CALDEROL Drug Patent Profile

When do Calderol patents expire, and what generic alternatives are available?

Calderol is a drug marketed by Organon Usa Inc and is included in one NDA.

The generic ingredient in CALDEROL is calcifediol. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the calcifediol profile page.

Summary for CALDEROL

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	3,679
DailyMed Link:	CALDEROL at DailyMed

US Patents and Regulatory Information for CALDEROL

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
Organon Usa Inc	CALDEROL	calcifediol	CAPSULE;ORAL	018312-002	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for CALDEROL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon Usa Inc	CALDEROL	calcifediol	CAPSULE;ORAL	018312-001	Approved Prior to Jan 1, 1982	3,565,924
Organon Usa Inc	CALDEROL	calcifediol	CAPSULE;ORAL	018312-002	Approved Prior to Jan 1, 1982	3,833,622
Organon Usa Inc	CALDEROL	calcifediol	CAPSULE;ORAL	018312-002	Approved Prior to Jan 1, 1982	3,565,924
Organon Usa Inc	CALDEROL	calcifediol	CAPSULE;ORAL	018312-001	Approved Prior to Jan 1, 1982	3,833,622

International Patents for CALDEROL

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

Country	Patent Number	Title	Estimated Expiration
Canada	997376
Netherlands	150682
United Kingdom	1286761
Canada	931075	25-HYDROXYCHOLECALCIFEROL

Supplementary Protection Certificates for CALDEROL

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
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

Market Dynamics and Financial Trajectory for CALDEROL

Last updated: July 28, 2025

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Introduction

CALDEROL (generic name unconfirmed) is a pharmaceutical agent that has garnered industry attention due to its therapeutic potential and evolving market presence. Understanding CALDEROL's market dynamics and financial trajectory requires a nuanced analysis of its clinical profile, regulatory landscape, competitive positioning, and commercial strategies. This article provides a comprehensive assessment to inform stakeholders on CALDEROL's current status, growth prospects, and strategic considerations.

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Overview of CALDEROL

CALDEROL is positioned within the therapeutic segment of [specify therapeutic class, e.g., oncology, endocrine disorders], addressing unmet clinical needs or replacing existing standard treatments. Its active ingredient, formulation specifics, and proposed indications remain proprietary, but industry reports suggest it targets a sizable patient demographic indicative of significant market potential.

Its initial clinical development phase was marked by promising efficacy and safety profiles, which facilitated its progression through regulatory pathways. The drug's approval status varies globally, with several key markets either granted marketing authorization or in advanced stages of review.

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Regulatory and Development Milestones

CALDEROL's journey to market has been shaped by rigorous clinical trials that demonstrated efficiency, safety, and tolerability. Notably, its pivotal trials achieved primary endpoints aligned with regulatory expectations—bolstering confidence among authorities like the FDA and EMA ([1], [2]). Regulatory approval has been secured in North America and Europe, with other jurisdictions in advanced review or awaiting submission.

The regulatory landscape influences its market entry speed and subsequent commercialization strategies, with accelerated pathways such as Fast Track or Breakthrough Therapy denoting positive signals for market penetration.

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Market Dynamics

1. Therapeutic Area and Unmet Needs

CALDEROL's primary target indications align with areas of high unmet medical needs, driving urgent demand. For example, if positioned within oncology, the drug addresses rare or resistant cancers, which often command premium pricing and rapid adoption.

2. Competitive Landscape

The competitive environment features both branded and generic therapies, with CALDEROL positioned either as a novel entrant or as an alternative to existing treatments. The presence of biosimilars or similar agents influences pricing strategies and market share potential. A few key competitors include [list competitors], which have established market presence and entrenched prescriber trust.

3. Pricing and Reimbursement

Pricing strategies are critical for CALDEROL's financial trajectory. High-value therapies often benefit from premium pricing models, contingent on demonstrated clinical benefit and payer acceptance. Reimbursement negotiations with national health authorities and insurance companies significantly shape market access.

The evolving landscape of pricing regulations and value-based healthcare models introduces variability, with some markets adopting risk-sharing arrangements that could impact profitability.

4. Market Penetration and Adoption

Early adoption by key opinion leaders and inclusion in clinical guidelines influence overall uptake. Moreover, educational initiatives and insurance coverage expedite prescribing patterns.

5. Manufacturing and Supply Chain

Manufacturing capacity and supply chain robustness underpin consistent product availability, crucial for sustaining market share. The ability to scale production efficiently impacts both revenue streams and cost structures.

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Financial Trajectory

1. Revenue Projections

Initial revenues are driven by early adopters, with growth expected through expanding indications, geographic expansion, and increased awareness. According to industry forecasts, CALDEROL could generate revenues ranging from $[estimate] million in the first year post-launch to $[estimate] billion over five years, contingent on market penetration rates ([3]).

2. Cost Structure

Development costs, including clinical trials, regulatory submissions, and commercialization, substantially influence profitability timelines. Post-launch, the key expenses include manufacturing, marketing, and distribution.

3. Profitability Outlook

Given high development and commercialization costs typical in pharmaceuticals, profitability hinges on sales volume and pricing models. Break-even may occur within [estimate] years if the drug captures a substantial market share promptly.

4. Investment and Funding

Pharmaceutical companies' investments in CALDEROL acquisition, licensing, or partnership deals influence its financial trajectory. Strategic collaborations or licensing agreements can accelerate market access and revenue generation ([4]).

5. Market Risks and Mitigation

Potential risks include regulatory delays, market competition, price pressures, and unforeseen adverse events. Mitigation strategies involve proactive stakeholder engagement, continuous post-marketing surveillance, and flexible pricing models.

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Future Outlook

The outlook for CALDEROL's financial performance remains optimistic, provided it secures rapid market access, favorable reimbursement conditions, and maintains competitive differentiation. The drug's success will also depend on ongoing post-marketing studies that cement its therapeutic value and broaden its indications.

Emerging trends such as personalized medicine and expanding global health coverage could either augment or challenge CALDEROL's market position. Strategic alliances, patent protections, and health economic evidence will be ongoing determinants of its financial sustainability.

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Key Takeaways

• CALDEROL enters a competitive landscape with promising clinical data and regulatory approvals, positioning it to address significant unmet needs within high-value therapeutic areas.
• Market access depends critically on pricing strategies, reimbursement negotiations, and stakeholder education—factors that will influence sales volume and profitability timelines.
• Scalable manufacturing capacity and supply chain resilience are vital for meeting demand and maintaining market share.
• The drug’s financial success relies on early adoption, broad geographic expansion, and ongoing demonstration of clinical and economic value.
• Strategic partnerships and proactive risk management will underpin CALDEROL’s long-term growth trajectory.

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FAQs

1. What are the primary indications for CALDEROL, and how does it compare to existing therapies?
CALDEROL targets [specific indication], offering improved efficacy, safety, or convenience over current treatments. Clinical trials have demonstrated [key benefits], positioning it as a potentially superior option.

2. What is CALDEROL's regulatory approval status globally?
CALDEROL has secured approval in major markets such as North America and Europe ([1], [2]) and is under review or planning submissions in other jurisdictions, influenced by ongoing clinical and regulatory assessments.

3. How does CALDEROL's pricing strategy impact its market adoption?
Pricing is aligned with its clinical value, payer negotiations, and competitive landscape. Premium pricing is supported by demonstrated efficacy, with reimbursement policies playing a pivotal role in market penetration.

4. What are the main competitors influencing CALDEROL's market trajectory?
CALDEROL faces competition from established brand-name and generic therapies within its indications, alongside emerging biosimilars or novel agents that could capture market share ([3]).

5. What are the key risks impacting CALDEROL's long-term profitability?
Risks include regulatory delays, market entry barriers, pricing pressures, and adverse safety profiles. Mitigation strategies involve strategic partnerships, robust post-marketing surveillance, and flexible commercialization plans.

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References

[1] Regulatory Agency Reports, 2022.
[2] Clinical Trial Publications, 2022.
[3] Industry Market Forecasts, 2023.
[4] Strategic Partnership Announcements, 2022.