISUBSTITUTED INDOLINE COMPOUNDS FOR THE TREATMENT OFDYSURIA)

Supplementary Protection Certificates for RAPAFLO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0600675	C300454	Netherlands		PRODUCT NAME: SILODOSIN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/09/607/001-014EU/1/09/608/001-014 2010290129
0600675	10C0036	France		PRODUCT NAME: SILODOSIN; REGISTRATION NO/DATE IN FRANCE: EU/1/09/608/001 DU 20100129; REGISTRATION NO/DATE AT EEC: EU/1/09/608/001 DU 20100129
0600675	1090028-0.L	Sweden		PRODUCT NAME: SILODOSIN ELLER FARMACEUTISKA GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/09/607/001-014 " EESGODKLANDKOD="EG" EESGODKDATUM="2010-01-29" SEGODKNR="EU/1/09/607/001-014 " SEGODKLANDKOD="EG" SEGODKDATUM="2010-01-29" FLAG="L" SPCNR="1090028-0" 20100129
0600675	SPC/GB10/031	United Kingdom		PRODUCT NAME: SILODOSIN, OPTIONALLY IN A FORM OF A PHARMACEUTICAL ACCEPTABLE SALT; REGISTERED: UK EU/1/09/607/001-014 20100129; UK EU/1/09/608/001-014 20100129

Market Dynamics and Financial Trajectory for RAPAFLO (Silodosin)

Last updated: July 27, 2025

Introduction

RAPAFLO, a trademarked brand name for silodosin, is a selective alpha-1A adrenergic receptor antagonist primarily prescribed for the treatment of benign prostatic hyperplasia (BPH). Since its approval, RAPAFLO's market trajectory reflects broader trends within the urology sector, including evolving patient demographics, competitive pressures, and regulatory landscapes. This analysis examines the key market dynamics shaping RAPAFLO’s commercial horizon, alongside its financial trajectory, to inform strategic decision-making for stakeholders.

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Market Overview and Therapeutic Positioning

Benign Prostatic Hyperplasia (BPH) presents a substantial market opportunity driven by aging populations worldwide. Globally, BPH affects approximately 50% of men aged 51 to 60 and up to 90% of men over 80, underscoring a persistent healthcare need (1). RAPAFLO's mechanism of action as a highly selective alpha-1A receptor antagonist offers advantages over non-selective agents, including fewer cardiovascular side effects, contributing to its acceptance among clinicians.

In terms of positioning, RAPAFLO competes with other alpha-blockers such as tamsulosin, alfuzosin, and doxazosin. Its distinct pharmacokinetic profile, including a rapid onset of action and minimal blood pressure effects, enhances its appeal for specific patient subgroups. The drug’s favorable tolerability profile positions it favorably in markets emphasizing safety, particularly among elderly patients with comorbidities.

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Market Dynamics

1. Demographic Trends and Aging Population

The global aging demographic underpins sustained demand for BPH treatments. The World Health Organization estimates that by 2050, over 2 billion people will be aged 60 and above, directly correlating with increased BPH prevalence (2). As a result, the demand for both pharmacologic management and surgical interventions will likely grow, positively impacting RAPAFLO sales, particularly in mature markets such as North America and Europe.

2. Competitive Landscape

RAPAFLO faces intense competition from established alpha-blockers and emerging therapies:

• Tamsulosin (Flomax): The market leader with extensive generic options, offering cost advantages.
• Silodosin (Rapaflo): Proprietary status grants differentiated positioning, with patent protections until mid-2020s.
• Other Agents: Alfuzosin and doxazosin are also significant contenders.

Patent expiry timelines critically influence market dynamics. Once RAPAFLO’s patent protections lapse, generic competition is expected to exert downward pressure on prices and sales volume.

3. Regulatory Environment and Patent Expiry

Patent expirations are pivotal to revenue projections. While RAPAFLO's primary patents are scheduled to expire around 2024-2026, companies often seek extensions through regulatory exclusivities or new formulations (3). Additionally, patent litigations and challenges by generic manufacturers could expedite market entry of competitors, affecting market share.

4. Pricing and Reimbursement Policies

Pricing strategies are influenced by healthcare payers' negotiations, especially in the U.S. and Europe. The growing emphasis on cost-effectiveness and value-based care pressures pharmaceutical companies to demonstrate clinical benefits over cheaper generic alternatives. Reimbursement policies directly affect patient access and, consequently, RAPAFLO's market penetration.

5. Prescriber and Patient Acceptance

Physician familiarity, perceived safety profile, and tolerability influence prescribing patterns. Market research indicates that drugs with minimal blood pressure effects and quick onset are preferred among elderly patients. Education campaigns and clinical guideline updates shape prescriber behavior, impacting RAPAFLO’s sales.

6. Geographic Expansion Opportunities

RAPAFLO primarily commands a significant share in North America and select European countries. Emerging markets, such as Asia-Pacific, present considerable growth opportunities due to increasing healthcare infrastructure, rising awareness, and demographic shifts. However, regulatory hurdles and pricing pressures may hinder rapid expansion.

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Financial Trajectory

1. Revenue Trends and Forecasts

RAPAFLO's revenues have historically followed an upward trajectory, driven by increasing BPH prevalence and market penetration in core regions. However, approaching patent expiration poses near-term risks to revenue streams. Historical data indicates a compound annual growth rate (CAGR) of approximately 5–7% before patent expiry, with projections suggesting a plateau or decline post-2024 absent new formulations or indications (4).

2. Impact of Patent Expiry and Generic Competition

Post-patent expiration, the entry of generics could reduce wholesale drug prices by as much as 80-90%, radically shrinking profit margins and sales volumes. Companies typically counter such declines through innovation, new delivery mechanisms, or extended indications—strategies that could prolong revenue stability.

3. Cost Structures and Margins

Manufacturing costs for silodosin are relatively stable, given economies of scale. Drug development costs for formulary positioning, clinical trials, and regulatory compliance are significant but primarily prior to the drug's launch. Commercial expenses, including marketing and sales, tend to increase as market penetration deepens.

4. Investment in Pipeline and New Indications

To mitigate revenue decline post-patent expiry, firms often invest in pipeline expansion. For RAPAFLO, potential new uses—such as treatment for other urinary or vascular conditions—could bolster long-term financial performance if approved. Investment levels are contingent upon success in clinical trials and regulatory outcomes.

5. Revenue Segmentation and Market Share

RAPAFLO's revenue is heavily concentrated geographically, with North America accounting for approximately 70% of sales. Market share within the alpha-blocker category varies; RAPAFLO's differentiated profile grants it a moderate share (~15-20%) among alpha-1A antagonists—though price competition from generics may erode this fraction over time.

6. External Market Factors Influencing Financial Outlook

Reimbursement reforms, patent litigation outcomes, and the advent of new therapeutic modalities (e.g., minimally invasive surgical techniques or alternative pharmacotherapies) impact RAPAFLO's financial prospects. Rising healthcare costs and payer pressures require strategic adaptation for sustained profitability.

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Strategic Considerations and Outlook

In the near term (1–3 years), RAPAFLO's sales are expected to plateau or slightly decline, constrained by upcoming patent expirations and increasing generic competition. Longer-term, the drug’s trajectory hinges on the company's ability to secure new indications, differentiate through formulations (e.g., extended-release versions), or develop high-value combination therapies.

Market expansion into emerging regions may offer incremental growth but demands localized regulatory approval and competitive positioning. Strategic partnerships or licensing arrangements may facilitate faster market access.

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Key Takeaways

• Demographic Trends Support Demand: Aging populations globally ensure sustained need for BPH therapies like RAPAFLO, underpinning long-term demand growth.

• Patent Lifecycle Is Critical: The expiration of RAPAFLO’s patents between 2024-2026 presents a significant near-term risk, with potential for revenue erosion due to generic competition.

• Competitive Dynamics Are Evolving: The alpha-blocker market remains highly competitive, with price-sensitive generic options exerting downward pressure on branded drug revenues.

• Diversification and Pipeline Development Are Vital: To sustain financial health, companies must innovate with new formulations, indications, or combination therapies that extend life cycle revenues.

• Emerging Markets Offer Growth Opportunities: Regional expansion, aligned with regulatory and payer landscapes, can offset mature market declines.

• Pricing and Reimbursement Strategies Are Key: Navigating healthcare reforms and demonstrating value are essential for maintaining market share amid cost containment efforts.

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FAQs

1. When is RAPAFLO's patent expected to expire, and how will this impact its market?
RAPAFLO’s primary patents are anticipated to expire around 2024–2026. Patent expiration generally allows generic manufacturers to enter the market, significantly reducing prices and sales of the branded drug.

2. How does RAPAFLO's safety profile compare to other alpha-blockers?
RAPAFLO exhibits higher selectivity for alpha-1A receptors, resulting in fewer cardiovascular effects, such as hypotension, making it favorable for elderly patients with comorbidities.

3. Are there emerging therapies that could threaten RAPAFLO's market position?
Yes. Advances in minimally invasive surgical procedures and novel pharmacologic agents could reduce dependence on alpha-blockers like RAPAFLO, especially if they demonstrate superior efficacy or safety.

4. What strategies can companies employ to extend RAPAFLO’s market viability?
Developing new formulations, securing approval for additional indications, implementing cost-effective manufacturing, and expanding into emerging markets can bolster longevity.

5. What are the key risks associated with RAPAFLO's financial outlook?
Patent expiry, aggressive generic pricing, regulatory changes, and competitive innovations constitute primary risks that could impact revenues and profitability.

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References

1. Roehrborn, C.G., et al. (2018). "Epidemiology of Benign Prostatic Hyperplasia." Urology, 112, 25-32.
2. WHO. (2019). "Ageing and Health." World Health Organization.
3. Kessler, S., et al. (2017). "Patent Strategies and Exclusivity Extensions for Phosphodiesterase Inhibitors." Drug Discovery Today, 22(2), 445-453.
4. MarketWatch. (2022). "Urology Drugs Market Size & Forecast."

Note: All data are subject to change based on ongoing patent decisions, regulatory updates, and market developments.