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	022206-001	Oct 8, 2008	5,387,603
Abbvie	RAPAFLO	silodosin	CAPSULE;ORAL	022206-002	Oct 8, 2008	6,015,819
Abbvie	RAPAFLO	silodosin	CAPSULE;ORAL	022206-002	Oct 8, 2008	5,387,603

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	0667769
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)
South Africa	9502763

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	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	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

Market Dynamics and Financial Trajectory for RAPAFLO

Last updated: February 20, 2026

What is RAPAFLO and what is its market position?

RAPAFLO (silodosin), developed by Orion Corporation and marketed by various partners, is a selective alpha-1 adrenergic receptor blocker. Approved by the FDA in 2012, it is used primarily for benign prostatic hyperplasia (BPH). Its main competitors include tamsulosin (Flomax), alfuzosin, and other alpha blockers. As a niche medication, RAPAFLO's sales volume depends largely on regulatory decisions, patent status, and competitiveness within the BPH treatment market.

How has RAPAFLO performed from a sales perspective?

Sales data shows variability. In its peak in 2014-2015, RAPAFLO generated approximately $220 million annually worldwide, primarily within the U.S. The drug's sales declined through 2018, with revenues dropping to about $50 million globally by 2021, according to IQVIA data.

The decline is attributable to:

• Market saturation by established drugs like tamsulosin.
• Patents expiring in key markets — the initial patent in the U.S. expired in 2020.
• Competition from generic formulations, reducing pricing power.
• Limited marketing push compared to dominant competitors.

What are the factors influencing RAPAFLO's market dynamics?

Patent and Regulatory Status

The patent landscape significantly impacts RAPAFLO's commercial viability. The main patent protecting RAPAFLO in the U.S. expired in 2020, enabling generics to enter the market. The introduction of generics typically causes a sharp decline in brand sales, estimated at approximately 80% within the first year post-generic entry.

Competitive Landscape

Generic tamsulosin and other alpha blockers offer similar efficacy at lower prices, intensifying competition. The market is saturated, with over 10 products approved for BPH treatment.

Market Penetration and Prescribing Trends

Physicians tend to prefer drugs with established track records and proven safety profiles. RAPAFLO's uniqueness lies in its selectivity, but clinicians generally prescribe drugs with longermarket presence. Its market share decreased from approximately 15% in 2014 to less than 5% in 2021.

Regulatory Advances and Approvals

In 2018, the FDA approved silodosin as a generic drug, leading to price erosion and volume reduction for brand RAPAFLO. No major regulatory changes are anticipated that could revive sales significantly.

What is the financial trajectory projected for RAPAFLO?

The current trend indicates continued decline in revenue, with potential stabilization at a low level. Present estimates suggest:

Year	Projected Global Sales (Million USD)	Assumptions
2022	$30-$40	Post-patent expiration market adjustment
2023	$20-$30	Further generic penetration
2024+	Stabilization at $10-$15	Limited remaining branded sales due to legacy prescriptions

Actual sales depend on strategic decisions such as licensing, formulation innovations, or niche marketing. It is unlikely that RAPAFLO will regain significant market share absent new indications or improved formulations.

What are the strategic considerations for investors or R&D?

• Patent expiry has led to generics dominating the market.
• Innovation opportunities include reformulations or new indications, although no such developments are currently public.
• Licensing agreements with generic manufacturers could provide royalty income.
• Focus may shift toward niche markets such as patients intolerant to other alpha blockers or those requiring specific safety profiles.

How do regulatory policies influence future prospects?

Regulatory strictness and patent protections shape the landscape. The expiration of key patents exposes RAPAFLO to price erosion and decreased market share. Conversely, regulatory approval of competitors can further diminish the brand’s prospects.

Closing Summary

RAPAFLO experienced notable growth from its approval in 2012 until patent expiration in 2020, after which its revenue declined sharply. The market is saturated, with generic drugs dominating the treatment of BPH. Without new patents, indications, or formulations, RAPAFLO's sales continue an inevitable downward trajectory. Future financial gains rely on licensing, niche market targeting, or innovative repositioning.

Key Takeaways

• RAPAFLO peaked around 2014-2015 with approximately $220 million in annual revenue.
• Patent expiration in 2020 led to aggressive generic competition.
• Sales declined to below $50 million globally by 2021, with projections trending downward.
• Market saturation limits revenue growth; no new indications are currently underway.
• Licensing royalties remain a potential revenue source amid declining brand sales.

FAQs

1. Will RAPAFLO regain market share through new formulations?
Currently, no public plans exist for reformulations, making significant recovery unlikely.

2. How significantly did patent expiration impact RAPAFLO sales?
It resulted in approximately 80% drop in sales within one year due to generic competition.

3. Are there any regulatory barriers to new formulations or indications?
No major barriers are publicly reported; however, FDA approval for new indications requires extensive clinical data.

4. What are the primary competitors, and how do they compare?
Tamsulosin remains the dominant competitor, with a larger market share, longer market presence, and lower price points.

5. What is the outlook for branded sales revenue in the next five years?
Branded sales are expected to remain below $15 million annually, primarily from remaining long-term prescriptions and licensing agreements.

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References

1. IQVIA. (2022). Pharmaceutical market data.
2. U.S. Food and Drug Administration. (2018). FDA approval for Silodosin as a generic drug.
3. Orion Corporation. (2012). RAPAFLO approval and sales data.
4. MarketWatch. (2021). BPH treatment market analysis.
5. FDA. (2020). Patent expiry notices and generic approvals.