HECTOROL Drug Patent Profile

When do Hectorol patents expire, 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 CAPLIN on February 4^th, 2014.

Summary for HECTOROL

US Patents:	0
Applicants:	1
NDAs:	2

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		DISCN	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		DISCN	Yes	No

International Patents for HECTOROL

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0820290	UTILISATION DE DERIVES DE LA VITAMINE D 2 OU D 4 POUR FABRIQUER UN MEDICAMENT DESTINE AU TRAITEMENT DE L'HYPERPARATHYROIDISME SECONDAIRE (USE OF VITAMIN D 2 OR VITAMIN D 4-DERIVATIVES FOR THE MANUFACTURE OF A MEDICAMENT FOR THE TREATMENT OF SECONDARY HYPERPARATHYROIDISM)
Mexico	9707535	USO DE DERIVADOS DE VITAMINA D2 O DE VITAMINA D4 EN LA PREPARACION DE UN FARMACO PARA EL TRATAMIENTO DE HIPERPARATIROIDISMO SECUNDARIO. (USE OF VITAMIN D2 OR VITAMIN D4-DERIVATIVES FOR THE MANUFACTURE OF A MEDICAMENT FOR THE TREATMENT OF SECONDARY HYPERPARATHYROIDISM.)
China	1520301
Austria	250566
Canada	2222593
European Patent Office	0631500	1 alpha-HYDROXY-24-(EPI)-VITAMINE D4 (1 alpha-HYDROXY-24-(EPI)-VITAMIN D4)

Summary

Last updated: February 15, 2026

HECTOROL (doxercalciferol), a vitamin D analog used to manage secondary hyperparathyroidism in chronic kidney disease, presents limited growth prospects due to market saturation in its current indications. Its patent status expired in 2011, leading to the proliferation of generics. The drug's sales are primarily driven by existing formulations in dialysis settings, with minimal pipeline development. New investment in HECTOROL hinges on potential reformulations or expansion into novel indications, which remains unlikely without substantial R&D efforts.

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What Is HECTOROL’s Market Position and Revenue Outlook?

HECTOROL has been off-patent since 2011, with several generics available globally. Its primary use remains in dialysis patients with secondary hyperparathyroidism, a market with stable but mature demand. According to IQVIA, in 2022, global sales approximated $30 million, primarily in North America and Europe.

Market saturation, declining use of injectable vitamin D analogs, and the rise of long-acting formulations have limited revenue growth. Its current market share is overshadowed by other vitamin D analogs like calcitriol and paricalcitol, which have broader regulatory approvals and formulations.

Key Data:

• Estimated global annual sales (2022): ~$30 million
• Patent status: Expired since 2011 (U.S. patent 5,756,300)
• Market share: Less than 15% among vitamin D analogs in dialysis settings
• Competitive landscape: Multiple generics with similar efficacy

Implication: The drug’s revenue stream is stable but static, with little room for organic growth absent new formulations or indications.

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What Are HECTOROL’s Patents and Regulatory Barriers?

The patent covering HECTOROL expired in 2011, removing exclusivity rights. No recent patents restrict generic manufacturing. Its FDA approval, granted in 1998, remains valid, though new formulations would require supplemental approvals. The lack of patent protection limits ability to charge premium prices or defend market share through exclusivity.

Challenges:

• Cost competition from generics
• No patents to prevent market entry of competitors
• Regulatory hurdles for new indications or formulations

Conclusion: Patent expiration and lack of exclusivity diminish revenue prospects. Enhancing value would require significant R&D investment in reformulation or new indications.

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What R&D Strategies Could Revive HECTOROL’s Commercial Viability?

Potential avenues include:

1. Formulation Innovation: Developing long-acting or oral versions could improve patient compliance, but would need extensive clinical trials to establish bioequivalence and safety, costing upward of $50 million.

2. New Therapeutic Indications: Exploring its utility in vitamin D deficiency outside renal disease or in oncology. However, no current evidence supports such expansion without substantial preclinical and clinical validation.

3. Combination Therapies: Incorporating HECTOROL into combination regimens with other CKD-related drugs. This would depend on patent protection and demonstration of clinical benefit.

Risks:

• High R&D costs without guaranteed positive outcomes
• Regulatory delays or denials
• Small market size limits return on investment

Conclusion: R&D efforts for re-purposing or reformulation are high-risk, high-cost strategies with uncertain ROI.

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What Are the Investment Risks and Opportunities?

Risks:

• Market saturation and commoditization lead to low margins
• Absence of patent protection invites generic competition
• Limited pipeline or development efforts reduce upside potential

Opportunities:

• Potential niche applications if new indications are discovered
• Strategic acquisitions of patent rights or formulation assets
• Potential for lifecycle management via reformulation if justified

Overall, HECTOROL's investment proposition is weak in the absence of transformative R&D or market expansion strategies.

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Key Takeaways

• HECTOROL has a mature, commoditized market with declining growth prospects.
• Patent expiry in 2011 led to widespread generic competition.
• Revenue relies mainly on existing formulations in dialysis, with minimal pipeline activity.
• Significant R&D or regulatory investments are needed to create new value, with uncertain outcomes.
• Investment should be considered only in the context of potential niche or niche-like opportunities, or via strategic acquisitions.

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FAQs

1. Is HECTOROL still protected by patent or exclusivity rights?
No. Its primary patent expired in 2011, allowing generic manufacturers to produce similar formulations.

2. What is the primary clinical use of HECTOROL?
Managing secondary hyperparathyroidism in patients with chronic kidney disease on dialysis.

3. Are there any ongoing clinical trials for new indications?
No significant clinical trials for new indications are publicly registered or underway.

4. How does HECTOROL compare to other vitamin D analogs?
It offers similar efficacy but faces competitive pressure from agents like calcitriol and paricalcitol, which have broader formulations and indications.

5. What are the main barriers to increasing HECTOROL’s market share?
Generic price competition, lack of patent exclusivity, and limited development pipeline.

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Citations

[1] IQVIA. (2022). Global sales data for vitamin D analogs.
[2] U.S. Patent 5,756,300. (2011). Patent expiration details.
[3] FDA. (1998). Approval document for HECTOROL.
[4] EvaluatePharma. (2022). Market analysis of vitamin D analogs.