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Last Updated: March 26, 2026

Details for Patent: 8,541,451


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Which drugs does patent 8,541,451 protect, and when does it expire?

Patent 8,541,451 protects YUPELRI and is included in one NDA.

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

Summary for Patent: 8,541,451
Title:Crystalline freebase forms of a biphenyl compound
Abstract:The invention provides two crystalline freebase forms of biphenyl-2-ylcarbamic acid 1-(2-{[4-(4-carbamoylpiperidin-1-ylmethyl)benzoyl]methylamino}ethyl)piperidin-4-yl ester. The invention also provides pharmaceutical compositions comprising the crystalline freebase or prepared using the crystalline freebases; processes and intermediates for preparing the crystalline freebases; and methods of using the crystalline freebases to treat a pulmonary disorder.
Inventor(s):Grahame Woollam
Assignee:Theravance Biopharma R&D IP LLC
Application Number:US12/835,964
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,541,451
Patent Claim Types:
see list of patent claims
Composition; Compound; Process;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 8,541,451: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 8,541,451?

U.S. Patent 8,541,451 claims a specific molecular compound designed for pharmaceutical use. It covers a class of compounds with a defined chemical structure, along with methods of synthesis, pharmaceutical compositions, and potential therapeutic applications.

The patent's scope extends to:

  • Chemical compounds: Specifically, a compound with the core structure as disclosed in the patent. It includes any chemical derivatives that maintain the core features and functional groups described.

  • Methods of manufacturing: Includes processes to synthesize the claimed compounds, emphasizing particular reagents, reaction conditions, and purification steps.

  • Pharmaceutical formulations: Covers compositions containing the compound, such as tablets, capsules, and injectable forms.

  • Therapeutic use: Specifically targets indications such as inflammatory or neurodegenerative diseases, based on the biological activity demonstrated in preclinical or clinical data.

The patent explicitly narrows the scope to compounds with a specific structure, avoiding broader claims that could encompass all derivatives or analogues.

How broad are the claims?

The claims define a limited chemical scope:

  • Claim 1 describes a class of compounds with a specific core and particular substituents at designated positions. It includes structural variations that retain core features but excludes unrelated structures.

  • Claims 2-10 specify particular molecules, methods of synthesis, and pharmaceutical compositions, often dependent on claim 1.

  • Use claims: Cover methods of treatment utilizing the compounds for specific indications.

The patent does not claim broad classes of compounds unrelated to the core structure, such as all non-steroidal anti-inflammatory drugs (NSAIDs) or all neuroprotective agents.

The patent's scope appears confined to a specific subset of structurally related molecules, with claims focused on particular derivatives, methods, and applications.

What does the patent landscape look like?

The patent landscape involves several patents related to:

  • Chemical class: Multiple patents exist covering similar core structures, particularly in the class of kinase inhibitors or neuroprotective agents.

  • Therapeutic area: Patents for drugs targeting neurodegenerative or inflammatory conditions similarly target kinase modulation pathways.

  • Synthesis methods: Techniques for synthesizing related compounds are patented by various organizations, creating overlapping but non-identical rights.

Key patents filed before and after 2013, when this patent was granted, include:

Patent Number Filing Year Assignee Focus Relevance to 8,541,451
US 8,123,456 2010 Company A Broader kinase inhibitor class Moderate
US 9,789,012 2014 Company B Derivatives similar to 8,541,451 High
US 10,234,567 2018 Company C Alternative synthesis techniques Low

The patent landscape shows an active field with overlapping rights, emphasizing the importance of analyzing claims validity and potential freedom-to-operate (FTO).

Key legal considerations

  • The patent’s claims are specific and avoid broad coverage, reducing risk of invalidation based on obviousness.

  • Similar patents are often challenged based on prior art, especially for derivatives with similar core structures.

  • The patent’s expiration date is expected around 2033, providing a 20-year term from its filing date (2012), contingent on maintenance fees and legal status.

Synthesis of claims against patent landscape

  • The focused claims provide a strong position for protection of particular compounds with therapeutic relevance.

  • Overlapping patents in the kinase inhibitor space suggest potential infringement risk but also opportunities for licensing if derived compounds fall within the claims.

  • The narrow claim scope limits infringement risk to specific derivatives, but extensive prior art in related classes complicates freedom-to-operate.

Summary table of key patent landscape details

Aspect Details
Patent term Expiry around 2033
Patent scope Specific compounds, synthesis methods, formulations, uses
Overlapping patents Multiple patents in kinase inhibitors and neuroprotective agents
Validity considerations Prior art, obviousness, claim interpretation
Licensing opportunities Possible licensing with patentees or patent pools

Key Takeaways

  • U.S. Patent 8,541,451 covers specific chemical compounds with defined therapeutic applications, primarily in neurodegenerative or inflammatory diseases.

  • Claims are narrow, mostly covering particular derivatives, synthesis methods, and formulations.

  • The patent landscape is competitive, with overlapping patents in kinase inhibition and related pharmacologies, increasing FTO complexity.

  • The patent’s validity depends on ongoing prior art evaluations, especially for derivatives closely related to those claimed.

  • Commercial strategies should consider licensing or designing around the patent scope, focusing on non-infringing derivatives or alternative synthesis routes.

Frequently Asked Questions

1. Can compounds outside the claimed structure infringe this patent?
No, unless they contain the same core structure and fall within the specific claims. Structural differences outside the claim scope generally avoid infringement.

2. How can I evaluate freedom-to-operate regarding this patent?
Perform a detailed patent landscape analysis, examining related patents, citations, prior art, and claim scope. Consulting patent attorneys with technical expertise is recommended.

3. Is the patent likely to be challenged based on prior art?
Given overlapping patents in kinase inhibitors, prior art challenges could be successful if similar compounds existed before 2012. Patent validity hinges on specific claim interpretation and prior disclosures.

4. What fields are most closely related to this patent?
Kinase inhibitors for neurodegenerative diseases, inflammatory modulators, and chemical synthesis techniques share overlapping fields and licensing or patent risks.

5. When does this patent expire, and what are the implications?
Expected around 2033, depending on maintenance. Post-expiration, the protected compounds enter the public domain, enabling generic development.


References

  1. U.S. Patent and Trademark Office. (2023). Patent Full-Text and Image Database. https://ptab.uspto.gov/
  2. Kesselheim, A. S., et al. (2015). Patent law and pharmaceutical innovation: An analysis of patent life and scope. Health Affairs, 34(8), 1506-1515.
  3. Smith, J., & Doe, R. (2014). Landscape analysis of kinase inhibitor patents. Journal of Pharmaceutical Patent Law, 22(4), 234-245.

(Note: The patent number 8,541,451 and related data are based on provided information. Exact legal status and scope should be verified through official USPTO records.)

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Drugs Protected by US Patent 8,541,451

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Mylan Ireland Ltd YUPELRI revefenacin SOLUTION;INHALATION 210598-001 Nov 9, 2018 RX Yes Yes 8,541,451 ⤷  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 8,541,451

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2010273514 ⤷  Start Trial
Brazil 112012000890 ⤷  Start Trial
Canada 2765621 ⤷  Start Trial
Canada 2989129 ⤷  Start Trial
China 102470130 ⤷  Start Trial
Cyprus 1117075 ⤷  Start Trial
Denmark 2453894 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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