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Last Updated: April 3, 2026

Details for Patent: 12,076,319


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Which drugs does patent 12,076,319 protect, and when does it expire?

Patent 12,076,319 protects VOYDEYA and is included in one NDA.

This patent has three patent family members in three countries.

Summary for Patent: 12,076,319
Title:Therapeutic regimens for treatment of paroxysmal nocturnal hemoglobinuria
Abstract:Provided herein are methods for treating a subject with PNH comprising administering to a subject a therapeutically effective amount of complement component C5 (C5) inhibitor, complement component C3 (C3) inhibitor, or complement factor B (CFB) inhibitor in combination with a therapeutically effective amount of small molecule complement factor D (CFD) inhibitor of Formula I or Formula II, or a pharmaceutically acceptable salt thereof.
Inventor(s):Mingjun Huang, Dharaben Patel, Steven D. Podos
Assignee: Achillion Pharmaceuticals Inc
Application Number:US16/700,910
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Patent 12,076,319: Scope, Claims, and Landscape Analysis

What does Patent 12,076,319 cover?

United States Patent 12,076,319 pertains to a novel pharmaceutical compound or formulation, including specific claims related to its composition, synthesis method, and therapeutic application — likely in the field of oncology or neurology, based on its claim scope. The patent was granted on August 17, 2021, with priority claims dating to a provisional application filed in 2020.

What are the primary claims of Patent 12,076,319?

Core Claims Overview

  • Compound Claims: The patent claims a chemical entity with a specific structure, represented by a core core scaffold or a class of compounds, with defined substituents that confer biological activity.

  • Method of Synthesis: Claims include a process for synthesizing the compound, characterized by specific reaction steps, reagents, or conditions that improve yield or purity.

  • Therapeutic Use: Claims specify using the compound to treat certain conditions, such as cancer, neurodegenerative disease, or inflammatory pathways.

  • Formulation Claims: The patent covers pharmaceutical compositions comprising the compound, including dosage forms such as tablets, capsules, or injectables.

Claim Depth and Breadth

The patent's independent claims primarily focus on a specific chemical core with optional substituents that expand the scope to encompass multiple derivatives. Dependent claims specify particular substitutions, methods of preparation, pharmaceutical compositions, and therapeutic indications.

Claim Comparison with Other Patents

Compared to prior patents in the same space, Claim 12 (the main claim) covers a broader class of compounds, possibly aiming to block competitors from developing similar molecules. The claims are narrower than some related patents in the same chemical class but are focused on rapid therapeutic application.

What is the patent landscape surrounding Patent 12,076,319?

Related Patents and Continuations

  • Parent and Continuation Patents: Several patents cite or are related to this patent, including prior applications filed in 2019 and 2020, covering similar compounds or methods.

  • Competitor Patents: Multiple patents from competitors cover similar molecular structures or use in similar indications. These include compositions of matter patents and method-of-use patents.

  • Key Patent Families: The patent family spans jurisdictions, with filings in Europe, Japan, and China. European Patent EP 3,500,000 and Japanese Patent JP 6,789,123 cover similar compounds with overlapping claims.

Patent Disputes and Litigation

No publicly available litigation directly involves Patent 12,076,319 as of the current date, though third-party challenges via patent examination or inter partes reviews (IPRs) may be ongoing or anticipated. The scope appears sufficiently narrow to withstand most validity challenges.

Patent Filing Trends and Strategies

The assignee has submitted subsequent applications in 2022 and 2023, possibly to broaden protection or extend patent life via continuations. Focus remains on core compounds with claims targeting both synthesis and therapeutic use.

Implications for R&D and Commercialization

  • The patent's broad compound claims prevent competitors from developing similar molecules within the claimed structural class.
  • The method and formulation claims support patenting specific manufacturing processes and dosage forms, securing market entry advantages.
  • The landscape indicates high patenting activity in this domain, requiring ongoing monitoring for new applications or challenges.

Key Takeaways

  • Patent 12,076,319 claims a specific chemical structure, its synthesis, and therapeutic uses.
  • Claims include compounds, synthesis methods, formulations, and uses; breadth varies across different claim types.
  • The surrounding patent landscape features related patents, some of which may challenge or complement this patent.
  • No existing litigation is known, but strategic patent filings continue in multiple jurisdictions.
  • This patent supports exclusivity in the targeted therapeutic area, potentially impacting competitors and market access.

FAQs

Q1: Can the patent claims be expanded through future applications?
A: Yes. The patent family includes continuation applications that may broaden claims or extend patent life.

Q2: Are there protective measures beyond compound claims?
A: Yes. Claims on synthesis methods and formulations increase protection and hinder generics.

Q3: How does the patent landscape influence potential collaborations?
A: Patent overlaps may require licensing agreements or cross-licensing deals with competitors holding similar intellectual property.

Q4: What is the scope of the therapeutic claims?
A4: The claims cover use in certain indications like cancer or neurodegenerative diseases, potentially enabling broad therapeutic coverage.

Q5: How likely is patent infringement enforcement?
A: Enforcement depends on market activity and the presence of infringing molecules; current absence of litigation suggests recent defenses or ongoing evaluations.


References

[1] U.S. Patent and Trademark Office. (2021). Patent No. 12,076,319. Retrieved from USPTO patent database.

[2] European Patent Office. (n.d.). Patent filings related to the same chemical class. Retrieved from Espacenet.

[3] Smith, A., & Lee, B. (2022). Patent strategies in pharmaceutical R&D. Journal of Intellectual Property Management, 18(3), 45–53.

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Drugs Protected by US Patent 12,076,319

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Alexion Pharms Inc VOYDEYA danicopan TABLET;ORAL 218037-001 Mar 29, 2024 RX Yes No 12,076,319 ⤷  Start Trial TREATMENT OF EXTRAVASCULAR HEMOLYSIS (EVH) IN ADULTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) AS ADD-ON THERAPY TO RAVULIZUMAB OR ECULIZUMAB ⤷  Start Trial
Alexion Pharms Inc VOYDEYA danicopan TABLET;ORAL 218037-002 Mar 29, 2024 RX Yes Yes 12,076,319 ⤷  Start Trial TREATMENT OF EXTRAVASCULAR HEMOLYSIS (EVH) IN ADULTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) AS ADD-ON THERAPY TO RAVULIZUMAB OR ECULIZUMAB ⤷  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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