Calcifediol - Generic Drug Details

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

Calcifediol is the generic ingredient in two branded drugs marketed by Eirgen and Organon Usa Inc, and is included in two NDAs. There are sixteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Calcifediol has one hundred and seventy-two patent family members in thirty-six countries.

There are two drug master file entries for calcifediol. One supplier is listed for this compound.

Summary for calcifediol

International Patents:	172
US Patents:	16
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	201
Clinical Trials:	23
Patent Applications:	5,620
What excipients (inactive ingredients) are in calcifediol?	calcifediol excipients list
DailyMed Link:	calcifediol at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for calcifediol

Constraining patent/regulatory exclusivity:

9,861,644

Dosage:

CAPSULE, EXTENDED RELEASE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for calcifediol

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

Sponsor	Phase
Shanghai Jiao Tong University School of Medicine	Phase 3
Indonesia University	Phase 2
Faes Farma, S.A.	Phase 2/Phase 3

See all calcifediol clinical trials

Pharmacology for calcifediol

Drug Class

Vitamin D3 Analog

Medical Subject Heading (MeSH) Categories for calcifediol

Bone Density Conservation Agents

Vitamins

Anatomical Therapeutic Chemical (ATC) Classes for calcifediol

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

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

US Patents and Regulatory Information for calcifediol

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Eirgen	RAYALDEE	calcifediol	CAPSULE, EXTENDED RELEASE;ORAL	208010-001	Jun 17, 2016		RX	Yes	Yes	11,154,509
Eirgen	RAYALDEE	calcifediol	CAPSULE, EXTENDED RELEASE;ORAL	208010-001	Jun 17, 2016		RX	Yes	Yes	9,498,486
Eirgen	RAYALDEE	calcifediol	CAPSULE, EXTENDED RELEASE;ORAL	208010-001	Jun 17, 2016		RX	Yes	Yes	9,925,147		Y
Eirgen	RAYALDEE	calcifediol	CAPSULE, EXTENDED RELEASE;ORAL	208010-001	Jun 17, 2016		RX	Yes	Yes	11,253,528		Y
Eirgen	RAYALDEE	calcifediol	CAPSULE, EXTENDED RELEASE;ORAL	208010-001	Jun 17, 2016		RX	Yes	Yes	10,300,078		Y
Eirgen	RAYALDEE	calcifediol	CAPSULE, EXTENDED RELEASE;ORAL	208010-001	Jun 17, 2016		RX	Yes	Yes	8,207,149

Expired US Patents for calcifediol

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon Usa Inc	CALDEROL	calcifediol	CAPSULE;ORAL	018312-001	Approved Prior to Jan 1, 1982	3,833,622
Organon Usa Inc	CALDEROL	calcifediol	CAPSULE;ORAL	018312-002	Approved Prior to Jan 1, 1982	3,565,924
Eirgen	RAYALDEE	calcifediol	CAPSULE, EXTENDED RELEASE;ORAL	208010-001	Jun 17, 2016	6,582,727
Organon Usa Inc	CALDEROL	calcifediol	CAPSULE;ORAL	018312-002	Approved Prior to Jan 1, 1982	3,833,622
Organon Usa Inc	CALDEROL	calcifediol	CAPSULE;ORAL	018312-001	Approved Prior to Jan 1, 1982	3,565,924

International Patents for calcifediol

Country	Patent Number	Title	Estimated Expiration
Canada	2683997	COMPOSITIONS ORALES A LIBERATION CONTROLEE COMPRENANT DES COMPOSES DE VITAMINE D ET UN VEHICULE CIREUX (ORAL CONTROLLED RELEASE COMPOSITIONS COMPRISING VITAMIN D COMPOUND AND WAXY CARRIER)
Spain	2904546
Japan	2010525078
Slovenia	2148661
Philippines	12015502162	STABILIZED MODIFIED RELEASE VITAMIN D FORMULATION AND METHOD OF ADMINISTERING SAME
South Korea	20190095216	안정화되고 변형된 비타민 Ｄ 방출 제형 및 이의 투여 방법 (STABILIZED MODIFIED RELEASE VITAMIN D FORMULATION AND METHOD OF ADMINISTERING SAME)

Supplementary Protection Certificates for calcifediol

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2968172	CA 2021 00005	Denmark		PRODUCT NAME: CALCIFEDIOL; NAT. REG. NO/DATE: 62564 20200910; FIRST REG. NO/DATE: DE 2202115.00.00 20200818
2481400	122020000079	Germany		PRODUCT NAME: CALCIFEDIOL UND/ODER PHARMAZEUTISCH AKZEPTABLE SALZE UND HYDRATE DAVON, BEVORZUGT CALCIFEDIOLMONOHYDRAT; NAT. REGISTRATION NO/DATE: 2202115.00.00 20200818; FIRST REGISTRATION: VEREINIGTES KOENIGREICH GROSSBRITANNIEN UND NORDIRLAND PL 50784/0005 - 0001 20200721
2481400	301085	Netherlands		PRODUCT NAME: CALCIFEDIOL IN IEDERE VORM ZOALS BESCHERMD DOOR HET BASISOCTROOI; NATIONAL REGISTRATION NO/DATE: 124799 20200922; FIRST REGISTRATION: DE 2202115.00.00 20200819
2481400	C02481400/01	Switzerland		PRODUCT NAME: CALCIFEDIOL; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67614 22.12.2020
2481400	132021000000071	Italy		PRODUCT NAME: CALCIFEDIOLO(RAYALDEE); AUTHORISATION NUMBER(S) AND DATE(S): 047870011, 20201201;PL 50784/0005, 20200721
2968172	301095	Netherlands		PRODUCT NAME: CALCIFEDIOL IN IEDERE VORM ZOALS BESCHERMD DOOR HET BASISOCTROOI; NATIONAL REGISTRATION NO/DATE: 124799 20200922; FIRST REGISTRATION: DE 2202115.00.00 20200819

Calcifediol Market Analysis and Financial Projection Experimental

Calcifediol Market Dynamics and Financial Trajectory

Introduction to Calcifediol

Calcifediol, also known as 25-hydroxyvitamin D3, is a form of Vitamin D produced by the liver through the hydroxylation of Vitamin D3 obtained from sunlight or diet. It is further converted into calcitriol, the active form of Vitamin D, in the kidneys. Calcifediol is gaining significant attention due to its superior absorption and potency compared to other forms of Vitamin D, such as cholecalciferol[1][4].

Market Size and Growth

The calcifediol market is projected to experience substantial growth over the next few years. Here are some key statistics:

• The calcifediol market is expected to grow at a Compound Annual Growth Rate (CAGR) of 6.24%, reaching a market size of US$2,631.61 million by 2030 from US$1,943.95 million in 2025[1].
• The calcifediol supplements market, a subset of the broader calcifediol market, is anticipated to grow at a CAGR of 9.21%, achieving a market size of US$2,189.3 million by 2030 from US$1,409.4 million in 2025[4].

Market Drivers

Several factors are driving the growth of the calcifediol market:

• Rising Vitamin D Deficiency: The increasing prevalence of Vitamin D deficiency worldwide, particularly among the aging population, is a significant driver. Calcifediol is more potent and has a higher absorption rate than other forms of Vitamin D, making it a preferred choice for treating deficiencies[1][4].
• Health Awareness and Micronutrient Supplementation: Post-pandemic, there has been a heightened awareness of health and wellness, leading to an increased demand for dietary supplements. More than half of the US adults consume dietary supplements, indicating a growing market for calcifediol[4].
• Livestock and Poultry Health: The use of calcifediol in animal feed to enhance bone strength, reproductive performance, immunity, and meat quality is also driving market growth. Global meat production has increased significantly, necessitating better feed quality, which includes calcifediol[1].

Segment Analysis

By Application

• Pharmaceuticals: This segment is expected to dominate the calcifediol market. Calcifediol is used to treat Vitamin D deficiency, osteoporosis, secondary hyperparathyroidism, and other conditions. Its higher potency and better absorption make it a preferred choice in pharmaceutical applications[1][4].
• Animal Feed: The demand for calcifediol in animal feed is increasing due to its benefits in improving the health and quality of livestock and poultry[1].
• Others: This segment includes other uses such as in food fortification and nutritional supplements.

By Geography

• North America: This region is expected to hold the largest market share for calcifediol and its supplements. The aging population and advanced healthcare infrastructure in countries like the United States and Canada contribute to this dominance[1][4].
• Europe: The approval of DSM-Firmenich’s ampli-D calcifediol supplement as a novel food in the European Union in May 2024 is expected to unlock new market opportunities in this region[1][4].
• Asia Pacific, South America, Middle East, and Africa: These regions are also experiencing growth, driven by increasing health awareness and the need for better nutritional supplements.

Key Developments

Several recent developments are shaping the calcifediol market:

• European Union Approval: In May 2024, the European Union approved DSM-Firmenich’s ampli-D calcifediol supplement as a novel food, opening up new market opportunities[1][4].
• Collaborations and Product Launches: Collaborations such as the one between MD Pharmaceuticals and DSM to develop Rapid-D with Calcifediol, and the launch of ampli-D by Bioclinic and DSM, are expanding the market reach and product offerings[1][4].

Major Challenges

Despite the growth potential, the calcifediol market faces some challenges:

• Limited Awareness: One of the major restraints is the limited awareness of calcifediol and its properties among consumers. This lack of awareness hinders the market growth compared to other vitamin D supplements[1][4].
• Regulatory Hurdles: Ensuring compliance with regulatory standards and gaining approvals can be time-consuming and costly, which may slow down market expansion.

Financial Trajectory

The financial trajectory of the calcifediol market is promising, with significant growth projected over the next few years:

• Market Size: The calcifediol market is expected to reach US$2,631.61 million by 2030, while the calcifediol supplements market is projected to reach US$2,189.3 million by the same year[1][4].
• Revenue Streams: The revenue will be generated primarily from pharmaceutical applications, followed by animal feed and other segments. North America is expected to be the largest revenue contributor due to its advanced healthcare infrastructure and high demand for dietary supplements[1][4].

Competitive Environment

The competitive landscape of the calcifediol market includes several key players:

• Major Players: Companies like Chemvon Biotechnology Co., Haoyuan Chemexpress Co. Ltd., and BOC Science are significant players in the market. These companies are involved in various strategies such as mergers, acquisitions, and collaborations to enhance their market share[1].
• Market Share Analysis: The pharmaceutical segment dominates the market, with North America holding the largest share. Companies are focusing on expanding their product portfolios and geographical reach to capture a larger market share[1][4].

Conclusion

The calcifediol market is poised for significant growth driven by increasing health awareness, the rising prevalence of Vitamin D deficiency, and its superior properties compared to other forms of Vitamin D. Despite challenges such as limited awareness and regulatory hurdles, the market is expected to expand substantially over the next few years.

Key Takeaways

• Growth Potential: The calcifediol market is expected to grow at a CAGR of 6.24%, reaching US$2,631.61 million by 2030.
• Dominant Segments: Pharmaceuticals will dominate the market, with North America being the largest market shareholder.
• Key Drivers: Rising Vitamin D deficiency, health awareness, and use in animal feed are major drivers.
• Challenges: Limited awareness and regulatory hurdles are significant challenges.
• Key Developments: Recent approvals and collaborations are expanding market opportunities.

FAQs

Q: What is calcifediol and how is it produced? A: Calcifediol, or 25-hydroxyvitamin D3, is produced by the liver through the hydroxylation of Vitamin D3 obtained from sunlight or diet.

Q: Why is calcifediol preferred over other forms of Vitamin D? A: Calcifediol is 3 times more potent than cholecalciferol and has a higher absorption rate, making it a preferred choice for treating Vitamin D deficiency.

Q: What are the primary applications of calcifediol? A: The primary applications include pharmaceuticals for treating Vitamin D deficiency, osteoporosis, and secondary hyperparathyroidism, as well as in animal feed to improve livestock health.

Q: Which region is expected to dominate the calcifediol market? A: North America is expected to hold the largest market share due to its advanced healthcare infrastructure and high demand for dietary supplements.

Q: What are the major challenges facing the calcifediol market? A: Limited awareness of calcifediol and its properties, along with regulatory hurdles, are significant challenges hindering market growth.

Sources

1. Knowledge Sourcing: Calcifediol Market Insights: Size, Share, Trends, Forecast 2030.
2. NCBI: Calcifediol (25-hydroxyvitamin D) improvement and calcium-phosphate metabolism in Chinese PMO patients.
3. Research and Markets: Calcifediol Supplements Market - Forecasts from 2025 to 2030.
4. Knowledge Sourcing: Calcifediol Supplements Market Size: Industry Report, 2022 – 2027.
5. OPKO Health, Inc.: 2023 ANNUAL REPORT.