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Last Updated: December 22, 2024

RISEDRONATE SODIUM Drug Patent Profile


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

Risedronate Sodium is a drug marketed by Impax Labs Inc, Sun Pharm, Teva Pharms Usa, Zydus Pharms, Apotex, Aurobindo Pharma, Aurobindo Pharma Ltd, Hangzhou Binjiang, Macleods Pharms Ltd, Norvium Bioscience, and Orbion Pharms. and is included in fourteen NDAs.

The generic ingredient in RISEDRONATE SODIUM is risedronate sodium. There are nineteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the risedronate sodium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Risedronate Sodium

A generic version of RISEDRONATE SODIUM was approved as risedronate sodium by TEVA PHARMS USA on October 5th, 2007.

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Recent Clinical Trials for RISEDRONATE SODIUM

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SponsorPhase
Sheffield Children's NHS Foundation TrustPhase 2
Takeda
Chugai PharmaceuticalPhase 3

See all RISEDRONATE SODIUM clinical trials

Pharmacology for RISEDRONATE SODIUM
Drug ClassBisphosphonate
Medical Subject Heading (MeSH) Categories for RISEDRONATE SODIUM
Paragraph IV (Patent) Challenges for RISEDRONATE SODIUM
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ATELVIA Delayed-release Tablets risedronate sodium 35 mg 022560 1 2011-06-09
ACTONEL Tablets risedronate sodium 150 mg 020835 1 2008-08-12
ACTONEL Tablets risedronate sodium 75 mg 020835 1 2007-09-07
ACTONEL Tablets risedronate sodium 5 mg, 30 mg and 35 mg 020835 1 2004-04-23

US Patents and Regulatory Information for RISEDRONATE SODIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva Pharms Usa RISEDRONATE SODIUM risedronate sodium TABLET;ORAL 077132-001 Oct 5, 2007 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Teva Pharms Usa RISEDRONATE SODIUM risedronate sodium TABLET;ORAL 077132-002 Oct 5, 2007 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Impax Labs Inc RISEDRONATE SODIUM risedronate sodium TABLET, DELAYED RELEASE;ORAL 205066-001 Jun 29, 2018 DISCN 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

RISEDRONATE SODIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Risedronate Sodium

Introduction

Risedronate sodium, a bisphosphonate drug, has been a significant player in the treatment of osteoporosis, particularly in postmenopausal women. The market for this drug has experienced substantial growth and is projected to continue on this upward trajectory. Here, we delve into the market dynamics and financial outlook for risedronate sodium.

Market Growth and Projections

The risedronate sodium market has witnessed rapid and substantial growth in recent years. This trend is expected to persist from 2023 to 2031, with forecasts indicating continued significant expansion. The market is categorized based on type (purity levels such as ≥99% and ≥99.5%), application (tablets, capsules), and geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa)[1][4].

Market Segmentation

The market is segmented into various categories to provide a comprehensive analysis:

By Type

  • Purity Levels: The market is segmented based on the purity levels of risedronate sodium, such as ≥99% and ≥99.5%. This segmentation helps in understanding the demand for different purity levels, which can impact pricing and manufacturing processes[1][4].

By Application

  • Tablets and Capsules: Risedronate sodium is available in both tablet and capsule forms. The demand for these forms varies based on patient preferences, medical indications, and regional market conditions[1][4].

By Geographical Region

  • Global Markets: The market is analyzed across different geographical regions. Asia-Pacific, for instance, is expected to show significant growth due to an increasing elderly population and rising healthcare expenditures[1][4].

Market Dynamics

The market dynamics of risedronate sodium are influenced by several factors:

Drivers

  • Increasing Prevalence of Osteoporosis: The rising incidence of osteoporosis, especially among postmenopausal women, is a key driver. As the global population ages, the demand for osteoporosis treatments is expected to increase[1][4].
  • Advancements in Formulations: The development of new formulations, such as delayed-release tablets, enhances patient compliance and safety, driving market growth[5].

Restraints

  • Adverse Reactions: Common adverse reactions such as back pain, arthralgia, abdominal pain, and dyspepsia can limit market growth. These side effects may lead to patient discontinuation and affect market penetration[2][5].
  • Competition from Alternative Treatments: The presence of other osteoporosis treatments, including non-bisphosphonate drugs, can pose a competitive challenge to risedronate sodium[1][4].

Opportunities

  • Emerging Markets: Expanding into emerging markets, particularly in Asia-Pacific and Latin America, offers significant growth opportunities due to increasing healthcare spending and a growing elderly population[1][4].
  • Research and Development: Continuous R&D in improving drug formulations and reducing side effects can open new avenues for market expansion[3].

Challenges

  • Regulatory Hurdles: Strict regulatory requirements and the need for clinical trials can slow down the introduction of new formulations and impact market growth[3].
  • Economic Factors: Economic fluctuations and changes in healthcare policies can affect the affordability and accessibility of risedronate sodium, posing challenges to market expansion[1][4].

Financial Outlook

The financial trajectory of the risedronate sodium market is promising:

Revenue Projections

  • The market is expected to grow significantly from 2023 to 2031, with revenue projections indicating robust growth rates. The market size is measured in USD million across various segments[1][4].

Key Players

  • Established and emerging players in the market, including those involved in the development and manufacturing of risedronate sodium, are profiled in market reports. These companies play a crucial role in driving innovation and competition[1][4].

Pricing Analysis

  • The pricing of risedronate sodium is influenced by factors such as product purity, formulation type, and regional market conditions. A detailed pricing analysis is conducted to understand the impact on market dynamics[1][4].

Competitive Analysis

The competitive landscape of the risedronate sodium market is characterized by:

Porter's 5 Forces Framework

  • This framework is used to analyze the competitive forces at play, including the threat of new entrants, the bargaining power of suppliers and buyers, the threat of substitute products, and the intensity of rivalry among existing competitors[1][4].

Corporate Profiles

  • Market reports include extensive lists of prominent companies, their market entry year, and various market-related factors. This information is crucial for understanding the competitive positioning of each player[1][4].

Regulatory and Clinical Aspects

The regulatory and clinical aspects of risedronate sodium are critical:

Approval History

  • Risedronate sodium was first approved in the United States in March 1998 by Procter & Gamble Pharmaceuticals, Inc. This approval marked the beginning of its widespread use in treating osteoporosis[3].

Clinical Trials

  • The safety and efficacy of risedronate sodium have been assessed in numerous clinical trials. These trials have provided valuable data on its adverse reactions and overall safety profile[2][5].

Safety and Tolerability

The safety and tolerability of risedronate sodium are key considerations:

Adverse Reactions

  • Common adverse reactions include back pain, arthralgia, abdominal pain, and dyspepsia. These reactions are closely monitored in clinical trials to ensure the drug's safety profile[2][5].

Gastrointestinal Adverse Reactions

  • Gastrointestinal adverse reactions, such as diarrhea, abdominal pain, and dyspepsia, are significant concerns. These reactions can lead to study discontinuation and affect patient compliance[5].

Conclusion

The market for risedronate sodium is poised for significant growth driven by increasing demand for osteoporosis treatments, advancements in drug formulations, and expansion into emerging markets. However, the market also faces challenges such as adverse reactions, competition from alternative treatments, and regulatory hurdles.

Key Takeaways

  • Rapid Market Growth: The risedronate sodium market has experienced substantial growth and is projected to continue this trend from 2023 to 2031.
  • Segmentation: The market is segmented by type, application, and geographical region to provide a comprehensive analysis.
  • Drivers and Restraints: Increasing prevalence of osteoporosis and advancements in formulations are key drivers, while adverse reactions and competition pose restraints.
  • Financial Outlook: Revenue projections indicate robust growth rates, with the market size measured in USD million across various segments.
  • Competitive Analysis: The competitive landscape is characterized by established and emerging players, with a detailed analysis using Porter's 5 Forces Framework.

FAQs

Q1: What is the primary indication for risedronate sodium?

  • Risedronate sodium is primarily indicated for the treatment of postmenopausal osteoporosis[2][5].

Q2: What are the common adverse reactions associated with risedronate sodium?

  • Common adverse reactions include back pain, arthralgia, abdominal pain, and dyspepsia[2][5].

Q3: How is the risedronate sodium market segmented?

  • The market is segmented by type (purity levels), application (tablets, capsules), and geographical regions[1][4].

Q4: What are the key drivers of the risedronate sodium market?

  • Key drivers include the increasing prevalence of osteoporosis and advancements in drug formulations[1][4].

Q5: What are the potential challenges facing the risedronate sodium market?

  • Challenges include adverse reactions, competition from alternative treatments, and regulatory hurdles[1][4].

Sources

  1. Market Research Intellect: Global Risedronate Sodium API Market Size, Scope And Forecast Report.
  2. Drugs.com: Risedronate: Package Insert / Prescribing Information.
  3. Patsnap Synapse: Unleashing the Power of Risedronate sodium - A Comprehensive Review on R&D Breakthroughs.
  4. Market Research Intellect: Global Risedronate Sodiums Market Size, Scope And Forecast Report.
  5. Drugs.com: Risedronate Delayed Release: Package Insert / Prescribing Info.

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