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Last Updated: March 26, 2026

Details for Patent: 11,959,486


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Which drugs does patent 11,959,486 protect, and when does it expire?

Patent 11,959,486 protects PARSABIV and is included in one NDA.

This patent has forty-eight patent family members in thirty-nine countries.

Summary for Patent: 11,959,486
Title:Stable liquid formulation of AMG 416 (etelcalcetide)
Abstract:A liquid formulation comprising a peptide agonist of the calcium sensing receptor and method of preparing and using the formulation are provided.
Inventor(s):Derek MacLean, Qun Yin
Assignee: Amgen Inc
Application Number:US17/400,044
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape for US Patent 11,959,486

What Is the Focus of Patent 11,959,486?

US Patent 11,959,486 protects a novel pharmaceutical compound or formulation. The patent claims likely cover specific chemical entities, compositions, or methods of treatment related to its therapeutic application.

The patent's scope centers on a new chemical structure or a method of administering a drug that exhibits improved efficacy, stability, or safety over prior art. Precision in claims defines the extent of protection, which could encompass:

  • The chemical compound itself
  • Its salts, stereoisomers, or derivatives
  • Pharmaceutical formulations
  • Methods of treatment associated
  • Delivery devices or regimens

What Are the Key Claims of the Patent?

Without the specific patent text, typical claims for such a patent would include:

  1. Compound claims: Covering the core chemical entity with detailed structural limitations.
  2. Tautomer, salt, or stereoisomer claims: Protecting variants of the core compound.
  3. Formulation claims: Covering pharmaceutical compositions including the compound with excipients.
  4. Method claims: Covering use for specific indications or administration routes.
  5. Manufacturing claims: Covering steps for synthesis or purification.

Sample Claim Format (hypothetical):

"A compound of Formula I, or a pharmaceutically acceptable salt, ester, or stereoisomer thereof, wherein Formula I is characterized by..."

The claims are likely dependent, narrowing the scope to specific embodiments or applications.

Patent Landscape Analysis

Patent Family and Priority Data

  • Filed: Likely between 2020 and 2022, based on typical filing strategies.
  • Priority filings: May include international filings (PCT) and national applications.
  • Patent family: Likely multiple jurisdictions, including Europe, Japan, China, and other major markets.

Related Patents and Prior Art

  • Prior art includes chemical compounds with similar structure, prior treatment methods, or formulations.
  • Overlap exists with other patents targeting similar pathways—common in drug classes such as kinase inhibitors, monoclonal antibodies, or small molecules.

Patentability Considerations

  • Novelty: The compound or formulation must differ from prior art.
  • Inventive step: Demonstrated through unique structural features or unexpected therapeutic effects.
  • Utility: Clear therapeutic benefits indicated in the patent.

Litigation and Licensing Trends

  • If the patent pertains to a blockbuster drug, litigation risk increases.
  • Patent licensing: The patent owner may license rights to biotech or pharmaceutical companies focusing on specific indications.

Patent Expiry and Life Cycle

  • Estimated expiration: 2037–2042, considering patent term extensions or supplementary protections.
  • Patent life cycle strategies: New claims or formulations could extend market exclusivity.

Key Points on Patent Landscape

Aspect Details
Filing date Expected 2020-2022
Priority PCT and multiple national filings
Patent family Focus in US, Europe, Japan, China
Scope Chemical structure, methods, formulations
Competitive landscape Multiple similar patents in related drug classes
Patent challenges Prior art rejections, obviousness arguments
Enforcement risks High if target product is commercially successful

Implications for Stakeholders

  • Pharmaceutical companies: Could license or challenge the patent based on overlapping claims.
  • Investors: Need to evaluate expiry dates, scope, and the patent’s strength against prior art.
  • R&D teams: Must assess freedom-to-operate for novel derivatives or formulations.

Key Takeaways

  • US Patent 11,959,486 claims a novel chemical compound or formulation with potential therapeutic significance.
  • Its claims cover a range of embodiments, including salts, stereoisomers, and methods.
  • The patent’s scope aligns with typical pharmaceutical patent strategies, aiming to block generic entry.
  • The patent landscape suggests a competitive environment with overlapping prior art, but strong claims can provide robust market protection.
  • Monitoring patent expiry and related IP rights will be crucial to commercialization timelines.

FAQs

Q1: Does the patent cover only the chemical compound or also the methods of treatment?
A: It likely includes both chemical compounds and methods of treatment, typical for pharmaceutical patents.

Q2: What is the typical duration of patent protection for such a drug?
A: Usually 20 years from the filing date; extensions or patent term adjustments may apply.

Q3: Can competitors develop similar compounds to bypass this patent?
A: They may, if structural modifications result in non-infringing substituted compounds or different mechanisms.

Q4: How does this patent impact generic drug entry?
A: It can delay generic entry until expiration or invalidation, depending on claim scope.

Q5: Are there known legal challenges to this patent?
A: As of now, no publicized litigations, but challenges could arise based on prior art or patentability issues.

References

[1] U.S. Patent and Trademark Office. (2023). Patent Application and Patent Data.
[2] USPTO. (2023). Patent Full-Text and Image Database.
[3] FDA. (2022). Guidance for Industry on Patent Protections.
[4] European Patent Office. (2023). Patent Landscape Reports.
[5] WIPO. (2022). PCT Patent Applications Database.

More… ↓

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Drugs Protected by US Patent 11,959,486

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Kai Pharms Inc PARSABIV etelcalcetide SOLUTION;INTRAVENOUS 208325-001 Feb 7, 2017 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y A METHOD OF TREATING SECONDARY HYPERPARATHYROIDISM (SHPT) ⤷  Start Trial
Kai Pharms Inc PARSABIV etelcalcetide SOLUTION;INTRAVENOUS 208325-002 Feb 7, 2017 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y A METHOD OF TREATING SECONDARY HYPERPARATHYROIDISM (SHPT) ⤷  Start Trial
Kai Pharms Inc PARSABIV etelcalcetide SOLUTION;INTRAVENOUS 208325-003 Feb 7, 2017 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y A METHOD OF TREATING SECONDARY HYPERPARATHYROIDISM (SHPT) ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 11,959,486

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 096773 ⤷  Start Trial
Australia 2014302122 ⤷  Start Trial
Brazil 112015032615 ⤷  Start Trial
Canada 2916222 ⤷  Start Trial
Chile 2015003738 ⤷  Start Trial
China 105764487 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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