Doxercalciferol - Generic Drug Details

What are the generic sources for doxercalciferol and what is the scope of freedom to operate?

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

There are nine drug master file entries for doxercalciferol. Eight suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for doxercalciferol

US Patents:	0
Tradenames:	2
Applicants:	14
NDAs:	18
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	18
Patent Applications:	2,721
Drug Prices:	Drug price trends for doxercalciferol
What excipients (inactive ingredients) are in doxercalciferol?	doxercalciferol excipients list
DailyMed Link:	doxercalciferol at DailyMed

See drug prices for doxercalciferol

Recent Clinical Trials for doxercalciferol

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

Sponsor	Phase
Sanofi	Phase 3
OPKO Health, Inc.	Phase 3
OPKO Ireland Global Holdings Ltd.	Phase 3

See all doxercalciferol clinical trials

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.

Pharmacology for doxercalciferol

Drug Class

Vitamin D2 Analog

Anatomical Therapeutic Chemical (ATC) Classes for doxercalciferol

H05BX	Other anti-parathyroid agents
H05B	ANTI-PARATHYROID AGENTS
H05	CALCIUM HOMEOSTASIS
H	Systemic hormonal preparations, excluding sex hormones and insulins

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
Eugia Pharma	DOXERCALCIFEROL	doxercalciferol	INJECTABLE;INJECTION	213717-002	Jan 24, 2022	AP	RX	No	No
Sun Pharm	DOXERCALCIFEROL	doxercalciferol	INJECTABLE;INJECTION	203875-002	Nov 14, 2019		DISCN	No	No
Epic Pharma Llc	DOXERCALCIFEROL	doxercalciferol	INJECTABLE;INJECTION	203929-002	Mar 28, 2016		DISCN	No	No
Meitheal	DOXERCALCIFEROL	doxercalciferol	INJECTABLE;INJECTION	211670-001	Feb 7, 2020	AP	RX	No	No
Avet	DOXERCALCIFEROL	doxercalciferol	CAPSULE;ORAL	205360-001	Sep 15, 2020	AB	RX	No	No
Sandoz	DOXERCALCIFEROL	doxercalciferol	INJECTABLE;INJECTION	200926-001	Feb 4, 2014	AP	RX	No	No

Expired US Patents for doxercalciferol

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

Market Dynamics and Financial Trajectory for Doxercalciferol

Last updated: July 28, 2025

Introduction

Doxercalciferol, a synthetic vitamin D analog, is primarily prescribed for managing secondary hyperparathyroidism (SHPT) in patients undergoing dialysis due to chronic kidney disease (CKD). Its unique mechanism of action and specific clinical indications position it within a niche yet vital segment of the pharmaceutical market targeting renal diseases. Understanding the market dynamics and financial trajectory of doxercalciferol involves analyzing factors influencing demand, regulatory trends, competitive landscape, and pricing strategies shaping its commercial viability.

Market Overview

Doxercalciferol belongs to the vitamin D analogs class, which includes drugs like calcitriol, paricalcitol, and doxercalciferol itself. The global chronic kidney disease burden underpins an ongoing demand for treatments that mitigate secondary complications such as SHPT. The increasing prevalence of CKD and end-stage renal disease (ESRD), particularly in aging populations and regions with rising diabetes and hypertension rates, sustains market relevance.

According to the Global Dialysis Market Report, the dialysis market, including drugs for associated complications, is projected to grow at a CAGR of roughly 4-6% over the next five years. The demand for drugs like doxercalciferol is driven by their efficacy in controlling biochemical markers such as parathyroid hormone (PTH) levels, enhancing patient outcomes and reducing hospitalization rates for CKD-related complications.

Market Dynamics

Factors Driving Demand

• Rising CKD and ESRD Prevalence: The rising global incidence of CKD fuels demand for effective SHPT management solutions. The CDC reports approximately 15% of American adults suffer from CKD, with a significant portion progressing to ESRD requiring dialysis treatment (CDC, 2021).
• Limited Alternatives and Clinical Preference: Doxercalciferol's indication for secondary hyperparathyroidism positions it competitively among vitamin D analogs. Its distinct pharmacokinetics and safety profile result in clinical preference in specific regions and healthcare settings.
• Regulatory Approvals and Reimbursement Policies: Approvals by agencies such as the FDA and EMA enhance drug accessibility. Reimbursement frameworks influence prescribing patterns, with payers favoring cost-effective, evidence-backed treatments.

Market Constraints and Challenges

• Competitive Landscape: Doxercalciferol faces competition from established vitamin D analogs like calcitriol and paricalcitol, which are more widely used or have longer market presence. The emergence of new formulations and biosimilars intensifies pricing pressures.
• Manufacturing and Supply Chain Risks: Consistent production quality and supply chain robustness are critical, especially amid geopolitical or logistical disruptions.
• Safety and Efficacy Concerns: While effective, vitamin D analogs pose risks such as hypercalcemia, necessitating careful monitoring, which can impact overall prescribing rates.

Regulatory and Market Expansion Opportunities

• Label Expansion: Efforts to demonstrate additional indications or broaden existing ones could open new avenues, entailing regulatory submissions and clinical trials.
• Geographic Market Penetration: Developing markets in Asia, Latin America, and Eastern Europe present growth prospects, contingent upon regulatory approvals and healthcare infrastructure development.
• Combination Therapies: Exploring combined regimens with other CKD treatments could enhance therapeutic outcomes and market share.

Financial Trajectory

Revenue Trends

Current revenues for doxercalciferol are relatively modest compared to blockbuster drugs but demonstrate resilience within niche markets. Sales are influenced by factors like prescription volume, regional acceptance, and competition from higher-profile analogs.

• Historical Data: Sales estimates from industry sources indicate modest growth rates averaging 3-5% annually, driven mainly by market expansion into emerging regions.
• Pricing Strategies: Doxercalciferol’s pricing is comparable to other vitamin D analogs but remains sensitive to payer negotiations that focus on cost-effectiveness analyses.
• Patent Status: As of recent years, patents covering specific formulations or delivery methods have expired or are close to expiration, increasing generic competition and exerting downward pressure on prices.

Investment and R&D Outlook

Pharmaceutical companies may continue investing in R&D efforts to improve drug formulations, enhance safety profiles, or obtain new indications, potentially leading to incremental revenue streams through label extensions or formulation patents.

Impact of Market Trends

The increasing adoption of personalized medicine and digital health monitoring can influence the pharmacoeconomic landscape, potentially supporting favorable reimbursement if doxercalciferol’s use is proven to optimize outcomes and reduce long-term costs.

Competitive Positioning

Doxercalciferol's market share remains constrained due to several factors:

• Brand Presence of Competitors: Calcijex (calcitriol), Zemplar (paricalcitol), and other analogs have entrenched prescriber bases and extensive clinical data.
• Market Penetration Strategies: Genericization and price competition diminish margins and threaten proprietary positioning.
• Regulatory and Clinical Evidence: Clinical trials demonstrating superior safety, efficacy, or cost-effectiveness are vital to carving a niche.

Regulatory and Market Outlook

Regulatory authorities will scrutinize safety profiles and clinical benefits, influencing approval pathways for new indications or formulations. The trend toward stricter safety requirements for vitamin D analogs concerning hypercalcemia risk may affect market dynamics.

Emerging markets, especially in Asia-Pacific, present expansion opportunities due to increasing CKD prevalence and expanding healthcare coverage. However, registration processes and local clinical data requirements pose barriers.

Future Revenue Forecasts

Given the current market conditions, the financial trajectory for doxercalciferol is cautiously optimistic. The compound's niche positioning ensures steady revenue streams, especially if manufacturers pursue:

• Geographic expansion into underserved regions.
• Label extensions to include additional indications.
• Development of combination therapies with other CKD medications.

However, marginal growth is likely limited by patent expiries, generic competition, and the consolidation of clinical preferences favoring other vitamin D analogs.

Key Drivers and Risks

Drivers	Risks
Rising CKD prevalence	Patent expiry and generic competition
Favorable regulatory landscape	Clinical safety concerns
Market expansion in emerging markets	Competitive innovations
Value-based reimbursement trends	Reimbursement rate fluctuations

Key Takeaways

• Doxercalciferol sustains a stable niche market within CKD-related hyperparathyroidism management, with growth driven by rising CKD incidence and geographic expansion.
• Competitive pressures from established vitamin D analogs and generic versions challenge pricing power and market share.
• Strategic investments in clinical trials, formulation improvements, and regulatory submissions are crucial for maintaining relevance.
• Emerging markets offer substantial growth opportunities, contingent on navigating regulatory pathways and healthcare infrastructure development.
• Patents nearing expiration and price-based competition necessitate differentiation through clinical value demonstration.

FAQs

1. What are the main clinical advantages of doxercalciferol over other vitamin D analogs?
Doxercalciferol has a favorable safety profile with reduced risk of hypercalcemia compared to calcitriol, making it suitable for long-term management of SHPT in CKD patients.

2. How do patent expiries impact doxercalciferol’s market prospects?
Patent expiries typically lead to increased generic competition, lowering prices and compressing margins, thereby challenging existing revenue streams.

3. What are future opportunities for market expansion of doxercalciferol?
Expanding into emerging markets, obtaining additional indications through clinical trials, and developing combination therapies are potential avenues for growth.

4. How do safety concerns influence prescription patterns for vitamin D analogs?
Safety issues like hypercalcemia can lead clinicians to prefer analogs with better safety profiles or necessitate cautious monitoring, affecting prescribing behavior.

5. What role does reimbursement policy play in doxercalciferol’s market outlook?
Reimbursement strategies that favor cost-effective and clinically proven treatments are critical. Favorable policies can boost uptake, while restrictive reimbursement can hinder sales.

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Sources

[1] Centers for Disease Control and Prevention (CDC). Chronic Kidney Disease Surveillance Report, 2021.
[2] Global Dialysis Market Report, 2022.
[3] Industry data on vitamin D analogs and CKD treatment trends.