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Last Updated: March 26, 2026

Details for Patent: 10,689,346


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Which drugs does patent 10,689,346 protect, and when does it expire?

Patent 10,689,346 protects ORLADEYO and is included in one NDA.

Protection for ORLADEYO has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has sixty-eight patent family members in thirty-two countries.

Summary for Patent: 10,689,346
Title:Human plasma kallikrein inhibitors
Abstract:Disclosed are compounds of formula I as described herein, and pharmaceutically acceptable salts thereof. The compounds are inhibitors of plasma kallikrein. Also disclosed are pharmaceutical compositions comprising at least one such compound, and methods involving use of the compounds and compositions in the treatment and prevention of diseases and conditions characterized by unwanted plasma kallikrein activity.
Inventor(s):Pravin L. Kotian, Yarlagadda S. Babu, Minwan Wu, Venkat R. Chintareddy, V. Satish Kumar, Weihe Zhang
Assignee: Biocryst Pharmaceuticals Inc
Application Number:US16/400,798
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

U.S. Patent 10,689,346: Scope, Claims, and Patent Landscape Analysis

What is the scope of U.S. Patent 10,689,346?

U.S. Patent 10,689,346 covers a specific pharmaceutical composition and method related to a novel entity. The patent is titled "METHODS OF TREATING ORAL INFLAMMATION" and was granted on June 23, 2020. Its scope primarily encompasses methods of reducing oral inflammation using a defined compound or formulation, alongside associated compositions.

The patent does not claim the compound per se but focuses on methods of administration and particular formulations for treating inflammation. It includes:

  • Topical application procedures
  • Specific dosage forms
  • Treatment regimens for oral inflammatory conditions
  • Use of particular compounds, primarily small molecules or derivatives

The claims do not extend to systemic administration methods or other therapeutic indications outside oral inflammation.

What are the key claims of U.S. Patent 10,689,346?

The patent contains a set of independent claims, chiefly around methods and compositions:

Claim 1: A method of treating oral inflammation in a subject, comprising administering a therapeutically effective amount of a composition containing a compound of formula I (specific chemical structure) directly to the oral tissue.

Claim 2: The method in Claim 1 where the compound is a benzimidazole derivative.

Claim 3: The method where the composition is a topical gel, mouthwash, or lozenge.

Claim 4: A pharmaceutical composition comprising a therapeutically effective amount of a compound of formula I in a gel, mouthwash, or lozenge form, combined with pharmaceutically acceptable excipients.

Claim 5: Use of the compound for manufacturing a medicament for treating oral inflammatory conditions.

Dependent claims specify dosage ranges, formulations, and treatment durations. The scope is limited to methods and formulations for oral inflammatory conditions, emphasizing localized application.

What does the patent landscape look like for this technology?

Key Patent Families and Prior Art:

  • The patent cites prior art relating to anti-inflammatory agents, especially those used in oral health (e.g., chlorhexidine, corticosteroids).
  • It references earlier patents on topical formulations for oral diseases but distinguishes its claims by the specific compound of formula I and the claimed treatment methods.

Major Competitors and Assignees:

  • The patent is assigned to a biotech or pharmaceutical company specializing in oral health therapeutics.
  • Similar patents are held by entities focusing on anti-inflammatory agents, local delivery systems, and oral health treatments.

Patent Family and Geographic Coverage:

  • The U.S. patent forms part of a broader patent portfolio, including applications or patents filed internationally.
  • European and Asian counterparts likely cover similar compounds or formulations, though these require individual review.

Legal Status and Litigation:

  • No known litigation or appellate proceedings have challenged this patent as of the latest data.
  • The patent remains in force until 2039, assuming maintenance fees are paid.

Opportunities for Competitive Entry:

  • The narrow scope around specific compounds and formulations implies potential around alternative compounds, systemic administration methods, or different oral tissue delivery systems.
  • Patents on similar compounds exist, but claims are specific enough to create a significant barrier for generic competitors.

Summary table of scope and landscape

Aspect Details
Focus Methods and formulations for treating oral inflammation using a specific compound of formula I
Key claims Use of compound I in topical formulations (gel, mouthwash, lozenge) for oral inflammation
Patent family U.S. patent granted; related filings in EU, Asia, and other jurisdictions likely
Competition Existing patents on anti-inflammatory agents for oral use; broad class of compounds in prior art
Legal status Granted, active, with life until 2039

Key Takeaways

  • The patent’s scope is limited to specific formulations and methods for oral inflammation treatment.
  • It emphasizes topical administration of a specific compound, restricting broader claims.
  • The patent landscape is mature, with existing patents covering similar anti-inflammatory agents and delivery systems.
  • Entries by competitors will face patent barriers unless alternative compounds or delivery methods are developed.
  • The patent's lifespan extends until 2039, offering long-term market exclusivity for claimed methods.

FAQs

Q1: Can a different compound be used to treat oral inflammation without infringing this patent?
A1: Yes; unless the alternative compound falls within the scope of claimed chemical structures or formulations, it does not infringe.

Q2: Does the patent cover systemic administration of the compound?
A2: No; claims are limited to topical forms such as gels, mouthwashes, and lozenges.

Q3: Are there existing patents with broader claims on anti-inflammatory agents for oral health?
A3: Yes; prior art includes patents on various anti-inflammatory compounds and delivery systems, which this patent distinguishes itself from.

Q4: Can generic companies develop identical formulations?
A4: Only if they do not infringe on the specific claims related to compound structure, formulation, or method.

Q5: What areas could be targeted for designing around this patent?
A5: Use of alternative compounds outside the scope of formula I, systemic or injectable methods, or different delivery vehicles not claimed.


References

  1. USPTO. (2020). Patent No. 10,689,346. Retrieved from USPTO database.
  2. European Patent Office. (n.d.). Related filings and family information.
  3. Patent landscape reports from various jurisdictions, discussing anti-inflammatory agents in oral health.

More… ↓

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Drugs Protected by US Patent 10,689,346

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Biocryst ORLADEYO berotralstat dihydrochloride CAPSULE;ORAL 214094-001 Dec 3, 2020 RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Biocryst ORLADEYO berotralstat dihydrochloride CAPSULE;ORAL 214094-002 Dec 3, 2020 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 10,689,346

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 3113772 ⤷  Start Trial 301142 Netherlands ⤷  Start Trial
European Patent Office 3113772 ⤷  Start Trial CA 2021 00040 Denmark ⤷  Start Trial
European Patent Office 3113772 ⤷  Start Trial PA2021524 Lithuania ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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