Silodosin - Generic Drug Details

What are the generic drug sources for silodosin and what is the scope of patent protection?

Silodosin is the generic ingredient in two branded drugs marketed by Abbvie, Ajanta Pharma Ltd, Alembic, Amneal Pharms Co, Aurobindo Pharma Ltd, Chartwell Rx, Creekwood Pharms, Hetero Labs Ltd V, Lupin Ltd, Macleods Pharms Ltd, MSN, Prinston Inc, and Zydus Pharms, and is included in thirteen NDAs. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for silodosin. Fourteen suppliers are listed for this compound.

Summary for silodosin

US Patents:	0
Tradenames:	2
Applicants:	13
NDAs:	13
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	14
Raw Ingredient (Bulk) Api Vendors:	99
Clinical Trials:	28
Patent Applications:	1,492
Drug Prices:	Drug price trends for silodosin
What excipients (inactive ingredients) are in silodosin?	silodosin excipients list
DailyMed Link:	silodosin at DailyMed

See drug prices for silodosin

Recent Clinical Trials for silodosin

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

Sponsor	Phase
Amiri Hospital	Phase 3
Mansoura University	Phase 3
Benha University	N/A

See all silodosin clinical trials

Pharmacology for silodosin

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

Anatomical Therapeutic Chemical (ATC) Classes for silodosin

G04CA	Alpha-adrenoreceptor antagonists
G04C	DRUGS USED IN BENIGN PROSTATIC HYPERTROPHY
G04	UROLOGICALS
G	Genito-urinary system and sex hormones

Paragraph IV (Patent) Challenges for SILODOSIN

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 silodosin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aurobindo Pharma Ltd	SILODOSIN	silodosin	CAPSULE;ORAL	210626-002	Dec 10, 2018	AB	RX	No	No
Zydus Pharms	SILODOSIN	silodosin	CAPSULE;ORAL	204816-002	Dec 8, 2022		DISCN	No	No
Msn	SILODOSIN	silodosin	CAPSULE;ORAL	210687-001	Dec 3, 2018	AB	RX	No	No
Lupin Ltd	SILODOSIN	silodosin	CAPSULE;ORAL	206541-002	Dec 3, 2018	AB	RX	No	No
Ajanta Pharma Ltd	SILODOSIN	silodosin	CAPSULE;ORAL	211060-002	Dec 3, 2018	AB	RX	No	No
Amneal Pharms Co	SILODOSIN	silodosin	CAPSULE;ORAL	209745-002	Dec 3, 2018	AB	RX	No	No
Prinston Inc	SILODOSIN	silodosin	CAPSULE;ORAL	209029-002	Jan 4, 2022	AB	RX	No	No

Expired US Patents for silodosin

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	022206-001	Oct 8, 2008
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	022206-002	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 silodosin

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

Silodosin Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Silodosin

Introduction to Silodosin

Silodosin is a selective alpha-1 adrenergic receptor antagonist used primarily in the treatment of benign prostatic hyperplasia (BPH). Its unique mechanism of action, which offers improved urinary flow with minimal side effects, has made it a preferred choice in therapeutic regimens for BPH.

Market Size and Growth Projections

The Silodosin API market is anticipated to experience significant growth over the forecast period from 2024 to 2031. The market is expected to develop revenue at a remarkable Compound Annual Growth Rate (CAGR), driven by increasing demand for effective BPH treatments[1][3][4].

Segmentation of the Market

The Silodosin API market is segmented based on several key factors:

• Type: The market is categorized into two main types based on purity: Purity ≥ 98% and Purity < 98%. The higher purity segment is expected to dominate due to its superior quality and efficacy[1].
• Application: Silodosin is primarily used in the form of capsules and tablets. The capsule segment is gaining traction due to its ease of administration and patient compliance[1][3].
• Geography: The market is divided into regions such as North America, Europe, Asia-Pacific, South America, and the Middle East & Africa. The Asia-Pacific region is witnessing robust growth due to improving healthcare infrastructure and rising disposable incomes[1][3].

Emerging Trends and Growth Drivers

Several trends are driving the growth of the Silodosin market:

• Increasing Awareness: Rising awareness among healthcare professionals and patients about the benefits of Silodosin, particularly its selective alpha-1 adrenergic receptor antagonism, is a significant driver. This specificity enhances patient compliance and positions Silodosin as a preferred treatment option[3].
• Regulatory Support: Favorable reimbursement policies and regulatory support are propelling market growth. Governments are incentivizing the use of effective medications like Silodosin through reimbursement schemes, ensuring affordability for patients and encouraging healthcare providers to prescribe it more frequently[3].
• Improving Healthcare Infrastructure: Emerging economies, especially in Asia-Pacific and Latin America, are investing in healthcare facilities and awareness campaigns, leading to increased adoption of Silodosin[3].

Competitive Landscape

The competitive landscape of the Silodosin market is evolving with several key players focusing on strategic partnerships and collaborations:

• Key Players: Companies such as Kissei Pharmaceuticals Co Ltd, Cadila Healthcare Ltd, Hetero Drugs Ltd, and others are prominent in the market. These companies are involved in various market-related activities including product launches, mergers and acquisitions, and partnerships[1].
• Research and Development: Efforts are directed towards exploring combination therapies that integrate Silodosin with other agents for a synergistic effect, potentially increasing its therapeutic efficacy and market share[3].

Financial Trajectory

The financial trajectory of the Silodosin market is promising, with several factors contributing to its growth:

• Revenue Projections: The market is expected to generate significant revenue, measured in USD million, across various segments. The forecast period from 2024 to 2031 is anticipated to see substantial growth in market value[1][4].
• Market Dynamics: The market dynamics are influenced by a combination of drivers, restraints, opportunities, and challenges. Drivers include the increasing prevalence of BPH, rising awareness of Silodosin's benefits, and favorable regulatory environments. Restraints include patent expirations and the entry of generic alternatives, which could lead to reduced profit margins for branded products[1][3].

Geographical Performance

Geographically, the Silodosin market is performing well in various regions:

• Asia-Pacific: This region is witnessing robust growth due to a rapidly aging demographic and increasing urbanization. Countries like Japan and China are experiencing a surge in BPH cases, prompting healthcare professionals to prescribe Silodosin more frequently[3].
• Latin America: This region is gradually emerging as a significant player, driven by improving healthcare access and increased awareness of urological disorders. Brazil and Mexico are at the forefront, where healthcare reforms have enhanced the availability of medications[3].

Challenges and Opportunities

Despite the positive outlook, the Silodosin market faces several challenges and opportunities:

• Challenges: Patent expirations and the subsequent entry of generic alternatives pose a significant threat to revenue streams. Stringent regulatory landscapes governing pharmaceutical approvals can also delay the introduction of new formulations or combinations[3].
• Opportunities: Emerging markets present a wealth of opportunities, particularly in regions with expanding healthcare infrastructures. The integration of telemedicine and digital health platforms facilitates patient engagement and timely diagnosis, boosting the demand for Silodosin capsules[3].

Forecasting Future Growth

The future growth of the Silodosin market is driven by several factors:

• Increasing Geriatric Population: As the global population ages, the prevalence of BPH escalates, creating a robust demand for effective treatment options like Silodosin[3].
• Patient-Centric Approaches: The global market is shifting towards patient-centric approaches, with healthcare providers focusing on personalized medicine that tailors treatment plans according to individual patient needs[3].

Key Takeaways

• The Silodosin API market is poised for significant growth driven by increasing demand for effective BPH treatments.
• The market is segmented by type, application, and geography, with the Asia-Pacific region showing robust growth.
• Emerging trends include rising awareness of Silodosin's benefits, regulatory support, and improving healthcare infrastructure.
• The competitive landscape is characterized by strategic partnerships and R&D efforts towards combination therapies.
• Despite challenges like patent expirations and regulatory hurdles, the market presents opportunities in emerging economies and through patient-centric approaches.

Frequently Asked Questions (FAQs)

Q1: What is the primary use of Silodosin? Silodosin is primarily used in the treatment of benign prostatic hyperplasia (BPH), offering improved urinary flow with minimal side effects.

Q2: Which regions are driving the growth of the Silodosin market? The Asia-Pacific and Latin America regions are driving the growth of the Silodosin market due to improving healthcare infrastructure and rising awareness of urological disorders.

Q3: What are the key drivers of the Silodosin market? Key drivers include increasing awareness of Silodosin's benefits, favorable regulatory environments, and improving healthcare infrastructure in emerging economies.

Q4: What challenges does the Silodosin market face? The market faces challenges such as patent expirations, the entry of generic alternatives, and stringent regulatory landscapes governing pharmaceutical approvals.

Q5: How is the competitive landscape of the Silodosin market evolving? The competitive landscape is evolving with key players focusing on strategic partnerships, collaborations, and research and development efforts towards combination therapies.

Cited Sources

1. Market Research Intellect, "Global Silodosin API Market Size, Trends and Projections," December 2024.
2. Daiichi Sankyo Co., Ltd., "Annual Report 2010," July 31, 2008.
3. PW Consulting, "Silodosin Capsules Market," 2024.
4. QYResearch, "Global Silodosin Capsules Market Insights, Forecast to 2030," February 22, 2024.