CALCIFEDIOL - Generic Drug Details

What are the generic sources for calcifediol and what is the scope of patent protection?

Calcifediol is the generic ingredient in two branded drugs marketed by Eirgen and Organon Usa Inc, and is included in two NDAs. There are sixteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Calcifediol has one hundred and seventy-six patent family members in thirty-seven countries.

There are two drug master file entries for calcifediol. One supplier is listed for this compound.

Summary for CALCIFEDIOL

International Patents:	176
US Patents:	16
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	201
Clinical Trials:	24
What excipients (inactive ingredients) are in CALCIFEDIOL?	CALCIFEDIOL excipients list
DailyMed Link:	CALCIFEDIOL at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for CALCIFEDIOL

Dosage:

CAPSULE, EXTENDED RELEASE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for CALCIFEDIOL

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

Sponsor	Phase
Hospital Universitario Marqués de Valdecilla	PHASE4
Parc de Salut Mar	PHASE4
Hospital Universitario de Gran Canaria Doctor Negrín	PHASE4

See all CALCIFEDIOL clinical trials

Pharmacology for CALCIFEDIOL

Drug Class

Vitamin D3 Analog

Medical Subject Heading (MeSH) Categories for CALCIFEDIOL

Bone Density Conservation Agents

Vitamins

Anatomical Therapeutic Chemical (ATC) Classes for CALCIFEDIOL

A11CC	Vitamin D and analogues
A11C	VITAMIN A AND D, INCL. COMBINATIONS OF THE TWO
A11	VITAMINS
A	Alimentary tract and metabolism

H05BX	Other anti-parathyroid agents
H05B	ANTI-PARATHYROID AGENTS
H05	CALCIUM HOMEOSTASIS
H	Systemic hormonal preparations, excluding sex hormones and insulins

US Patents and Regulatory Information for CALCIFEDIOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Organon Usa Inc	CALDEROL	calcifediol	CAPSULE;ORAL	018312-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Eirgen	RAYALDEE	calcifediol	CAPSULE, EXTENDED RELEASE;ORAL	208010-001	Jun 17, 2016		RX	Yes	Yes
Eirgen	RAYALDEE	calcifediol	CAPSULE, EXTENDED RELEASE;ORAL	208010-001	Jun 17, 2016		RX	Yes	Yes

Expired US Patents for CALCIFEDIOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Eirgen	RAYALDEE	calcifediol	CAPSULE, EXTENDED RELEASE;ORAL	208010-001	Jun 17, 2016
Organon Usa Inc	CALDEROL	calcifediol	CAPSULE;ORAL	018312-001	Approved Prior to Jan 1, 1982
Organon Usa Inc	CALDEROL	calcifediol	CAPSULE;ORAL	018312-002	Approved Prior to Jan 1, 1982

International Patents for CALCIFEDIOL

Country	Patent Number	Title	Estimated Expiration
Japan	2016135814	ビタミンＤ化合物およびワックス状担体を含有する制御放出性経口組成 (CONTROLLED RELEASE ORAL COMPOSITION CONTAINING VITAMIN D COMPOUND AND WAXY CARRIER)
Denmark	3332773
Mexico	2015012625	FORMULACION DE VITAMINA D DE LIBERACION MODIFICADA ESTABILIZADA Y METODO PARA ADMINISTRATIVA Y METODO PARA ADMINISTRAR LA MISMA. (STABILIZED MODIFIED RELEASE VITAMIN D FORMULATION AND METHOD OF ADMINISTRING SAME.)

Supplementary Protection Certificates for CALCIFEDIOL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2481400	CA 2020 00059	Denmark		PRODUCT NAME: CALCIFEDIOL; NAT. REG. NO/DATE: 62564 20200910; FIRST REG. NO/DATE: UK PL 50784/0005-0001 20200721
2968172	122021000009	Germany		PRODUCT NAME: CALCIFEDIOL UND/ODER PHARMAZEUTISCH AKZEPTABLE SALZE UND HYDRATE DAVON, BEVORZUGT CALCIFEDIOLMONOHYDRAT; REGISTRATION NO/DATE: 2202115.00.00 20200818
2481400	132021000000071	Italy		PRODUCT NAME: CALCIFEDIOLO(RAYALDEE); AUTHORISATION NUMBER(S) AND DATE(S): 047870011, 20201201;PL 50784/0005, 20200721

Market Dynamics and Financial Trajectory for Calcifediol

Last updated: July 27, 2025

Introduction

Calcifediol, also known as 25-hydroxyvitamin D3, is an increasingly significant compound in the pharmaceutical landscape, primarily used for managing vitamin D deficiency and associated conditions. As the global health focus intensifies on managing deficiencies and related disorders, calcifediol’s market dynamics and financial trajectory warrant comprehensive analysis. This article explores the driving forces, competitive landscape, regulatory factors, and future growth prospects shaping calcifediol’s market.

Market Overview and Current Position

Calcifediol’s primary application revolves around correcting vitamin D deficiency, which affects a significant proportion of populations worldwide. Unlike native vitamin D3 supplements, calcifediol offers improved bioavailability and faster serum level elevation, making it attractive for specific patient cohorts such as individuals with malabsorption syndromes, chronic kidney disease (CKD), and hepatopancreatic disorders [1].

Market estimates suggest a compound annual growth rate (CAGR) of approximately 7% to 9% over the next five years, driven by increasing awareness of vitamin D’s role in immune function, bone health, and chronic disease prevention. The segment is characterized by a hybrid composition of innovator drugs, biosimilars, and compounded formulations, with key players including Diasorin, BL Science, and specialized biotech firms.

Market Drivers

1. Rising Incidence of Vitamin D Deficiency

Vitamin D deficiency affects roughly 1 billion people globally, according to the Global Vitamin D Status Report. The deficiency links to osteoporosis, cardiovascular disease, diabetes mellitus, and weakened immunity [2]. The rising prevalence, especially among the elderly and individuals with restricted sun exposure, sustains demand for corrective therapies like calcifediol.

2. Preference for More Bioavailable Forms

Compared to native vitamin D3, calcifediol’s rapid onset and superior absorption profile exert a competitive advantage. Healthcare providers increasingly favor calcifediol in cases requiring quick correction of deficiency or where absorption issues diminish efficacy of traditional supplements [3].

3. Emerging Evidence and Clinical Trials

Recent clinical investigations suggest calcifediol’s efficacy in improving immune function, especially relevant amid global health crises like the COVID-19 pandemic. The potential role as an adjunct therapy in respiratory and autoimmune conditions further fuels market interest.

4. Regulatory Progress and Approval Pathways

Regulatory authorities, including the FDA and EMA, have approved specific calcifediol formulations for deficiency management. Continued approvals and guideline endorsements bolster market confidence, facilitating broader adoption in clinical practice.

5. Growth in Specialty and Niche Markets

Calcifediol’s precise pharmacokinetics suit specialized populations (e.g., renal patients), leading to increased usage within nephrology and endocrinology segments. This specialization sustains premium pricing and niche market growth.

Market Challenges and Constraints

1. Pricing and Reimbursement Challenges

Calcifediol’s premium positioning as a specialized formulation results in higher costs compared to over-the-counter vitamin D supplements. Reimbursement policies vary across regions, influencing patient access and market expansion.

2. Competitive Landscape

The market faces competition from native vitamin D3 and other analogs, alongside emerging biosimilar products. Standardization issues and stability concerns for formulations also limit widespread adoption.

3. Regulatory Variability

Divergent regulatory pathways across jurisdictions pose hurdles. While some nations approve calcifediol as a prescription drug, others lack clear guidance, creating market entry barriers.

Emerging Trends and Innovation

1. Formulation Innovation

Development of sustained-release and injectable calcifediol formulations enhances compliance and broadens the scope of use, particularly among patients with malabsorption or adherence issues.

2. Personalized Medicine Integration

Advances in pharmacogenomics enable tailored supplementation strategies, positioning calcifediol within personalized treatment paradigms for vitamin D deficiency.

3. Combination Therapies

Research into combined formulations incorporating calcifediol with calcium or other micronutrients aims to optimize therapeutic outcomes and unlock new market segments.

Geographical Market Dynamics

North America

North America remains a leader, driven by high awareness, robust healthcare infrastructure, and favorable regulatory climate. The U.S. accounts for the majority share, with an increasing shift toward prescription-based formulations.

Europe

European markets exhibit steady growth, with countries like Germany and France adopting calcifediol for CKD and osteoporosis management, supported by national guidelines endorsing vitamin D therapy.

Asia-Pacific

Emerging markets such as China and India present significant growth prospects due to burgeoning awareness of vitamin D deficiency and expanding healthcare access. Local production and cost advantages further facilitate market penetration.

Latin America and Middle East

These regions demonstrate growing interest aligned with increasing chronic disease burden, though market development remains nascent due to regulatory and infrastructural challenges.

Financial Trajectory and Investment Outlook

Market Valuation and Revenue Projections

The global calcifediol market is projected to reach USD 300-400 million by 2030, with annual revenues increasing at a CAGR of approximately 8-9%. Market segments include branded pharmaceuticals, biosimilars, and compounded formulations, with the latter gaining popularity in specialized care.

Investment Trends

Investment in research and development (R&D) remains robust, with pharmaceutical companies and biotech firms seeking to expand formulations and indications. Strategic collaborations with healthcare providers and payers aim to enhance market access, especially within emerging economies.

Pricing and Reimbursement Dynamics

Pricing strategies are evolving toward premium models justified by clinical advantages. Payer acceptance remains variable, contingent on demonstrating cost-effectiveness and clinical superiority over conventional vitamin D supplements.

Challenges in Commercial Scale

Manufacturing complexity, stability of formulations, and regulatory compliance influence scaled production costs. Optimizing supply chains and investing in formulation technology will be critical to meet rising demand without compromising margins.

Regulatory Landscape

Regulatory approval pathways for calcifediol differ globally. In the U.S., it’s classified as a prescription drug, with specific labeling and safety evaluations. The EMA approves calcifediol formulations, with national agencies setting prescribing guidelines. These regulatory frameworks influence market access timelines and commercial strategies.

Future Outlook and Growth Catalysts

The outlook for calcifediol remains optimistic, buoyed by increasing health awareness, clinical evidence supporting benefits, and technological innovations. Potential growth catalysts include:

• Expanded indications including immune modulation and autoimmune disease management
• Integration into senior care and chronic disease management protocols
• Advances in personalized therapy aligning with genomic insights
• Regulatory approvals expanding geographic access

Key Takeaways

• Growing Demand: Rising prevalence of vitamin D deficiency and improved understanding of calcifediol’s bioavailability drive steady growth.

• Clinical Advantages: Faster serum level correction and suitability for absorption-impaired populations position calcifediol as a preferred formulation in specialized care.

• Regulatory Expansion: Approval and endorsement by health authorities will further legitimize and expand market penetration.

• Innovation and Personalization: Formulation improvements and personalized treatment approaches will unlock new revenue streams.

• Emerging Markets: Asia-Pacific and Latin America present significant growth opportunities due to increasing awareness and healthcare infrastructure development.

Conclusion

Calcifediol’s market dynamics reflect a confluence of clinical validation, technological innovation, and strategic regional expansion. While challenges remain, especially around pricing and regulation, its trajectory remains promising. Stakeholders investing in or developing calcifediol-based therapies should leverage clinical evidence, capitalize on niche markets, and navigate regulatory nuances to realize sustainable growth.

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FAQs

Q1: What distinguishes calcifediol from traditional vitamin D therapy?
A: Calcifediol offers superior bioavailability, faster serum level elevation, and effectiveness in absorption-impaired patients compared to native vitamin D3, making it ideal for specific clinical scenarios.

Q2: Which patient populations benefit most from calcifediol therapy?
A: Patients with malabsorption syndromes, chronic kidney disease, autoimmune disorders, and those requiring rapid correction of vitamin D deficiency benefit most.

Q3: How do regulatory differences influence calcifediol market growth?
A: Divergent approval pathways and guidelines can delay market entry, impacting sales and R&D investments but also presenting opportunities for market expansion as approvals broaden.

Q4: What are the main factors influencing calcifediol pricing and reimbursement?
A: Clinical efficacy, manufacturing costs, regulatory status, and healthcare reimbursement policies primarily influence pricing and access.

Q5: What trends are shaping the future innovation landscape for calcifediol?
A: Innovations include sustained-release formulations, combination therapies, and integration into personalized medicine strategies driven by advances in pharmacogenomics.

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References

[1] Holick MF. Vitamin D deficiency. N Engl J Med. 2007;357(3):266-281.
[2] Wacker M, Holick MF. Sunlight and Vitamin D: A global perspective for health. Dermatoendocrinol. 2013;5(3): 51-108.
[3] Dantzer E, et al. Calcifediol versus vitamin D3 supplements: Which is better for correcting vitamin D deficiency? Clin Pharmacokinet. 2020;59(2):161-174.