Risedronate sodium - Generic Drug Details

What are the generic drug sources for risedronate sodium and what is the scope of freedom to operate?

Risedronate sodium is the generic ingredient in three branded drugs marketed by Apil, 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 sixteen NDAs. There are three patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Risedronate sodium has eighty-four patent family members in thirty-three countries.

There are seventeen drug master file entries for risedronate sodium. Thirteen suppliers are listed for this compound.

Summary for risedronate sodium

International Patents:	84
US Patents:	3
Tradenames:	3
Applicants:	12
NDAs:	16
Drug Master File Entries:	17
Finished Product Suppliers / Packagers:	13
Raw Ingredient (Bulk) Api Vendors:	87
Clinical Trials:	16
Patent Applications:	3,859
Drug Prices:	Drug price trends for risedronate sodium
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for risedronate sodium
What excipients (inactive ingredients) are in risedronate sodium?	risedronate sodium excipients list
DailyMed Link:	risedronate sodium at DailyMed

See drug prices for risedronate sodium

Recent Clinical Trials for risedronate sodium

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

Sponsor	Phase
Sheffield Children's NHS Foundation Trust	Phase 2
Takeda
Chugai Pharmaceutical	Phase 3

See all risedronate sodium clinical trials

Pharmacology for risedronate sodium

Drug Class

Bisphosphonate

Medical Subject Heading (MeSH) Categories for risedronate sodium

Bone Density Conservation Agents

Calcium Channel Blockers

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
Apotex	RISEDRONATE SODIUM	risedronate sodium	TABLET;ORAL	090877-003	Jun 10, 2014	AB	RX	No	No
Apotex	RISEDRONATE SODIUM	risedronate sodium	TABLET;ORAL	090877-002	Jun 10, 2014	AB	RX	No	No
Impax Labs Inc	RISEDRONATE SODIUM	risedronate sodium	TABLET, DELAYED RELEASE;ORAL	205066-001	Jun 29, 2018		DISCN	No	No
Macleods Pharms Ltd	RISEDRONATE SODIUM	risedronate sodium	TABLET;ORAL	203533-001	Dec 9, 2015	AB	RX	No	No
Apotex	RISEDRONATE SODIUM	risedronate sodium	TABLET;ORAL	090877-001	Nov 30, 2015	AB	RX	No	No
Norvium Bioscience	RISEDRONATE SODIUM	risedronate sodium	TABLET;ORAL	200477-003	Nov 30, 2015		DISCN	No	No
Aurobindo Pharma Ltd	RISEDRONATE SODIUM	risedronate sodium	TABLET;ORAL	200296-002	Nov 30, 2015	AB	RX	No	No

Expired US Patents for risedronate sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-004	Apr 16, 2007
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-002	Apr 14, 2000
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-003	May 25, 2002
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-003	May 25, 2002
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-004	Apr 16, 2007
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-001	Mar 27, 1998
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-002	Apr 14, 2000

International Patents for risedronate sodium

Country	Patent Number	Title	Estimated Expiration
Canada	2675652	DOSAGE FORMS OF RISEDRONATE
Mexico	2007012821
Taiwan	201138783
World Intellectual Property Organization (WIPO)	2010014765
Poland	2283825
Norway	20075834
Japan	2010275319

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.