doxercalciferol - Profile

What are the generic drug sources for doxercalciferol and what is the scope of patent protection?

Doxercalciferol is the generic ingredient in two branded drugs marketed by Avet, Hikma, Rising, Sanofi, Alembic, Amneal, Caplin, Epic Pharma Llc, Eugia Pharma, Gland, Hospira, Lupin, Meitheal, Sandoz, and Sun Pharm, and is included in eighteen NDAs. Additional information is available in the individual branded drug profile pages.

There is one tentative approval for this compound.

Summary for doxercalciferol

US Patents:	0
Tradenames:	2
Applicants:	15
NDAs:	18

Generic filers with tentative approvals for DOXERCALCIFEROL

Applicant	Application No.	Strength	Dosage Form
		2MCG/ML	INJECTABLE; INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Paragraph IV (Patent) Challenges for DOXERCALCIFEROL

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 doxercalciferol

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Avet	DOXERCALCIFEROL	doxercalciferol	CAPSULE;ORAL	205360-001	Sep 15, 2020	AB	RX	No	No
Avet	DOXERCALCIFEROL	doxercalciferol	CAPSULE;ORAL	205360-002	Sep 15, 2020	AB	RX	No	No
Avet	DOXERCALCIFEROL	doxercalciferol	CAPSULE;ORAL	205360-003	Sep 15, 2020	AB	RX	No	Yes
Hikma	DOXERCALCIFEROL	doxercalciferol	CAPSULE;ORAL	091433-001	Sep 23, 2011		DISCN	No	No
Hikma	DOXERCALCIFEROL	doxercalciferol	CAPSULE;ORAL	091433-002	Jan 14, 2014		DISCN	No	No

Expired US Patents for doxercalciferol

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi	HECTOROL	doxercalciferol	CAPSULE;ORAL	020862-003	Jul 13, 2009	5,602,116
Sanofi	HECTOROL	doxercalciferol	INJECTABLE;INJECTION	021027-001	Apr 6, 2000	7,148,211
Sanofi	HECTOROL	doxercalciferol	CAPSULE;ORAL	020862-001	Jun 9, 1999	5,707,980
Sanofi	HECTOROL	doxercalciferol	CAPSULE;ORAL	020862-001	Jun 9, 1999	5,861,386
Sanofi	HECTOROL	doxercalciferol	CAPSULE;ORAL	020862-002	Apr 23, 2004	5,602,116

Last updated: February 14, 2026

What is Doxercalciferol and its Market Position?

Doxercalciferol is a synthetic vitamin D2 analog used primarily for managing secondary hyperparathyroidism in patients with chronic kidney disease (CKD). Commercially, it is marketed under the brand name Hectorol by Genzyme, a Sanofi company, and approved in multiple countries, including the US and EU.

The drug competes mainly with similar vitamin D analogs such as calcitriol, paricalcitol, and maxacalcitol. Despite its established use, the market landscape shows limited growth opportunities, constrained by patent expirations, generic entry, and evolving treatment protocols.

What are the Key Market and Revenue Drivers?

• Target Population: CKD patients undergoing dialysis or pre-dialysis, estimated globally at approximately 10 million cases.

• Market Size: The global secondary hyperparathyroidism therapeutics market was valued at around $800 million in 2022. Doxercalciferol accounts for roughly 10-15% of this, approximating $80-$120 million annually.

• Growth Rate: The market displays a compound annual growth rate (CAGR) of 2-3% driven by rising CKD prevalence but offset by generic competition.

• Pricing: Average annual cost per patient ranges from $2,000 to $4,000, depending on dosing and insurance coverage.

What are the Patent and Regulatory Risks?

• Patent Expiry: Doxercalciferol’s primary patents expired in the early 2010s in most jurisdictions, leading to increased generic competition.

• Regulatory Approvals: It holds approval in major markets but faces potential challenges from new-generation vitamin D analogs with better safety profiles.

• Off-Label Use: Limited scope for off-label applications minimizes market expansion but also reduces regulatory exposure.

What is the Competitive Landscape?

Candidate Drug	Market Share	Formulation	Approval Year	Status	Key Competitors
Doxercalciferol	10-15%	Injection	1990s	Generic, Mature	Calcijex, Zemplar, Maxacalcitol
Zemplar (Paricalcitol)	25%	Injection	1990s	Patented, Expiring	Doxercalciferol, Calcijex
Calcijex (Calcitriol)	20%	Injection	1970s	Off-patent	Competitive market members, including generics
Maxacalcitol	Limited	Injection	1990s	Niche	Japan-focused, smaller share

Entry barriers remain moderate, with patent expirations enabling generics but still limited new drug development driven by patent protection and clinical advantages.

What are the R&D and Innovation Trends?

• Development of non-injective, oral formulations for better compliance.
• Research into vitamin D analogs with reduced hypercalcemia risk.
• Limited pipeline activity targeting CKD-related indications, reducing potential for new revenue streams from this drug class.

What are the Investment and Policy Implications?

• Market Maturity: The drug class exhibits a mature market with slow growth, limiting upside unless new formulations or indications emerge.

• Patents and Exclusivity: Generics dominate market share; investment relies on narrowly focused niche strategies or lifecycle management.

• Regulatory Environment: Potential limitations from evolving safety regulations and reimbursement policies for CKD treatments.

What Are the Key Financial Indicators for Investment?

• Revenue Trends: Stable but declining revenues due to generics.
• Profitability: Dependent on manufacturing efficiencies, with generic filers often operating at lower margins.
• Market Forecast: Limited growth expected through 2030, approximately 2-3% CAGR in the segment.

Final Assessment

Doxercalciferol's investment appeal depends on the investor's appetite for mature, slow-growing markets with limited innovation. Opportunities are primarily in lifecycle management and niche differentiation; large-scale revenue expansion appears unlikely within existing indications. Entry of generics has compressed profit margins but stabilized income streams, especially for incumbent manufacturers.

Key Takeaways

• Doxercalciferol is a mature, off-patent vitamin D analog with steady but declining revenue.
• Market growth is restrained by competition from generics and newer analogs with improved safety profiles.
• The drug's primary use remains in CKD-related hyperparathyroidism, with limited expansion potential.
• R&D activity focuses on formulation improvements rather than new indications.
• Investment risk is primarily from patent erosion, pricing pressures, and regulatory shifts.

FAQs

1. What is the primary clinical use of doxercalciferol? It treats secondary hyperparathyroidism in CKD patients.

2. How does doxercalciferol compare to other vitamin D analogs? It has a similar efficacy profile but less safety or convenience advantages, limiting differentiation.

3. Is there potential for market growth? Limited unless new formulations or indications develop, or if patents are secured for specific formulations.

4. What is the main regulatory concern? Loss of patent protection and resulting commoditization of the product.

5. Are there any promising pipeline candidates? Few, as the class is mature; innovation focuses on formulation, not new active substances.

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References: [1] Market data from Global Data, IBISWorld (2022).
[2] FDA and EMA drug approvals, 2020-2022.
[3] Clinical trials registries, 2023.
[4] Patent expiry dates, USPTO, EPO.