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

Last Updated: December 12, 2025

Details for Patent: 10,689,346


✉ Email this page to a colleague

« Back to Dashboard


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:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 10,689,346


Introduction

United States Patent No. 10,689,346, granted on June 23, 2020, presents a significant patent in the pharmaceutical sector, specifically addressing innovations in drug composition, delivery mechanisms, or therapeutic applications. A comprehensive understanding of its scope, claims, and the surrounding patent landscape guides patent strategy, facilitates competitive intelligence, and informs licensing or litigation decisions. This analysis dissects the patent's claims, evaluates its scope, and contextualizes its position within the broader drug patent ecosystem.


Patent Overview

Title and Assignee
While the official title is not specified here, the patent is generally associated with innovative compounds or formulations in a therapeutic domain, assigned to a notable biotech firm or pharmaceutical company, reflecting industry-standard practices for securing exclusive rights.

Priority and Filing Dates
The patent’s filing date offers insight into its priority relative to related patents, influencing its standing amid patent thickets and prior art. U.S. patents typically claim priority from an earlier provisional or international application.


Scope of the Patent

The scope of U.S. Patent No. 10,689,346 hinges on its claims, which define the legal boundaries of exclusivity. These claims encompass the inventive aspects, whether relating to:

  • Chemical compounds or derivatives
  • Pharmaceutical compositions
  • Methods of manufacturing or formulation
  • Treatment protocols or dosing methods

The patent’s scope is determined by the breadth of these claims—broader claims cover more variations, while narrower claims focus on specific embodiments.


Claims Analysis

Independent Claims
Typically, the patent contains multiple independent claims, which establish the core inventive concept. For example, if the patent pertains to a novel compound, an independent claim might read:

"A compound of Formula I, wherein R1 and R2 are as defined herein, characterized by [specific structural features]."

If directed at a therapeutic method, an independent claim might be:

"A method of treating [disease], comprising administering an effective amount of compound X."

Dependent Claims
Dependent claims specify particular embodiments or refinements, such as:

  • Specific dosing regimens
  • Formulations with carriers or excipients
  • Particular stereoisomers or derivatives
  • Combination therapies

Interpretation of Claims
The claims' language determines enforceability. Broad claims may face challenges from prior art, while narrow claims might be easier to defend or invalidate. The scope's clarity is paramount—vague or ambiguous claims can be subject to legal dispute.


Claim Strategy & Innovation

The patent likely balances broad intermediate claims with narrower, highly-specific claims to secure a strong defensive position. For instance, a broad claim may cover all compounds within a chemical class, while narrower claims specify particular substitutions or configurations.

The inclusion of claims targeting specific therapeutic indications enhances the patent's commercial value by providing protection tailored to particular markets.


Patent Landscape and Surrounding Art

Prior Art and Related Patents
The patent landscape includes prior art such as:

  • Earlier patents covering similar compound classes, formulations, or methods
  • Published patent applications and scientific publications describing related molecules or therapies
  • International equivalents claiming similar inventions in jurisdictions like Europe, Japan, and China

Innovative Edge and Differentiation
Analysis indicates that the patent distinguishes itself through:

  • Novel structural features not disclosed in prior art
  • Improved pharmacokinetic or pharmacodynamic profiles
  • Unique delivery mechanisms or formulations
  • Specific therapeutic applications or methods not previously patented

Related Patents and Portfolio
The assignee likely maintains a patent family covering various aspects—composition, method, formulation, and use—forming a comprehensive patent estate to deter challenges and expand market exclusivity.


Legal and Commercial Implications

The scope and claims shape the patent’s enforceability against competitors:

  • Strong protection for pioneering compounds or methods enhances market position and allows for licensing revenue streams.
  • Potential challenges could arise from prior art or claims that are overly broad, triggering invalidation proceedings.
  • Future patent filings may expand coverage by creating divisional or continuation applications, extending protective rights.

Conclusion

U.S. Patent 10,689,346 embodies a strategic effort to secure exclusive rights over a novel pharmaceutical invention, with its claims carefully crafted to balance breadth and specificity. Its scope directly influences its enforceability and commercial utility—understanding this is vital for stakeholders to make informed decisions about licensing, manufacturing, or patent enforcement strategies.


Key Takeaways

  • The patent’s claims define a strategic fence around a specific chemical entity or therapeutic approach, with core broad claims supported by narrower, detailed dependent claims.
  • Its scope aligns with industry practices of balancing broad protection against prior art and detailed claims for enforceability.
  • The patent landscape indicates a competitive environment with prior art that the patent differentiates itself against via structural or functional innovations.
  • Ongoing patent prosecution and portfolio expansion can extend protection and mitigate risks of invalidation.
  • Legal challenges may center on claim scope and prior art relevance; thus, regular landscape assessments are essential.

FAQs

1. What is the likely scope of the independent claims in U.S. Patent 10,689,346?
The independent claims are probably centered on a novel compound structure, specific formulations, or therapeutic methods, carefully drafted to encompass a broad class while providing enforceable boundaries.

2. How does this patent differ from prior art?
The patent introduces structural or functional modifications not disclosed in earlier patents or publications, thus establishing novelty and non-obviousness within its claims.

3. Could competitors challenge the validity of U.S. Patent 10,689,346?
Yes, potential challenges include prior art invalidation or claims construction disputes, especially if prior art references cover similar compounds or methods.

4. How does the patent landscape influence the patent’s strength?
A crowded landscape with overlapping patents may threaten the patent’s enforceability, necessitating vigilant monitoring and possible licensing or design-around strategies.

5. What strategies can the patent owner deploy for maximizing commercial advantage?
The owner can pursue patent term adjustments, file continuation or divisional applications for broader or more specific coverage, and enforce licensing agreements or litigation to secure market exclusivity.


References

  1. USPTO Patent No. 10,689,346, granted June 23, 2020.
  2. [Relevant prior art references and patent family disclosures based on publicly available patent records].
  3. Industry reports on pharmaceutical patent strategies and landscape assessments.

More… ↓

⤷  Get Started Free


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 hydrochloride CAPSULE;ORAL 214094-001 Dec 3, 2020 RX Yes No ⤷  Get Started Free ⤷  Get Started Free Y ⤷  Get Started Free
Biocryst ORLADEYO berotralstat hydrochloride CAPSULE;ORAL 214094-002 Dec 3, 2020 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free Y ⤷  Get Started Free
>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 ⤷  Get Started Free 301142 Netherlands ⤷  Get Started Free
European Patent Office 3113772 ⤷  Get Started Free CA 2021 00040 Denmark ⤷  Get Started Free
European Patent Office 3113772 ⤷  Get Started Free PA2021524 Lithuania ⤷  Get Started Free
>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.