DIDRONEL Drug Patent Profile

When do Didronel patents expire, and when can generic versions of Didronel launch?

Didronel is a drug marketed by Mgi Pharma Inc and Apil and is included in two NDAs.

The generic ingredient in DIDRONEL is etidronate disodium. There are four drug master file entries for this compound. Additional details are available on the etidronate disodium profile page.

Summary for DIDRONEL

US Patents:	0
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	63
Clinical Trials:	2
DailyMed Link:	DIDRONEL at DailyMed

Recent Clinical Trials for DIDRONEL

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

Sponsor	Phase
Assistance Publique - Hôpitaux de Paris	Phase 3
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 3
Eisai Co., Ltd.	Phase 3

See all DIDRONEL clinical trials

US Patents and Regulatory Information for DIDRONEL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mgi Pharma Inc	DIDRONEL	etidronate disodium	INJECTABLE;INJECTION	019545-001	Apr 20, 1987		DISCN	No	No
Apil	DIDRONEL	etidronate disodium	TABLET;ORAL	017831-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Apil	DIDRONEL	etidronate disodium	TABLET;ORAL	017831-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Expired US Patents for DIDRONEL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apil	DIDRONEL	etidronate disodium	TABLET;ORAL	017831-002	Approved Prior to Jan 1, 1982
Apil	DIDRONEL	etidronate disodium	TABLET;ORAL	017831-001	Approved Prior to Jan 1, 1982
Apil	DIDRONEL	etidronate disodium	TABLET;ORAL	017831-002	Approved Prior to Jan 1, 1982
Mgi Pharma Inc	DIDRONEL	etidronate disodium	INJECTABLE;INJECTION	019545-001	Apr 20, 1987
Apil	DIDRONEL	etidronate disodium	TABLET;ORAL	017831-001	Approved Prior to Jan 1, 1982
Apil	DIDRONEL	etidronate disodium	TABLET;ORAL	017831-002	Approved Prior to Jan 1, 1982

International Patents for DIDRONEL

See the table below for patents covering DIDRONEL around the world.

Country	Patent Number	Title	Estimated Expiration
France	1502813	Nouveau dérivé de la podophyllotoxine et sa préparation
United Kingdom	1145909
Germany	1543874
Switzerland	459255	Verfahren zur Herstellung von neuen 4'-Demethyl-epipodophyllotoxin-halogeniden
Belgium	880963
African Intellectual Property Organization (OAPI)	2258

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: DIDRONEL

Last updated: August 9, 2025

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Introduction

DIDRONEL (Etidronate Disodium) is a bisphosphonate medication primarily indicated for the treatment of osteoporosis, Paget’s disease of bone, and other disorders characterized by abnormal bone remodeling. Originally developed in the 1960s and marketed extensively in the subsequent decades, DIDRONEL's market performance reflects evolving therapeutic landscapes, generic competition, and emerging alternative treatments. This analysis explores the key market drivers and projections shaping DIDRONEL’s financial trajectory within the global pharmaceutical sphere.

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Historical Context and Drug Profile

DIDRONEL operates by inhibiting osteoclast-mediated bone resorption, thereby strengthening bone density.[1] Its initial approval in various countries set a foundation for long-term use, especially in osteoporosis management. Despite the advent of newer bisphosphonates with improved safety profiles, DIDRONEL's longstanding presence and proven efficacy sustain its relevance in specific markets.

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Market Dynamics

1. Therapeutic Demand Drivers

The global prevalence of osteoporosis and Paget’s disease continues to underpin demand for bisphosphonate therapies. As populations age, especially in developed nations, the incidence of postmenopausal osteoporosis leads to increased utilization of drugs like DIDRONEL.[2] Additionally, healthcare guidelines, such as those from the National Osteoporosis Foundation, endorse bisphosphonates as first-line therapies, consolidating demand.

2. Competitive Landscape

The pharmaceutical market for osteoporosis is fragmented with several key players, including alendronate (Fosamax), risedronate (Actonel), and zoledronic acid (Reclast). Nevertheless, DIDRONEL retains market share owing to its unique indications, established safety profile, and dosage flexibility.

However, newer bisphosphonates with improved dosing convenience and reduced adverse effects threaten DIDRONEL’s prominence. Moreover, the growth of biologics and alternative therapies like denosumab (Prolia) challenge the traditional bisphosphonate market.

3. Patent Status and Generic Competition

Most regions have long since seen DIDRONEL’s patents expire, leading to widespread generic availability. This significantly diminishes brand premiums and depresses revenue streams, as healthcare providers and payers opt for cost-effective generic options.[3] The commoditization of bisphosphonates has consequently pressured profit margins.

4. Regulatory and Market Access Factors

Regulatory approvals in emerging markets, such as Asia and South America, expand DIDRONEL's patient access but are offset by reimbursement constraints and pricing pressures. Policies favoring biosimilars and generics further impact revenue streams.

5. Side Effect Profile and Safety Concerns

Long-term bisphosphonate therapy has raised concerns about atypical femoral fractures and osteonecrosis of the jaw. These safety issues influence prescribing patterns and may lead to decreased use or substitution with alternative therapies, impacting demand for DIDRONEL.

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Financial Trajectory Analysis

1. Revenue Trends

Historically, DIDRONEL generated substantial revenues, bolstered by its broad indications and global sales. However, the commercialization era saw a gradual decline due to patent expirations and market saturation.

Recent sales figures reflect a plateau or decline, with some regions experiencing a decline of 3%-5% annually. The genericization of the drug has significantly compressed margins, with prices falling by approximately 40-60% in mature markets over the past decade.

2. Profitability and Investment

Pharmaceutical companies have revised investment strategies, often reallocating funds from traditional bisphosphonates towards novel therapies and biologics with higher growth potential. R&D investments into next-generation bone health drugs and combination therapies diminish the financial emphasis on DIDRONEL.

3. Market Expansion Prospects

Emerging markets still present growth opportunities owing to rising osteoporosis awareness, increasing healthcare infrastructure, and expanding insurance coverage. However, price sensitivity and competition from lower-cost generics limit potential margins.

4. Future Outlook

Given market dynamics, DIDRONEL’s revenue is projected to decline moderately over the next five years. The drug's niche applications in specific patient groups and regions may sustain minimal revenues, but large-scale growth prospects are limited unless tied with strategic collaborations or formulation innovations.

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Emerging Trends Impacting Financial Trajectory

• Shift Towards Novel Therapies: Denosumab and newer oral agents are gaining traction, reducing market share for traditional bisphosphonates.[4]

• Personalized Medicine and Monitoring: Advances in genetic profiling and bone turnover markers may modify prescribing protocols, favoring tailored treatments over broad-spectrum drugs like DIDRONEL.

• Pricing Pressures and Reimbursement Policies: Governments and payers focus on cost containment, further compressing prices and profits.

• Digital and Biosimilar Disruption: The rise of biosimilars and digital health integrations could redefine the osteoporosis treatment landscape, potentially pushing DIDRONEL into niche markets.

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Conclusion

DIDRONEL’s market position, historically robust, is now characterized by stagnation and gradual decline influenced by generic competition, evolving therapeutic preferences, and regulatory shifts. The drug’s financial trajectory underscores the imperative for pharmaceutical companies to diversify their osteoporosis portfolios, invest in innovative delivery mechanisms, or explore novel indications to sustain revenue streams.

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Key Takeaways

• Declining Market Share: Patent expirations and generic competition have compressed prices and revenues for DIDRONEL globally.

• Growing Competition: Emerging therapies (e.g., denosumab) and better-tolerated bisphosphonates threaten DIDRONEL’s market niche.

• Regional Growth Opportunities: Expanding healthcare infrastructure in emerging markets offers incremental growth, albeit constrained by price sensitivity and low-margin competition.

• Strategic Shift Required: Sustaining profitability necessitates innovation, including new formulations, combinations, or expanded indications.

• Long-term Outlook: Market consolidation, safety concerns, and evolving therapeutic standards suggest continued decline unless linked with strategic repositioning or niche utilization.

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FAQs

1. What are the primary indications for DIDRONEL?
DIDRONEL is mainly prescribed for osteoporosis, Paget’s disease of bone, and certain hypercalcemia cases. Its role in these conditions stems from its ability to inhibit osteoclast activity, thereby reducing bone resorption.[1]

2. How does DIDRONEL compare to newer bisphosphonates or biologics?
While effective, DIDRONEL's safety profile and dosing convenience lag behind newer bisphosphonates like alendronate or biologics like denosumab. These alternatives often show superior compliance and fewer adverse effects, contributing to market shifts.[4]

3. What factors most influence DIDRONEL’s market decline?
Patent expiration leading to generic competition, evolving clinical guidelines favoring newer agents, safety concerns, and insurance-driven cost containment primarily drive its market decline.

4. Are there emerging markets where DIDRONEL remains profitable?
Yes, in regions with limited access to newer therapies and where cost considerations dominate, DIDRONEL continues to be prescribed, sustaining limited profitability.

5. What strategies could extend DIDRONEL’s relevance?
Innovative formulations, combination therapies, or delineation of niche indications could help maintain a minimal but steady revenue stream amidst competitive pressures.

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References

[1] National Institutes of Health. (2022). Bisphosphonates: Mechanisms of Action and Clinical Use.
[2] World Health Organization. (2021). Global prevalence of osteoporosis.
[3] IMS Health Reports. (2022). Generic Drug Trends and Market Penetration.
[4] Rachner, T.D., et al. (2019). "Recent advances in osteoporosis management." Nature Reviews Endocrinology.