Calcitriol - Generic Drug Details

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

Calcitriol is the generic ingredient in four branded drugs marketed by Amneal Pharms, Bionpharma, Hikma, Strides Pharma, Sun Pharm, Teva, Esjay Pharma, Abbvie, Am Regent, Fresenius Kabi Usa, Fresenius Medcl, Gland Pharma Ltd, Hospira, Long Grove Pharms, Rockwell Medcl, Sagent Pharms, Teva Parenteral, Galderma Labs Lp, Anda Repository, and Rising, and is included in twenty-two NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for calcitriol. Twenty-four suppliers are listed for this compound.

Summary for calcitriol

US Patents:	0
Tradenames:	4
Applicants:	20
NDAs:	22
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	24
Raw Ingredient (Bulk) Api Vendors:	90
Clinical Trials:	173
Patent Applications:	5,939
Drug Prices:	Drug price trends for calcitriol
Drug Sales Revenues:	Drug sales revenues for calcitriol
What excipients (inactive ingredients) are in calcitriol?	calcitriol excipients list
DailyMed Link:	calcitriol at DailyMed

See drug prices for calcitriol

See drug sales revenues for calcitriol

Recent Clinical Trials for calcitriol

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

Sponsor	Phase
Shanghai Jiao Tong University Affiliated Sixth People's Hospital	Phase 4
Chugai Pharma China Co., Ltd.	Phase 4
Xiaoyan Jia	Phase 4

See all calcitriol clinical trials

Pharmacology for calcitriol

Drug Class

Vitamin D3 Analog

Medical Subject Heading (MeSH) Categories for calcitriol

Bone Density Conservation Agents

Calcium Channel Agonists

Vitamins

Anatomical Therapeutic Chemical (ATC) Classes for calcitriol

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

D05AX	Other antipsoriatics for topical use
D05A	ANTIPSORIATICS FOR TOPICAL USE
D05	ANTIPSORIATICS
D	Dermatologicals

US Patents and Regulatory Information for calcitriol

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Strides Pharma	CALCITRIOL	calcitriol	CAPSULE;ORAL	091356-001	Dec 12, 2014	AB	RX	No	No
Fresenius Medcl	CALCITRIOL	calcitriol	INJECTABLE;INJECTION	075766-001	Feb 20, 2003		DISCN	No	No
Hikma	CALCITRIOL	calcitriol	SOLUTION;ORAL	076242-001	Jul 18, 2003	AA	RX	No	No

Expired US Patents for calcitriol

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	CALCIJEX	calcitriol	INJECTABLE;INJECTION	018874-001	Sep 25, 1986	4,308,264*PED
Abbvie	CALCIJEX	calcitriol	INJECTABLE;INJECTION	018874-002	Sep 25, 1986	6,265,392*PED
Abbvie	CALCIJEX	calcitriol	INJECTABLE;INJECTION	018874-002	Sep 25, 1986	3,697,559

Calcitriol Market dynamics and financial trajectory Experimental

Market Dynamics and Financial Trajectory for Calcitriol

Introduction to Calcitriol

Calcitriol, a hormonally active, synthetic vitamin D analog, is crucial in maintaining calcium balance and ensuring proper bone health. It is prescribed to treat various conditions, including hypocalcemia, osteoporosis, and the prevention of corticosteroid-induced osteoporosis[4].

Market Size and Growth

The global calcitriol market has been experiencing steady growth, driven by several key factors.

• Current Market Size: As of 2023, the calcitriol market was valued at approximately USD 441.62 million[1].
• Projected Growth: The market is estimated to reach USD 608.42 million by 2032, growing at a Compound Annual Growth Rate (CAGR) of 3.3% during the forecast period (2024-2032)[1].

Drivers of Market Growth

Several factors are driving the growth of the calcitriol market:

Increasing Prevalence of Bone-Related Diseases

The rising prevalence of osteoporosis, osteomalacia, rickets, and hypoparathyroidism is a significant driver. Osteoporosis, in particular, leads to weak bones, making them more prone to fractures, with around 8.9 million fractures annually attributed to osteoporosis worldwide[2].

Aging Population

The growing elderly population, especially in regions like North America and the Asia-Pacific, is a key factor. This demographic is more susceptible to conditions such as osteoporosis and chronic kidney disease, which benefit from calcitriol's ability to regulate calcium and phosphate levels[1][3].

Advancements in Healthcare Infrastructure

Improvements in healthcare infrastructure, particularly in developed countries like the U.S. and Canada, and emerging economies like China and India, are enhancing the accessibility and quality of calcitriol treatments[1][2][3].

Personalized Vitamin D Therapies

The exploration of personalized vitamin D therapies using calcitriol holds promise for more targeted and effective treatments, further propelling the market forward[1].

Market Segmentation

Product Type

The calcitriol market is segmented into calcitriol capsules and calcitriol solutions. Capsules dominate the market due to their ease of use, precise dosing, stability, and cost-efficiency[1][3].

Application

The market is categorized by application into osteoporosis, renal osteodystrophy, and others. Osteoporosis is the leading application segment, driven by the increasing prevalence of fractures associated with this condition[2][3].

Distribution Channel

The market is bifurcated into direct sales and distributors. Hospital pharmacies currently hold the largest market share due to their role in managing chronic diseases that require close supervision by specialists. However, drug stores and retail pharmacies are also significant, offering enhanced accessibility and personalized services[1][3].

Regional Analysis

North America

North America is the most significant market shareholder and is expected to expand substantially during the forecast period. The U.S. and Canada drive this growth due to their advanced healthcare infrastructure and large aging populations susceptible to osteoporosis and chronic kidney disease[1][2][3].

Asia-Pacific

The Asia-Pacific region is a pivotal market for calcitriol, with countries like China and India experiencing rapid growth. This is driven by a growing elderly population, increasing healthcare spending, and government healthcare initiatives[1][2][3].

Europe

Europe is expected to emerge as the second leading region, driven by the presence of advanced research and development facilities, patent expiry of branded drugs, and increasing government initiatives for reimbursement coverage[2][3].

Challenges and Constraints

Product Recalls

The market may be hindered by product recalls due to quality control issues. For instance, the recall of various products by Akorn Operating Company LLC in 2023 could damage patient and physician confidence in calcitriol products, leading to a temporary slowdown in market growth[1].

Regulatory Processes

Stringent regulatory processes and intellectual property rights can also inhibit market growth. The expiry of branded drugs and increased investments in new drug research and development, however, create opportunities for market expansion[2].

Financial Trajectory

Historical Performance

In 2017, the global calcitriol market was valued at approximately USD 350 million and was expected to reach USD 470 million by 2024, growing at a CAGR of around 4.3% between 2018 and 2024[2].

Future Projections

The market is projected to continue its growth trajectory, reaching USD 608.42 million by 2032. This growth is supported by increasing demand driven by the aging population, advancements in healthcare, and the exploration of personalized therapies[1].

Key Players

The calcitriol market includes major players such as F. Hoffmann-La Roche Ltd., Sun Pharmaceutical Industries Ltd., GlaxoSmithKline PLC, Hikma Pharmaceuticals PLC, Glenmark Pharmaceuticals, Akorn, Incorporated, Strides Pharma Science Limited, and Amneal Pharmaceuticals LLC. These companies play a crucial role in driving market growth through their product offerings and research and development activities[2].

Conclusion

The calcitriol market is poised for significant growth driven by the increasing prevalence of bone-related diseases, an aging population, and advancements in healthcare infrastructure. While challenges such as product recalls and stringent regulatory processes exist, the overall financial trajectory of the market remains positive.

Key Takeaways

• The global calcitriol market is valued at USD 441.62 million in 2023 and is expected to reach USD 608.42 million by 2032.
• The market is driven by the increasing prevalence of osteoporosis, osteomalacia, and other bone-related diseases.
• North America and the Asia-Pacific region are key markets due to their aging populations and advancing healthcare infrastructures.
• Capsules are the dominant product type due to their ease of use and cost-efficiency.
• Product recalls and stringent regulatory processes are potential constraints.

FAQs

What is the current market size of the global calcitriol market?

The global calcitriol market was valued at approximately USD 441.62 million in 2023[1].

What is the projected growth rate of the calcitriol market?

The calcitriol market is expected to grow at a CAGR of 3.3% during the forecast period (2024-2032)[1].

Which region dominates the calcitriol market?

North America is the most significant market shareholder and is expected to expand substantially during the forecast period[1][2][3].

What are the main applications of calcitriol?

The main applications include osteoporosis, renal osteodystrophy, and the prevention of corticosteroid-induced osteoporosis[2][3][4].

What are the potential challenges facing the calcitriol market?

Product recalls due to quality control issues and stringent regulatory processes are potential challenges[1][2].

Sources

1. Straits Research: Global Calcitriol Market Size to Grow at a CAGR of 3.3% by 2032.
2. GlobeNewswire: Global Calcitriol Market Expected to Reach USD 470 Million By 2024.
3. Fortune Business Insights: Calcitriol Market Size, Share, Global Demand, Forecast, 2032.
4. NCBI Bookshelf: Calcitriol - StatPearls.