MIACALCIN Drug Patent Profile

Which patents cover Miacalcin, and what generic alternatives are available?

Miacalcin is a drug marketed by Mylan Ireland Ltd and Pharmobedient and is included in two NDAs.

The generic ingredient in MIACALCIN is calcitonin salmon. There are fourteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the calcitonin salmon profile page.

Summary for MIACALCIN

US Patents:	0
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	4
Drug Prices:	Drug price information for MIACALCIN
What excipients (inactive ingredients) are in MIACALCIN?	MIACALCIN excipients list
DailyMed Link:	MIACALCIN at DailyMed

See drug prices for MIACALCIN

Recent Clinical Trials for MIACALCIN

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

Sponsor	Phase
University of Missouri-Columbia	Phase 4
ProMedica Health System	Phase 4
University of Toledo Health Science Campus	Phase 4

See all MIACALCIN clinical trials

Pharmacology for MIACALCIN

Drug Class

Calcitonin

US Patents and Regulatory Information for MIACALCIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan Ireland Ltd	MIACALCIN	calcitonin salmon	INJECTABLE;INJECTION	017808-001	Jul 3, 1986		DISCN	Yes	No
Mylan Ireland Ltd	MIACALCIN	calcitonin salmon	INJECTABLE;INJECTION	017808-002	Mar 29, 1991	AP	RX	Yes	Yes
Pharmobedient	MIACALCIN	calcitonin salmon	SPRAY, METERED;NASAL	020313-002	Aug 17, 1995		DISCN	Yes	No

Expired US Patents for MIACALCIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pharmobedient	MIACALCIN	calcitonin salmon	SPRAY, METERED;NASAL	020313-002	Aug 17, 1995	5,733,569
Pharmobedient	MIACALCIN	calcitonin salmon	SPRAY, METERED;NASAL	020313-002	Aug 17, 1995	5,759,565

International Patents for MIACALCIN

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

Country	Patent Number	Title	Estimated Expiration
Austria	A349483
Ireland	56601	GALENIC COMPOSITIONS COMPRISING CALCITONIN AND THEIR USE
Hungary	192246	PROCESS FOR PRODUCING OF GALENIC COMPOSITIONS CONSISTING OF CALCITONIN
Netherlands	8303386
Japan	H02262526	CALCITONINE COMPOSITION AND USE THEREOF
Germany	3335086

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: MIACALCIN

Last updated: July 29, 2025

Introduction

MIACALCIN, known generically as calcitonin, is a hormone used primarily to treat conditions associated with elevated calcium levels and certain types of osteoporosis. As a therapeutic agent with a specific niche in managing hypercalcemia and osteoporosis, MIACALCIN occupies a unique position in the pharmaceutical landscape. Its market dynamics are shaped by clinical efficacy, safety profile, regulatory environment, competition, and evolving healthcare trends. This article offers an in-depth analysis of the current market environment and projects the financial trajectory for MIACALCIN, equipping stakeholders with actionable insights.

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Market Overview and Therapeutic Landscape

MIACALCIN’s primary indications, hypercalcemia of malignancy and Paget’s disease, have historically limited its use to specialized or acute care settings. The drug's core advantage lies in its rapid action in lowering serum calcium levels, with a well-established safety profile over decades of clinical use. However, advancements in alternative therapies, such as bisphosphonates (e.g., zoledronic acid) and denosumab, have introduced competitive challenges [1].

Despite these challenges, the demand for MIACALCIN persists, especially among patients with contraindications to alternative therapies, or where rapid calcium reduction is necessary. The global hypercalcemia treatment market was valued at approximately USD 125 million in 2022, with expected growth driven by rising cancer incidence and aging populations [2].

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Market Dynamics

1. Clinical Efficacy and Safety Profile

MIACALCIN’s efficacy in rapidly lowering serum calcium levels is well documented, with a relatively favorable safety profile. Nonetheless, newer agents such as bisphosphonates have demonstrated superior long-term efficacy and fewer adverse effects, impacting prescriber preference [3]. The route of administration (intranasal or injectable) and the pharmacokinetics also influence market acceptance.

2. Regulatory Environment

Regulatory bodies like the FDA and EMA have maintained approval pathways for MIACALCIN, though some formulations have faced reclassification or restricted indications. Regulatory constraints and evolving clinical guidelines favor newer, safer treatments, which could impact MIACALCIN's market access and approval in emerging markets.

3. Competitive Landscape

The competitive environment is characterized by:

• Bisphosphonates: Agents like zoledronic acid and pamidronate dominate the osteoporosis segment and hypercalcemia management due to their sustained efficacy and cost-effectiveness.
• Denosumab: Approved for osteoporosis and certain malignancies, offering longer dosing intervals.
• Emerging Biologics: Novel calcitonin analogs and monoclonal antibodies under development aim to outperform current options regarding safety and convenience.

The presence of these competitors influences market share, pricing strategies, and formulary placements.

4. Patent Status and Market Exclusivity

Most calcitonin formulations, including MIACALCIN, are approaching patent expiration, opening opportunities for generic manufacturing. Generics typically lead to price reductions and broader accessibility but also intensify competitive pressure.

5. Healthcare Economics and Reimbursement

In developed markets, reimbursement policies significantly influence prescribing behavior. The high costs associated with biologics and newer therapies challenge MIACALCIN’s market share due to cost-effectiveness considerations. In emerging economies, affordability remains a hurdle, yet the unmet need in certain indications sustains demand.

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Financial Trajectory and Forecasting

1. Historical Financial Performance

Data indicates that MIACALCIN’s revenue peaked in the early 2010s, followed by a gradual decline due to market saturation and competition [4]. Sales in mature markets have plateaued, with decline rates averaging around 4-6% annually, influenced by patent expiry and the rise of competing therapies.

2. Market Potential and Growth Drivers

Despite challenges, the global hypercalcemia market is projected to grow at a CAGR of approximately 4% between 2023 and 2030, driven by:

• Increasing prevalence of malignancies leading to hypercalcemia.
• Aging populations with osteoporosis and Paget’s disease.
• Limited alternatives suitable for specific patient populations.

MIACALCIN’s niche positioning could capitalize on segments where alternative therapies are contraindicated or less effective. Forecasts suggest that, with strategic repositioning or formulation improvements, MIACALCIN could recapture a modest market share, growing at a CAGR of 2-3% over the next decade.

3. Financial Projections

Assuming current market conditions, projected revenues might mirror a declining trend with stabilization around USD 60-80 million by 2025 due to the maturation of the market and patent expirations. However, long-term potential hinges on expanding indications, geographic penetration, and formulation innovations. License agreements and partnerships could generate additional revenue streams.

4. Strategic Opportunities

• Formulation Innovation: Developing longer-acting or less invasive delivery systems could improve adherence and expand use cases.
• Indication Expansion: Investigating MIACALCIN's utility in other calcium-related disorders or as adjunct therapy could open new markets.
• Market Penetration: Targeting emerging markets with lower-cost formulations offers growth potential.
• Partnerships: Collaborations with biotech firms for novel calcitonin analogs could revitalize product profile.

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Conclusion

The market dynamics for MIACALCIN are intricately linked to advancements in alternative therapies, patent lifecycle, regulatory shifts, and healthcare economics. While facing competitive pressures, the drug maintains a niche reinforcing its therapeutic importance. Financially, the trajectory points toward plateauing revenues with modest growth prospects contingent upon strategic innovation and market expansion.

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Key Takeaways

• Market position is constrained yet valuable in specific indications, especially where rapid calcium reduction is critical.
• Competition from bisphosphonates and denosumab significantly influences prescribing patterns and market share.
• Patent expirations and generic availability threaten price stability but may improve accessibility.
• Long-term growth hinges on formulation innovations, indication expansion, and penetration into emerging markets.
• Investments in strategic partnerships and R&D can reposition MIACALCIN within evolving therapeutic paradigms.

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FAQs

1. What are the main clinical advantages of MIACALCIN compared to newer therapies?
MIACALCIN offers rapid calcium reduction, a well-established safety profile, and straightforward administration. Its targeted efficacy makes it valuable in acute settings where quick intervention is necessary.

2. How does patent expiration affect MIACALCIN’s market prospects?
Patent expiration typically leads to generic versions, reducing costs and increasing accessibility but intensifying competition, which may decrease revenues unless differentiated through formulation or expanded indications.

3. Are there ongoing developments to improve MIACALCIN’s efficacy or delivery?
Yes, pharmaceutical researchers are exploring longer-acting formulations, nasal sprays, and combination therapies to enhance convenience, adherence, and clinical outcomes.

4. Which regions present the most growth opportunities for MIACALCIN?
Emerging markets in Asia, Latin America, and parts of Africa offer growth potential due to unmet needs, less mature competitive landscapes, and increasing healthcare spending.

5. What strategic moves can extend MIACALCIN’s market viability?
Focusing on formulation innovation, indication expansion, strategic licensing, and targeted marketing in niches where alternatives are less effective can preserve and grow its market relevance.

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Sources:
[1] Statista, "Global Hypercalcemia Market Size," 2022.
[2] MarketsandMarkets, "Osteoporosis and Related Fractures—Market Analysis," 2021.
[3] Journal of Clinical Endocrinology & Metabolism, "Comparative Efficacy of Calcitonin and Bisphosphonates," 2020.
[4] Company Annual Reports and Market Analytics Data, 2022.