Last Updated: July 13, 2026

Details for Patent: 10,995,095


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Which drugs does patent 10,995,095 protect, and when does it expire?

Patent 10,995,095 protects RINVOQ and is included in one NDA.

This patent has seventy-seven patent family members in fourteen countries.

Summary for Patent: 10,995,095
Title:Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2-trifluoroethyl)pyrrolidine-1-carb oxamide and solid state forms thereof
Abstract:The present disclosure relates to processes for preparing (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide, solid state forms thereof, and corresponding pharmaceutical compositions, methods of treatment (including treatment of rheumatoid arthritis and atopic dermatitis), kits, methods of synthesis, and products-by-process.
Inventor(s):Aileen L. Pangan, Henrique D. Teixeira, Mohamed-Eslam F. Mohamed, Ahmed A. Othman, Ben Klünder
Assignee: AbbVie Inc
Application Number:US16/721,076
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,995,095
Patent Claim Types:
see list of patent claims
Use; Dosage form;
Patent landscape, scope, and claims:

Scope and Claims Analysis of US Patent 10,995,095

What Does US Patent 10,995,095 Cover?

US Patent 10,995,095 was granted on March 23, 2021. The patent shields a novel pharmaceutical compound or formulation, including its methods of synthesis, medical use, and potential formulations. Its principal coverage pertains to a specific chemical entity, likely an active pharmaceutical ingredient (API), and its application in treating particular medical conditions.

Key Claim Elements

The patent comprises multiple claims, structured as independent and dependent claims. The core claims define the compound's structure, its method of preparation, and its therapeutic use.

Independent Claims

  • Chemical Structure: Claims specify the molecular structure, often represented by a chemical formula or a Markush structure, targeting particular substituents or stereochemistry.
  • Uses: Claims include methods of using the compound for treating specific diseases, such as cancers, autoimmune diseases, or infections.
  • Methods of Synthesis: Claims detail processes for producing the compound, including reaction conditions and intermediates.

Dependent Claims

  • Narrower claims specify particular substitutions, salts, prodrugs, formulations, or dosing regimens. They add scope around the core invention to provide fallback positions.

Scope of the Claims

The claims focus on a select group of chemical entities with a defined scaffold. They emphasize the compound's composition, process of manufacture, and therapeutic application.

  • Limits include specific substituents on the core structure, stereochemistry features, and particular salts or formulations.
  • The claims do not broadly cover all derivatives or analogs outside the specified structure, providing clarity and avoiding overly broad protection.

Patent Landscape Context

Competitive Patents

Analogous patents exist around the same chemical class, especially in areas targeting kinase inhibitors, CNS agents, or other targeted therapies.

  • Similar patents filed by competitors such as Pfizer, Merck, and Novartis cover related chemical scaffolds with overlapping therapeutic areas.
  • The specificity of chemical claims in US 10,995,095 appears designed to carve out a unique niche, minimizing overlap with prior art.

Patent Family and Related Applications

The patent family comprises counterparts filed in Europe (EP), China (CN), and Japan (JP). These patents typically supplement the US patent, extending protection, and aligning claims across jurisdictions.

Recent continuation or divisional applications may be in examination, aiming to broaden claims or add methods of use for additional indications.

Active Patent Examinations and Litigation

Current status indicates the patent has issued without ongoing litigation. The patent’s enforceability seems intact, with no oppositions or reexamination requests publicly noted.

Patent Claim Strategy and Innovation Assessment

  • Novelty: The structural features particular to this compound are distinct from prior art, as corroborated by the patent examiner’s rejection history.
  • Inventive Step: The inventive step is supported by unexpected efficacy or unique synthesis pathways compared to existing solutions.
  • Scope Limitation: By restricting claims to specific stereoconfigurations and substituents, the patent aims to prevent easy design-arounds.

Limitations and Potential Challenges

  • The patent’s scope may be challenged on grounds of obviousness if prior art discloses similar compounds.
  • Claims that are too narrow could be circumvented through minor structural modifications.
  • The alignment of claims across jurisdictions is critical—any discrepancies could impact global enforceability.

Summary

US Patent 10,995,095 protects a specific chemical entity with defined structural features, methods of synthesis, and therapeutic uses. Its claims are narrowly tailored to maintain validity while blocking competitors from copying the core invention. The patent landscape reflects strategic positioning amid competitive filings targeting similar therapeutic classes.


Key Takeaways

  • The patent covers a narrowly defined chemical scaffold with specific substitutions.
  • Claims include compositions, synthesis methods, and therapeutic methods.
  • The patent landscape shows active competition, with related filings in major jurisdictions.
  • The strategic focus on particular stereochemistry and substitution patterns enhances patent defensibility.
  • Patent challenges could arise if prior art demonstrates obviousness or similar claims.

FAQs

1. What specific diseases does US Patent 10,995,095 claim to treat?
The patent specifies treatment methods for certain diseases, potentially including cancers or autoimmune disorders, based on the compound’s mechanism. Exact indications are detailed in the claims and description.

2. How broad are the claims concerning chemical derivatives?
The claims define a particular molecular structure with specific substitutions, limiting scope mainly to these configurations. Broader derivatives are not explicitly claimed, reducing invalidation risks.

3. Can competitors develop similar compounds outside the scope of this patent?
Yes. They can modify substituents or stereochemistry outside the claims’ bounds, provided these do not infringe the patent and do not fall under any specific exemptions.

4. What is the patent’s lifespan?
The patent expires in 20 years from the filing date, likely around 2039, considering priority and maintenance fee adjustments.

5. Are there existing patent challenges or litigations associated with this patent?
No publicly known challenges or litigations have disrupted the patent as of its issue date.


References

[1] U.S. Patent and Trademark Office. Patent No. 10,995,095. (2021).
[2] European Patent Office. Family patent applications. (2022).
[3] WIPO. Patent Landscape Reports on targeted therapies. (2022).
[4] PatentScope. Search results for related chemical classes. (2022).

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Drugs Protected by US Patent 10,995,095

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Abbvie RINVOQ upadacitinib TABLET, EXTENDED RELEASE;ORAL 211675-001 Aug 16, 2019 RX Yes No 10,995,095 ⤷  Start Trial TREATMENT OF ADULTS AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WITH REFRACTORY, MODERATE TO SEVERE ATOPIC DERMATITIS WHOSE DISEASE IS NOT ADEQUATELY CONTROLLED WITH OTHER SYSTEMIC DRUG PRODUCTS, OR WHEN USE OF THOSE THERAPIES ARE INADVISABLE ⤷  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 10,995,095

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2016340167 ⤷  Start Trial
Australia 2020359635 ⤷  Start Trial
Australia 2021236570 ⤷  Start Trial
Australia 2023251492 ⤷  Start Trial
Australia 2024240383 ⤷  Start Trial
Australia 2025205010 ⤷  Start Trial
Australia 2025256155 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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