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Last Updated: June 21, 2025

Details for Patent: 10,080,733


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Which drugs does patent 10,080,733 protect, and when does it expire?

Patent 10,080,733 protects VUMERITY and is included in one NDA.

This patent has fifty-five patent family members in twenty-eight countries.

Summary for Patent: 10,080,733
Title:Prodrugs of fumarates and their use in treating various diseases
Abstract: The present invention provides compounds of formula (I), and pharmaceutical compositions thereof. ##STR00001##
Inventor(s): Zeidan; Tarek A. (Lexington, MA), Duncan; Scott (Bedford, MA), Hencken; Christopher P. (Boston, MA), Wynn; Thomas Andrew (Lexington, MA), Sanrame; Carlos N. (Lexington, MA)
Assignee: Alkermes Pharma Ireland Limited (Dublin, IE)
Application Number:15/782,128
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,080,733
Patent Claim Types:
see list of patent claims
Use; Composition; Compound;
Patent landscape, scope, and claims:

Detailed Analysis of the Scope and Claims of United States Patent 10,080,733

Introduction

United States Patent 10,080,733, titled "Prodrugs of fumarates and their use in treating various diseases," is a significant patent in the pharmaceutical industry, particularly in the treatment of autoimmune and inflammatory diseases. This patent, assigned to Alkermes Pharma Ireland Limited, covers a range of compounds and their applications, which are crucial for understanding the patent landscape and its implications.

Patent Overview

Issuance and Expiration

The patent was issued on September 25, 2018, and is set to expire on September 20, 2033[5].

Inventors and Assignees

The inventors listed on the patent include Tarek A. Zeidan, Scott Duncan, Christopher P. Hencken, Thomas Andrew Wynn, and Carlos N. Sanrame. The assignee is Alkermes Pharma Ireland Limited[5].

Scope of the Patent

Compounds and Formulations

The patent covers prodrugs of fumarates, which are compounds designed to release fumaric acid esters (FAEs) in the body. These prodrugs are formulated to improve the bioavailability and stability of FAEs, making them more effective for treating various diseases. The compounds are described by specific chemical formulas and structures, ensuring a clear definition of what is protected under the patent[1][5].

Therapeutic Uses

The primary therapeutic use of these prodrugs is in the treatment of autoimmune and inflammatory diseases, such as multiple sclerosis and psoriasis. The patent also explores the potential use of these compounds in treating other conditions, highlighting the broad therapeutic scope of the invention[1].

Claims of the Patent

Independent and Dependent Claims

The patent includes a series of independent and dependent claims that define the scope of the invention. Independent claims outline the core aspects of the prodrugs, such as their chemical structure and pharmaceutical compositions. Dependent claims further specify various aspects, including methods of preparation, dosages, and specific therapeutic applications[5].

Claim Language and Scope

The claim language is precise and detailed, ensuring that the scope of the patent is well-defined. This precision is crucial for distinguishing the invention from prior art and for determining the breadth of protection. The claims are structured to cover a range of scenarios, from the synthesis of the compounds to their administration in patients[1].

Patent Landscape

Related Patents

The patent landscape surrounding U.S. Patent 10,080,733 includes several related patents, such as U.S. Patent 8,669,281 and U.S. Patent 9,090,558. These patents, also assigned to Alkermes Pharma Ireland Limited, cover similar compounds and methods, indicating a comprehensive strategy to protect the intellectual property related to fumarate prodrugs[2][5].

Patent Term Extension

The patent term extension for U.S. Patent 10,080,733 is an important aspect of its landscape. The patent is eligible for extension under 35 U.S.C. § 156 due to the regulatory review period for the drug product VUMERITY® (diroximel fumarate). However, the extension is limited to 39 days due to the 14-year limit imposed by 35 U.S.C. § 156(c)(3)[2].

Impact on the Pharmaceutical Industry

Market Dominance

The patent provides Alkermes Pharma Ireland Limited with significant market protection for their fumarate prodrugs. This protection is crucial for maintaining market dominance, especially since there is currently no generic version of VUMERITY® available in the United States[5].

Innovation and Research

The patent encourages innovation by protecting the intellectual property of the inventors, allowing them to recoup their investment in research and development. This protection also incentivizes further research into the therapeutic applications of fumarate prodrugs[3].

Challenges and Criticisms

Patent Scope and Quality

There are ongoing debates about patent scope and quality, particularly regarding the breadth and clarity of patent claims. The metrics used to measure patent scope, such as independent claim length and count, can indicate the complexity and validity of the patent. However, broader claims can sometimes lead to increased licensing and litigation costs, potentially hindering innovation[3].

Regulatory Considerations

FDA Approval and Regulatory Review

The regulatory review period for VUMERITY® played a critical role in determining the patent term extension. The FDA's approval process and the subsequent regulatory review period are essential factors in the patent's lifecycle, influencing both its term and its market impact[2].

Key Takeaways

  • Patent Scope: The patent covers prodrugs of fumarates with specific chemical structures and therapeutic applications.
  • Claims: The claims are detailed and precise, defining the core aspects of the invention.
  • Related Patents: The patent is part of a broader portfolio of related patents protecting fumarate prodrugs.
  • Patent Term Extension: The patent is eligible for a limited extension due to regulatory review periods.
  • Market Impact: The patent provides significant market protection, maintaining Alkermes Pharma Ireland Limited's market dominance.
  • Innovation: The patent protects intellectual property, encouraging further research and innovation.

FAQs

What is the primary therapeutic use of the prodrugs covered by U.S. Patent 10,080,733?

The primary therapeutic use is in the treatment of autoimmune and inflammatory diseases, such as multiple sclerosis and psoriasis.

Who is the assignee of U.S. Patent 10,080,733?

The assignee is Alkermes Pharma Ireland Limited.

What is the expiration date of U.S. Patent 10,080,733?

The patent is set to expire on September 20, 2033.

Is there a generic version of VUMERITY® available in the United States?

No, there is currently no therapeutically equivalent version of VUMERITY® available in the United States.

How does the patent term extension affect U.S. Patent 10,080,733?

The patent term extension is limited to 39 days due to the 14-year limit imposed by 35 U.S.C. § 156(c)(3).

Sources

  1. US10080733B2 - Prodrugs of fumarates and their use in treating various diseases - Google Patents
  2. NOTICE OF FINAL DETERMINATION AND REQUIREMENT FOR ELECTION - U.S. Patent and Trademark Office
  3. Patent Claims and Patent Scope - Hoover Institution
  4. Our Patent Portfolio - Biogen Investor Relations
  5. Generic Vumerity Availability - Drugs.com

More… ↓

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Drugs Protected by US Patent 10,080,733

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Biogen Inc VUMERITY diroximel fumarate CAPSULE, DELAYED RELEASE;ORAL 211855-001 Oct 29, 2019 RX Yes Yes ⤷  Try for Free ⤷  Try for Free Y Y METHOD OF TREATING MULTIPLE SCLEROSIS ⤷  Try for 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 10,080,733

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 2970101 ⤷  Try for Free 301165 Netherlands ⤷  Try for Free
European Patent Office 2970101 ⤷  Try for Free PA2022003 Lithuania ⤷  Try for Free
European Patent Office 2970101 ⤷  Try for Free 2022C/507 Belgium ⤷  Try for Free
European Patent Office 2970101 ⤷  Try for Free LUC00251 Luxembourg ⤷  Try for Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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