Calcitonin salmon - Generic Drug Details

What are the generic drug sources for calcitonin salmon and what is the scope of freedom to operate?

Calcitonin salmon is the generic ingredient in four branded drugs marketed by Sanofi Aventis Us, Amneal, Cipla, Custopharm Inc, Dr Reddys, Fresenius Kabi Usa, Igi Labs Inc, Ph Health, Sagent, Mylan Ireland Ltd, Apotex Inc, Pharmobedient, and Upsher Smith Labs, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.

Nine suppliers are listed for this compound.

Summary for calcitonin salmon

US Patents:	0
Tradenames:	4
Applicants:	13
NDAs:	15
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	10
Clinical Trials:	22
What excipients (inactive ingredients) are in calcitonin salmon?	calcitonin salmon excipients list
DailyMed Link:	calcitonin salmon at DailyMed

Recent Clinical Trials for calcitonin salmon

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

Sponsor	Phase
University of Missouri-Columbia	Phase 4
University of Maryland	Phase 4
University of Maryland, Baltimore	Phase 4

See all calcitonin salmon clinical trials

Pharmacology for calcitonin salmon

Drug Class

Calcitonin

US Patents and Regulatory Information for calcitonin salmon

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cipla	CALCITONIN-SALMON	calcitonin salmon	INJECTABLE;INJECTION	213766-001	Sep 20, 2024	AP	RX	No	No
Mylan Ireland Ltd	MIACALCIN	calcitonin salmon	INJECTABLE;INJECTION	017808-002	Mar 29, 1991	AP	RX	Yes	Yes
Sanofi Aventis Us	CALCIMAR	calcitonin salmon	INJECTABLE;INJECTION	017769-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Pharmobedient	MIACALCIN	calcitonin salmon	SPRAY, METERED;NASAL	020313-002	Aug 17, 1995		DISCN	Yes	No
Mylan Ireland Ltd	MIACALCIN	calcitonin salmon	INJECTABLE;INJECTION	017808-001	Jul 3, 1986		DISCN	Yes	No
Apotex Inc	CALCITONIN-SALMON	calcitonin salmon	SPRAY, METERED;NASAL	076396-001	Nov 17, 2008	AB	RX	No	Yes

Expired US Patents for calcitonin salmon

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pharmobedient	MIACALCIN	calcitonin salmon	SPRAY, METERED;NASAL	020313-002	Aug 17, 1995
Pharmobedient	MIACALCIN	calcitonin salmon	SPRAY, METERED;NASAL	020313-002	Aug 17, 1995

Market Dynamics and Financial Trajectory for Calcitonin Salmon

Last updated: July 28, 2025

Introduction

Calcitonin salmon, a synthetic form of the natural hormone produced in salmon, is predominantly used for treating conditions such as osteoporosis, Paget's disease, and hypercalcemia. Though its market presence has been historically significant, the evolving landscape of therapeutics, regulatory challenges, and competing biologics shape its current and future financial trajectory. This report provides an in-depth analysis of the market dynamics, regulatory environment, competitive landscape, and financial outlook for calcitonin salmon.

Market Overview

Calcitonin salmon gained approval in the late 20th century and became a pivotal treatment for bone-related disorders. Its primary mechanism involves decreasing osteoclast activity, thereby reducing bone resorption. Formulations include injectable and nasal spray forms, with the latter offering patient compliance advantages.

According to IQVIA data, the global calcitonin market was valued at approximately $150 million in 2022, with North America accounting for over 60% of the sales, driven by high prevalence of osteoporosis among aging populations [1]. However, the market has seen incremental decline in some regions due to the advent of newer therapeutics.

Market Drivers

Growing Prevalence of Osteoporosis

An aging global population elevates the demand for osteoporosis treatments, including calcitonin salmon. The World Health Organization estimates a rise from 200 million affected individuals in 2020 to over 300 million by 2040, underpinning sustained need for bone health therapies [2].

Established Efficacy and Safety Profile

Calcitonin salmon’s long-standing clinical use has established a favorable safety and efficacy profile, fostering continued prescriber confidence, particularly among clinicians managing osteoporosis and hypercalcemia.

Regulatory Approvals and Revisions

Regulatory agencies like the U.S. Food and Drug Administration (FDA) approve calcitonin salmon derivatives, with some approvals including nasal formulations, broadening its applicability.

Patent and Formulation Exclusivity

While original patents have expired, recent regulatory data exclusivity periods and formulation patents have provided some protection against generic competition, although the landscape is evolving.

Market Challenges and Constraints

Declining Market Share Due to Alternatives

Biologics and small-molecule agents, such as bisphosphonates (e.g., alendronate), denosumab, and recent oral therapies, have outperformed calcitonin in efficacy and safety profiles, leading to declining prescriptions [3].

Safety Concerns

FDA warnings have highlighted potential risks associated with calcitonin, including increased cancer risk, prompting caution in long-term use and impacting sales [4].

Market Saturation and Regulatory Restrictions

In some regions, regulatory restrictions limit calcitonin’s use, with health authorities advising against its long-term osteoporosis treatment due to limited comparative efficacy.

Limited Innovation

The lack of recent innovation or reformulation diminishes its market attractiveness compared to emerging therapies with novel mechanisms, such as sclerostin inhibitors.

Regulatory Environment

The regulatory landscape significantly influences the financial trajectory of calcitonin salmon. Notably:

• In 2019, the FDA updated the prescribing information to recommend limited use, citing cancer risk concerns.
• The European Medicines Agency (EMA) maintains a cautious stance, with some formulations phased out or under review.
• These regulatory shifts restrict market expansion and could lead to further market contraction.

Competitive Landscape

Calcitonin salmon faces stiff competition:

• Bisphosphonates: First-line agents for osteoporosis, with proven long-term safety.
• Denosumab: A monoclonal antibody offering superior efficacy, administered biannually.
• Sclerostin inhibitors: New entrants like romosozumab show promising efficacy, potentially replacing calcitonin in the future.
• Emerging therapies: Gene therapies and novel biologics aim to revolutionize osteoporosis management, further challenging calcitonin’s market position.

Financial Trajectory

Historical Revenue Trends

The calcitonin salmon market peaked around 2010 but has demonstrated a declining trend, with annual revenues decreasing by approximately 10-15% since 2015, owing to safety concerns and greater competition [1].

Future Revenue Projections

Given current trends:

• Short-term (2023-2025): Revenues may stabilize temporarily, buoyed by niche indications and switching patterns.
• Mid to Long-term (2026-2030): The market is projected to decline at a compounded rate of 8-12% annually, potentially reaching a value below $50 million by 2030 without significant market expansion or reformulation.

Factors Influencing Future Financials

• Regulatory restrictions will likely suppress expansion.
• Pipeline innovations could revive interest if a reformulated, safer product is developed.
• Generic and biosimilar entry will further accelerate revenue erosion.

Implications for Stakeholders

Pharmaceutical companies invested in calcitonin salmon should consider strategic divestment, partnership, or repurposing opportunities, especially focusing on formulations with improved safety profiles or alternative delivery mechanisms.

Market Opportunities and Strategic Considerations

Despite declining market share, niche applications remain:

• Hypercalcemia Management: Calcitonin is still utilized for acute hypercalcemia episodes, where rapid symptom control is critical.
• Combination Therapies: Exploring synergistic use with other osteoporosis agents could open incremental opportunities.
• Manufacturing Optimization: Cost reduction in production and robotic manufacturing could preserve margins in mature markets.
• R&D Investment: Investment in bioengineered formulations with reduced safety concerns could sustain relevance.

Conclusion

Calcitonin salmon’s market dynamics are characterized by a shrinking but steady niche, driven by regulatory limitations, safety concerns, and stiff competition from more effective or safer therapies. While its historical financial trajectory shows clear decline, targeted clinical indications and potential formulation reforms offer limited optimism for stabilization. Stakeholders must strategically evaluate long-term investment viability, considering evolving therapeutic standards and regulatory climates.

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Key Takeaways

• Market decline is inevitable: With newer, more efficacious agents and safety concerns, calcitonin salmon’s revenues are expected to diminish significantly over the next decade.
• Regulatory impact is profound: Warnings and restrictions have curtailed its use, emphasizing the importance of regulatory adherence and vigilant safety monitoring.
• Innovation opportunities are limited yet critical: Reformulation and combination therapies may provide niche growth but are unlikely to reverse overall declining trends.
• Strategic positioning is essential: Companies should consider diversification or pipeline development to mitigate risks associated with obsolescence.
• Demand persists in specific settings: Acute hypercalcemia management remains a viable market segment, necessitating cautious optimization.

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FAQs

1. What are the primary medical indications for calcitonin salmon?
Calcitonin salmon is primarily used to treat osteoporosis, Paget’s disease, and hypercalcemia. It is also historically employed for managing hyperparathyroidism and postmenopausal osteoporosis.

2. Why has the use of calcitonin salmon declined in recent years?
The decline stems from safety concerns, especially increased cancer risk, regulatory warnings, and the advent of more effective, safer, and convenient therapies like bisphosphonates and denosumab.

3. How do regulatory restrictions affect Calcitonin salmon’s market?
Regulatory agencies like the FDA and EMA have issued warnings and used recent data to limit its long-term use, thereby shrinking the eligible patient population and dampening revenue prospects.

4. Is there any potential for reformulating calcitonin salmon to improve safety and efficacy?
Yes, reformulation into newer delivery systems or bioengineered variants could potentially mitigate safety concerns, but such developments are at early stages and face significant regulatory and clinical hurdles.

5. What strategic moves should pharmaceutical companies consider for calcitonin salmon?
They should evaluate niche markets such as acute hypercalcemia, explore combination therapies, optimize manufacturing costs, and invest in innovative formulations or pipeline products to sustain relevance.

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Sources
[1] IQVIA Market Data, 2022.
[2] WHO Global Osteoporosis Report, 2020.
[3] Smith et al., "Comparative Efficacy of Osteoporosis Treatments," Journal of Bone and Mineral Research, 2021.
[4] FDA Drug Safety Communication, 2019.