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
Raw Ingredient (Bulk) Api Vendors:	5
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	021762-002	Apr 26, 2007	5,358,941*PED
Organon Llc	FOSAMAX PLUS D	alendronate sodium; cholecalciferol	TABLET;ORAL	021762-001	Apr 7, 2005	4,621,077*PED
Organon Llc	FOSAMAX PLUS D	alendronate sodium; cholecalciferol	TABLET;ORAL	021762-002	Apr 26, 2007	5,681,590*PED
Organon Llc	FOSAMAX PLUS D	alendronate sodium; cholecalciferol	TABLET;ORAL	021762-002	Apr 26, 2007	6,090,410*PED

Market Dynamics and Financial Trajectory for Alendronate Sodium and Cholecalciferol

Last updated: July 29, 2025

---

Introduction

The global pharmaceutical landscape is heavily influenced by demographic shifts, technological advancements, regulatory environments, and evolving healthcare needs. Two prominent compounds—Alendronate Sodium and Cholecalciferol—serve critical roles in the management of osteoporosis and vitamin D deficiency, respectively. Understanding their market dynamics and financial trajectories offers vital insights for stakeholders aiming to navigate this complex industry.

---

Market Overview

Alendronate Sodium, a bisphosphonate, primarily treats osteoporosis by inhibiting bone resorption. It has been a cornerstone in osteoporosis therapy for decades, with formulations including oral tablets and intravenous variants. The drug's widespread adoption results from a well-established efficacy profile, although concerns over adverse effects such as osteonecrosis of the jaw and atypical femoral fractures influence prescribing trends.

Cholecalciferol (Vitamin D3) addresses vitamin D deficiency, a condition with increasing prevalence due to lifestyle, urbanization, and aging populations. It is vital for calcium absorption and bone health, and its supplementation ranges from over-the-counter products to prescription medications. The rising awareness of vitamin D’s broader health benefits, including immune modulation, magnifies its market relevance.

---

Market Drivers

1. Demographic Shifts and Aging Populations

Globally, populations are aging rapidly. The World Health Organization estimates that the number of people over 60 will double by 2050, reaching 2.1 billion ([1]). Aging heightens osteoporosis risk, propelling demand for alendronate-based therapies. Similarly, older adults are more susceptible to vitamin D deficiency, feedbacking increased cholecalciferol use.

2. Osteoporosis Prevalence

Osteoporosis affects an estimated 200 million worldwide ([2]), with prevalence escalating due to increased longevity. The direct correlation between reduced bone mineral density and fracture risk fuels the sustained demand for alendronate. The drug's global market share benefits from its long-standing clinical familiarity and generic availability.

3. Vitamin D Deficiency Awareness

Heightened awareness about vitamin D's role in bone and immune health is boosting supplement consumption. The COVID-19 pandemic further amplified interest, positioning cholecalciferol as a prophylactic and therapeutic agent, especially among vulnerable populations.

4. Regulatory and Policy Environment

Stringent regulatory frameworks influence market access. Both drugs face rigorous approval and post-marketing surveillance requirements, which can delay or expand market opportunities. Incentives for osteoporosis and vitamin D deficiency management programs, especially in developed markets, create favorable policy environments.

5. Innovation and Formulation Improvements

Advances in drug delivery, such as once-weekly alendronate and bioavailable cholecalciferol formulations, enhance patient adherence and therapeutic outcomes, fostering market stability.

---

Market Constraints and Challenges

Alendronate Sodium: The drug’s safety profile concerns may limit usage. Risks like gastrointestinal irritation and rare but serious adverse events compel clinicians to reconsider long-term use. Moreover, patient compliance challenges with oral bisphosphonates affect market penetration.

Cholecalciferol: The lack of standardization in over-the-counter formulations and variability in dosing hinder precise management. Differing regulatory classifications across jurisdictions complicate marketing and distribution strategies.

Competitive Landscape and Market Share

Alendronate Sodium: Dominated historically by drug giants like Pfizer and Novartis, with generic versions capturing significant market segments due to cost competitiveness. Patent expirations have increased accessibility, expanding market volume but intensifying competition.

Cholecalciferol: The ubiquitous nature of vitamin D supplements means a highly fragmented market with numerous players, from pharmaceutical companies to nutraceutical brands. This results in intense price competition and innovation in delivery systems.

---

Financial Trajectory and Market Forecasts

Historical Market Values

The global osteoporosis drugs market, encompassing alendronate, was valued at approximately USD 11.1 billion in 2021 ([3]). Alendronate’s segment has historically maintained a substantial share owing to its efficacy and brand recognition.

Vitamin D supplement sales, driven by cholecalciferol, reached over USD 1.7 billion in 2021, with a compound annual growth rate (CAGR) of approximately 6% over the previous five years ([4]).

Predicted Growth Trends

• Alendronate Sodium: Projected CAGR of 4-5% through 2030, driven by aging demographics and increasing osteoporosis awareness, with compounded growth potentially limited by safety concerns and market saturation in developed regions ([3]).

• Cholecalciferol: Expected to grow at a CAGR of 6-8% internationally, fueled by rising health consciousness, vitamin D deficiency prevalence, and expanding fortification and supplementation initiatives ([4]).

Market Challenges and Opportunities

Emerging markets represent significant growth vectors, attributed to rising healthcare investments, urbanization, and increased health literacy. However, patent expiries and generic competition pressure margins. Novel delivery routes, such as lipid nanoparticle formulations of cholecalciferol, offer differentiation opportunities.

---

Regulatory Environment Impact

Stringent regulatory approvals and evolving guidelines influence market evolution. For alendronate, safety concerns led to revised prescribing information and risk mitigation strategies. For cholecalciferol, harmonization of vitamin D intake recommendations impacts formulations and marketing strategies.

The US FDA and EMA’s evolving stance on osteoporosis therapies necessitate ongoing clinical data submission, influencing investment decisions and R&D pipelines.

---

Conclusion

The pharmaceutical markets for Alendronate Sodium and Cholecalciferol are characterized by stable growth driven by demographic aging, increasing disease awareness, and regulatory adaptations. While bleeding-edge innovations and expanding access markets underpin future opportunities, safety concerns, patent expirations, and competitive dynamics continue to shape their financial trajectories. Strategic positioning, enhanced R&D, and market diversification will be pivotal for stakeholders aiming to capitalize on this sustainably growing sector.

---

Key Takeaways

• Demographic and epidemiological trends underpin steady growth for both drugs, especially in developing regions.
• Safety profiles and regulatory updates influence market adoption and prescribing patterns.
• Patent expirations and generic competition may suppress profit margins but expand market accessibility.
• Innovation in formulations and delivery methods present avenues for growth and differentiation.
• Expanding markets, especially in emerging economies, offer significant upside amid regulatory and safety considerations.

---

FAQs

Q1. What are the primary drivers of growth in the alendronate sodium market?
The aging population, increasing osteoporosis prevalence, and demand for long-term osteoporosis management therapies drive growth. Advances in formulations and expanded indications also contribute.

Q2. How does safety concern impact alendronate sodium’s market?
Risks like osteonecrosis of the jaw and atypical fractures have prompted prescribers to be cautious, influencing market share and stimulating development of safer alternatives.

Q3. What factors are fueling the growth of cholecalciferol globally?
Rising awareness of vitamin D deficiency, increased health consciousness, and broad dietary fortification initiatives are key drivers.

Q4. How do patent expirations affect these markets?
Patent expiries increase generic availability, reducing prices and profit margins but expanding access, especially in cost-sensitive markets.

Q5. What regulatory trends could influence future market trajectories?
Enhanced safety monitoring, updated guideline recommendations, and standardization of dosages may influence product approval, marketing strategies, and clinical uptake globally.

---

Sources:

[1] World Health Organization. Ageing and health. 2021.
[2] National Osteoporosis Foundation. Osteoporosis Overview. 2022.
[3] Market Research Future. Osteoporosis Drugs Market Analysis. 2022.
[4] Grand View Research. Vitamin D Market Forecast. 2022.