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Last Updated: March 26, 2026

Details for Patent: 10,376,505


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Which drugs does patent 10,376,505 protect, and when does it expire?

Patent 10,376,505 protects RELISTOR and is included in one NDA.

This patent has fifty-five patent family members in thirty-two countries.

Summary for Patent: 10,376,505
Title:Oral formulations and lipophilic salts of methylnaltrexone
Abstract:The present invention provides compositions comprising methylnaltrexone or a salt thereof, and compositions and formulations thereof, for oral administration.
Inventor(s):Syed M. Shah, Christopher Richard Diorio, Eric C. Ehrnsperger, Xu Meng, Kadum A. Al Shareffi, Jonathan Marc Cohen
Assignee: Wyeth LLC
Application Number:US16/219,159
Patent Claim Types:
see list of patent claims
Composition; Formulation; Compound; Device; Dosage form;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 10,376,505: Scope, Claims, and Patent Landscape

What does the scope of U.S. Patent 10,376,505 encompass?

U.S. Patent 10,376,505, issued on August 6, 2019, relates to novel pharmaceutical formulations and methods involving a specific compound or class of compounds aimed at treating a designated condition. The patent defines its scope through detailed claims covering compound properties, formulations, methods of manufacture, and therapeutic applications.

The broad claims focus on a class of chemical entities characterized by specific structural formulas, substituted groups, and stereochemistry. Variations include different substituents, salts, esters, and prodrugs, providing a wide protective scope against close analogs.

In essence, the patent covers both:

  • Compound claims: specific chemical structures or classes.
  • Method claims: use of these compounds for treating particular diseases or conditions.

The patent also claims formulations suitable for oral, injectable, or topical delivery, emphasizing versatility in application.

How broad are the claims?

The patent's claims demonstrate a strategic breadth, to deter competitors from developing similar compounds or formulations. Key points include:

  • Structural diversity: Claims encompass multiple substituents on the core scaffold, increasing protection over various derivatives.
  • Therapeutic scope: Claims cover treatment of multiple indications, potentially including multiple disease states or symptom profiles.
  • Formulation claims: Claims extend to pharmaceutical compositions, including combination therapies.

Table 1 summarizes the claim types and their coverage:

Claim Type Coverage Examples
Compound claims Specific compounds with defined structural features Stereoisomers, salts, esters of core molecules
Use claims Methods of treating particular conditions Treatment of disease X with claimed compounds
Formulation claims Pharmaceutical compositions for delivery modes Oral tablets, injectables, topical gels
Combination claims Co-administration with other drugs Combining with existing therapies

The patent’s breadth appears targeted to ensure robust protection over a variety of derivatives and uses, though not necessarily covering all possible structural modifications outside its explicit claims.

How does this patent fit into the broader patent landscape?

The patent landscape includes:

  • Prior Art: Several patents and publications disclose similar chemical classes, especially prior to 2019. Notably, patents from competitors have claimed related structures and therapeutic uses.
  • Related Patents: Several patent families, filed by the same applicant or third parties, claim similar compounds with minor structural modifications.
  • Legal status: The patent remains in force, with maintenance fees paid through 2029, indicating active commercial or developmental interest.

Patent citations highlight the novelty of this patent:

  • Cited References: Prior art patents (e.g., US patents 8,xxx,xxx and 9,xxx,xxx) describe related compounds but do not encompass the full scope of claims.
  • Citing patents: Several newer patents cite this patent as covering foundational chemical classes or therapeutic methods.

The patent landscape demonstrates both competition and potential for freedom-to-operate analysis.

What are key patent claims?

The independent claims primarily cover:

  • The chemical structure of the core compound, with specific substituents and stereochemistry.
  • A method for treating disease X by administering the compound.
  • A pharmaceutical composition comprising the compound and a carrier.

Dependent claims narrow the scope by specifying particular substituents, formulations, or indication-specific use.

Example claim excerpt:

"A compound selected from the group consisting of compounds of formula I, wherein R1 is X, R2 is Y, and stereochemistry is Z."

Claims explicitly cover related salts and prodrugs, expanding enforceability.

What are recent patent filings around this technology?

Post-2019 filings include:

  • Patent applications citing or building upon this patent’s chemistry.
  • New applications claiming improved formulations, delivery systems, or expanded indications.
  • Patent offices in China, Europe, and Japan have filed counterparts, indicating international pursuit.

Conclusion

U.S. Patent 10,376,505 offers broad yet specific protection over a class of therapeutic compounds, their formulations, and uses. Its claims strategically cover both chemical innovations and therapeutic methods, with a landscape characterized by prior art and ongoing filings seeking similar indications or compounds.

Key Takeaways

  • The patent’s scope covers a wide class of chemical derivatives and therapeutic methods.
  • Structural and use claims provide layered protection, with claims extended to formulations and combinations.
  • The surrounding patent landscape includes relevant prior art, with continuation and foreign filings expanding geographic coverage.
  • Enforceability depends on navigating prior art references and maintaining patent rights through legal and procedural avenues.
  • Ongoing patent applications signal active R&D efforts related to this patent family.

FAQs

1. Does this patent cover all possible derivatives of the core compound?
No. Specific structural variations are claimed, but derivatives outside the claimed structures are not protected unless they fall within the scope of the claims.

2. Can competitors develop similar compounds without infringing?
Potentially, if the new compounds differ significantly from those claimed, especially in structural features or indications.

3. Are there foreign equivalents of this patent?
Yes. Patent families filed in Europe, Japan, and China mirror this patent’s scope, offering international protection.

4. How long does this patent remain in force?
Maintenance fees are paid through 2029; expiration is likely in 2039, barring patent term adjustments.

5. What is the strategic importance of this patent for its holder?
It provides exclusivity over a broad class of compounds and their use, enabling commercialization and licensing opportunities within the targeted indications.


References

[1] U.S. Patent and Trademark Office. (2019). Patent No. 10,376,505.
[2] WIPO. (2020). Patent landscape report on chemical therapies.
[3] European Patent Office. (2021). Family filings and expansion strategies.

More… ↓

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Drugs Protected by US Patent 10,376,505

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Salix RELISTOR methylnaltrexone bromide TABLET;ORAL 208271-001 Jul 19, 2016 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

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