CALCITRIOL - Generic Drug Details

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

Calcitriol is the generic ingredient in four branded drugs marketed by Amneal Pharms, Bionpharma, Hikma, Onesource Specialty, Sun Pharm, Teva, Esjay Pharma, Abbvie, Am Regent, Fresenius Kabi Usa, Fresenius Medcl, Gland, 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:	1
Clinical Trials:	180
Patent Applications:	6,645
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
Al-Azhar University	NA
University of Split, School of Medicine	NA
University of Aarhus	PHASE4

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
Fresenius Kabi Usa	CALCITRIOL	calcitriol	INJECTABLE;INJECTION	075836-001	Dec 31, 2002		DISCN	No	No
Fresenius Medcl	CALCITRIOL	calcitriol	INJECTABLE;INJECTION	075766-001	Feb 20, 2003		DISCN	No	No
Teva Parenteral	CALCITRIOL	calcitriol	INJECTABLE;INJECTION	075823-002	Mar 31, 2003		DISCN	No	No
Teva	CALCITRIOL	calcitriol	CAPSULE;ORAL	075765-001	Oct 12, 2001	AB	RX	No	No
Rising	CALCITRIOL	calcitriol	SOLUTION;ORAL	209798-001	Nov 21, 2018	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
Esjay Pharma	ROCALTROL	calcitriol	CAPSULE;ORAL	018044-002	Approved Prior to Jan 1, 1982	3,697,559
Abbvie	CALCIJEX	calcitriol	INJECTABLE;INJECTION	018874-001	Sep 25, 1986	3,697,559

Market Dynamics and Financial Trajectory for CALCITRIOL

Last updated: July 27, 2025

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Introduction to CALCITRIOL

Calcitriol, known chemically as 1,25-dihydroxyvitamin D3, is the active form of vitamin D utilized primarily in treating various forms of secondary hyperparathyroidism, osteoporosis, hypocalcemia, psoriasis, and certain renal disorders. Since its approval, calcitriol has cemented a vital position in endocrinology and nephrology by facilitating calcium homeostasis and bone health. Its market viability hinges on factors such as rising prevalence of chronic kidney disease (CKD), aging populations, and increasing awareness around bone health. This comprehensive analysis examines ongoing market dynamics, competitive landscape, regulatory influences, and future financial trajectories impacting calcitriol.

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Market Overview and Key Drivers

Global Market Size and Growth Trends

The global calcitriol market was valued at approximately USD 150 million in 2022, with a compound annual growth rate (CAGR) projected at approximately 4.5%-6% over the next five years. This expansion reflects increased demand driven by rise in CKD patients, osteoporosis, and vitamin D deficiency globally, especially in Asia-Pacific and Latin America regions where healthcare infrastructure is expanding rapidly [1].

Prevalence of Chronic Kidney Disease and Osteoporosis

CKD remains a primary driver, accounting for around 10% of the global population affected by some degree of renal impairment [2]. As CKD progresses, secondary hyperparathyroidism becomes prevalent, necessitating calcitriol therapy to regulate calcium and phosphate levels. Concurrently, osteoporosis, affecting over 200 million individuals worldwide, sustains demand for bone health therapeutics, where calcitriol plays a complementary role alongside bisphosphonates and vitamin D analogs [3].

Aging Populations and Demographic Shifts

The aging demographic amplifies calcitriol’s market by expanding the patient base for osteoporosis and CKD. According to WHO projections, individuals aged 65+ will constitute over 16% of the global population by 2050, notably in developed nations [4]. This acceleration enhances prospects for long-term demand and revenue growth in established markets.

Rising Awareness and Healthcare Infrastructure Development

Enhanced public awareness regarding vitamin D deficiency’s impact on overall health fosters increased prescription and OTC use of calcitriol. Simultaneously, infrastructural investments, particularly in emerging markets, facilitate better diagnosis and management of renal and bone diseases, fueling sales.

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Competitive Landscape and Market Segmentation

Key Players and Market Share

The calcitriol market remains segmented primarily between branded formulations and generic equivalents. Major pharmaceutical companies, including AbbVie (via AbbVie-licensed formulations), Teva Pharmaceuticals, Mylan (acquired by Viatris), and local generic manufacturers, dominate supply chains. Branded formulations typically command premium pricing, while generics sustain widespread accessibility.

Product Differentiation and Innovation

Most calcitriol formulations feature oral capsules or solutions, with limited innovation in delivery mechanisms. Recent developments include sustained-release formulations and combination products (e.g., calcitriol with calcium). However, the market largely remains commoditized, putting pressure on pricing and margins.

Regulatory and Patent Landscape

While calcitriol is off-patent in many jurisdictions, some formulations have patent extensions or proprietary delivery methods, offering competitive advantages. Patent expirations in originating markets have led to increased generic penetration, intensifying price competition.

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Regulatory Environment and Impact

Approvals and Manufacturing Standards

Regulatory agencies such as the FDA, EMA, and WHO enforce stringent standards for manufacturing, stability, and pharmacovigilance. These procedures influence market access, especially for new formulations or combination therapies. In emerging markets, evolving regulations are lowering barriers to registration.

Reimbursement Policies

Coverage varies from region to region. In developed nations like the U.S. and European countries, reimbursement pathways for calcitriol are well-established when prescribed for approved indications. Conversely, reimbursement challenges in some developing countries hinder access and market growth.

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Challenges and Market Restraints

Safety Concerns and Side Effect Profile

Calcitriol’s hypercalcemia risk necessitates careful therapeutic monitoring, which can limit its use, especially in outpatient settings. Concerns over toxicity restrict broader OTC adoption and contribute to cautious prescribing behaviors.

Availability of Alternatives

Vitamin D analogs, including alfacalcidol and paricalcitol, offer alternative therapeutic options with different safety profiles. The competitive landscape thus necessitates differentiation based on efficacy and safety advantages, which are somewhat limited.

Pricing and Reimbursement Constraints

Pricing pressures, especially in commodity markets, can impede profit margins. The rise of generics results in declining prices, constraining revenue growth potential for branded products.

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Future Financial Trajectory

Market Expansion Opportunities

• Emerging Markets: Rapid urbanization and increasing disease prevalence position Asia-Pacific, Africa, and Latin America as key regions for expansion. Local manufacturing, regulatory approvals, and pricing strategies tailored to these markets could drive growth.

• Combination Therapies: Development of calcitriol-based combination products addressing comprehensive patient needs (e.g., with calcium or phosphate binders) presents new revenue streams.

• Innovative Delivery Systems: Long-acting formulations or novel delivery methods (such as transdermal patches) could enhance patient adherence and therapeutics' marketability, driving premium pricing.

Forecasted Revenue Streams

• Year-over-year growth is anticipated to be driven predominantly by increased patient diagnosis rates, especially in CKD and osteoporosis.
• Premium segments in developed countries will likely maintain profitability despite price competition, through branding and advanced formulations.
• Generic penetration will sustain overall market volume but with decreased margins, emphasizing the importance of volume-based growth strategies.

Potential Disruptors

Emerging gene therapies, novel vitamin D receptor modulators, and digital health tools aimed at optimizing management could influence traditional calcitriol demand. Although these innovations are in nascent stages, their impact warrants monitoring.

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Concluding Perspectives

The calcitriol market exhibits steady growth characterized by demographic expansions, rising disease burden, and increasing healthcare infrastructure, especially in markets with developing economies. Competitive dynamics favor generics with price sensitivity, although opportunities exist in innovation, particularly in delivery systems and combination formulations. Strategic positioning in emerging markets, coupled with product differentiation, will be crucial for sustained financial success.

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Key Takeaways

• Growing global prevalence of CKD and osteoporosis propels calcitriol demand, fueling a forecasted CAGR of about 5-6% over the next five years.
• Aging populations and healthcare infrastructure development in Asia-Pacific and Latin America are primary growth catalysts.
• Market competition is intense, dominated by generics, emphasizing price competition and the need for differentiated, innovative formulations.
• Regulatory and reimbursement policies significantly influence market accessibility, with developed nations offering more stable pathways.
• Future growth will hinge on expanding into emerging markets, developing combination therapies, and innovating delivery mechanisms to enhance adherence and safety.

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FAQs

1. What are the primary therapeutic indications for calcitriol?
Calcitriol is mainly used to treat secondary hyperparathyroidism, osteoporosis, hypocalcemia, and certain renal disorders, particularly in CKD patients.

2. How does the patent landscape impact calcitriol market competition?
Most calcitriol formulations are off-patent, leading to widespread generic manufacturing, which increases competition and reduces prices.

3. What demographic trends are influencing calcitriol market growth?
An aging global population and increased awareness of bone and renal health are expanding the patient base, especially in Asia-Pacific and developing nations.

4. What are the main challenges facing calcitriol commercialization?
Safety concerns such as hypercalcemia, competition from alternative vitamin D analogs, and pricing pressures from generics pose significant challenges.

5. Which regions present the highest growth opportunities for calcitriol?
Emerging markets in Asia-Pacific, Latin America, and Africa, driven by growing disease prevalence and healthcare infrastructure improvements, offer robust growth potential.

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Sources

[1] MarketWatch, "Global Calcitriol Market Size," 2022.
[2] WHO, "Global Burden of Chronic Kidney Disease," 2021.
[3] International Osteoporosis Foundation, "Global Osteoporosis Prevalence," 2020.
[4] WHO, "Aging Populations and Healthcare," 2021.