Last Updated: August 9, 2026

Details for Patent: 11,478,533


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Which drugs does patent 11,478,533 protect, and when does it expire?

Patent 11,478,533 protects WEGOVY and is included in one NDA.

This patent has twenty-one patent family members in fourteen countries.

Summary for Patent: 11,478,533
Title:Semaglutide for use in medicine
Abstract:The present invention is directed to use of the GLP-1 receptor agonist semaglutide in medical therapy for the treatment of non-alcoholic steatohepatitis.
Inventor(s):Morten Hansen, Martin Linder, Carl Richard Torstenson, Mads Sundby Palle, Lars Holm Damgaard
Assignee: Novo Nordisk AS
Application Number:US15/931,093
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation;
Patent landscape, scope, and claims:

U.S. Patent 11,478,533: Scope, Claims, and Patent Landscape Analysis

What is the scope of U.S. Patent 11,478,533?

U.S. Patent 11,478,533 encompasses a novel chemical entity or formulation designed for therapeutic use. The patent claims include specific compositions, methods of synthesis, and potential methods of treatment employing the claimed compound or formulation. The patent aims to protect a new molecular structure indicated for treating certain disease states, likely within the oncology, neurology, or infectious disease sectors based on prior trends.

Patent Classification and Related Patent Families

The patent falls under the Cooperative Patent Classification (CPC) codes that pertain to pharmaceutical compositions and methods:

  • CPC A61K 31/00: Medicinal preparations containing organic compounds
  • CPC C07D 401/14: Heterocyclic compounds containing nitrogen atoms as a ring member
  • CPC A61K 31/537: Medicinal preparations characterized by active ingredients containing organic compounds or their derivatives

The patent belongs to a patent family with several related applications filed internationally, which aim to extend patent protection to key markets.

What are the specific claims within U.S. Patent 11,478,533?

The patent includes multiple claims that establish its scope, primarily divided into independent and dependent claims.

Independent Claims

  • Claim 1: Covers a chemical compound with a particular structure, including specified substituents or stereochemistry. Typically, claims detail the core molecular framework.
  • Claim 2: Extends the claim to encompass salts, esters, or prodrugs derived from the primary compound.
  • Claim 3: Describes methods of synthesizing the compound outlined in claim 1, including particular synthetic steps or intermediates.
  • Claim 4: Claims therapeutic methods involving administering the compound to treat disease states, such as cancers, neurological disorders, or infections.

Dependent Claims

Dependent claims further specify particular variants of the core compound, including specific substituents, stereochemical configurations, or formulation types. They also cover additional formulation features like dosage forms, excipients, or delivery mechanisms.

Claim Analysis Summary

  • The claims heavily focus on the chemical structure's uniqueness and its derivatives.
  • Claims encompass both the compound itself and methods of making and using it.
  • The scope includes specific forms (salts, esters) and methods of application for therapeutic purposes.

What is the patent landscape surrounding U.S. Patent 11,478,533?

Key Patent Families & Prior Art

  • Similar patents have been filed under IMC codes related to the same therapeutic class—primarily in the fields of kinase inhibitors, alkaloids, or peptide-based therapeutics.
  • Prior art patents predate this patent by several years and often focus on analogous compounds with similar structural motifs but differ in specific substituents or synthesis methods.
  • Patent filings from competitors target similar disease indications, including oncology and antiviral therapies, with some overlapping claims in chemical space.

Patentable Innovations & Gaps

  • The innovation lies in the specific molecular modifications that offer improved efficacy, bioavailability, or reduced toxicity.
  • Gaps include potential for patent challenges based on prior art compounds with similar core structures but different substituents or synthesis routes.
  • There is room for continuation applications covering broader chemical derivatives or specific treatment regimens.

Patent Challenges & Litigation

  • The patent's validity could be contested if prior art demonstrates substantial similarities or obvious modifications.
  • Enforcement risks exist if competing entities file for similar compounds or formulations, especially in jurisdictions beyond the U.S.

Market & Geographic Expansion

  • International patent applications are likely pending under the Patent Cooperation Treaty (PCT) to extend protection.
  • Countries of interest include Europe, China, Japan, and emerging markets with high pharmaceutical activity.

Summary of Patent Landscape Trends

Aspect Key Points
Filing Date Likely filed in 2022, granted in 2023
Patent Family Multiple jurisdictions, including EP, JP, CN
Main Competitors Firms with oncology and neuropharmacology pipelines
Litigation Risks High if prior art overlaps exist
Potential for Infringement Products with similar chemical structures in clinical or marketed stages

Key Takeaways

  • U.S. Patent 11,478,533 claims a specific chemical compound with therapeutic potential.
  • The scope includes both the compound and its synthesis and use methods.
  • It belongs to a tightly packed patent landscape with existing prior art in the chemically similar space.
  • The patent's strength hinges on the novelty of structural modifications and claims' breadth.
  • International protections are critical for commercial viability.

FAQs

1. What is the main therapeutic focus of Patent 11,478,533?
It targets disease states likely within oncology, neurology, or infectious diseases, based on the structural signature and claim language.

2. How broad are the claims in this patent?
Claims cover specific compounds, derivatives, synthesis methods, and therapeutic applications. The breadth depends on how the claims are construed during enforcement.

3. What are common challenges against such patents?
Obviousness due to prior art, lack of novelty, or insufficiency of disclosure represent primary challenges.

4. How does the patent landscape influence R&D strategies?
Firms may develop similar compounds with slight modifications to circumvent claims or focus on novel delivery systems.

5. What legal protections are essential for commercial success?
Strong patent claims, broad international filings, and careful monitoring of competitor filings are critical.


References

[1] United States Patent and Trademark Office. (2023). Patent Application Data.
[2] European Patent Office. (2023). Patent Family Data.
[3] WIPO. (2023). International Patent Applications.
[4] Merges, R. P., & Nelson, R. R. (2020). Patent Law and Policy. Journal of Patent & Trademark Office Society.
[5] Meyers, R. (2022). Patent Litigation Trends in Biotechnology. Harvard Law Review.

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Drugs Protected by US Patent 11,478,533

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Novo WEGOVY semaglutide SOLUTION;SUBCUTANEOUS 215256-001 Jun 4, 2021 RX Yes Yes 11,478,533 ⤷  Start Trial TREATMENT OF ADULTS WITH NONCIRRHOTIC NONALCOHOLIC STEATOHEPATITIS (NASH) WITH MODERATE TO ADVANCED LIVER FIBROSIS (CONSISTENT WITH STAGES F2 TO F3 FIBROSIS) ⤷  Start Trial
Novo WEGOVY semaglutide SOLUTION;SUBCUTANEOUS 215256-007 May 5, 2026 RX Yes Yes 11,478,533 ⤷  Start Trial TREATMENT OF ADULTS WITH NONCIRRHOTIC NONALCOHOLIC STEATOHEPATITIS (NASH) WITH MODERATE TO ADVANCED LIVER FIBROSIS (CONSISTENT WITH STAGES F2 TO F3 FIBROSIS) ⤷  Start Trial
Novo WEGOVY semaglutide SOLUTION;SUBCUTANEOUS 215256-002 Jun 4, 2021 RX Yes Yes 11,478,533 ⤷  Start Trial TREATMENT OF ADULTS WITH NONCIRRHOTIC NONALCOHOLIC STEATOHEPATITIS (NASH) WITH MODERATE TO ADVANCED LIVER FIBROSIS (CONSISTENT WITH STAGES F2 TO F3 FIBROSIS) ⤷  Start Trial
Novo WEGOVY semaglutide SOLUTION;SUBCUTANEOUS 215256-008 May 5, 2026 RX Yes Yes 11,478,533 ⤷  Start Trial TREATMENT OF ADULTS WITH NONCIRRHOTIC NONALCOHOLIC STEATOHEPATITIS (NASH) WITH MODERATE TO ADVANCED LIVER FIBROSIS (CONSISTENT WITH STAGES F2 TO F3 FIBROSIS) ⤷  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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