CALCIJEX Drug Patent Profile

When do Calcijex patents expire, and when can generic versions of Calcijex launch?

Calcijex is a drug marketed by Abbvie and is included in one NDA.

The generic ingredient in CALCIJEX is calcitriol. There are ten drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the calcitriol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Calcijex

A generic version of CALCIJEX was approved as calcitriol by TEVA on October 12^th, 2001.

Summary for CALCIJEX

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	90
Clinical Trials:	5
Patent Applications:	4,220
DailyMed Link:	CALCIJEX at DailyMed

Recent Clinical Trials for CALCIJEX

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

Sponsor	Phase
National Cancer Institute (NCI)	Phase 1
Roswell Park Cancer Institute	Phase 1
Statistika Consultoria Ltda	Phase 4

See all CALCIJEX clinical trials

US Patents and Regulatory Information for CALCIJEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	CALCIJEX	calcitriol	INJECTABLE;INJECTION	018874-001	Sep 25, 1986		DISCN	Yes	No
Abbvie	CALCIJEX	calcitriol	INJECTABLE;INJECTION	018874-002	Sep 25, 1986		DISCN	Yes	No

Expired US Patents for CALCIJEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	CALCIJEX	calcitriol	INJECTABLE;INJECTION	018874-002	Sep 25, 1986	6,274,169*PED
Abbvie	CALCIJEX	calcitriol	INJECTABLE;INJECTION	018874-001	Sep 25, 1986	6,274,169*PED
Abbvie	CALCIJEX	calcitriol	INJECTABLE;INJECTION	018874-002	Sep 25, 1986	6,265,392*PED

International Patents for CALCIJEX

See the table below for patents covering CALCIJEX around the world.

Country	Patent Number	Title	Estimated Expiration
France	2498450
France	2126414
Japan	S57144218	STABILIZED DILUTE AQUEOUS MEDICINE OF 1 ALPHA,25-DIHYDROXYCHOLECALCIFEROL FOR NEONATAL ADMINISTRATION

CALCIJEX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Calcitriol (Calcijex)

Introduction to Calcitriol (Calcijex)

Calcitriol, also known as Calcijex, is the active form of vitamin D, crucial for maintaining calcium and phosphate levels in the body. It is widely used in the treatment of osteoporosis, chronic kidney disease, and other conditions related to vitamin D deficiency.

Global Market Size and Growth

The global calcitriol market has been experiencing steady growth, driven by increasing demand for treatments addressing osteoporosis and chronic kidney disease. As of 2023, the market size was valued at approximately USD 441.62 million to USD 442.53 million[1][4].

Forecasted Growth

The market is projected to grow at a compound annual growth rate (CAGR) of 3.3% to 4.88% between 2024 and 2032, reaching an estimated value of USD 608.42 million to USD 679.49 million by 2032[1][4].

Regional Market Dynamics

North America

North America is the most significant market for calcitriol, driven by an aging population susceptible to osteoporosis and chronic kidney disease. The advanced healthcare infrastructure and significant investments in research and development (R&D) for novel formulations further bolster the market in this region[1][4].

Asia-Pacific

The Asia-Pacific region is emerging as a pivotal market, with rapid growth anticipated due to increasing awareness of health issues, rising incomes, and an aging population. Countries like China and India are driving this growth, making the region the fastest-growing market for calcitriol[1][4].

Europe, Latin America, and Middle East & Africa

Europe is expected to closely follow North America in terms of revenue, while Latin America and the Middle East & Africa are anticipated to experience moderate growth in the near future[4].

Product Type and Application Segmentation

Product Type

Capsules are the dominant product type due to their ease of use. Other forms, such as injectables and oral solutions, also exist but are less prevalent[1].

Application Segmentation

The primary applications of calcitriol include the treatment of osteoporosis and chronic kidney disease. Osteoporosis treatment is the leading application segment, followed by treatments for other conditions related to vitamin D deficiency[1][4].

Distribution Channels

Hospital Pharmacies

Hospital pharmacies hold the largest market share for the distribution of calcitriol, as these settings require close supervision by specialists for the treatment of chronic diseases[1].

Key Players and Market Competition

The global calcitriol market is led by several major pharmaceutical companies, including 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[4].

Financial Performance of Key Companies

CalciMedica

CalciMedica, a company involved in the development of calcitriol-related treatments, reported significant financial activities in 2024. As of September 30, 2024, the company had approximately $14.6 million in cash, cash equivalents, and short-term investments. Following a public offering in October 2024, the company's cash position was expected to fund operations into the first half of 2026. Despite operational losses, the company is progressing with clinical trials for its product candidates, such as Auxora™ for acute pancreatitis and other conditions[2][3].

Regulatory and Quality Control

The calcitriol market is subject to stringent regulatory requirements. Companies must adhere to rigorous quality control measures to maintain investor confidence and support market growth. Recent recalls of certain products highlight the importance of these measures[1].

Clinical Trials and R&D

Ongoing Trials

Companies like CalciMedica are actively involved in clinical trials for various applications of calcitriol and related compounds. For example, CalciMedica is conducting Phase 2 trials for acute kidney injury and asparaginase-induced pancreatic toxicity, with data expected in 2025[2][3].

Future Outlook

The initiation of Phase 3 programs for certain treatments, such as Auxora™ for acute pancreatitis, is anticipated in 2025. These developments are expected to further drive the market growth and expand the therapeutic applications of calcitriol[2][3].

Market Drivers

Aging Population

The increasing elderly population with conditions like osteoporosis and chronic kidney disease is a significant driver of the calcitriol market. As the global population ages, the demand for treatments to manage these conditions is expected to rise[1][4].

Increasing Awareness

Growing awareness of vitamin D deficiency and the importance of calcium and phosphate balance in the body is also driving the market. Customizable treatment options are further enhancing market potential[1].

Market Challenges

Regulatory Hurdles

Stringent regulatory requirements and the need for rigorous quality control measures pose challenges for companies operating in the calcitriol market. Recent product recalls have underscored the importance of adhering to these standards[1].

Financial Constraints

Companies like CalciMedica face financial constraints, including operational losses and the need for continuous fundraising to support R&D activities. This can impact the pace of product development and market expansion[2][3].

Key Takeaways

• The global calcitriol market is valued at approximately USD 441.62 million to USD 442.53 million as of 2023.
• The market is projected to grow at a CAGR of 3.3% to 4.88% between 2024 and 2032.
• North America is the dominant market, followed by Europe and the rapidly growing Asia-Pacific region.
• Capsules are the dominant product type, and osteoporosis treatment is the leading application segment.
• Hospital pharmacies hold the largest market share for distribution.
• Key players include F. Hoffmann-La Roche Ltd., Sun Pharmaceutical Industries Ltd., and others.
• Regulatory compliance and quality control are critical for market growth.
• Clinical trials and R&D activities are ongoing, with promising future outlooks.

FAQs

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

The global calcitriol market size was valued at approximately USD 441.62 million to USD 442.53 million in 2023[1][4].

Q: What is the projected growth rate of the calcitriol market?

The market is expected to grow at a CAGR of 3.3% to 4.88% between 2024 and 2032[1][4].

Q: Which region dominates the calcitriol market?

North America is the most significant market for calcitriol, driven by an aging population and advanced healthcare infrastructure[1][4].

Q: What are the primary applications of calcitriol?

The primary applications include the treatment of osteoporosis and chronic kidney disease[1][4].

Q: Which companies are leading the calcitriol market?

Key players include F. Hoffmann-La Roche Ltd., Sun Pharmaceutical Industries Ltd., GlaxoSmithKline PLC, and others[4].

Sources

1. Straits Research: "Global Calcitriol Market Size to Grow at a CAGR of 3.3% by 2032" - July 8, 2024.
2. CalciMedica: "CalciMedica Reports Third Quarter 2024 Financial Results and Provides Clinical & Corporate Updates" - November 13, 2024.
3. PR Newswire: "CalciMedica Reports Third Quarter 2024 Financial Results and Provides Clinical & Corporate Updates" - November 13, 2024.
4. Zion Market Research: "Calcitriol Market Size, Share, Growth and Forecast 2024 - 2032" - April 8, 2024.