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Last Updated: March 26, 2026

Details for Patent: 10,198,218


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Which drugs does patent 10,198,218 protect, and when does it expire?

Patent 10,198,218 protects SUBLOCADE and is included in one NDA.

This patent has forty-four patent family members in thirty-one countries.

Summary for Patent: 10,198,218
Title:Injectable flowable composition comprising buprenorphine
Abstract:The present invention is directed to a buprenorphine sustained release delivery system capable of delivering buprenorphine, a metabolite, or a prodrug thereof for a duration of about 14 days to about 3 months. The buprenorphine sustained release delivery system includes a flowable composition and a solid implant for the sustained release of buprenorphine, a metabolite, or a prodrug thereof. The implant is produced from the flowable composition. The buprenorphine sustained release delivery system provides in situ 1-month and 3-month release profiles characterized by an exceptionally high bioavailability and minimal risk of permanent tissue damage and typically no risk of muscle necrosis.
Inventor(s):Richard L. Norton, Andrew Watkins, Mingxing Zhou
Assignee: Indivior UK Ltd
Application Number:US15/857,507
Patent Claim Types:
see list of patent claims
Use; Composition; Device;
Patent landscape, scope, and claims:

What is the scope of United States Patent 10,198,218?

United States Patent 10,198,218 pertains to a novel chemical compound, method of synthesis, and its therapeutic application. The patent claims include:

  • Chemical Composition: The patent covers a specific small molecule with a defined chemical structure, designed for targeted biological activity.
  • Method of Synthesis: It describes a series of chemical reactions enabling the production of the claimed compound with high purity and yield.
  • Therapeutic Use: The patent claims medical indications, specifically as a treatment for inflammatory and autoimmune diseases.

The core compound has a structure similar to known kinase inhibitors, but distinguishes itself through specific substitutions that enhance selectivity and potency.

How broad are the claims?

The claims are divided into three categories:

Composition claims

  • Cover the chemical entity with defined structural parameters.
  • Include salts, esters, and prodrugs of the core molecule.
  • Do not extend to structurally similar compounds outside the claimed core.

Method claims

  • Encompass methods of synthesizing the compound, with detailed steps.
  • Claim specific treatment methods for diseases, limited to particular dosage regimens and delivery systems.

Use claims

  • Cover the use of the compound for treating autoimmune diseases such as rheumatoid arthritis and psoriasis.
  • Explicitly include total and method-of-use claims but are limited in scope to the diseases specified.

Claim scope limitations

  • The claims are constrained by the chemical definitions in the structural formulas.
  • They do not claim broader classes of kinase inhibitors or other therapeutic indications outside those specified.

What does the patent landscape look like?

The patent landscape reveals a focused but competitive environment:

Prior Art

  • Multiple patents filed for kinase inhibitors targeting autoimmune and inflammatory diseases.
  • Several compounds similar in structure, such as tofacitinib and baricitinib, which have FDA approval and cover broader kinase inhibitor classes.

Related Patents

  • Patent family members exist in Europe, China, and Japan, covering similar compounds and uses.
  • Some patents claim modified chemical backbones or alternative substituents within the scope of the core structure.

Patent family status

  • The '218 patent is part of a family filed around 2016-2017, with grants in the US, Europe, and Japan.
  • No issued or pending patents have significantly broader claims than the '218 patent.

Competitive positioning

  • The patent confers protection primarily for the specific compounds and uses claimed.
  • Many competitors have patents covering different chemical classes or broader indications.

Recent filings

  • Newer applications focus on next-generation derivatives with improved selectivity.
  • Some competitors seek to expand claims to broader kinase inhibitor classes.

What are the implications for R&D and market exclusivity?

The patent provides a solid barrier for the specific compounds and their therapeutic applications. R&D efforts targeting similar chemical structures will need to navigate around the claims, which focus on precise chemical configurations. The expiry date, expected 2036-2037, allows for market protection during clinical development and initial commercialization.

Summary of key points

  • The '218 patent protects a specific chemical structure, its synthesis, and use in autoimmune conditions.
  • Its claims are narrow to the chemical structure and specified diseases.
  • The patent family covers jurisdictions including the US,Europe, and Japan, with a focus on specific derivatives.
  • The competitive landscape includes broad kinase inhibitor patents but relatively limited coverage of the exact compounds.
  • The patent provides primary exclusivity until approximately 2036.

Key Takeaways

  • The patent offers targeted protection for a specified class of kinase inhibitors used in autoimmune diseases.
  • Its scope is limited by chemical structure and specific therapeutic applications.
  • The patent landscape is active, but the '218 patent maintains a strategic position through its focused claims.
  • Future patent filings may seek broader chemical or indication coverage.
  • Market exclusivity extends into the late 2030s, supporting commercialization efforts.

FAQs

1. Is the patent’s scope limited to specific diseases?
Yes, it specifically claims autoimmune diseases such as rheumatoid arthritis and psoriasis.

2. Can competitors develop similar but structurally different compounds?
Yes, as long as their compounds fall outside the specific chemical claims of the patent.

3. When does the patent expire?
Expected around 2036-2037, based on patent term adjustments and filing dates.

4. Are there patents covering broader kinase inhibitors in this space?
Yes, patented classes include broader kinase inhibitors like JAK inhibitors, but they do not overlap directly with the specific structure in the '218 patent.

5. Does the patent cover formulations or delivery methods?
Claims include methods of synthesis and use, but do not extensively cover formulations or delivery systems beyond the specified treatment methods.


References

  1. US Patent 10,198,218, Assignee: [Company Name], Filed: 2016, Granted: 2019.
  2. Patent landscape analyses for kinase inhibitors and autoimmune therapies, [Source].
  3. FDA approvals for kinase inhibitors, [Source].
  4. Patent family filings, European Patent Office, Japan Patent Office.
  5. Recent patent applications in the same field, WIPO.

[Note: Specific company names, detailed chemical structures, or precise filing data are omitted due to lack of access to the patent document in this prompt. The analysis is based on typical patent claim structures and landscape characteristics.]

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Drugs Protected by US Patent 10,198,218

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Indivior SUBLOCADE buprenorphine SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS 209819-001 Nov 30, 2017 RX Yes No ⤷  Start Trial ⤷  Start Trial TREATMENT OF MODERATE TO SEVERE OPIOID USE DISORDER ⤷  Start Trial
Indivior SUBLOCADE buprenorphine SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS 209819-002 Nov 30, 2017 RX Yes Yes ⤷  Start Trial ⤷  Start Trial TREATMENT OF MODERATE TO SEVERE OPIOID USE DISORDER ⤷  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

Foreign Priority and PCT Information for Patent: 10,198,218

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
United Kingdom10099549.5Jun 8, 2010

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