ALENDRONATE SODIUM; CHOLECALCIFEROL - Generic Drug Details

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

Alendronate sodium; cholecalciferol is the generic ingredient in one branded drug marketed by Organon Llc and is included in one NDA. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for ALENDRONATE SODIUM; CHOLECALCIFEROL

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	1
DailyMed Link:	ALENDRONATE SODIUM; CHOLECALCIFEROL at DailyMed

Recent Clinical Trials for ALENDRONATE SODIUM; CHOLECALCIFEROL

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

Sponsor	Phase
Children's Hospital Medical Center, Cincinnati	Phase 2

See all ALENDRONATE SODIUM; CHOLECALCIFEROL clinical trials

Pharmacology for ALENDRONATE SODIUM; CHOLECALCIFEROL

Drug Class

Bisphosphonate Vitamin D

Paragraph IV (Patent) Challenges for ALENDRONATE SODIUM; CHOLECALCIFEROL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FOSAMAX PLUS D	Tablets	alendronate sodium; cholecalciferol	70 mg/2800 IU and 70 mg/5600 IU	021762	1	2007-11-20

US Patents and Regulatory Information for ALENDRONATE SODIUM; CHOLECALCIFEROL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Organon Llc	FOSAMAX PLUS D	alendronate sodium; cholecalciferol	TABLET;ORAL	021762-001	Apr 7, 2005		RX	Yes	No
Organon Llc	FOSAMAX PLUS D	alendronate sodium; cholecalciferol	TABLET;ORAL	021762-002	Apr 26, 2007		RX	Yes	Yes

Expired US Patents for ALENDRONATE SODIUM; CHOLECALCIFEROL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon Llc	FOSAMAX PLUS D	alendronate sodium; cholecalciferol	TABLET;ORAL	021762-001	Apr 7, 2005	6,090,410*PED
Organon Llc	FOSAMAX PLUS D	alendronate sodium; cholecalciferol	TABLET;ORAL	021762-002	Apr 26, 2007	6,090,410*PED
Organon Llc	FOSAMAX PLUS D	alendronate sodium; cholecalciferol	TABLET;ORAL	021762-001	Apr 7, 2005	4,621,077*PED

ALENDRONATE SODIUM; CHOLECALCIFEROL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Alendronate Sodium and Cholecalciferol

Introduction

Alendronate sodium, often combined with cholecalciferol (vitamin D3), is a widely used medication for the treatment of osteoporosis. The market dynamics and financial trajectory of this drug are influenced by several factors, including demographic changes, healthcare policies, and advancements in pharmaceutical formulations.

Global Market Size and Growth

The global Alendronate market is projected to experience significant growth. As of 2024, the market size is estimated to be USD 102,151.2 million, with a forecasted growth to USD 158,741.59 million by 2031, at a Compound Annual Growth Rate (CAGR) of 6.50% from 2024 to 2031[1].

Regional Market Analysis

North America

North America holds the largest market share, accounting for more than 40% of the global revenue, with a market size of USD 40,860.48 million in 2024. This region is expected to grow at a CAGR of 4.7% from 2024 to 2031[1].

Europe

Europe follows closely, with a market share of over 30% and a market size of USD 30,645.36 million in 2024. The European market is anticipated to grow at a CAGR of 5.0% during the same period[1].

Asia-Pacific

The Asia-Pacific region is the fastest-growing market, driven by a rapidly aging population and increasing awareness of osteoporosis management. This region holds around 23% of the global revenue, with a market size of USD 23,494.78 million in 2024, and is expected to grow at a CAGR of 8.5% from 2024 to 2031[1].

Latin America and Middle East & Africa

Latin America and the Middle East & Africa also contribute to the global market, though to a lesser extent. Latin America holds around 5% of the global revenue with a market size of USD 5,107.56 million in 2024, growing at a CAGR of 5.9%. The Middle East & Africa account for around 2% with a market size of USD 2,043.02 million in 2024, growing at a CAGR of 6.2% from 2024 to 2031[1].

Market Drivers

Aging Population

The global population is aging, leading to an increased prevalence of osteoporosis. This demographic shift is a significant driver for the Alendronate market, as older populations are more likely to require treatments for bone health[1].

Advancements in Pharmaceutical Formulations

Improvements in pharmaceutical formulations and delivery methods enhance patient compliance, which is crucial for the effectiveness of Alendronate. These advancements are expected to boost sales and market growth[1].

Public Health Initiatives

Public health initiatives aimed at educating communities about osteoporosis and its prevention further stimulate demand for effective treatments like Alendronate. These initiatives are particularly impactful in regions like Asia-Pacific, where there is a growing awareness of bone health[1].

Economic Factors

The economic evaluation of Alendronate therapy indicates that it is cost-effective for the treatment of osteoporotic fractures. For instance, a study in Chinese postmenopausal women showed that Alendronate treatment was associated with an additional 0.052 quality-adjusted life-years (QALYs) at an additional cost of USD 738, yielding an incremental cost-effectiveness ratio (ICER) of USD 14,192.308/QALY[3].

Market Restraints

Compliance and Persistence

Despite its cost-effectiveness, the market is affected by issues of compliance and persistence. Full compliance and persistence with Alendronate therapy significantly enhance its cost-effectiveness, but real-world settings often fall short of these ideals. This can lead to higher costs and reduced health outcomes[3].

COVID-19 Pandemic

The COVID-19 pandemic had a temporary impact on the Alendronate market due to disruptions in healthcare services and delayed diagnoses and treatments. However, the market has started to recover as healthcare services resume and telemedicine and home delivery of medications become more prevalent[1].

Financial Trajectory

Revenue Projections

The global Alendronate market is expected to grow substantially, with revenue projected to increase from USD 102,151.2 million in 2024 to USD 158,741.59 million by 2031. This growth is driven by the increasing demand for osteoporosis treatments and the expanding healthcare infrastructure in key regions[1].

Cost-Effectiveness

The cost-effectiveness of Alendronate therapy is a significant financial factor. Studies have shown that Alendronate is more cost-effective than no treatment, especially when considering full compliance and persistence. For example, the ICER for full persistence was found to be USD 3,006.849/QALY, indicating a favorable financial profile for the drug[3].

Impact of Vitamin D3 Combination

Market Dynamics

The combination of Alendronate with cholecalciferol (vitamin D3) addresses the common issue of vitamin D deficiency among osteoporosis patients. This combination enhances the efficacy of the treatment and is a market driver, particularly in regions where vitamin D deficiency is prevalent[4].

Clinical Effectiveness

The safety and effectiveness of FOSAMAX PLUS D, which combines Alendronate and cholecalciferol, are supported by clinical data. This combination ensures that patients receive both the necessary bone mineral density treatment and vitamin D supplementation, which is crucial for maintaining bone health[5].

Key Takeaways

• The global Alendronate market is projected to grow significantly, driven by an aging population and advancements in pharmaceutical formulations.
• Regional markets, especially Asia-Pacific, are expected to see rapid growth due to increasing awareness and healthcare infrastructure.
• Compliance and persistence with Alendronate therapy are critical for its cost-effectiveness.
• The combination with vitamin D3 enhances the treatment's efficacy and addresses common deficiencies.
• The COVID-19 pandemic had a temporary impact, but the market is recovering with the resumption of healthcare services.

FAQs

What is the projected global market size for Alendronate by 2031?

The global Alendronate market is projected to reach USD 158,741.59 million by 2031[1].

How does the COVID-19 pandemic affect the Alendronate market?

The COVID-19 pandemic led to temporary disruptions in healthcare services, delaying diagnoses and treatments. However, the market is recovering as healthcare services resume and telemedicine and home delivery of medications become more prevalent[1].

What is the significance of combining Alendronate with vitamin D3?

Combining Alendronate with cholecalciferol (vitamin D3) addresses vitamin D deficiency, enhancing the treatment's efficacy and ensuring patients receive necessary bone mineral density treatment and vitamin D supplementation[4][5].

What are the key drivers for the Alendronate market?

Key drivers include an aging population, advancements in pharmaceutical formulations, public health initiatives, and the cost-effectiveness of the treatment[1][3].

How important is compliance and persistence in Alendronate therapy?

Compliance and persistence are crucial for the cost-effectiveness of Alendronate therapy. Full compliance and persistence significantly enhance the treatment's cost-effectiveness and health outcomes[3].

Sources

1. Cognitive Market Research, "Alendronate Market Report 2024 (Global Edition)".
2. JAMA, "Effects of Continuing or Stopping Alendronate After 5 Years of Treatment".
3. Frontiers in Pharmacology, "Economic Evaluation of Oral Alendronate Therapy for Osteoporosis".
4. 360iResearch, "Alendronate Sodium Vitamin D3 Tablets Market Size 2025-2030".
5. DailyMed, "FOSAMAX PLUS D - alendronate sodium and cholecalciferol tablet".