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, Orbion Pharms, and Pharmobedient, 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-five patent family members in thirty-three countries.

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

Summary for risedronate sodium

International Patents:	85
US Patents:	3
Tradenames:	3
Applicants:	12
NDAs:	16
Drug Master File Entries:	17
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	16
Patent Applications:	4,363
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
Teva Pharms Usa	RISEDRONATE SODIUM	risedronate sodium	TABLET, DELAYED RELEASE;ORAL	203217-001	May 18, 2015	AB	RX	No	No
Macleods Pharms Ltd	RISEDRONATE SODIUM	risedronate sodium	TABLET;ORAL	203533-003	Nov 29, 2016	AB	RX	No	No
Sun Pharm	RISEDRONATE SODIUM	risedronate sodium	TABLET;ORAL	090886-004	Jun 10, 2014	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	020835-003	May 25, 2002
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-003	May 25, 2002
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-002	Apr 14, 2000

International Patents for risedronate sodium

Country	Patent Number	Title	Estimated Expiration
South Korea	101388777
Australia	2005330654	Dosage forms of risedronate
Germany	602005022578

Market Dynamics and Financial Trajectory for Risedronate Sodium: An In-depth Analysis

Last updated: July 27, 2025

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Introduction

Risedronate sodium, a bisphosphonate derivative, has been a cornerstone in the management of osteoporosis and other bone-resorptive disorders since its approval. As a potent inhibitor of osteoclast-mediated bone resorption, risedronate has established a significant presence in the pharmaceutical landscape. With evolving demographic trends, regulatory landscapes, and technological innovations, understanding the market dynamics and financial trajectory of risedronate sodium is imperative for stakeholders aiming to capitalize on growth opportunities and mitigate risks.

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Pharmaceutical Market Landscape for Risedronate Sodium

Therapeutic Area and Clinical Demand

Risedronate targets osteoporosis—a condition characterized by decreased bone density and increased fracture risk—primarily impacting postmenopausal women, older adults, and certain patient populations with corticosteroid-induced osteoporosis. The global prevalence of osteoporosis is projected to reach 1.2 billion by 2050, spurring sustained demand for effective therapies. Currently, risedronate accounts for a significant share within bisphosphonate therapeutics, with therapies favored for their efficacy and safety profiles.

Regulatory Environment and Approvals

Risedronate received notable regulatory approvals across major markets, including the FDA (1998), EMA (1998), and other national agencies, for indications such as postmenopausal osteoporosis, Paget’s disease of bone, and corticosteroid-induced osteoporosis. Post-approval, regulatory bodies have continued to scrutinize safety profiles, especially concerning rare adverse effects like osteonecrosis of the jaw and atypical femoral fractures, influencing prescribing behaviors and patent strategies.

Patent Expiry and Generic Competition

A critical driver impacting market dynamics is the patent expiration of several risedronate formulations, notably initial formulations in the early 2010s. Patent cliffs have led to increasing generic entry, exerting downward pressure on prices and impacting revenue streams for original developers. The proliferation of generics has democratized access, expanding the patient base but compressing profit margins for innovators.

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Market Drivers

Growing Demographic Burden

The aging global population remains the dominant catalyst for sustained demand. According to WHO, the population aged 60 and above is projected to double by 2050, amplifying osteoporosis prevalence and related fracture risks, thereby fueling prescription rates of risedronate.

Advancements in Formulation and Delivery

Innovations such as weekly versus daily dosing regimens, intravenous options, and improved bioavailability have enhanced patient adherence and broadened market reach. The development of combination therapies further emphasizes the drug's relevance.

Increased Awareness and Screening

Enhanced osteoporosis screening programs and public health initiatives have increased early diagnosis rates, translating into higher prescription volumes. Furthermore, growing awareness about fracture prevention elevates demand for maintenance therapies like risedronate.

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Market Challenges

Safety and Side Effect Profile

Concerns regarding long-term bisphosphonate safety influence prescribing patterns. Regulatory warnings and patient education efforts demand heightened pharmacovigilance, potentially limiting widespread adoption.

Pricing Pressures and Reimbursement

Universal pressure to curb healthcare costs impacts revenue, especially in markets with stringent reimbursement policies. The advent of generics has intensified price competition, necessitating strategic positioning.

Alternatives and Shift Toward Novel Therapies

The advent of newer therapeutic classes—such as anabolic agents (e.g., teriparatide) and monoclonal antibodies (denosumab)—has diversified treatment options. These alternatives, offering differing mechanisms and dosing advantages, pose competitive threats to risedronate.

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Financial Trajectory and Market Forecast

Historical Revenue Trends

Historically, risedronate has achieved peak sales in its initial years post-approval, driven by extensive clinical use. The patent lifecycle’s progression saw a shift towards generic competition, resulting in a decline in brand-specific revenues but an expansion in overall market size due to increased accessibility.

Current Market Valuation

As of 2022, the global bisphosphonate market—dominated by risedronate, alendronate, and ibandronate—was valued at approximately USD 4 billion, with risedronate accounting for an estimated 35–40% of this segment. The segment is expected to grow at a CAGR of 3–5% through 2028, driven mainly by emerging markets and aging populations.

Future Growth Drivers

Emerging markets present significant room for growth, supported by increasing osteoporosis awareness and improving healthcare infrastructure. Additionally, extended indications, such as for Paget’s disease, and combination regimens will bolster sales.

Impact of Biosimilars and Generics

The increasing penetration of biosimilar and generic versions from 2014 onward influences overall market share and revenue potential. While reducing prices, these entrants push incumbent companies toward innovation, biosimilar development, and strategic alliances to sustain profitability.

Investment Trends and Pharma Strategies

Pharmaceutical companies are exploring lifecycle management opportunities through reformulations, new indications, and combination strategies to extend the commercial viability of risedronate. Investment in pharmacovigilance, targeted marketing, and clinical research aims to mitigate safety concerns and differentiate offerings.

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Regulatory and Market Outlook

The outlook for risedronate’s market trajectory remains cautiously optimistic. The aging demographic sustains natural demand, while advancements in drug delivery and formulations expand its applicability. Nevertheless, safety concerns, patent expirations, and competitive pressures necessitate strategic innovation. Companies that invest in clinical research, diversify portfolios, and adapt to evolving regulatory landscapes will position favorably for sustained revenue streams.

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Key Takeaways

• Demographics Drive Demand: Global aging populations are the primary long-term growth driver, necessitating ongoing access to effective osteoporosis therapies.
• Patent Expiry Amplifies Competition: Generic and biosimilar entries following patent expirations have compressed profit margins but expanded market access and volume.
• Innovation is Critical: Advances in formulations, combination therapies, and indications are essential to maintain market relevance.
• Safety Profile Management: Vigilant pharmacovigilance and transparent communication are vital amid safety concerns affecting prescribing behaviors.
• Emerging Markets Present Opportunities: Rapid healthcare infrastructure development and increased screening facilitate growth prospects in Asia-Pacific, Latin America, and Africa.

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FAQs

1. How has patent expiry affected risedronate sodium’s market sales?
Patent expirations led to the entry of generic competitors, significantly reducing prices and revenue for brand-name formulations. However, increased accessibility broadened the patient base, partially offsetting revenue declines.

2. What are the key safety concerns influencing risedronate’s market trajectory?
Risks such as osteonecrosis of the jaw and atypical femoral fractures have prompted regulatory warnings, impacting prescriber confidence and patient adherence.

3. Which emerging therapies threaten risedronate’s market share?
Agents like denosumab (a monoclonal antibody) and anabolic drugs such as teriparatide offer alternative mechanisms, often with simplified dosing, thus challenging bisphosphonate dominance.

4. How are developers extending risedronate’s lifecycle?
Through new formulations (e.g., IV options), expanded indications, combination therapies, and exploring biosimilar development.

5. What growth strategies should pharmaceutical companies consider?
Focusing on emerging markets, investing in clinical research to demonstrate safety, and developing innovative formulations to improve adherence.

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References

[1] WHO. Osteoporosis Fact Sheet. World Health Organization, 2021.

[2] MarketLine. Global Osteoporosis Treatment Market Report, 2022.

[3] U.S. Food and Drug Administration. Risedronate Sodium Approvals and Safety Warnings, 1998–2022.

[4] IMS Health. Pharmacovigilance and Safety Concerns in Bisphosphonates, 2021.

[5] Grand View Research. Bisphosphonate Drugs Market Size & Trends, 2022–2028.