Calcifediol - Generic Drug Details

What are the generic drug 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 ninety-two patent family members in thirty-eight countries.

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

Summary for calcifediol

International Patents:	192
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 Ramon y Cajal	PHASE4
Hospital Universitario Doctor Peset	PHASE4
Hospitales Universitarios Virgen del Rocío	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
Eirgen	RAYALDEE	calcifediol	CAPSULE, EXTENDED RELEASE;ORAL	208010-001	Jun 17, 2016		RX	Yes	Yes			Y
Organon Usa Inc	CALDEROL	calcifediol	CAPSULE;ORAL	018312-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Organon Usa Inc	CALDEROL	calcifediol	CAPSULE;ORAL	018312-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Eirgen	RAYALDEE	calcifediol	CAPSULE, EXTENDED RELEASE;ORAL	208010-001	Jun 17, 2016		RX	Yes	Yes			Y
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			Y

Expired US Patents for calcifediol

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon Usa Inc	CALDEROL	calcifediol	CAPSULE;ORAL	018312-002	Approved Prior to Jan 1, 1982
Organon Usa Inc	CALDEROL	calcifediol	CAPSULE;ORAL	018312-002	Approved Prior to Jan 1, 1982
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	018312-001	Approved Prior to Jan 1, 1982

International Patents for calcifediol

Country	Patent Number	Title	Estimated Expiration
Chile	2015002659
Finland	3335712
Eurasian Patent Organization	201991774
Hungary	E055591
Japan	2014065751	VITAMIN D INSUFFICIENCY AND DEFICIENCY TREATMENT WITH 25-HYDROXY VITAMIN D2 AND 25-HYDROXY VITAMIN D3
Denmark	2481400

Supplementary Protection Certificates for calcifediol

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2481400	CR 2020 00059	Denmark		PRODUCT NAME: CALCIFEDIOL; NAT. REG. NO/DATE: 62564 20200910; FIRST REG. NO/DATE: DE 2202115.00.00 20200818
2481400	122020000079	Germany		FORMER OWNERS: OPKO IRELAND GLOBAL HOLDINGS, LTD., DUBLIN 24, IE; OPKO RENAL, LLC, MIAMI, FL 33137, US
2481400	301085	Netherlands		PRODUCT NAME: CALCIFEDIOL IN IEDERE VORM ZOALS BESCHERMD DOOR HET BASISOCTROOI; NATIONAL REGISTRATION NO/DATE: 124799 20200922; FIRST REGISTRATION: DE 2202115.00.00 20200819
2968172	132021000000074	Italy		PRODUCT NAME: CALCIFEDIOLO(RAYALDEE); AUTHORISATION NUMBER(S) AND DATE(S): 047870011, 20201201;PL 50784/0005, 20200721
2968172	301095	Netherlands		PRODUCT NAME: CALCIFEDIOL IN IEDERE VORM ZOALS BESCHERMD DOOR HET BASISOCTROOI; NATIONAL REGISTRATION NO/DATE: 124799 20200922; FIRST REGISTRATION: DE 2202115.00.00 20200819
2968172	CR 2021 00005	Denmark		PRODUCT NAME: CALCIFEDIOL; NAT. REG. NO/DATE: 62564 20200910; FIRST REG. NO/DATE: DE 2202115.00.00 20200818

Calcifediol: Market Dynamics and Financial Trajectory

Last updated: April 24, 2026

Calcifediol (25-hydroxyvitamin D3) sits in the vitamin D therapeutic class but trades on a distinct value proposition versus cholecalciferol: faster elevation of 25(OH)D in clinical use. Commercial outcomes depend on geography, regulatory posture for vitamin D indications, payer behavior for supplementation versus disease-related claims, and intensity of competition from branded calcifediol and high-volume vitamin D products.

This report maps market dynamics and financial trajectory using observable commercialization signals: product availability by jurisdiction, branded penetration, pricing pressure drivers, and pipeline-adjacent risks from newer vitamin D receptor and analog strategies. The focus is on calcifediol’s commercial path from launch to mature-market economics.

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Where does calcifediol compete, and why does it win or lose?

Therapeutic and reimbursement positioning

Calcifediol is marketed around:

• Correction of vitamin D deficiency with more rapid serum response than standard supplementation (cholecalciferol).
• Adjunct roles in conditions where vitamin D status is a modifiable risk factor, subject to local regulatory labeling.

The payer lens typically splits into two buckets:

• Supplementation reimbursement (low willingness to pay; high price sensitivity)
• Disease-claim reimbursement (higher willingness to pay when labeling or clinical pathways support medical necessity)

In most markets, the financial swing factor is whether calcifediol is reimbursed under a treatment pathway rather than as a general supplement.

Pricing power drivers

Calcifediol pricing power improves when three conditions align:

• Clear label positioning for vitamin D deficiency correction.
• Demonstrable clinical response expectations that align with physician workflow.
• Limited generic exposure in the specific branded strength/formulation.

It weakens when:

• Generic entry compresses wholesale and pharmacy net prices.
• Payers prefer cheaper vitamin D analogs and high-volume generics regardless of onset kinetics.
• Health technology assessment (HTA) bodies treat it as a cost-effectiveness question without premium benefit.

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What are the market dynamics shaping growth and margin?

1) Regulatory labeling and indication scope

Calcifediol commercialization tracks the breadth of approved claims. Where regulators restrict indications to deficiency treatment, demand behaves like a deficiency market with seasonal spikes and physician-led prescribing.

Where claims extend to broader patient populations, market penetration follows clinical guidelines and hospital protocols.

Financial implication:

• Narrow indications produce steady but capped growth.
• Broader indications produce faster adoption and better retention in formularies.

2) Formulation and route intensity

Calcifediol is commonly offered as oral drops or capsules. Route and formulation drive:

• Patient adherence in elderly and chronic-care settings.
• Physician preference in dose titration pathways.
• Tolerability profiles that influence switching.

Market implication:

• Forms that support easy titration tend to sustain higher prescriber stickiness during deficiency management seasons.

3) Generic substitution and brand durability

Calcifediol faces the same structural risk as other small-molecule nutraceutical-adjacent therapies: once generics become available, branded pricing typically erodes unless differentiation exists via:

• Distinct formulation or delivery system.
• Strong physician awareness and payer contracts.
• Managed entry agreements.

Margin implication:

• Branded gross margin declines after generic entry.
• Net sales can stabilize if patient switching is limited and dosing habits persist.

4) Competitive pressure from cholecalciferol and analogs

Competition comes from:

• Bulk cholecalciferol products at very low price points.
• Calcifediol competitors where present, including alternative formulations with similar efficacy targets.
• Vitamin D receptor-focused approaches and newer vitamin D-related therapies that may capture segments of “special population” prescribing.

Financial implication:

• In payer-driven tender markets, calcifediol can lose share to lowest-cost vitamin D options.
• In clinician-driven deficiency correction settings, calcifediol can retain share if onset kinetics are valued.

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How is calcifediol’s demand behaving in the real world?

Demand profile (what market players typically observe)

Calcifediol sales usually exhibit:

• Seasonality tied to winter deficiency risk and outpatient visits.
• Clinical cohort concentration in geriatrics, chronic kidney disease-adjacent care, osteoporosis pathways, and endocrine/primary care deficiency treatment.

Sensitivity to supply and contracting

Sales volatility tends to be driven less by biologic demand shock and more by:

• Pharmacy contracting terms and wholesaler allocations.
• Changes in reimbursement rules or formulary decisions.
• New generic launches in key geographies.

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What does the financial trajectory look like across a product lifecycle?

Stage 1: Launch and early adoption

In early commercialization, calcifediol behaves like a branded therapy:

• Higher launch pricing.
• Prescriber learning and clinic protocol adoption.
• Demand grows as awareness increases and physicians standardize deficiency correction.

Typical financial pattern:

• Sales ramp through targeted physician segments.
• Gross margin holds while exclusivity and limited competitors persist.

Stage 2: Mature growth with tightening pricing

As the market expands:

• Contracts and tendering begin to favor lower-cost options.
• Payer restrictions appear for vitamin D supplementation claims.
• Competitors intensify promotion and distribution.

Typical financial pattern:

• Sales can keep growing modestly, but margin compresses.
• Net sales depend on retention in formularies and pharmacy channels.

Stage 3: Generic pressure and brand retreat

When generics gain share:

• Branded price drops fast.
• Market shifts to low-cost prescribing.
• Brand may focus on limited niches where differentiation persists (titration preferences or protocol retention).

Typical financial pattern:

• Revenue growth slows or declines.
• Profit contribution shifts from price to volume, often failing to offset price erosion.

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Which products and geographies define calcifediol commercial reality?

Calcifediol is commercially significant primarily through branded preparations in multiple European markets, with variability in market share driven by reimbursement and generic timing. Commercial strength concentrates in jurisdictions where:

• The branded product retains reimbursement access.
• Formularies allow calcifediol for deficiency treatment without restrictive step edits.
• Physician adoption is entrenched through guideline alignment.

Where generic availability rises early or reimbursement is strict, calcifediol’s financial path trends toward price compression and share dilution.

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What are the main value drivers for investors and R&D planners?

Commercial levers that increase net sales

• Maintain branded dosing convenience in protocols (capsules vs drops, titration ease).
• Defend reimbursement category by aligning with deficiency management pathways.
• Target high-need cohorts with stable physician prescribing behaviors.

Commercial levers that protect margins

• Offset price erosion with channel contracting and managed entry strategies.
• Focus promotional spend on formulary access rather than broad awareness.
• Reduce supply risk and rebate volatility in core accounts.

Key risks that compress the financial trajectory

• Generic entry timing in core markets.
• Payer policy shifts treating calcifediol as interchangeable with cheaper cholecalciferol.
• HTA cost-effectiveness thresholds that fail to support a premium.

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How does the competitive landscape affect mid-to-long term earnings?

Calcifediol’s mid-to-long term earnings profile is shaped by two opposing forces:

1) Market growth tailwinds

• Aging populations and chronic disease cohorts.
• Continued diagnosis of vitamin D deficiency through outpatient testing.
• Persistent clinician reliance on measured 25(OH)D levels.

2) Market erosion headwinds

• Generic price competition.
• Payer preference for lowest-cost vitamin D correction options.
• Loss of differential value if clinical guidelines converge on inexpensive cholecalciferol strategies.

Net result:

• In mature markets, calcifediol tends toward stable-to-declining margins under generic pressure unless the branded product defends formulary placement.

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Key Takeaways

• Calcifediol’s financial trajectory follows a classic branded-to-generic curve, driven by reimbursement posture and generic entry timing more than by pure clinical efficacy narratives.
• Market expansion depends on whether the drug is treated as deficiency correction within a medical pathway (supportive pricing) versus general supplementation (price-sensitive).
• Margins compress when payers and tender markets equate calcifediol with cheaper vitamin D products, and the biggest swing factor is formularies after generic penetration.
• Sustainable earnings come from protocol retention (dose titration convenience, physician habits) and contract defense rather than from broad label expansion.

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FAQs

1) Is calcifediol positioned as a treatment or a supplement?

It is commercialized for vitamin D deficiency correction, but payer behavior determines whether reimbursement aligns with medical treatment pathways or routine supplementation budgets.

2) What most directly drives calcifediol revenue growth in mature markets?

Formulary access and retention in deficiency treatment protocols, plus seasonality in outpatient deficiency management.

3) What factor most impacts calcifediol profitability?

Generic substitution and resulting net price compression under payer and pharmacy contracting.

4) Does seasonality materially change calcifediol sales?

Typically yes, with higher demand during winter deficiency risk and increased clinic visits for testing and correction.

5) How should competition from cholecalciferol affect expectations for calcifediol?

Expect pricing pressure in markets where payers treat vitamin D correction options as interchangeable and steer prescribing to lower-cost cholecalciferol products.

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References (APA)

[1] Endocrine Society. (2011). Evaluation, treatment, and prevention of vitamin D deficiency: An Endocrine Society clinical practice guideline. The Journal of Clinical Endocrinology & Metabolism, 96(7), 1911-1930.
[2] Holick, M. F. (2007). Vitamin D deficiency. The New England Journal of Medicine, 357(3), 266-281.
[3] Lips, P., Cashman, K. D., Jean, J., et al. (2019). Current vitamin D status in Europe and strategies to prevent vitamin D deficiency: A position statement of the European Calcified Tissue Society. European Journal of Endocrinology, 180(1), P1-P16.
[4] Tang, B. M., Eslick, G. D., Nowson, C., Smith, C., & Bensoussan, A. (2007). Use of calcium or calcium in combination with vitamin D supplementation to prevent fractures in people aged 50 years and older: A meta-analysis. The Lancet, 370(9588), 657-666.