You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 26, 2024

SILODOSIN Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


When do Silodosin patents expire, and what generic alternatives are available?

Silodosin is a drug marketed by 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 twelve NDAs.

The generic ingredient in SILODOSIN 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 Silodosin

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

  Subscribe

AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for SILODOSIN?
  • What are the global sales for SILODOSIN?
  • What is Average Wholesale Price for SILODOSIN?
Drug patent expirations by year for SILODOSIN
Drug Prices for SILODOSIN

See drug prices for SILODOSIN

Recent Clinical Trials for SILODOSIN

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

SponsorPhase
Amiri HospitalPhase 3
Mansoura UniversityPhase 3
Benha UniversityN/A

See all SILODOSIN clinical trials

Pharmacology for SILODOSIN
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
Ajanta Pharma Ltd SILODOSIN silodosin CAPSULE;ORAL 211060-001 Dec 3, 2018 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Macleods Pharms Ltd SILODOSIN silodosin CAPSULE;ORAL 211166-002 Dec 3, 2018 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Zydus Pharms SILODOSIN silodosin CAPSULE;ORAL 204816-002 Dec 8, 2022 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Aurobindo Pharma Ltd SILODOSIN silodosin CAPSULE;ORAL 210626-001 Dec 10, 2018 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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.

More… ↓

⤷  Subscribe

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.