Ergocalciferol - Generic Drug Details

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

Ergocalciferol is the generic ingredient in four branded drugs marketed by Lilly, Esjay Pharma, Chartwell Rx, Puracap Pharm Llc, Sigmapharm Labs Llc, Strides Pharma, Sun Pharm Inds Inc, Bionpharma, Chartwell Molecular, Chase Chem, Everylife, Impax Labs, Vitarine, and West Ward, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for ergocalciferol. Twenty-four suppliers are listed for this compound.

Summary for ergocalciferol

US Patents:	0
Tradenames:	4
Applicants:	14
NDAs:	14
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	24
Raw Ingredient (Bulk) Api Vendors:	82
Clinical Trials:	48
Patent Applications:	7,086
Drug Prices:	Drug price trends for ergocalciferol
Drug Sales Revenues:	Drug sales revenues for ergocalciferol
What excipients (inactive ingredients) are in ergocalciferol?	ergocalciferol excipients list
DailyMed Link:	ergocalciferol at DailyMed

See drug prices for ergocalciferol

See drug sales revenues for ergocalciferol

Recent Clinical Trials for ergocalciferol

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

Sponsor	Phase
National Center for Complementary and Integrative Health (NCCIH)	Phase 2
University of North Carolina, Chapel Hill	Phase 2
National Institute on Minority Health and Health Disparities (NIMHD)	Phase 2

See all ergocalciferol clinical trials

Pharmacology for ergocalciferol

Drug Class

Provitamin D2 Compound

Anatomical Therapeutic Chemical (ATC) Classes for ergocalciferol

A11CC	Vitamin D and analogues
A11C	VITAMIN A AND D, INCL. COMBINATIONS OF THE TWO
A11	VITAMINS
A	Alimentary tract and metabolism

US Patents and Regulatory Information for ergocalciferol

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
West Ward	VITAMIN D	ergocalciferol	CAPSULE;ORAL	083102-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Puracap Pharm Llc	ERGOCALCIFEROL	ergocalciferol	CAPSULE;ORAL	204276-001	Dec 7, 2018	AA	RX	No	No
Vitarine	VITAMIN D	ergocalciferol	CAPSULE;ORAL	084053-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Sigmapharm Labs Llc	ERGOCALCIFEROL	ergocalciferol	CAPSULE;ORAL	091004-001	Jul 14, 2010		DISCN	No	No
Lilly	DELTALIN	ergocalciferol	CAPSULE;ORAL	080884-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Sun Pharm Inds Inc	ERGOCALCIFEROL	ergocalciferol	CAPSULE;ORAL	040865-001	Dec 29, 2009		DISCN	No	No

Ergocalciferol Market Analysis and Financial Projection Experimental

Vitamin D Market Dynamics and Financial Trajectory: Focus on Ergocalciferol

Introduction

Ergocalciferol, also known as vitamin D2, is a crucial component of the broader vitamin D market, which is experiencing significant growth driven by various factors. This article delves into the market dynamics, financial trajectory, and key drivers influencing the ergocalciferol segment.

Global Vitamin D Market Overview

The global vitamin D market, which includes both vitamin D2 (ergocalciferol) and vitamin D3 (cholecalciferol), is projected to grow substantially. By 2027, the market is expected to reach USD 1.9 billion, growing at a CAGR of 7.1% from 2022[1].

Market Segmentation and Ergocalciferol

The vitamin D market is segmented by type, application, and region. Ergocalciferol, specifically, is used in various applications including feed industry, medicine, and nutritional supplements.

Type and Application

Ergocalciferol is primarily used in the feed industry for animal nutrition and in the medicine industry for treating conditions such as rickets, osteomalacia, and osteoporosis. It is also a key component in nutritional supplements due to its role in bone health and immune function[4][5].

Regional Outlook

The Asia Pacific region is a significant growth area for the vitamin D2 market, driven by increasing health awareness, rising disposable incomes, and urbanization. Countries like China, Japan, and India are seeing a surge in demand for nutritional supplements and fortified foods[4].

Market Drivers

Several factors are driving the growth of the ergocalciferol market:

Growing Health-Conscious Population

There is a rising preference for fortified foods and nutritional supplements among health-conscious consumers. This trend is particularly strong in both developed and developing regions, where consumers are seeking preventive health measures through their diet[1].

Rise in Demand for Feed Fortification

The livestock sector is expanding to meet the increasing global demand for high-value animal products. This has led to an increased focus on feed fortification, including the use of vitamin D2 to enhance the quality and safety of meat products[1].

Increasing Incidences of Vitamin D Deficiency

Global health concerns related to vitamin D deficiency are driving the demand for vitamin D2 supplements. Ergocalciferol is widely used to address these deficiencies and support overall health[4].

Financial Trajectory

Current Market Size and Growth

The vitamin D2 market, specifically, is expected to grow from USD 1.38 billion in 2023 to USD 2.9 billion by 2030, at a CAGR of 8.3%. This growth is driven by the increasing demand for nutritional supplements and fortified foods[4].

Historical and Forecasted Values

• 2021: USD 1,256.1 million
• 2022: USD 1,344.0 million
• 2023: USD 1,438.1 million
• 2027: USD 1.9 billion (for the broader vitamin D market)[1]

Regional Growth

The Asia Pacific region is expected to be the fastest-growing market for vitamin D2, driven by the factors mentioned earlier. This region's growth will significantly contribute to the overall financial trajectory of the ergocalciferol market[4].

Competitive Landscape

The market for ergocalciferol is competitive, with several key players including pharmaceutical companies, nutraceutical producers, and food fortification firms. Companies like Pfizer Inc. and Divi’s Nutraceuticals are actively involved in research and development, which further fuels market growth[4].

Opportunities and Challenges

Opportunities

• Advances in Formulation Technologies: Continuous research and development in formulation technologies are enhancing the efficacy and appeal of vitamin D2 products.
• Growing Awareness: Increasing awareness about the health benefits of vitamin D2 is driving consumer demand.
• Expanding Applications: Ergocalciferol is being explored for additional medical applications, such as in the treatment of type 1 diabetes, where it has shown immunomodulatory and anti-inflammatory effects[2][5].

Challenges

• Regulatory Frameworks: Strict regulatory requirements can pose challenges for new product approvals and market entry.
• Competition: The intense competition among existing players can make it difficult for new entrants to gain market share.

Clinical and Therapeutic Uses of Ergocalciferol

Ergocalciferol has several clinical and therapeutic applications:

Rickets and Osteomalacia

Ergocalciferol is used to treat rickets and osteomalacia by increasing the reabsorption of calcium and phosphate in the intestine and kidney, thereby enhancing bone mineral density[5].

Type 1 Diabetes

Recent studies have shown that high-dose ergocalciferol supplementation can protect residual beta-cell function and prolong the remission phase in children and adolescents with newly diagnosed type 1 diabetes[2].

Psoriasis and Other Conditions

Ergocalciferol analogues, such as calcitriol and calcipotriol, are used in the treatment of psoriasis and other skin conditions by inhibiting the proliferation of epidermal keratinocytes and T-lymphocytes[5].

Key Takeaways

• The global vitamin D market, including ergocalciferol, is projected to reach USD 1.9 billion by 2027.
• Ergocalciferol is driven by growing health awareness, demand for feed fortification, and increasing incidences of vitamin D deficiency.
• The Asia Pacific region is a key growth area for the vitamin D2 market.
• Ergocalciferol has various clinical applications, including the treatment of rickets, osteomalacia, and type 1 diabetes.
• Advances in formulation technologies and growing awareness are significant opportunities for market growth.

FAQs

What is the projected market size of the vitamin D2 market by 2030?

The vitamin D2 market is expected to grow to USD 2.9 billion by 2030, at a CAGR of 8.3% from 2023[4].

What are the primary applications of ergocalciferol?

Ergocalciferol is primarily used in the feed industry, medicine industry, and as a nutritional supplement[4].

Which region is expected to be the fastest-growing market for vitamin D2?

The Asia Pacific region is expected to be the fastest-growing market for vitamin D2, driven by increasing health awareness and rising disposable incomes[4].

What are the clinical benefits of ergocalciferol in type 1 diabetes?

Ergocalciferol has been shown to protect residual beta-cell function and prolong the remission phase in children and adolescents with newly diagnosed type 1 diabetes through its immunomodulatory and anti-inflammatory actions[2].

Who are the major players in the vitamin D2 market?

Major players include pharmaceutical companies, nutraceutical producers, and food fortification firms such as Pfizer Inc. and Divi’s Nutraceuticals[4].

Sources

1. MarketsandMarkets: Vitamin D Market Size, Share, Growth and Industry Report, 2022-2030.
2. Frontiers in Endocrinology: Guidance for high-dose vitamin D supplementation for prolonging remission in type 1 diabetes.
3. NewsChannelNebraska: Vitamin D Market Growth Insights 2024: Competitive Strategies, Future Trends, and Global Share Forecast to 2032.
4. ForInsightsConsultancy: Vitamin D2 Market Companies, Research & Trends [2024-2030].
5. MDPI: Vitamin D and Its Analogues: From Differences in Molecular Structure to Clinical Applications.