ROCALTROL Drug Patent Profile

When do Rocaltrol patents expire, and when can generic versions of Rocaltrol launch?

Rocaltrol is a drug marketed by Esjay Pharma and is included in two NDAs.

The generic ingredient in ROCALTROL is calcitriol. There are ten drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the calcitriol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Rocaltrol

A generic version of ROCALTROL was approved as calcitriol by TEVA on October 12^th, 2001.

Summary for ROCALTROL

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	75
Clinical Trials:	27
Patent Applications:	4,510
Drug Prices:	Drug price information for ROCALTROL
What excipients (inactive ingredients) are in ROCALTROL?	ROCALTROL excipients list
DailyMed Link:	ROCALTROL at DailyMed

See drug prices for ROCALTROL

See drug sales revenues for ROCALTROL

Recent Clinical Trials for ROCALTROL

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

Sponsor	Phase
RenJi Hospital	N/A
Berta Alemany	Phase 4
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta	Phase 4

See all ROCALTROL clinical trials

Pharmacology for ROCALTROL

Drug Class

Vitamin D3 Analog

US Patents and Regulatory Information for ROCALTROL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Esjay Pharma	ROCALTROL	calcitriol	CAPSULE;ORAL	018044-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	No
Esjay Pharma	ROCALTROL	calcitriol	CAPSULE;ORAL	018044-002	Approved Prior to Jan 1, 1982	AB	RX	Yes	No
Esjay Pharma	ROCALTROL	calcitriol	SOLUTION;ORAL	021068-001	Nov 20, 1998	AA	RX	Yes	Yes

Expired US Patents for ROCALTROL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Esjay Pharma	ROCALTROL	calcitriol	CAPSULE;ORAL	018044-002	Approved Prior to Jan 1, 1982	4,341,774
Esjay Pharma	ROCALTROL	calcitriol	CAPSULE;ORAL	018044-001	Approved Prior to Jan 1, 1982	3,697,559
Esjay Pharma	ROCALTROL	calcitriol	CAPSULE;ORAL	018044-002	Approved Prior to Jan 1, 1982	4,391,802
Esjay Pharma	ROCALTROL	calcitriol	CAPSULE;ORAL	018044-002	Approved Prior to Jan 1, 1982	4,225,596
Esjay Pharma	ROCALTROL	calcitriol	CAPSULE;ORAL	018044-001	Approved Prior to Jan 1, 1982	4,391,802

International Patents for ROCALTROL

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

Country	Patent Number	Title	Estimated Expiration
United Kingdom	1331011
Germany	2209352
Japan	S5626820	IMMUNOSUPPRESSING AGENT
Japan	S57149224	TUMOR-SUPPRESSING AGENT
Canada	962666	1,25-DIHYDROXYCHOLECALIFEROL

Market Dynamics and Financial Trajectory for ROCALTROL (Calcitriol)

Last updated: July 27, 2025

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Introduction

ROCALTROL, marketed as Calcitriol, is a pharmaceutical agent primarily used in the management of secondary hyperparathyroidism in chronic kidney disease (CKD) patients undergoing dialysis and in certain cases of hypocalcemia. As a synthetic analog of active vitamin D3, Calcitriol enhances calcium absorption, regulating mineral metabolism in patients with compromised renal function.

Understanding the market dynamics and financial trajectory of ROCALTROL requires an analysis of its therapeutic landscape, competitive positioning, regulatory environment, and emerging commercial opportunities. This report synthesizes these elements, focusing on current trends, growth drivers, challenges, and future potential within global markets.

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Market Overview and Key Drivers

Therapeutic Demand and Clinical Adoption

The rising prevalence of CKD and end-stage renal disease (ESRD) globally positions Calcitriol as a cornerstone therapy in mineral bone disorder management. According to the Global Burden of Disease Study, CKD affects approximately 9.1% of the global population, with incidence escalating in aging populations and developing economies [1]. As a result, the demand for efficacious vitamin D analogs like ROCALTROL remains robust.

Clinicians prefer Calcitriol due to its proven efficacy, rapid onset, and established safety profile. Its role extends to managing hypocalcemia associated with hypoparathyroidism, further broadening its therapeutic scope.

Regulatory Approvals and Market Penetration

The regulatory approval landscape remains generally favorable, with key markets such as the United States (via the FDA), European Union (via EMA), and Japan (via PMDA) recognizing ROCALTROL for specific indications. However, patent protections for original formulations have largely expired, leading to the proliferation of generic equivalents, exerting pressure on pricing and margins.

Competitive Landscape

The pharmacological class of vitamin D analogs includes therapies like Paricalcitol, Doxercalciferol, and Alphacalcidol. While ROCALTROL maintains a significant market share due to longstanding clinical use and brand recognition, generics and newer agents—offering improved safety profiles (e.g., reduced hypercalcemia)—pose competitive threats.

Innovations such as extended-release formulations and combination therapies are emerging, potentially impacting ROCALTROL's market positioning.

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Market Challenges and Limitations

Pricing and Reimbursement Constraints

Generic entry and pricing pressures diminish revenue streams, especially in cost-sensitive markets. Reimbursement policies increasingly favor newer agents or alternatives perceived as having better safety profiles, constraining ROCALTROL's market share growth.

Safety Concerns and Clinical Practice Trends

Hypercalcemia risk remains a critical concern during therapy, leading clinicians to adopt alternative vitamin D analogs with improved safety margins. These safety concerns influence prescribing behaviors, particularly in countries with stringent regulatory oversight.

Regulatory and Patent Expiration Impact

Patent expirations facilitate generic manufacturing, dramatically reducing ROCALTROL’s price point and turnover. While increasing accessibility, these shifts threaten the profitability of original formulations.

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Emerging Market Opportunities

Expanding Indications and Clinical Applications

Research exploring ROCALTROL’s efficacy in other conditions—such as psoriasis or certain cancers—may catalyze new clinical use cases, expanding its market horizon.

Geographic Diversification

Emerging markets in Asia, Africa, and Latin America exhibit rising CKD prevalence combined with limited access to innovative therapies. These regions offer substantial growth potential, contingent on pricing strategies and local regulatory approvals.

Value-Added Formulations and Combination Products

Development of fixed-dose combinations and modified-release formulations could improve patient compliance and safety, creating differentiation opportunities. Such innovations appeal to clinicians seeking tailored treatment options.

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Financial Trajectory and Revenue Outlook

Historical Performance and Current Trends

While precise revenue figures vary, ROCALTROL’s initial launch period in the 1990s yielded robust revenues driven by its status as a first-line treatment. Post-patent expiry, revenues declined as generics entered the market; however, steady demand persists in specific populations requiring effective vitamin D analogs.

Forecasted Revenue Growth

Market analysts project moderate growth in the coming decade, primarily fueled by increased CKD prevalence and expanding indications. According to IQVIA data, the global vitamin D analogs market is expected to grow at a compound annual growth rate (CAGR) of around 4-6% from 2023 to 2030 [2].

In developed markets, growth will be tempered by cost-containment measures and competition from newer agents. Conversely, the Asia-Pacific region, particularly China and India, offers higher growth potential owing to demographic trends and healthcare expansion.

Profitability Considerations

The commoditization trend hampers profitability margins. Manufacturers adopting strategic differentiation—such as biosimilar development or novel formulations—may enhance financial resilience. Additionally, licensing agreements and partnerships with regional pharma firms could drive revenue streams.

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Regulatory and Market Access Outlook

Regulatory agencies emphasize safety and efficacy, leading to evolving guidelines that influence prescribing practices. Market access depends on reimbursement policies and domestically tailored pricing strategies.

The introduction of biosimilars and generics in major markets could further lower costs, expand access, and impact ROCALTROL's revenue basis. Nonetheless, patent expirations necessitate continuous innovation to safeguard market share.

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Conclusion

ROCALTROL’s market dynamics are shaped by a complex interplay of clinical demand, competitive pressures, regulatory environment, and socio-economic factors. While facing challenges from generics and safety preferences, its entrenched role in CKD management ensures stable, if moderate, demand. The future financial trajectory hinges on strategic product innovation, geographic expansion, and navigating evolving healthcare policies.

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Key Takeaways

• Persistent Clinical Need: The prevalence of CKD ensures steady demand for Calcitriol, particularly in dialysis-dependent populations.

• Competitive Pressures: Patent expirations and the rise of generics have compressed margins, fostering a more cost-sensitive market environment.

• Market Expansion Opportunities: Emerging economies and novel indication research can unlock new revenue streams if strategically approached.

• Innovation as a Differentiator: Developing new formulations or combination therapies can preserve ROCALTROL’s market relevance and profitability.

• Regulatory Navigation: Proactive adaptation to evolving safety and reimbursement policies is essential for sustained financial performance.

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FAQs

1. What are the primary therapeutic uses of ROCALTROL?
   ROCALTROL is primarily used to treat secondary hyperparathyroidism in CKD patients on dialysis and manages hypocalcemia in certain conditions, leveraging its role as an active vitamin D3 analog.

2. How has patent expiry affected ROCALTROL’s market position?
   Patent expiration has led to increased generic competition, reducing prices and market share for original formulations, prompting manufacturers to explore formulations innovation.

3. Which markets hold the most growth potential for ROCALTROL?
   Emerging markets in Asia, Latin America, and Africa offer significant growth opportunities due to increasing CKD prevalence and expanding healthcare infrastructure.

4. What are the key challenges facing ROCALTROL’s commercial success?
   Challenges include pricing pressures from generics, safety concerns related to hypercalcemia, regulatory shifts, and competition from newer vitamin D analogs with improved safety profiles.

5. What strategies can sustain ROCALTROL’s financial trajectory?
   Investing in formulations innovation, expanding indications, geographically diversifying, and forming strategic partnerships are crucial to maintaining revenue stability amid market pressures.

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Sources

[1] GBD 2019 Kidney Disease Collaborators, 2020. "Global, regional, and national burden of chronic kidney disease, 1990–2017: a systematic analysis for the Global Burden of Disease Study 2017." Lancet. 395(10225): 662–677.

[2] IQVIA, 2023. "Global Market Analysis for Vitamin D Analogs."