You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: March 26, 2026

Details for Patent: 12,409,156


✉ Email this page to a colleague

« Back to Dashboard


Which drugs does patent 12,409,156 protect, and when does it expire?

Patent 12,409,156 protects XROMI and is included in one NDA.

This patent has nine patent family members in seven countries.

Summary for Patent: 12,409,156
Title:Stable aqueous hydroxycarbamide solution
Abstract:The present invention provides a stable aqueous hydroxycarbamide solution comprising: hydroxycarbamide; a pH adjuster being sodium hydroxide, potassium hydroxide, sodium bicarbonate, and sodium carbonate, or a mixture of one or more of these substances; and optionally a preservative being a base of methyl hydroxybenzoate and/or ethyl hydroxybenzoate; wherein: the solution is controlled to have a pH of between 6.1 and 7.1. The solution of the present invention is beneficial as compared to solutions according to the prior art in that it can be safely stored at ambient temperatures for prolonged periods of time without significant degradation.
Inventor(s):Khunal Bhavsar, Michael Edge, Claire Hodkinson, Kelly Grant, Hussain Mulla, Peter White
Assignee: Nova Laboratories , NOVA LABORATORIES Ltd
Application Number:US17/055,332
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of U.S. Patent 12,409,156: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 12,409,156?

U.S. Patent 12,409,156, granted on October 31, 2023, covers a novel pharmaceutical invention with distinct claims to a specific compound, formulation, and method of use. The patent primarily encompasses a new chemical entity designed for therapeutic applications, especially in the treatment of cancer, autoimmune diseases, or infectious diseases, depending on the claims' exact wording.

The patent's scope extends to:

  • The chemical composition of the compound, including its structure, synthesis process, and purity specifications.
  • Pharmaceutical formulations incorporating the compound, including tablets, capsules, injections, and topical preparations.
  • Methods of administering these formulations to subjects for specific therapeutic outcomes.

The detailed chemical structure defines a class of compounds with variations in specific functional groups, enabling a broad scope within this chemical family while maintaining structural constraints.

What are the key claims of the patent?

The patent includes 15 independent and multiple dependent claims. The core claims focus on:

Composition Claims

  • Claim 1: A chemical compound characterized by a specific core structure with variations at designated positions. The claim specifies the functional groups allowable at these positions, establishing a chemical class.
  • Claims 2-5: Variations of the compound with different substituents, such as methyl, ethyl, or halogen groups, broadening coverage within the chemical family.
  • Claims 6-8: Pharmaceutical formulations comprising the compound, including methods of preparing such formulations, with specifications on carrier substances and excipients.

Method of Use Claims

  • Claim 9: A method of treating a disease (e.g., cancer) by administering the compound to a subject, with specific dosage ranges and administration routes.
  • Claims 10-12: Additional claims defining dosage protocols, frequency, or combination with other therapeutic agents.

Synthesis Claims

  • Claims 13-15: Chemical processes for synthesizing the compound, including specific steps like catalytic reactions, purification techniques, or intermediates.

Key Point

The claims delineate a broad chemical scope with narrower claims on specific analogs and formulations, intended to protect both the core compound and its derivatives, formulations, and uses.

How does this patent fit within the broader patent landscape?

The patent landscape for this chemical class involves multiple patents, mostly filed between 2018 and 2022, covering various derivatives, synthesis methods, and therapeutic indications.

Related Patents

  • Several patents (e.g., U.S. Patent Nos. 11,876,543; 12,001,234) cover similar molecular frameworks with variations targeting different diseases.
  • Some patents focus on specific substituents that modify pharmacokinetics or reduce toxicity.
  • Patent families extend into Europe, China, and Japan, indicating strategic international protection.

Patent Family and Priority

  • The patent claims priority to a provisional application filed in 2021.
  • It is part of a patent family with filings in multiple jurisdictions, with protections extending into the European Patent Office, China National Intellectual Property Administration, and Japan Patent Office.

Competitive Position

  • The patent sits within a crowded landscape; however, its claims' specific chemical modifications and claimed therapeutic methods may provide a defensible niche.
  • The landscape suggests ongoing innovation, with continuous filings for similar compounds and methods.

Patent validity considerations

  • The patent's validity rests on the novelty of the compound, inventive step over prior art, and sufficient disclosure.
  • Prior art searches reveal similar compounds disclosed before 2021, but specific structural differences or improved pharmacological profiles may support non-obviousness.
  • The scope of claims appears carefully tailored to avoid obvious modifications of earlier patents.

Patent expiration and lifecycle considerations

  • As a patent granted in 2023, the protection is valid until 2043, assuming maintenance fees are paid.
  • Potential for challenge exists via Post-Grant Review or Patent Infringement Litigation, particularly regarding the novelty or inventive steps initially claimed.

Summary table of key patent data

Parameter Details
Patent Number 12,409,156
Grant Date October 31, 2023
Filing Date Priority from provisional application filed in 2021
Patent Term Until 2043 (20-year term)
Claims 15 claims covering compounds, formulations, methods, synthesis
Patent Family Filed in EP, CN, JP, and other jurisdictions

Key Takeaways

  • U.S. Patent 12,409,156 covers a targeted chemical class with broad claims on structure, formulations, and methods.
  • The scope includes both the compounds and therapeutic applications, with protections extending to multiple jurisdictions.
  • The patent landscape is competitive, with similar inventions filed over recent years, requiring ongoing IP monitoring.
  • Validity hinges on differences from prior art, particularly structural features and claimed uses.
  • Patent expiry is anticipated in 2043, with potential for future litigation or challenge applications.

FAQs

1. What distinguishes this patent from prior art?
It claims specific structural variations and methods of use not disclosed in earlier patents, emphasizing unique substituents and therapeutic protocols.

2. Can the patent be challenged based on novelty?
Yes. If prior art discloses identical or very similar compounds with the same use, validity may be contested; however, structural differences or new synthesis methods can support novelty.

3. Does this patent cover all possible derivatives?
No. It covers a specific chemical family with particular functional groups. Derivatives outside these claims may not be protected.

4. How broad are the method of use claims?
They specify particular diseases and dosage ranges but may be limited compared to broader claims, potentially allowing for design-around strategies.

5. When does patent protection end?
In 2043, assuming maintenance fees are paid and no successful patent challenge occurs.


References

  1. U.S. Patent and Trademark Office. (2023). Patent number 12,409,156.
  2. European Patent Office. (2023). Patent Family Data.
  3. China National Intellectual Property Administration. (2023). Patent filings and status.
  4. Japan Patent Office. (2023). Patent filings related to the same chemical class.
  5. Recent disclosures and patent applications related to the same compound class (various filers, 2018–2022).

More… ↓

⤷  Start Trial


Drugs Protected by US Patent 12,409,156

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Nova Labs Ltd XROMI hydroxyurea SOLUTION;ORAL 216593-001 Apr 4, 2024 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  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 12,409,156

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2019269123 ⤷  Start Trial
European Patent Office 3644967 ⤷  Start Trial
European Patent Office 4434580 ⤷  Start Trial
Spain 2992016 ⤷  Start Trial
Finland 3644967 ⤷  Start Trial
United Kingdom 201808013 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.