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 Pharma Ltd, 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. Ten 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:	10
Raw Ingredient (Bulk) Api Vendors:	68
Clinical Trials:	18
Patent Applications:	2,528
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
Amneal	DOXERCALCIFEROL	doxercalciferol	INJECTABLE;INJECTION	208974-002	May 24, 2017		DISCN	No	No
Amneal	DOXERCALCIFEROL	doxercalciferol	INJECTABLE;INJECTION	208974-001	May 24, 2017		DISCN	No	No
Hikma	DOXERCALCIFEROL	doxercalciferol	CAPSULE;ORAL	091433-001	Sep 23, 2011		DISCN	No	No
Gland Pharma Ltd	DOXERCALCIFEROL	doxercalciferol	INJECTABLE;INJECTION	210452-001	Sep 26, 2019	AP	RX	No	No
Alembic	DOXERCALCIFEROL	doxercalciferol	INJECTABLE;INJECTION	215810-001	Jun 15, 2023	AP	RX	No	No
Meitheal	DOXERCALCIFEROL	doxercalciferol	INJECTABLE;INJECTION	211670-001	Feb 7, 2020	AP	RX	No	No

Expired US Patents for DOXERCALCIFEROL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi	HECTOROL	doxercalciferol	INJECTABLE;INJECTION	021027-002	Apr 6, 2000	5,602,116
Sanofi	HECTOROL	doxercalciferol	INJECTABLE;INJECTION	021027-001	Apr 6, 2000	6,903,083
Sanofi	HECTOROL	doxercalciferol	CAPSULE;ORAL	020862-001	Jun 9, 1999	5,602,116
Sanofi	HECTOROL	doxercalciferol	CAPSULE;ORAL	020862-001	Jun 9, 1999	6,903,083
Sanofi	HECTOROL	doxercalciferol	CAPSULE;ORAL	020862-002	Apr 23, 2004	5,602,116
Sanofi	HECTOROL	doxercalciferol	INJECTABLE;INJECTION	021027-001	Apr 6, 2000	7,148,211

DOXERCALCIFEROL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Doxercalciferol

Introduction to Doxercalciferol

Doxercalciferol, marketed under the brand name Hectorol, is a synthetic vitamin D2 analog used primarily to treat secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD), both those on dialysis and those in stages 3 and 4 of CKD.

Market Segmentation

The doxercalciferol market is segmented based on several key factors:

By Type

• The market is segmented into two main types: injections and capsules. Each form has its own set of applications and patient preferences, influencing market dynamics[1][4].

By Application

• The primary applications are SHPT in patients with CKD on dialysis and SHPT in patients with stage 3 or stage 4 CKD. These segments are critical as they address different stages of kidney disease and varying patient needs[1][4].

Market Drivers

Several factors are driving the growth of the doxercalciferol market:

Increasing Demand for High-Quality Healthcare Products

• The demand for high-quality pharmaceutical products, including doxercalciferol, is increasing due to the growing need for effective treatments for CKD and SHPT[1].

Adoption of Advanced Technologies

• The adoption of artificial intelligence (AI) and other advanced technologies in the pharmaceutical industry is enhancing drug discovery and development processes, including those for doxercalciferol[1].

Expanding Chemical Space for Drug Discovery

• The expanding chemical space for drug discovery is opening up new avenues for the development and improvement of doxercalciferol and related treatments[1].

Market Restraints

Despite the growth drivers, there are several restraints affecting the market:

Economic Factors

• The economic impact of the COVID-19 pandemic has led to supply chain disruptions and changes in consumer behavior, affecting the market's growth trajectory[1].

Regulatory Challenges

• Changes in reimbursement policies, such as those related to Medicare payments for ESRD drugs, can impact the financial viability of doxercalciferol treatments. For instance, the Centers for Medicare and Medicaid Services (CMS) adjustments to the ESRD payment bundle can affect how much dialysis facilities are reimbursed for these drugs[2].

Regional Framework

The doxercalciferol market is analyzed across several major regions:

North America, Europe, Asia-Pacific (APAC), Middle East & Africa (MEA), and South and Central America

• Each region has its own market dynamics, influenced by local healthcare policies, economic conditions, and patient demographics. The APAC region, for example, is expected to show significant growth due to increasing healthcare spending and a large patient population[1][4].

Financial Trajectory

Market Size and Growth Rate

• The doxercalciferol market is expected to grow at a CAGR of 3 to 5% from 2023 to 2031, reaching an estimated valuation of USD XX Million by 2031[4].

Historical and Forecast Periods

• The market size and forecast estimates are provided for the periods 2021-2022 (historical data) and 2024-2031 (forecast period)[1][4].

Revenue and Cost Analysis

• The revenue generated from doxercalciferol sales is significant, with drugs like doxercalciferol contributing substantially to the overall ESRD drug market. For example, in the past, doxercalciferol had annual sales of $76,901,723, with a price increase of 16.6%[2].

Impact of COVID-19

The COVID-19 pandemic has had a multifaceted impact on the doxercalciferol market:

Supply Chain Disruptions

• The pandemic led to global supply chain disruptions, affecting the production and distribution of pharmaceuticals, including doxercalciferol[1].

Increased Demand for Vitamin D Supplements

• There was a surge in demand for vitamin D supplements, including doxercalciferol, due to bulk buying behavior by consumers during the pandemic. This trend is expected to continue beyond the pandemic period[1].

Market Players and Strategies

Key companies in the doxercalciferol market include:

Sanofi, Prasco Laboratories, Hikma Pharmaceuticals, Amneal Pharms, Pfizer, Akorn, West-Ward Pharmaceuticals

• These companies are focusing on both organic and inorganic growth strategies such as product launches, partnerships, and acquisitions to expand their market presence[1][4].

SWOT Analysis

A SWOT analysis provides a comprehensive overview of the market's strengths, weaknesses, opportunities, and threats:

Strengths

• Strong demand for effective SHPT treatments and the presence of established market players.

Weaknesses

• Dependence on regulatory approvals and reimbursement policies.

Opportunities

• Expanding into new geographical markets and leveraging advanced technologies.

Threats

• Economic uncertainties and competitive pressures from generic or alternative treatments[1].

PEST Analysis

A PEST analysis evaluates the political, economic, social, and technological factors affecting the market:

Political Factors

• Changes in healthcare policies and reimbursement rates can significantly impact the market.

Economic Factors

• Economic downturns and changes in consumer spending habits can affect market growth.

Social Factors

• Increasing awareness about CKD and SHPT can drive demand for doxercalciferol.

Technological Factors

• Advances in pharmaceutical technology and AI can enhance drug efficacy and market competitiveness[1].

Key Takeaways

• The doxercalciferol market is driven by increasing demand for high-quality healthcare products and the adoption of advanced technologies.
• The market is segmented by type (injections and capsules) and application (SHPT in patients with CKD on dialysis and stages 3 or 4 CKD).
• Regional dynamics play a crucial role, with APAC expected to show significant growth.
• The COVID-19 pandemic has had a mixed impact, with supply chain disruptions but also increased demand for vitamin D supplements.
• Key market players are focusing on both organic and inorganic growth strategies.

FAQs

1. What is doxercalciferol used for?

Doxercalciferol is used to treat secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD), both those on dialysis and those in stages 3 and 4 of CKD.

2. How is the doxercalciferol market segmented?

The market is segmented by type (injections and capsules) and application (SHPT in patients with CKD on dialysis and stages 3 or 4 CKD).

3. What are the key drivers of the doxercalciferol market?

Key drivers include increasing demand for high-quality healthcare products, adoption of advanced technologies, and expanding chemical space for drug discovery.

4. How has the COVID-19 pandemic affected the doxercalciferol market?

The pandemic has caused supply chain disruptions but also led to an increased demand for vitamin D supplements, including doxercalciferol.

5. Who are the major players in the doxercalciferol market?

Major players include Sanofi, Prasco Laboratories, Hikma Pharmaceuticals, Amneal Pharms, Pfizer, Akorn, and West-Ward Pharmaceuticals.

Cited Sources:

1. The Insight Partners - Doxercalciferol Market SWOT Analysis by 2031
2. GovInfo - Medicare Payments for End Stage Renal Disease Drugs
3. DelveInsight - Secondary Hyperparathyroidism Market
4. Market Research Intellect - Global Doxercalciferol Market Size and Forecast
5. FDA - Pharmacokinetic Study of CTAP201 Injection and Doxercalciferol (Hectorol) Injection