Last Updated: May 3, 2026

CALCITONIN-SALMON Drug Patent Profile


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Which patents cover Calcitonin-salmon, and when can generic versions of Calcitonin-salmon launch?

Calcitonin-salmon is a drug marketed by Amneal, Cipla, Custopharm Inc, Dr Reddys, Fresenius Kabi Usa, Igi Labs Inc, Ph Health, Sagent, Zydus Pharms, and Apotex Inc. and is included in eleven NDAs.

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

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Summary for CALCITONIN-SALMON
US Patents:0
Applicants:10
NDAs:11

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
Amneal CALCITONIN-SALMON calcitonin salmon INJECTABLE;INJECTION 216294-001 Sep 26, 2025 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Ph Health CALCITONIN-SALMON calcitonin salmon INJECTABLE;INJECTION 209358-001 Nov 10, 2021 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Dr Reddys CALCITONIN-SALMON calcitonin salmon INJECTABLE;INJECTION 215715-001 Apr 11, 2024 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Sagent CALCITONIN-SALMON calcitonin salmon INJECTABLE;INJECTION 219196-001 Jul 9, 2025 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Cipla CALCITONIN-SALMON calcitonin salmon INJECTABLE;INJECTION 213766-001 Sep 20, 2024 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Custopharm Inc CALCITONIN-SALMON calcitonin salmon INJECTABLE;INJECTION 212416-001 May 14, 2021 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

CALCITONIN-SALMON (Calcitonin-salmon): Investment Scenario and Fundamentals Analysis

Last updated: April 25, 2026

What is CALCITONIN-SALMON and where is it used?

Calcitonin-salmon is a synthetic salmon calcitonin product used to treat conditions driven by abnormal bone resorption, primarily:

  • Postmenopausal osteoporosis
  • Paget’s disease of bone
  • Hypercalcemia of malignancy (in some jurisdictions and historical labels)

Commercial reality: the drug’s addressable market has narrowed over time as newer antiresorptives (bisphosphonates, denosumab) and other agents have displaced calcitonin in many use cases. Remaining demand is mainly tied to specific label indications, patient intolerance, and country-specific reimbursement patterns.

What is the supply and competition structure?

Calcitonin-salmon is widely marketed in multiple dosage forms and brands across geographies. The competitive landscape typically includes:

  • Multiple branded versions and historical originator lines
  • Generics and authorized copies where regulatory pathways permit
  • Alternative antiresorptive therapies that compete for the same clinical channel

From an investment lens, this structure creates a high probability of:

  • Price erosion in markets where calcitonin-salmon generics are active
  • Relatively low incremental growth in mature markets
  • Volatility driven by guideline and reimbursement changes rather than new clinical differentiation

How does the patent and exclusivity picture shape investment value?

Calcitonin products have long development timelines and many products are now off-patent in major markets. The economic consequence is that investors should treat branded calcitonin-salmon as a commercial asset with generics pressure, not as a platform with long duration exclusivity.

Investment implication

  • The highest value tends to sit in countries where exclusivity still exists, where supply is constrained, or where reimbursement preserves branded pricing.
  • New-entry economics rely on formulation life-cycle, distribution strength, and litigation outcomes rather than true innovation.

What does demand look like and what drives it?

Demand for calcitonin-salmon is driven by:

  • Indication volume (osteoporosis and Paget’s)
  • Guideline adoption (where calcitonin is recommended less often)
  • Reimbursement and national health system restrictions
  • Physician preference in patients who do not tolerate other therapies
  • Safety and risk-benefit perceptions, which influence prescribing intensity

Key sensitivity: prescriber and payer guidance. In mature markets, even small shifts in reimbursement criteria can change volumes materially.

What are the practical fundamentals investors model?

Commercial KPIs to track

  1. Prescriptions and treated patients by indication (postmenopausal osteoporosis, Paget’s)
  2. Average net price by country and channel (hospital vs retail, tender dynamics)
  3. Market share versus bisphosphonates and denosumab in osteoporosis cohorts
  4. Inventory and supply continuity (calcitonin products can show discontinuations and re-entries across brands)
  5. Tender pricing and reimbursement caps

Typical financial profile (mature, off-exclusivity profile)

  • Revenue growth generally tracks market stability and share rather than new-patient expansion
  • Gross margin compresses when generics enter or when price caps activate
  • EBITDA stability depends on manufacturing scale, pack-out performance, and logistics cost control

What does the regulatory posture imply for commercial risk?

Calcitonin is an established class. The investment risk is less about foundational regulatory feasibility and more about:

  • Label consistency across geographies
  • Safety communications affecting willingness to prescribe
  • Guideline updates changing clinical positioning

For an investor, that translates into a thesis built on:

  • Sustained reimbursement access in target markets
  • Defensive manufacturing and supply execution
  • Active lifecycle management (device, concentration, dosing convenience) where permitted

What should investors expect for pipeline and R&D upside?

Most “R&D upside” for calcitonin-salmon products comes from:

  • Lifecycle reformulation (device, concentration, stability, patient experience)
  • Manufacturing optimization and cost reduction
  • Label extensions within existing regulatory frameworks

True “breakthrough” pipeline value is typically limited for calcitonin-salmon due to the class maturity and competitive saturation.

Which investor archetypes fit CALCITONIN-SALMON best?

1) Generics and authorized-entry investors

  • Value comes from entry timing, manufacturing cost, and tender execution.
  • Core risk is competitive price compression after launch.

2) Branded-defense investors

  • Value depends on securing and maintaining reimbursement at premium or stable price points.
  • Core risk is guideline or payer restriction that reduces eligible population.

3) Regional distributors with market access advantages

  • Value comes from channel control and continuity of supply.
  • Core risk is sudden contract loss or supply interruption from manufacturing sites.

Investment scenario: Base case, downside case, upside case

Base case (most likely in mature markets):

  • Volume is stable to modestly declining.
  • Net price trends down due to generics and tender pressure.
  • EBITDA holds if manufacturing scale offsets price erosion.

Downside case (risk-tail):

  • Payer restriction tightens (e.g., reduced eligible indications).
  • Competition increases (additional entrants, forced tender repricing).
  • Safety communications or guideline updates further reduce prescribing.

Upside case (execution-driven):

  • Favorable tender outcomes preserve relative pricing.
  • Product mix shifts to higher-margin channels or dosage forms.
  • Market access expands in geographies with less generics penetration or stronger reimbursement.

What are the actionable diligence points?

Investors should diligence these specific items because they map to cashflow durability:

1) Geographic revenue concentration

  • Identify which countries carry the majority of revenue.
  • Assess each country’s tender and reimbursement mechanics for calcitonin-salmon.

2) Supply chain resilience

  • Confirm manufacturing capacity and backup sourcing for active ingredient and finished product.
  • Review discontinuation history and re-entry patterns for competing brands.

3) Competitive pricing triggers

  • Track generic launch timelines and whether price reductions were step-changes or gradual.
  • Evaluate whether the firm’s product is tendered versus reimbursed through fixed tariffs.

4) Prescriber channel behavior

  • Separate hospital-only dynamics from outpatient prescribing.
  • Assess physician reliance driven by intolerance to alternatives.

Key Takeaways

  • Calcitonin-salmon is a mature, label-constrained asset with economics shaped more by reimbursement, competition, and tender pricing than by patent-led growth.
  • Investment upside is primarily execution-driven (market access, price defense, manufacturing cost) rather than innovation-led.
  • The core risk is guideline and payer restriction plus generics pressure, which can compress net price and reduce eligible patient populations.
  • The best-fitting investment theses are branded-defense, generics-entry, or regional market-access models that can manage price and supply execution.

FAQs

1) Is CALCITONIN-SALMON an off-patent product?

Yes in most major markets, making the economic model heavily dependent on reimbursement and generics/tender dynamics rather than remaining exclusivity.

2) What are the main indications that drive sales?

Postmenopausal osteoporosis and Paget’s disease of bone are the central recurring indications; historical use includes hypercalcemia of malignancy in some jurisdictions.

3) What is the biggest commercial risk for investors?

Reimbursement or guideline restrictions that reduce eligible prescribing volume, followed by increased generic competition that forces price concessions.

4) Where does upside typically come from?

From preserving market access and pricing in specific countries, winning tenders, improving supply continuity, and optimizing manufacturing costs.

5) How should investors benchmark performance?

By tracking net price (by channel and country), treated patient volume or prescriptions by indication, market share versus alternatives in osteoporosis, and tender repricing events.


References (APA)

[1] European Medicines Agency. (n.d.). Calcitonin salmon (products and assessments) within EMA resources. European Medicines Agency. https://www.ema.europa.eu/
[2] U.S. Food and Drug Administration. (n.d.). Calcitonin salmon product information and drug approvals in FDA resources. U.S. Food and Drug Administration. https://www.fda.gov/
[3] National Institutes of Health. (n.d.). PubChem compound summary for calcitonin salmon and related references. PubChem. https://pubchem.ncbi.nlm.nih.gov/

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