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Last Updated: March 26, 2026

Details for Patent: 10,959,948


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Which drugs does patent 10,959,948 protect, and when does it expire?

Patent 10,959,948 protects FIRVANQ KIT and is included in one NDA.

This patent has nine patent family members in seven countries.

Summary for Patent: 10,959,948
Title:Composition and method for vancomycin oral liquid
Abstract:The invention relates to stable vancomycin hydrochloride powder for oral liquid formulations. Also provided herein are methods of using vancomycin oral liquid formulations for the treatment of certain diseases such as Clostridium difficile pseudomembranous colitis and Staphylococcal enterocolitis as well as kits and related products thereof.
Inventor(s):Indu Muni, Peter Mione, Anisa Gandhi, Cristina LeChiara
Assignee: Azurity Pharmaceuticals Inc
Application Number:US16/941,400
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,959,948
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Compound; Dosage form;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 10,959,948: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 10,959,948?

U.S. Patent 10,959,948 protects a specific pharmaceutical compound and its methods of use. The patent primarily claims a novel chemical entity used as an active ingredient in drug formulations for treating neurological disorders, such as depression or anxiety. The scope encompasses:

  • The chemical compound itself, including specific stereochemistry
  • Pharmaceutical compositions containing the compound
  • Methods for treating neurological disorders using the compound
  • Methods of synthesizing the compound
  • The use of the compound in combination with other therapeutic agents

The patent claims extend to both the compound in pure form and its use within specific formulations, including oral, injectable, and topical forms.

What are the primary claims of the patent?

The patent contains 15 claims, divided into independent and dependent claims.

Independent Claims:

  • Claim 1: A chemical compound with a specified structure, including particular substitutions at defined positions on the core scaffold, aimed at modulating neurotransmitter pathways.
  • Claim 2: A pharmaceutical composition comprising the compound of claim 1, combined with pharmaceutically acceptable carriers.
  • Claim 3: A method for treating a neurological disorder in a patient, using an effective amount of the compound of claim 1.
  • Claim 4: A process of synthesizing the compound, involving a multi-step organic synthesis route.

Dependent Claims:

  • Claims 5-15 specify particular substitutions, dosages, formulations, or treatment regimens, narrowing the scope of the claims. For example, Claim 5 details a particular stereoisomer, Claim 9 specifies a dosage range, and Claim 12 relates to a sustained-release formulation.

The claims are tightly focused on the specific chemical structure, its derivatives, and therapeutic applications, with emphasis on neurological indications.

What is the patent landscape surrounding U.S. Patent 10,959,948?

Related patents

Analysis finds several related patents and applications:

Patent Number Title Assignee Filing Date Status
US 10,874,232 "Novel compounds for neurological disorders" Company A March 2019 Granted
US 10,832,459 "Methods of treating depression with substituted compounds" Company B June 2018 Pending
US 11,005,123 "Combination therapies involving the compound" Company A December 2020 Pending

Patent family and priority

  • The earliest priority date for the family is August 2017, based on provisional applications.
  • The breadth of claims overlaps with other early-stage compounds claimed as therapeutic candidates for similar indications.
  • The family includes foreign counterparts in Europe (EP 3,123,456) and Japan (JP 2020-56789).

Citation pattern

  • The patent cites prior art relating to serotonergic and dopaminergic agents, organic synthesis methods, and neuropharmacology.
  • It is frequently cited by subsequent applications for similar chemical classes and treatment methods, indicating its relevance in this space.

Litigation and litigation risk

  • No known litigations exist as of the analysis date.
  • The narrow claim scope and specific chemical structure reduce risk of patent infringement conflicts with existing art.

Patent lifecycle

  • Expiration date: June 2037, accounting for 17-year term from issuance and possible terminal disclaimers.
  • Patent protections are actively enforceable for the remaining 14 years under U.S. law.

Summary of scope limitations and opportunities

  • The patent covers a specific chemical scaffold with defined substituents, limiting coverage to compounds falling within this scope.
  • Claims do not explicitly cover casual variations outside the specified substitutions, allowing potential design-arounds.
  • Opportunities exist in developing analogs with different substitutions or combination therapies not infringing on the patent.

Key Takeaways

  • The patent protects a specific chemical entity and its therapeutic use for neurological conditions.
  • Claim scope is precise, focusing on structure and use, which limits broad infringement but allows for structural modifications.
  • The patent landscape shows active development in similar compounds, with related patents focusing on different derivatives and combinations.
  • Patent life extends into mid-2030s, offering exclusivity for the protected compound during this period.
  • Potential opportunities for competitors include designing structurally related compounds outside the patent claims or pursuing combination treatments not explicitly covered.

FAQs

Q1: Does U.S. Patent 10,959,948 cover all compounds with the core structure?
A1: No. It protects specific substitutions and stereochemistry as claimed. Variations outside these parameters are not covered.

Q2: Can a compound with different substitutions infringe the patent?
A2: Only if the modifications fall within the scope of claim 1 or its dependent claims.

Q3: Are there foreign counterparts to this patent?
A3: Yes, family members exist in Europa and Japan, with similar claims but jurisdiction-specific differences.

Q4: How risky is patent infringement for developing related compounds?
A4: Reduced risk if modifications avoid the core structural elements and claims described in the patent.

Q5: What is the patent's expiration date?
A5: Expected in June 2037, considering the patent's 20-year term from the filing date.


References

[1] Patent and licensing databases, USPTO records (2023).

More… ↓

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Drugs Protected by US Patent 10,959,948

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Azurity FIRVANQ KIT vancomycin hydrochloride FOR SOLUTION;ORAL 208910-001 Jan 26, 2018 AB RX Yes Yes 10,959,948 ⤷  Start Trial Y TREATMENT OF STAPHYLOCOCCAL ENTEROCOLITIS ⤷  Start Trial
Azurity FIRVANQ KIT vancomycin hydrochloride FOR SOLUTION;ORAL 208910-001 Jan 26, 2018 AB RX Yes Yes 10,959,948 ⤷  Start Trial Y TREATMENT OF C. DIFFICILE-ASSOCIATED DIARRHEA ⤷  Start Trial
Azurity FIRVANQ KIT vancomycin hydrochloride FOR SOLUTION;ORAL 208910-002 Jan 26, 2018 AB RX Yes Yes 10,959,948 ⤷  Start Trial Y TREATMENT OF C. DIFFICILE-ASSOCIATED DIARRHEA ⤷  Start Trial
Azurity FIRVANQ KIT vancomycin hydrochloride FOR SOLUTION;ORAL 208910-002 Jan 26, 2018 AB RX Yes Yes 10,959,948 ⤷  Start Trial Y TREATMENT OF STAPHYLOCOCCAL ENTEROCOLITIS ⤷  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 10,959,948

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2015229069 ⤷  Start Trial
Canada 2941867 ⤷  Start Trial
China 106573037 ⤷  Start Trial
European Patent Office 3145527 ⤷  Start Trial
European Patent Office 4000628 ⤷  Start Trial
Spain 2903419 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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