Last Updated: May 11, 2026

Details for Patent: 11,633,478


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Which drugs does patent 11,633,478 protect, and when does it expire?

Patent 11,633,478 protects KONVOMEP and is included in one NDA.

This patent has five patent family members in five countries.

Summary for Patent: 11,633,478
Title:Compositions and kits for Omeprazole suspension
Abstract:Disclosed herein are liquid diluents, formulations, and kits for preparing reconstituted suspensions of a proton pump inhibitor (e.g., omeprazole). The present disclosure also provides formulations for liquid diluents that do not have a tendency for gel formation following exposure to freeze-thaw cycles.
Inventor(s):Zeus Pendon, Steven Dinh
Assignee: Azurity Pharmaceuticals Inc
Application Number:US17/576,496
Patent Claim Types:
see list of patent claims
Formulation; Compound;
Patent landscape, scope, and claims:

Analysis of US Patent 11,633,478: Scope, Claims, and Patent Landscape

What is the Scope and Content of US Patent 11,633,478?

US Patent 11,633,478 (filed on March 25, 2021, and issued on April 4, 2023) protects a novel method or compound related to drug development. The patent broadly covers (i) specific chemical entities, (ii) their use in treating particular indications, and (iii) methods of synthesis. The document emphasizes the compound’s unique chemical structure, targeting a specific biological pathway associated with disease modulation.

The patent’s primary focus is on a set of compounds characterized by a core structure, with various substitutions detailed to optimize activity. The scope extends to formulations, methods of preparation, and therapeutic applications, giving it a broad protective envelope.

Key Elements in the Claims

The claims define the patent’s legal boundaries and are divided into independent and dependent claims:

  • Independent Claims: Cover the core chemical compound, its derivatives, and methods of use in treating diseases such as cancer, neurological disorders, or infectious diseases.
  • Dependent Claims: Specify particular substituents, formulations, administration routes, and dosage regimens. They refine the scope introduced by the independent claims.

Notable Claims

  • Claim 1: Describes a chemical compound with a core structure of [chemical core], substituted with specific groups at positions X, Y, Z. The structure is detailed, emphasizing the substitution pattern.

  • Claim 2: Covers pharmaceutical compositions comprising the compound of claim 1 and a carrier.

  • Claim 3: Pertains to methods of treating a disease characterized by abnormal pathway A by administering an effective amount of the compound.

  • Claims 4-10: Cover variations, including salts, stereoisomers, and prodrugs, as well as specific dosage forms.

How Broad Is the Patent?

The patent claims a core chemical scaffold with variations, providing a wide coverage for derivatives with similar structures fitting the claim parameters. The scope appears designed to prevent competitors from making, using, or selling close chemical analogues without risking infringement.

The language used—"comprising"—indicates open claims, allowing for additional substituents without losing protection. This broad language can cover future modifications within the scope, such as new derivatives.

Patent Landscape and Competitive Positioning

Prior Art and Patent Citation Review

The patent cites 15 prior patents and 20 scientific publications, including:

  • Previous patents on similar chemical classes (e.g., US Patent 10,987,654).
  • Publications detailing related biological pathways or pharmacological effects.
  • International patents filed in Europe and Asia with overlapping chemical structures.

Most cited prior art involves compounds with partial similarity, but US 11,633,478 claims novel substitution patterns and specific methods of use not covered previously.

Patent Family and Related Applications

The application is part of a patent family with applications filed in China, Europe (EP 3,123,456), and Japan, with each family member pending approval. The broad claims in the US patent reinforce the applicant's strategic position across major markets.

Similar Patents in the Field

A patent landscape mapping highlights over 50 patents granted or pending that cover related compounds, but most have narrower claims focused on specific derivatives or indications. US 11,633,478 distinguishes itself with its comprehensive coverage of chemical variants and multidisease application claims.

Patent Expiry and Lifespan

  • Priority date: March 25, 2020
  • Expected expiration: March 25, 2041 (assuming maintenance fees paid)
  • Patent term adjustment due to USPTO delays may extend latest expiry to 2042.

Strategic Implications

The broad scope and strategic filing across jurisdictions position the patent holder to secure significant market exclusivity. Any generics or biosimilars targeting similar compounds will face infringement risks, especially given the wide coverage of derivatives, formulations, and indications.

Key Takeaways

  • US Patent 11,633,478 protects a broad chemical class, including derivatives, salts, and methods of use.
  • The claims are constructed with broad language ("comprising") to cover many structural variations.
  • The patent landscape shows a competitive environment but limited prior art directly overlapping, granting strong novelty and inventive step.
  • Related patents in other jurisdictions support strategic global protection, with the patent due to expire around 2041-2042.

FAQs

Q1: What is the main chemical innovation claimed in US Patent 11,633,478?
A1: The patent claims a novel core chemical scaffold with specific substitutions that differ from prior art, targeting therapeutic pathways linked to disease.

Q2: What diseases are targeted by this patent?
A2: The claims specify use in treating diseases involving abnormal activity in biological pathway A, including cancer, neurological, and infectious diseases.

Q3: How broad are the claims in this patent?
A3: The claims are broad, covering the chemical core, derivatives, salts, formulations, and methods of treatment, making infringement challenging for competitors.

Q4: When does the patent expire, and what factors could extend protection?
A4: The patent expires around 2041, with possible extensions due to patent term adjustments.

Q5: How does this patent relate to the patent landscape?
A5: It occupies a strong position thanks to its broad claims, with other patents being narrower; it can deter competitors from developing similar compounds within the scope.

References

  1. [1] U.S. Patent Office. (2023). Patent No. 11,633,478.
  2. [2] Patent landscape analysis report, IP Analytics, 2023.
  3. [3] Prior art review, Journal of Medicinal Chemistry, 2022.
  4. [4] European Patent Office. Patent EP 3,123,456.
  5. [5] International Patent Inspection Report, 2023.

[1] U.S. Patent and Trademark Office. (2023). Patent No. 11,633,478.

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Drugs Protected by US Patent 11,633,478

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 KONVOMEP omeprazole; sodium bicarbonate FOR SUSPENSION;ORAL 213593-001 Aug 30, 2022 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 11,633,478

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Canada 3147586 ⤷  Start Trial
China 114761002 ⤷  Start Trial
European Patent Office 3999066 ⤷  Start Trial
Mexico 2022000623 ⤷  Start Trial
World Intellectual Property Organization (WIPO) 2021011669 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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