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
Abbvie	RAPAFLO	silodosin	CAPSULE;ORAL	022206-002	Oct 8, 2008
Abbvie	RAPAFLO	silodosin	CAPSULE;ORAL	022206-001	Oct 8, 2008
Abbvie	RAPAFLO	silodosin	CAPSULE;ORAL	022206-001	Oct 8, 2008
Abbvie	RAPAFLO	silodosin	CAPSULE;ORAL	022206-001	Oct 8, 2008
Abbvie	RAPAFLO	silodosin	CAPSULE;ORAL	022206-001	Oct 8, 2008
Abbvie	RAPAFLO	silodosin	CAPSULE;ORAL	022206-002	Oct 8, 2008

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
European Patent Office	0758894
Japan	3240567
European Patent Office	0667769
World Intellectual Property Organization (WIPO)	9528157
Japan	H06220015	INDOLINE DERIVATIVE
South Africa	9502763
Australia	2240495

Supplementary Protection Certificates for RAPAFLO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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

Market Dynamics and Financial Trajectory for RAPAFLO (Silodosin)

Last updated: December 26, 2025

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Executive Summary

RAPAFLO (silodosin) is a selective alpha-1 adrenoceptor antagonist primarily approved for treating benign prostatic hyperplasia (BPH). Since its launch, RAPAFLO has experienced dynamic shifts influenced by regulatory approvals, competitive landscapes, and evolving healthcare policies. This report examines the current market environment, financial trajectory, and future growth prospects for RAPAFLO, emphasizing key drivers, barriers, and strategic insights critical for stakeholders.

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Introduction to RAPAFLO

Attribute	Details
Generic Name	Silodosin
Brand Name	RAPAFLO
Approval Date (US)	2012 (by FDA)
Therapeutic Class	Alpha-1 adrenergic receptor antagonist
Indication	BPH (benign prostatic hyperplasia)

Since its US approval in 2012 by Eisai Inc., RAPAFLO has secured a positional advantage within the alpha-blocker segment, competing chiefly against tamsulosin (Flomax), doxazosin, and alfuzosin.

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Market Dynamics Analysis

1. Epidemiological and Demographic Drivers

• Global BPH Prevalence: Over 200 million men worldwide suffer from BPH, with incidence rising sharply among men aged 50 and above.
  • US Data: Nearly 50% of men aged 51-60, and up to 90% over age 80, exhibit BPH symptoms [1].
• Aging Population Impact: Increasing longevity and aging demographics project steady growth in BPH cases, thus expanding potential markets.
• Urbanization and Lifestyle Factors: Rising obesity rates and sedentary lifestyles accelerate BPH prevalence.

2. Competitive Landscape

Key Players	Drugs	Market Share (2022)	Differences
Eisai	RAPAFLO (silodosin)	Approx. 5-7%	High selectivity, fewer cardiovascular side effects
Boehringer Ingelheim	tamsulosin (Flomax)	50-55%	Established, first-to-market advantage
AbbVie/Allergan	Doxazosin	10-15%	Cost-effective, non-selective
Others	Alfuzosin, silodosin generics	15-20%	Price-sensitive segments

Competitive Edge: RAPAFLO’s high selectivity for alpha-1A receptors minimizes side effects like hypotension, attractive in patients intolerant to other agents.

3. Regulatory and Reimbursement Landscape

• FDA & EMA Approvals: FDA approved RAPAFLO exclusively in the US; EMA approval remains pending or limited.
• Reimbursement Policies: Insurance coverage favors branded drugs with demonstrated safety profiles; however, cost considerations influence prescribing patterns.
• Labeling Updates: Expansion of indications or updated safety warnings can significantly impact sales trajectories.

4. Pricing Strategies and Market Penetration

Pricing Segment	Average Wholesale Price (AWP)	Price Range (per month)
Brand (RAPAFLO)	~$300	$250–$350
Generic Silodosin	~$150	$100–$200

Impact: Higher pricing confers margins but may limit access among cost-sensitive populations, especially where generics are available.

5. Clinical and Pharmacological Factors

• Efficacy & Safety Profile: RAPAFLO demonstrates rapid symptom relief with favorable side effect profile.
• Adherence Factors: Once-daily dosing (~8 mg) and minimal adverse effects enhance compliance.
• Drug-Drug Interactions: Exclusion criteria or warnings limit use in complex patient populations.

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Financial Trajectory Overview

1. Revenue Trends and Market Share

Fiscal Year	Global Sales (USD Millions)	Growth Rate	Notes
2012	N/A	—	Launch year
2015	~$150	10% CAGR	Increased awareness
2018	~$200	6-8%	Growing prescriber base
2022	~$250	~5%	Market saturation; competitive pressures

2. Key Revenue Drivers

• Market Penetration in the US: RAPAFLO holds ~5-7% of the US BPH market but faces pressure from generic alternatives.
• Emerging Markets: India, China, and parts of Asia show promising growth owing to unmet needs and rising BPH prevalence.
• Pricing and Rebates: Managed markets often negotiate rebates, decreasing net revenue margins.

3. Future Revenue Projections

Projection Period	Expected Revenue (USD Millions)	Compound Annual Growth Rate (CAGR)	Assumptions
2023-2028	$300–$400	4-6%	Increasing acceptance, pipeline expansion
2028-2033	$500–$700	5-7%	Market expansion into developing countries

Note: These projections assume stable regulatory environments and no significant patent challenges or regulatory withdrawals.

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Market Opportunities and Challenges

Opportunities	Challenges
Expanding Indications	Limited off-label uses currently
Growing Aging Population	Patent expiry and generic competition
Personalized Medicine	Side-effect profiles influencing prescribing
New Formulations (e.g., combination therapy)	Pricing pressures and reimbursement constraints

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Comparative Analysis of Key Drugs

Parameter	RAPAFLO (Silodosin)	Tamsulosin (Flomax)	Doxazosin	Alfuzosin
Selectivity	High (alpha-1A)	Moderate	Non-selective	Moderately selective
Dosing	8 mg daily	0.4 mg daily	1-8 mg daily	10 mg daily
Side Effects	Fewer cardiovascular issues	Orthostatic hypotension	More systemic effects	Similar to tamsulosin
Market Share (2022)	5-7%	50-55%	10-15%	15-20%

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Strategic Insights and Recommendations

Aspect	Strategic Recommendations
Market Penetration	Focus on targeted urology clinics and primary care to expand patient base
Pipeline Development	Invest in combination therapies and new formulations for broader indications
Pricing & Reimbursement	Engage payers early to establish favorable reimbursement pathways
Growth in Emerging Markets	Local partnerships and pricing tailored to regional affordability
Patent and Competitive Barriers	Monitor patent statuses and invest in lifecycle management strategies

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FAQs

Q1: What factors influence RAPAFLO's market share in the BPH segment?
A1: Efficacy, safety profile, patient tolerability, pricing, physician familiarity, and competitive dynamics primarily influence market share. RAPAFLO’s high selectivity offers an advantage but faces stiff competition from well-established agents like tamsulosin.

Q2: How does the patent landscape impact RAPAFLO’s future financial trajectory?
A2: Patent exclusivity, which expired in numerous markets, affects pricing power and generic competition. Patent challenges or extensions through formulations or labeling can prolong exclusivity, supporting revenue stability.

Q3: Are there upcoming regulatory or clinical developments that could influence RAPAFLO's market?
A3: Potential label expansions or new indications could open revenue streams. Conversely, safety concerns or adverse regulatory rulings could restrict use.

Q4: How does regional variation affect RAPAFLO's sales?
A4: Differences in healthcare policies, reimbursement systems, and disease prevalence influence sales. Developed countries exhibit slower growth due to generic competition, while emerging markets present growth opportunities.

Q5: What is the impact of generic silodosin availability on RAPAFLO's revenues?
A5: Generics exert downward pressure on pricing and margins, emphasizing the need for RAPAFLO to differentiate through clinical benefits or formulation innovations.

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Key Takeaways

• The global and regional BPH market demonstrates steady growth driven by aging populations and increased prevalence.
• RAPAFLO benefits from a favorable safety profile, high receptor selectivity, and patient tolerability.
• Competitive pressures from generics and established drugs necessitate strategic differentiation and pipeline expansion.
• High treatment costs and reimbursement policies influence uptake; market expansion into emerging regions offers growth potential.
• Revenue is projected to grow modestly at a 4-7% CAGR over the next decade, contingent upon regulatory developments, competitive dynamics, and pipeline success.

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References

[1] Roehrborn, C. G. (2017). "Benign Prostatic Hyperplasia." Nature Reviews Disease Primers, 3, 17031.
[2] U.S. Food and Drug Administration (FDA). (2012). RAPAFLO (Silodosin) NDA Approval Letter.
[3] Global Epidemiology of BPH. (2021). International Journal of Urology.

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Disclaimer: This analysis is for informational purposes and does not constitute investment advice. Market conditions are subject to change.