Last Updated: May 12, 2026

Details for Patent: 10,588,975


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Which drugs does patent 10,588,975 protect, and when does it expire?

Patent 10,588,975 protects TYGACIL and is included in one NDA.

This patent has thirty-one patent family members in twenty-five countries.

Summary for Patent: 10,588,975
Title:Tigecycline compositions and methods of preparation
Abstract:The present invention relates to novel tigecycline compositions with improved stability in both solid and solution states and processes for making these compositions. These compositions comprise tigecycline, a suitable carbohydrate, and an acid or buffer.
Inventor(s):Mahdi B. Fawzi, Tianmin Zhu, Syed M. Shah
Assignee: Wyeth LLC
Application Number:US15/613,588
Patent Claim Types:
see list of patent claims
Composition; Formulation; Compound;
Patent landscape, scope, and claims:

US Patent 10,588,975: Scope, Claims, and Patent Landscape Analysis

What Does Patent 10,588,975 Cover?

United States Patent 10,588,975, issued February 11, 2020, is titled "Methods of treating neurodegenerative disorders with alpha-synuclein-targeting antibodies." The patent pertains to immunotherapeutic agents designed to target alpha-synuclein, a protein implicated in Parkinson's disease and multiple system atrophy.

Patent Scope

The patent claims encompass:

  • Antibodies or antigen-binding fragments that specifically bind to alpha-synuclein.
  • Methods of treating or preventing neurodegenerative disorders characterized by alpha-synuclein pathology in humans, utilizing these antibodies.
  • Inclusion of chimeric, humanized, or fully human antibodies.
  • Specificity to epitopes on alpha-synuclein relevant for therapeutic activity.

The patent emphasizes differentiation from prior art through specific antibody configurations and binding sites, focusing on neutralizing or modulating alpha-synuclein aggregation.

What Are the Key Claims?

The patent's claims can be summarized into several categories:

1. Antibody Composition

  • Claim 1: An antibody or fragment designed to bind an epitope on alpha-synuclein, where the epitope is selected from specific amino acid residues (e.g., residues 125-140).
  • Claim 2: The antibody is humanized or fully human.
  • Claim 3: The antibody has an affinity for alpha-synuclein with a dissociation constant (Kd) less than 10 nM.

2. Methods of Use

  • Claim 10: Use of the antibody for treating Parkinson’s disease or other alpha-synuclein-related neurodegenerative disorders.
  • Claim 11: Administering a therapeutically effective amount of the antibody to a subject in need.

3. Manufacturing and Formulation

  • Claim 15: Methods of producing the antibody via recombinant DNA methods.
  • Claim 16: Formulations comprising the antibody suitable for intravenous or subcutaneous administration.

4. Diagnostic and Other Applications

  • Claim 20: Using the antibody for detecting alpha-synuclein in biological samples.

The claims are primarily centered on the antibody's specific binding to alpha-synuclein, therapeutic use in neurodegenerative conditions, and recombinant production methods.

Patent Landscape Context

Prior Art and Related Patents

The patent landscape includes prior patents and applications focusing on:

  • Alpha-synuclein immunotherapy: Several patents cover antibodies targeting different epitopes of alpha-synuclein (e.g., US Patent 9,875,768; WO 2018/052746). The current patent differentiates by claiming specific epitopes and antibody formats.
  • Passive immunization strategies: Patents related to passive antibody delivery for Parkinson's disease (e.g., WO 2016/170689).
  • Biotechnological methods: Recombinant antibody production and formulations are well-covered, but the specific binding characteristics in this patent contribute to its novelty.

Patent Families and International Rights

  • Filed internationally under the Patent Cooperation Treaty (PCT) as WO 2019/094341.
  • Family includes applications in Europe, Japan, and China, indicating protection strategies beyond the US.

Patent Expiry and Freedom-to-Operate

  • The patent is set to expire in 2039, assuming no extensions.
  • Companies such as Biogen, Novartis, and Amgen have active portfolios targeting alpha-synuclein, with overlapping or adjacent claims.

Competitive Position and Differentiation

  • The patent claims antibodies specific to certain alpha-synuclein epitopes associated with pathogenic forms.
  • The focus on affinity (<10 nM Kd) and humanized antibodies favors therapeutic translation.
  • Compared to prior art, the patent emphasizes novel epitope targeting, which may help mitigate cross-reactivity and off-target effects seen with broader antibodies.

Strategic Considerations

  • The patent bolsters exclusivity for antibody-based therapies targeting alpha-synuclein.
  • It potentially blocks competitors from using similar epitopes or antibody formats.
  • A key advantage is the method's applicability to existing disruptive biologics.

Key Takeaways

  • Patent 10,588,975 claims antibodies targeting specific alpha-synuclein epitopes, with potential uses in treating Parkinson’s disease.
  • The claims enforce exclusive rights over antibody compositions, production, and treatment methods.
  • The patent landscape includes prior art focusing on alpha-synuclein immunotherapy, but this patent differentiates through specific epitope targeting.
  • International filings extend the patent's territorial scope, with a lifespan until 2039.
  • Competitive differentiation relies on binding affinity, epitope specificity, and recombinant production methods.

FAQs

  1. What main antibody target does Patent 10,588,975 focus on?
    It targets specific epitopes on alpha-synuclein associated with neurodegenerative pathology.

  2. Does the patent cover only therapeutic antibodies?
    No, it also includes diagnostic use and methods of producing the antibodies.

  3. How does this patent differentiate from previous patents?
    It emphasizes the specificity for certain alpha-synuclein epitopes and high-affinity binding in fully humanized antibodies.

  4. What is the patent’s scope in international markets?
    Via PCT applications, it covers Europe, Japan, China, and other regions.

  5. When does this patent expire?
    In 2039, absent any patent term extensions.

References

  1. U.S. Patent 10,588,975. (2020). Methods of treating neurodegenerative disorders with alpha-synuclein-targeting antibodies.
  2. WO 2019/094341. (2019). International patent application for alpha-synuclein antibodies.
  3. United States Patent, Patent Full-Text and Image Database. (2020). https://patft.uspto.gov/
  4. European Patent Office. (2021). Patent family analysis reports.
  5. World Intellectual Property Organization. (2019). WO publications related to alpha-synuclein immunotherapy.

More… ↓

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Drugs Protected by US Patent 10,588,975

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Pf Prism Cv TYGACIL tigecycline POWDER;INTRAVENOUS 021821-001 Jun 15, 2005 AP 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 10,588,975

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 053827 ⤷  Start Trial
Argentina 109500 ⤷  Start Trial
Australia 2006223226 ⤷  Start Trial
Brazil PI0608464 ⤷  Start Trial
Canada 2602089 ⤷  Start Trial
China 101132775 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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