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Last Updated: December 22, 2024

Calcitonin salmon recombinant - Generic Drug Details


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What are the generic sources for calcitonin salmon recombinant and what is the scope of patent protection?

Calcitonin salmon recombinant is the generic ingredient in one branded drug marketed by Upsher Smith Labs and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for calcitonin salmon recombinant
Recent Clinical Trials for calcitonin salmon recombinant

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SponsorPhase
University of Missouri-ColumbiaPhase 4
University of MarylandPhase 4
University of Maryland, BaltimorePhase 4

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Paragraph IV (Patent) Challenges for CALCITONIN SALMON RECOMBINANT
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
FORTICAL Nasal Spray calcitonin salmon recombinant 200 IU/spray 021406 1 2006-03-29

US Patents and Regulatory Information for calcitonin salmon recombinant

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Upsher Smith Labs FORTICAL calcitonin salmon recombinant SPRAY, METERED;NASAL 021406-001 Aug 12, 2005 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for calcitonin salmon recombinant

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Upsher Smith Labs FORTICAL calcitonin salmon recombinant SPRAY, METERED;NASAL 021406-001 Aug 12, 2005 6,440,392 ⤷  Subscribe
Upsher Smith Labs FORTICAL calcitonin salmon recombinant SPRAY, METERED;NASAL 021406-001 Aug 12, 2005 RE43580 ⤷  Subscribe
Upsher Smith Labs FORTICAL calcitonin salmon recombinant SPRAY, METERED;NASAL 021406-001 Aug 12, 2005 RE40812 ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Calcitonin salmon recombinant Market Analysis and Financial Projection Experimental

Calcitonin Salmon Recombinant Market Dynamics and Financial Trajectory

Market Overview

The Calcitonin Salmon market is experiencing significant growth, driven by several key factors. The increasing prevalence of osteoporosis, rising demand for advanced bone health treatments, and growing awareness about bone health are primary drivers of this market[1][3][5].

Key Drivers of Market Growth

Increasing Prevalence of Osteoporosis

Osteoporosis affects a large and growing population globally, with over 200 million people suffering from the condition. This rising prevalence, particularly among the aging population, is a major driver of the Calcitonin Salmon market[3].

Technological Advancements

Advancements in medical technology, especially in drug delivery systems, are enhancing the efficacy and safety of Calcitonin Salmon. Innovations such as oral recombinant calcitonin and improved nasal sprays are expanding the market potential[1][4].

Growing Awareness and Patient Education

Educational initiatives and awareness campaigns targeting patients and healthcare professionals are crucial in increasing the demand for Calcitonin Salmon. Emphasizing the benefits of early diagnosis and timely treatment helps in market growth[1].

Strategic Collaborations

Collaborations between pharmaceutical companies and research institutions are accelerating the development of novel treatments for bone-related disorders. These partnerships can lead to new product launches and enhanced market penetration[1].

Market Dynamics

Demographic Factors

The aging population is a significant demographic factor driving the market. As populations age, the incidence of osteoporosis and other bone-related disorders increases, leading to higher demand for Calcitonin Salmon[1][3].

Technological Innovations

Continuous research and development efforts are focused on enhancing the efficacy and safety of Calcitonin Salmon. Innovations in drug delivery systems, such as oral formulations, are providing new treatment alternatives and improving patient outcomes[4].

Regulatory Influences

Regulatory bodies play a crucial role in shaping the market. For instance, the FDA has reviewed the safety and efficacy of calcitonin-salmon products, focusing on potential cancer risks and evidence of efficacy in postmenopausal osteoporosis. Such reviews can impact market dynamics and product approvals[5].

Challenges and Restraints

Safety Concerns

Prolonged use of Calcitonin Salmon has been associated with safety concerns, including a potential increased risk of cancer. This has led to regulatory scrutiny and recommendations for limited use durations[3][5].

Availability of Alternatives

The presence of alternative treatments for osteoporosis can restrain the growth of the Calcitonin Salmon market. Other medications often serve as first-line treatments, reducing the demand for Calcitonin Salmon[3].

Treatment Costs

The cost of Calcitonin Salmon treatments can be a barrier, especially in regions with limited healthcare resources. High treatment costs can hinder market expansion[1].

Regional Analysis

Market Segmentation

The Calcitonin Salmon market is segmented into regions such as North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa. Emerging markets, particularly in Asia-Pacific and Latin America, offer significant growth opportunities due to expanding healthcare infrastructure and increasing prevalence of osteoporosis[1][3].

Revenue Generation and Market Expansion

Pharmaceutical companies, manufacturers, and distributors can generate substantial revenue through the sale of Calcitonin Salmon products. The market presents opportunities for industry participants to expand their market presence by catering to the rising demand for effective bone health treatments[1].

Financial Trajectory

Market Size and Growth

The Calcitonin Salmon market is expected to grow significantly during the forecast period (2024-2031), driven by the rising number of osteoporosis patients globally. The market is projected to develop revenue at a remarkable CAGR, reflecting substantial growth rates over the last few years[1][3].

Key Players and Competitive Landscape

Major players in the market include Novartis, Sanofi, Mylan Pharmaceuticals, Apotex, and others. These companies are actively involved in research and development, product innovation, and strategic collaborations to maintain and expand their market share[3].

Product Development and Innovation

Oral Recombinant Calcitonin

Studies such as the Oral Calcitonin in Postmenopausal Osteoporosis (ORACAL) trial have shown that oral recombinant calcitonin is superior to nasal synthetic calcitonin in increasing bone mineral density (BMD) and reducing bone turnover. This innovation provides an additional treatment alternative for postmenopausal osteoporosis[4].

Nasal Sprays and Injections

Calcitonin Salmon is available in various forms, including nasal sprays and injections. These formulations have different bioavailability and efficacy profiles, with nasal sprays showing a mean bioavailability of approximately 3% compared to injectable forms[2].

Patient Outcomes and Safety

Efficacy in Bone Health

Calcitonin Salmon plays a vital role in improving patient outcomes by reducing bone resorption, increasing bone density, and preventing fractures. It has been shown to increase spinal bone mass in postmenopausal women with established osteoporosis[2][4].

Adverse Reactions

Common adverse reactions include nasal symptoms, back pain, arthralgia, and epistaxis. Serious allergic-type reactions, including anaphylaxis, have also been reported, highlighting the need for careful patient monitoring[2].

SWOT Analysis

Strengths

  • Increasing prevalence of osteoporosis
  • Growing awareness about bone health
  • Technological advancements in drug delivery systems
  • Strategic collaborations and partnerships

Weaknesses

  • Safety concerns and potential cancer risks
  • Availability of alternative treatments
  • Regulatory compliance challenges
  • High treatment costs

Opportunities

  • Emerging markets in Asia-Pacific and Latin America
  • Product development and innovation
  • Focus on patient education and awareness
  • Collaborations and partnerships

Threats

  • Evolving regulatory guidelines
  • Competition from alternative treatment options
  • Lack of awareness in rural areas about osteoporosis and other bone disorders[1][3].

Key Takeaways

  • The Calcitonin Salmon market is driven by the increasing prevalence of osteoporosis and advancements in medical technology.
  • Emerging markets, particularly in Asia-Pacific and Latin America, offer significant growth opportunities.
  • Product innovation, such as oral recombinant calcitonin, is expanding treatment alternatives.
  • Safety concerns and regulatory scrutiny are key challenges to market growth.
  • Strategic collaborations and patient education initiatives are crucial for market expansion.

FAQs

Q: What are the primary drivers of the Calcitonin Salmon market?

A: The primary drivers include the increasing prevalence of osteoporosis, rising demand for advanced bone health treatments, and growing awareness about bone health.

Q: What are the common forms of Calcitonin Salmon?

A: Calcitonin Salmon is available in various forms such as nasal sprays, injections, and tablets.

Q: What are the potential safety concerns associated with Calcitonin Salmon?

A: Prolonged use of Calcitonin Salmon has been associated with a potential increased risk of cancer and other adverse reactions such as nasal symptoms and allergic reactions.

Q: Which regions offer significant growth opportunities for the Calcitonin Salmon market?

A: Emerging markets in Asia-Pacific and Latin America offer significant growth opportunities due to expanding healthcare infrastructure and increasing prevalence of osteoporosis.

Q: How does Calcitonin Salmon impact patient outcomes?

A: Calcitonin Salmon helps in reducing bone resorption, increasing bone density, and preventing fractures, thereby improving patient outcomes in the treatment of osteoporosis and other bone-related disorders.

Sources

  1. MarkWide Research: Calcitonin Salmon market 2024-2032 | Size, Share, Growth.
  2. FDA: FORTICAL® calcitonin-salmon (rDNA origin) Nasal Spray For Osteoporosis.
  3. Verified Market Research: Calcitonin Salmon Market Size, Trends, Growth, Analysis, Forecast.
  4. PubMed: The Oral Calcitonin in Postmenopausal Osteoporosis (ORACAL) trial.
  5. FDA: Changes to the Indicated Population for Miacalcin (calcitonin-salmon).

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