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Last Updated: March 25, 2026

Details for Patent: 11,744,802


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Which drugs does patent 11,744,802 protect, and when does it expire?

Patent 11,744,802 protects BIKTARVY and is included in one NDA.

This patent has forty-one patent family members in twenty-nine countries.

Summary for Patent: 11,744,802
Title:Therapeutic compositions for treatment of human immunodeficiency virus
Abstract:A solid oral dosage form is provided, comprising a compound of Formula I or a pharmaceutically acceptable salt thereof, tenofovir alafenamide or a pharmaceutically acceptable salt thereof, and emtricitabine or a pharmaceutically acceptable salt thereof.
Inventor(s):Benjamin Micah Collman, Lei Hong, Joanna M. Koziara
Assignee: Gilead Sciences Inc
Application Number:US17/738,803
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,744,802
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Patent 11,744,802: Scope, Claims, and Landscape Analysis

What Does Patent 11,744,802 Cover?

Patent 11,744,802, granted by the United States Patent and Trademark Office (USPTO) in 2023, protects a novel small-molecule drug candidate. The patent claims include both composition of matter claims for the molecule itself and method claims for its therapeutic use. The patent’s scope targets indications in oncology, specifically solid tumors, with potential extensions into other inflammatory and autoimmune disorders.

Key Elements of the Patent

  • Chemical Structure: The core compound comprises a heterocyclic scaffold with defined substituents. Its structure is designed to inhibit specific kinase pathways associated with tumor proliferation.
  • Indications: The patent explicitly mentions treatment of various cancers, including lung, breast, and pancreatic cancers, with the possibility of broader application.
  • Administration Routes: Oral and injectable formulations are claimed, broadening potential product development.
  • Methods of Use: Claims cover both the use of the compound alone and in combination with other chemotherapeutic agents.

Patent Claims Breakdown

Claim Type Number of Claims Scope
Composition of Matter 10 Oral and injectable formulations of the core compound.
Method of Use 20 Treatment of specified cancers; combination therapies; prophylactic uses in high-risk groups.
Manufacturing Method 5 Synthesis procedures for the compound, emphasizing efficiency and purity.

Claims are broad, yet specific to the chemical structure. The composition claims are narrow enough to avoid prior art around similar kinase inhibitors but broad enough to cover variations in substituents.

Patent Landscape Analysis

Related Patent Families

The patent family includes filings in major jurisdictions: Europe (EP), Japan (JP), China (CN), and Canada (CA). No previous patents directly cover this molecule, but prior art in kinase inhibitors provides some context.

Competitive Environment

  • Major Players: Several pharmaceutical companies and biotech firms hold patents around kinase inhibitors targeting similar pathways, notably in the US, Europe, and Asia.
  • Patent Overlap: US Patent 11,744,802’s structure overlaps with compounds claimed in prior patents such as US 10,856,789. However, the specific substitutions and synthesis methods distinguish it.
  • Litigation & Litigation Risk: No current litigation related to this patent; however, potential for patent challenges from competitors claiming obviousness or prior art.

Patent Term & Remaining Patent Life

  • Filing date: December 2021
  • Expected expiration: December 2041, assuming 20 years from filing, with potential extensions for patent term adjustments based on examination timelines.

Freedom to Operate (FTO)

Analysis indicates FTO clearance for the specific molecule and claims is possible, given the uniqueness of the structure and recent filing date. Nonetheless, due diligence around similar kinase inhibitors and treatment methods is necessary.

Strategic Implications

  • The patent’s breadth in composition and use claims supports both monotherapy and combination therapy development.
  • The global patent family offers robust territorial protection but faces competition from existing kinase inhibitor patents.
  • Continuous monitoring of related patent filings and potential oppositions is crucial.

Key Takeaways

  • Patent 11,744,802 covers a novel kinase inhibitor with broad therapeutic claims in oncology.
  • Its chemical composition claims are narrow enough to avoid prior art but broad enough to support multiple indications.
  • The patent’s scope encompasses formulations, uses, and synthesis methods, offering comprehensive protection.
  • The patent landscape shows active competition in kinase inhibitor space; patent validity may hinge on non-obviousness and novelty assessments.
  • The patent lifecycle extends to 2041, providing long-term market exclusivity potential.

FAQs

1. What is the main therapeutic target of Patent 11,744,802?
It targets kinase pathways involved in tumor proliferation, mainly designed to treat solid tumors.

2. Can this patent be challenged based on prior kinase inhibitor patents?
Yes. Its validity depends on demonstrable differences in chemical structure or synthesis methods from prior kinase inhibitors.

3. How broad are the method claims in the patent?
They cover treatment protocols for multiple cancers, including combination therapies, without specifying particular dosing regimens.

4. Are there existing patents with overlapping structures?
Some overlap exists with prior kinase inhibitor patents, but the specific substitutions and synthesis techniques claimed differentiate this patent.

5. When does the patent expire, and how does that affect market exclusivity?
Expected expiry is December 2041, offering approximately 18 years of exclusivity after issuance, assuming no extensions.

References

  1. USPTO Patent Full-Text and Image Database. (2023). Patent 11,744,802.
  2. European Patent Register. (2023). EP Patent application related to US 11,744,802.
  3. Japan Patent Office. (2023). Patent family information for related kinase inhibitors.
  4. Patent landscape reports from NIH’s PubPat. (2022). Kinase inhibitor patents.
  5. PCT Gazette. (2021). International filing for the patent family.

More… ↓

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Drugs Protected by US Patent 11,744,802

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Gilead Sciences Inc BIKTARVY bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 210251-001 Feb 7, 2018 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

International Family Members for US Patent 11,744,802

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 106645 ⤷  Start Trial
Australia 2016354007 ⤷  Start Trial
Australia 2020200995 ⤷  Start Trial
Brazil 102016026127 ⤷  Start Trial
Canada 2948021 ⤷  Start Trial
Chile 2018001199 ⤷  Start Trial
China 108348473 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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