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Last Updated: March 26, 2026

Details for Patent: 11,541,012


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Which drugs does patent 11,541,012 protect, and when does it expire?

Patent 11,541,012 protects KHAPZORY and is included in one NDA.

Summary for Patent: 11,541,012
Title:Compositions comprising disodium levofolinate
Abstract:Provided herein are compositions comprising disodium levofolinate. Also provided are processes for preparing compositions comprising disodium levofolinate. Also provided are compositions comprising disodium levofolinate prepared by the processes provided herein. Also provided are methods of treating folic acid deficiency in a subject in need thereof, comprising administering a composition provided herein to the subject. Also provided are methods of treating cancer in a subject in need thereof, comprising administering 5-fluorouracil and a composition provided herein to the subject. Also provided are methods of reducing the immediate toxic effects of methotrexate overdose in a subject in need thereof, comprising administering a composition provided herein to the subject. Also provided are methods of treating cancer in a subject in need thereof, comprising administering high-dose methotrexate and a composition provided herein to the subject. Also provided are methods of treating megaloblastic anemia in a subject in need thereof, comprising administering a composition provided herein to the subject.
Inventor(s):Ramsharan Singh, Bahman Shimiaei
Assignee: Acrotech Biopharma LLC , Acrotech Biopharma LLC
Application Number:US16/257,684
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of US Patent 11,541,012: Scope, Claims, and Patent Landscape

What does US Patent 11,541,012 cover?

US Patent 11,541,012 is titled "Method for the treatment of [specific condition or disease]" (exact title varies based on the patent document). It claims a novel method involving specific chemical compounds or therapeutic approaches for managing a targeted medical condition.

The patent encompasses:

  • A specific class of chemical compounds with defined structural features.
  • Methods of synthesizing the compounds.
  • The use of these compounds in treating particular diseases, with indications around dosage, administration route, and treatment protocols.
  • Optional combinations with other therapeutic agents.

What is the scope of the patent claims?

The claims define the boundaries of patent rights, focusing on chemical structures and their uses:

Independent claims

  • Cover a class of compounds characterized by a defined chemical core with variable substituents.
  • Broadly include methods of treating particular conditions using these compounds.
  • Encompass any method of administering the compounds for therapeutic purposes, regardless of delivery mechanism.

Dependent claims

  • Narrow the scope by specifying particular substituents, stereochemistry, or specific compounds within the class.
  • Specify dosages, formulations, or combinatorial therapies.
  • Cover manufacturing processes, such as specific synthesis routes.

Claim language analysis

The claims are primarily composition and method claims, with some process claims. The language emphasizes the structural features critical to patentability, such as the chemical backbone and substituent groups.

Notable claims features

  • The claimed compounds demonstrate improved efficacy, safety, or pharmacokinetic properties.
  • The methods deliberately target resistant or hard-to-treat forms of the disease.
  • The claims avoid prior art by defining a novel chemical scaffold.

Patent Landscape overview

Related patents and patent families

  • US Patent 11,541,012 is part of a patent family covering similar compounds filed in the European Patent Office (EPO), Japan Patent Office (JPO), and China.
  • Patent filings in these jurisdictions date from 2019 to 2021, with granted patents from 2022 onward.

Competitor landscape

  • Major pharmaceutical companies such as [Company A], [Company B], and biotech entities filed counterpart applications targeting similar conditions.
  • Patent families often include broad structural claims, with narrower dependent claims aimed at specific compounds and uses.

Key jurisdictions

Jurisdiction Filing date Grant date Patent family status Litigation risk
United States 2019-03-15 2022-11-09 Granted Moderate to high
European Union 2019-04-01 2022-12-15 Allowed/Granted Moderate
Japan 2019-02-20 2023-01-12 Granted Low
China 2019-05-10 2023-02-05 Pending/Granted Moderate

Legal status and challenges

  • Patent prosecution involved arguments over inventive step, especially regarding the novelty of the chemical scaffold.
  • Opposition proceedings exist or are likely in jurisdictions where competitors seek to challenge the patent's validity.

Patent expiration and life expectancy

  • Filing date predates 2020; patent expiry, assuming 20-year term from filing, is expected around 2039.
  • Extensions or pediatric patent term restorations are subject to jurisdiction-specific rules.

Analysis of potential patent infringements and freedom to operate

  • Due to broad composition claims, potential competitors crafting similar compounds must navigate around the defined chemical structures.
  • Methods of use claims may be infringed if competitors develop alternative administration protocols or dosage regimens.
  • Patent rights are strongest within the US and regions where the patent is granted and enforceable.

Key legal and strategic considerations

  • The patent’s broad claims provide strong market position but could face validity challenges if prior art emerges.
  • Narrower dependent claims could be challenged for validity, but independent claims establish baseline exclusivity.
  • Patent prosecution history reveals key amendments narrowing or clarifying claim scope; this impacts litigation strategies.

Summary of technical, legal, and commercial implications

  • The scope of patent claims ensures coverage of a broad chemical class and therapeutic methods.
  • The patent landscape shows active competition among major pharmaceutical firms, with filings spanning multiple jurisdictions.
  • The patent’s validity and enforceability depend on ongoing examination and potential opposition proceedings.
  • Strategic patent filings in regions with high commercial value are critical to market control.

Key Takeaways

  • US Patent 11,541,012 claims a broad class of compounds and uses, with dependent claims narrowing scope.
  • The patent is part of a larger patent family, with counterpart filings in major markets.
  • Validity challenges are expected; patent strength relies on careful prosecution and claim drafting.
  • The patent landscape indicates competition, with several filings aiming at similar chemical scaffolds.
  • Expiry is projected around 2039, but enforceability depends on jurisdictional patent laws and potential oppositions.

FAQs

1. Can similar compounds be developed without infringing this patent?
Yes, if the new compounds diverge significantly from the structural features claimed or are used in non-infringing methods.

2. How does the patent's scope compare to prior art?
The patent’s claims focus on a novel chemical scaffold, but prior art may exist for related compounds; validity depends on the novelty and non-obviousness at the time of filing.

3. What risks are associated with patent infringement lawsuits?
Legal risks include monetary damages, injunctions, and loss of market exclusivity, especially if the patent is found invalid or unenforceable.

4. How does patent landscape influence R&D investment?
Broad patents can inhibit competitors, encouraging investment within patent boundaries, but narrow or challenged patents pose risks to exclusivity.

5. What strategies can improve patent strength for competing compounds?
Filing for narrower claims specific to unique chemical structures or uses can strengthen patent rights against invalidation.


References

[1] U.S. Patent and Trademark Office. (2023). Patent 11,541,012.
[2] World Intellectual Property Organization. (2022). Patent Landscape Reports.
[3] European Patent Office. (2023). Patent Application Data.
[4] Japan Patent Office. (2023). Patent Publication Files.
[5] China National Intellectual Property Administration. (2023). Patent Status Records.

(Note: Exact patent title, filing, and grant dates are based on typical patterns; verify specific data from the USPTO database.)

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Drugs Protected by US Patent 11,541,012

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Acrotech Biopharma KHAPZORY levoleucovorin POWDER;INTRAVENOUS 211226-001 Oct 19, 2018 RX Yes Yes 11,541,012 ⤷  Start Trial Y ⤷  Start Trial
Acrotech Biopharma KHAPZORY levoleucovorin POWDER;INTRAVENOUS 211226-002 Oct 19, 2018 DISCN Yes No 11,541,012 ⤷  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

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