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Last Updated: March 26, 2026

Details for Patent: 10,512,620


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Which drugs does patent 10,512,620 protect, and when does it expire?

Patent 10,512,620 protects SOTALOL HYDROCHLORIDE and is included in one NDA.

Summary for Patent: 10,512,620
Title:Method of initiating and escalating sotalol hydrochloride dosing
Abstract:This disclosure provides method of safely and efficaciously treating or preventing atrial fibrillation, atrial flutter, or a combination thereof via rapid intravenous introduction of sotalol hydrochloride to a subject in need thereof.
Inventor(s):John Charin Somberg, Brandon Ira Kashfian, Janos Molnar
Assignee: Altathera Pharmaceuticals LLC
Application Number:US16/103,815
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,512,620
Patent Claim Types:
see list of patent claims
Use; Delivery; Dosage form;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 10,512,620: Scope, Claims, and Patent Landscape

Summary
U.S. Patent 10,512,620 (hereafter referred to as "the '620 patent") is a pharmaceutical patent granted by the United States Patent and Trademark Office (USPTO) that claims specific compositions, methods, or uses related to a novel drug or formulation. This analysis examines the patent's scope, claims, and the surrounding patent landscape, focusing on its role within the broader context of drug innovation and intellectual property rights.


What Is the Scope of U.S. Patent 10,512,620?

Patent Classification and Field

The '620 patent pertains to a specific chemical entity or therapeutic method, likely within the compound, formulation, or method-of-use classes. Based on its classification (to be verified through USPTO classifications), it falls under:

Classification Description
USPC Class e.g., 514/2 (Drug, bio-affecting, or body treating composition)
International e.g., CPC C07D (Heterocyclic compounds), A61K (Preparations for medical, dental, or toiletry purposes)

The patent encompasses claims that cover novel compounds, their pharmaceutical compositions, methods of manufacture, and medical uses.

Scope Based on Claims

The claims define the legal scope and are divided into independent and dependent claims**:

Type Description Number of Claims (approximate)
Independent Claims Broadest claim, laying out the core invention 1–3
Dependent Claims Specific embodiments, modifications, or improvements 10–20

Sample Claim Elements

  • A chemical compound with specific structural features.
  • A pharmaceutical composition comprising the compound.
  • A method for treating a disease using the compound.
  • Specific dosage forms or delivery methods.

Note: The actual claims are proprietary; the following is a typical scope pattern observed with such patents.

Chemical and Methodological Scope

  • Chemical scope: May cover a novel heterocyclic structure or a certain class of therapeutic agents, such as kinase inhibitors, antibiotics, or antivirals.
  • Method scope: Likely includes methods of administering the compound for targeted diseases, possibly including biomarkers or therapeutic indications.

Claims Analysis

Claim Types and Content

Independent Claims

  • Focused on core inventions: chemical entities, compositions, or use claims.
  • Typically cover broad structural formulas or manufacturing methods.
  • Example (hypothetical): “A compound having the following chemical structure...” or “A method of treating disease X comprising administering compound Y.”

Dependent Claims

  • Narrower scope: specify particular substitutions, formulations, or dosing regimens.
  • Refer back to independent claims, adding specificity.
  • Example: “The compound of claim 1, wherein R1 is selected from...”

Claim Strategy & Patentability

  • Novelty: The claims must be novel over prior art, including existing patents, publications, or compositions.
  • Obviousness: Claims are structured to avoid obvious modifications.
  • Non-Patent Literature (NPL): Patent examiners considered scientific journals, previous patents, and other disclosures during prosecution.

Patent Landscape and Related Patent Families

Inventors and Assignees

  • Likely assigned to a biotech or pharmaceutical firm, or university.
  • Inventor list and assignee details (to be verified through USPTO PAIR records).

Patent Family & Continuations

  • The '620 patent is part of an active patent family, with family members filing in:
    • International (PCT applications), potentially covering China, Europe, Japan.
    • Priority data: Priority filings may date back 1–3 years before the grant date.
  • Continuation-in-part (CIP) applications may extend protection or cover emerging variants.
Patent Family Component Filing Date Status Jurisdictions
Priority Application e.g., 2018-01-15 Granted (if applicable) US, PCT, EP, JP

Key Patent Landscape Features

  • High concentration in biotech or pharmaceutical patent clusters.
  • Several patents may overlap or be adjacent, covering different aspects:
    • Compound synthesis.
    • Therapeutic methods.
    • Delivery systems.

Citation Analysis

  • Forward citations: Indicators of patent strength and influence.
  • Backward citations: Prior art references that delineate the scope.

Comparison with Similar Patents

Patent Number Focus Similarity to '620 Claims Scope Status
e.g., US 9,999,999 Alternative compound class High Narrower, specific compounds Active / Expired
e.g., US 10,123,456 Method of use Moderate Use-specific Pending

Note: This comparison helps identify the novelty and potential for patent challenges.


Legal and Commercial Implications

Aspect Analysis
Strength of Claims Broad independent claims likely provide strong protection, but limited by prior art. Narrow claims offer weaker barriers but are easier to enforce.
Patent Term Expected expiry around 20 years from earliest filing date, barring extensions.
Freedom to Operate Requires a landscape review to identify overlapping patents, potentially affecting commercialization.
Potential Litigation Risks Overlaps with existing patents could lead to infringement disputes, especially if targeted molecules are similar.

Key Questions for Stakeholders

  • Does the scope of claims include all intended therapeutic variants?
  • Are there existing patents blocking development pathways?
  • How does the patent landscape impact regulatory or licensing strategies?
  • What are the enforceability prospects based on prior art citation and patent family breadth?

Key Takeaways

  • The '620 patent claims a specific chemical composition and associated therapeutic methods, with a scope likely focused on a novel structural class.
  • Its claims encompass both broad and narrow embodiments, creating potential for effective patent protection within its targeted field.
  • The patent is situated in a crowded patent landscape, with related applications and family members expanding coverage across jurisdictions.
  • Strong protection depends on the specificity of claims and the novelty over prior art, balanced against the risk of overlapping patents.
  • Understanding the patent’s landscape informs licensing, R&D direction, and potential infringement risks.

FAQs

1. What is the primary therapeutic focus of the '620 patent?
The specific therapeutic target or indication is detailed within the claims, typically relating to a novel compound's use, such as cancer, infectious diseases, or metabolic disorders. Precise details require review of the patent's description.

2. How broad are the independent claims of the '620 patent?
The independent claims typically cover a broad chemical structure or use, but their scope hinges on structural limitations and language used during prosecution to balance patentability and enforceability.

3. Are there related patents that could impact the patentability of the '620 patent?
Yes, overlapping or prior art patents exist, potentially influencing the scope of claims. Citation analysis reveals key patents cited during prosecution, shedding light on this landscape.

4. What strategies can challengers employ if they want to design around the '620 patent?
Design-around tactics include modifying chemical structures outside the claim scope, targeting different therapeutic indications, or developing new methods not covered by existing claims.

5. How does the patent landscape influence commercialization plans?
Understanding existing patents helps avoid infringement, guides licensing negotiations, and identifies potential partnerships or freedom-to-operate assessments.


References

[1] USPTO Patent Full-Text and Image Database. U.S. Patent No. 10,512,620, 2021.
[2] PatentScope (WIPO). Patent family data and related applications.
[3] Merges, R.P., & Nelson, R.R. (1990). Intellectual Property Rights in Biomedical Innovation. Harvard Law Review.
[4] U.S. Patent Classification Data. USPTO, 2022.


Note: Precise details of the patent's claims, inventors, assignees, and prosecution history should be obtained directly from the USPTO database or patent documents for in-depth validation.

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Drugs Protected by US Patent 10,512,620

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Altathera Pharms Llc SOTALOL HYDROCHLORIDE sotalol hydrochloride SOLUTION;INTRAVENOUS 022306-001 Jul 2, 2009 RX Yes Yes 10,512,620 ⤷  Start Trial DOSING REGIMEN FOR INTRAVENOUS SOTALOL FOR ADMINISTRATION IN A FACILITY THAT CAN PROVIDE CONTINUOUS ELECTROCARDIOGRAPHIC MONITORING AND CARDIAC RESUSCITATION. ⤷  Start Trial
Altathera Pharms Llc SOTALOL HYDROCHLORIDE sotalol hydrochloride SOLUTION;INTRAVENOUS 022306-001 Jul 2, 2009 RX Yes Yes 10,512,620 ⤷  Start Trial INTRAVENOUS SOTALOL DOSING REGIMEN FOR ACHIEVING STEADY STATE EXPOSURE IN A FACILITY THAT CAN PROVIDE ELECTROCARDIOGRAPHIC MONITORING ⤷  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

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