HECTOROL Drug Patent Profile

Which patents cover Hectorol, and what generic alternatives are available?

Hectorol is a drug marketed by Sanofi and is included in two NDAs.

The generic ingredient in HECTOROL is doxercalciferol. There are nine drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the doxercalciferol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Hectorol

A generic version of HECTOROL was approved as doxercalciferol by HIKMA on August 30^th, 2013.

Summary for HECTOROL

US Patents:	0
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	59
Clinical Trials:	11
Patent Applications:	1,579
Drug Prices:	Drug price information for HECTOROL
What excipients (inactive ingredients) are in HECTOROL?	HECTOROL excipients list
DailyMed Link:	HECTOROL at DailyMed

See drug prices for HECTOROL

See drug sales revenues for HECTOROL

Recent Clinical Trials for HECTOROL

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

Sponsor	Phase
Sanofi	Phase 3
OPKO IP Holdings II, Inc.	Phase 1
State University of New York - Downstate Medical Center	Phase 4

See all HECTOROL clinical trials

Paragraph IV (Patent) Challenges for HECTOROL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
HECTOROL	Injection	doxercalciferol	2 mcg/mL, 1 mL in 2 mL vial	021027	1	2011-12-28
HECTOROL	Capsules	doxercalciferol	1 mcg	020862	1	2010-02-12
HECTOROL	Capsules	doxercalciferol	0.5 mcg and 2.5 mcg	020862	1	2009-03-25
HECTOROL	Injection	doxercalciferol	2 mcg/mL, 2 mL ampules	021027	1	2007-10-15

US Patents and Regulatory Information for HECTOROL

HECTOROL is protected by zero US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sanofi	HECTOROL	doxercalciferol	CAPSULE;ORAL	020862-002	Apr 23, 2004		DISCN	Yes	No
Sanofi	HECTOROL	doxercalciferol	INJECTABLE;INJECTION	021027-002	Apr 6, 2000	AP	RX	Yes	No
Sanofi	HECTOROL	doxercalciferol	CAPSULE;ORAL	020862-003	Jul 13, 2009		DISCN	Yes	No
Sanofi	HECTOROL	doxercalciferol	CAPSULE;ORAL	020862-001	Jun 9, 1999		DISCN	Yes	No
Sanofi	HECTOROL	doxercalciferol	INJECTABLE;INJECTION	021027-001	Apr 6, 2000	AP	RX	Yes	Yes

Expired US Patents for HECTOROL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi	HECTOROL	doxercalciferol	CAPSULE;ORAL	020862-001	Jun 9, 1999
Sanofi	HECTOROL	doxercalciferol	INJECTABLE;INJECTION	021027-001	Apr 6, 2000
Sanofi	HECTOROL	doxercalciferol	INJECTABLE;INJECTION	021027-001	Apr 6, 2000
Sanofi	HECTOROL	doxercalciferol	INJECTABLE;INJECTION	021027-002	Apr 6, 2000
Sanofi	HECTOROL	doxercalciferol	CAPSULE;ORAL	020862-002	Apr 23, 2004

International Patents for HECTOROL

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1601364
Australia	723835
Germany	69629184
World Intellectual Property Organization (WIPO)	9961398
China	1520302

Market Dynamics and Financial Trajectory for HECTOROL

Last updated: July 28, 2025

Introduction

HECTOROL (doxercalciferol) is a synthetic vitamin D analog primarily utilized to manage secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) undergoing dialysis. Approved initially by the U.S. Food and Drug Administration (FDA) in the late 1990s, HECTOROL has established itself within a niche therapeutic segment, driven by the increasing prevalence of CKD and its associated complications. This analysis provides a comprehensive overview of the market dynamics shaping HECTOROL’s commercial landscape, alongside its future financial trajectory, considering regulatory, clinical, and economic factors influencing its position.

Market Overview

Disease Burden and Epidemiology

Chronic kidney disease affects approximately 10% of the global population, with advanced stages leading to end-stage renal disease (ESRD). As of 2022, approximately 0.3% to 0.4% of the adult population in developed countries undergo dialysis, emphasizing a steady demand for CKD management therapies like HECTOROL (1). The rising prevalence of diabetes and hypertension—primary CKD risk factors—further propels the need for effective vitamin D analogs to manage mineral and bone disorders.

Therapeutic Role of HECTOROL

HECTOROL’s pharmacological profile positions it as a selective agent to suppress parathyroid hormone (PTH) levels, reducing secondary hyperparathyroidism complications. Its advantages include high potency, rapid onset of action, and a favorable side-effect profile compared to older vitamin D therapies such as calcitriol. Nonetheless, its market positioning is influenced by competition from newer, more convenient agents and alternative treatment modalities.

Market Dynamics

Competitive Landscape

The market for vitamin D analogs in CKD management is characterized by several players offering drugs like paricalcitol, calcitriol, and recently developed agents such as maxacalcitol and doxercalciferol-specific formulations (2). While HECTOROL maintained a leading position for years, recent entry of novel, longer-acting analogs has reshaped competitive dynamics.

Major competitors include:

• Paricalcitol (Zemplar®): Approved for SHPT management; offers dosing flexibility.
• Calcitriol: The traditional standard but with higher hypercalcemia risk.
• Maxacalcitol: Emerging as an alternative, with less calcium absorption.

The transition toward more convenient oral formulations and reduced hypercalcemia risk has pressured older agents like HECTOROL to innovate or carve out niche markets.

Regulatory Environment

Regulatory scrutiny and approvals influence HECTOROL’s market accessibility. Although already approved, ongoing reviews for generic versions or biosimilars could impact market share and pricing strategies. Additionally, evolving guidelines emphasizing individualized mineral disorder management influence prescribing patterns favoring newer agents with better safety profiles.

Pricing and Reimbursement Dynamics

Cost considerations significantly impact usage. While HECTOROL’s production costs are relatively stable, reimbursement policies for CKD treatments fluctuate based on health system reforms. Payers favor cost-effective therapies balancing efficacy, safety, and patient compliance, creating both challenges and opportunities for HECTOROL's market share management.

Clinical Adoption and Prescriber Trends

Clinicians tend to prefer agents with improved safety profiles, ease of administration, and minimal adverse effects—attributes favoring newer analogs. Prescription trends reflect a gradual shift away from older agents like HECTOROL, especially in markets emphasizing early intervention with modern therapies. Nonetheless, HECTOROL retains utility in specific patient subsets—such as those with tolerability issues or contraindications to newer drugs.

Manufacturing and Supply Chain Considerations

Supply chain stability impacts pharmaceutical availability and pricing. The aging manufacturing infrastructure or regulatory compliance costs could constrain HECTOROL’s market growth or reduce price competitiveness if newer manufacturing processes prove more efficient.

Financial Trajectory

Revenue Projections

In established markets, HECTOROL's revenues are projected to decline modestly over the next five years due to competition from newer vitamin D analogs and changing clinical practice patterns. However, in emerging markets with limited access to cutting-edge therapies, demand remains stable or potentially grows, fueled by high CKD prevalence and resource constraints.

Market Penetration Opportunities

Holders and distributors can explore niche segments, such as:

• Developing markets: Cost-effective solutions remain in demand.
• Particular patient populations: Those contraindicated for newer agents or with specific metabolic profiles.
• Formulation innovations: Developing extended-release or combination formulations to improve compliance and efficacy.

Innovation and Lifecycle Management

To sustain market relevance, companies might pursue formulation advancements, such as fixed-dose combinations or delivery via novel routes, to enhance adherence and broaden indications. Licensing agreements and partnerships with biotech firms focused on mineral metabolism could also expand HECTOROL’s therapeutic use.

Potential for Generic Competition

Patent expirations in some markets could lead to generic entries, exerting downward pressure on pricing and margins, potentially diminishing revenue streams unless accompanied by differentiation strategies.

Regulatory and Reimbursement Risks

Evolving health policies that favor newer therapies with superior safety profiles could restrict reimbursement for HECTOROL, further constraining its financial outlook. Conversely, value-based reimbursement models that consider overall cost savings from reduced adverse events could bolster its position.

Market Outlook Summary

The global market for secondary hyperparathyroidism treatment is expected to grow in tandem with CKD prevalence. However, HECTOROL’s market share will likely decline relative to innovative analogs, with revenues stabilizing mainly in developing economies. Companies focusing on differentiated formulations, enhanced safety, and cost-effective delivery methods could extend HECTOROL’s lifecycle and profitability.

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Key Takeaways

• The rising prevalence of CKD, especially in aging populations, sustains demand for mineral metabolism therapies like HECTOROL.
• Competitive pressures from newer vitamin D analogs, combined with evolving clinical guidelines prioritizing safety and convenience, challenge HECTOROL’s market dominance.
• Strategic focus on niche markets—such as developing countries, cost-sensitive healthcare systems, and treatment of specific patient categories—can sustain revenues.
• Innovation in formulations and combination therapies presents opportunities to extend HECTOROL’s market lifespan.
• Regulatory and reimbursement dynamics remain pivotal; proactive engagement and evidence generation are crucial for maintaining market relevance.

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FAQs

1. What are the primary advantages of HECTOROL over older vitamin D therapies?
HECTOROL offers higher potency, reduced hypercalcemia risk, and rapid onset of action compared to calcitriol, making it a preferred option in certain clinical settings.

2. How does competition from agents like paricalcitol impact HECTOROL’s market share?
Paricalcitol has advantages in dosing flexibility and safety profile, leading to increased preference among prescribers, thereby constraining HECTOROL’s market penetration.

3. Are there any recent regulatory developments affecting HECTOROL?
While existing approval remains intact, ongoing review processes for biosimilars or generics could influence market access and pricing.

4. What role does cost play in the utilization of HECTOROL globally?
Cost-effectiveness is vital, especially in emerging markets where budget constraints drive demand for affordable therapies like HECTOROL compared to newer, often more expensive analogs.

5. What strategies can manufacturers adopt to extend HECTOROL’s market longevity?
Formulation innovations, targeting niche patient populations, forming strategic partnerships, and focusing on cost-effective delivery methods can help sustain its relevance.

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References

1. United States Renal Data System. 2022 USRDS Annual Data Report.
2. Goodman WG, Goldfarb D, et al. Vitamin D analogs in CKD: clinical implications. J Nephrol. 2021.