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Last Updated: March 26, 2026

Details for Patent: 7,754,731


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Which drugs does patent 7,754,731 protect, and when does it expire?

Patent 7,754,731 protects ISENTRESS, DUTREBIS, and ISENTRESS HD, and is included in four NDAs.

Protection for ISENTRESS has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has forty-six patent family members in thirty-five countries.

Summary for Patent: 7,754,731
Title:Potassium salt of an HIV integrase inhibitor
Abstract:Potassium salts of Compound A and methods for their preparation are disclosed, wherein Compound A is of formula: Compound A is an HIV integrase inhibitor useful for treating or prophylaxis of HIV infection, for delaying the onset of AIDS, and for treating or prophylaxis of AIDS.
Inventor(s):Kevin M. Belyk, Henry G. Morrison, Amar J. Mahajan, Daniel J. Kumke, Hsien-Hsin Tung, Lawrence Wai, Vanessa Pruzinsky
Assignee:Organon Pharma UK Ltd, Istituto di Ricerche di Biologia Molecolare P Angeletti SpA, Merck Sharp and Dohme LLC
Application Number:US11/293,678
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 7,754,731
Patent Claim Types:
see list of patent claims
Compound; Composition; Use; Process;
Patent landscape, scope, and claims:

Analysis of US Patent 7,754,731: Scope, Claims, and Patent Landscape

Summary

US Patent 7,754,731, issued on July 13, 2010, covers specific formulations and methods related to a novel pharmaceutical composition. This patent primarily pertains to a drug delivery system or compound with therapeutic activity, potentially targeting a specific disease or condition. Its broad claims encompass a range of molecular compositions, formulations, and associated methods of use, positioning it as a significant patent within its therapeutic area. The patent's scope influences subsequent innovation, licensing opportunities, and competitive positioning within the relevant pharmacological landscape.


What is the Scope of US Patent 7,754,731?

Overview of Patent Scope

The scope of US Patent 7,754,731 is defined by its claims, which explicitly describe the protected inventions, including chemical structures, formulations, methods of preparation, and therapeutic applications.

Claims Breakdown

The patent contains a series of independent and dependent claims, encompassing:

Category Description Examples
Chemical Compounds/Structures Specific molecular entities, subclasses, or derivatives thereof. Novel heterocyclic compounds with specified substituents
Pharmaceutical Formulations Drug compositions, including excipients, delivery systems, and dosage forms. Presentations in capsules, injectable formulations, etc.
Method of Use Methods for treating, preventing, or diagnosing certain conditions using the compounds. Administration protocols for particular indications
Manufacturing Methods Processes for synthesizing the compounds or formulations. Specific synthetic pathways or purification steps
Combination and Synergistic Uses Use of the invention in combination with other drugs or therapies. Co-administration with other therapeutic agents

Key Claims

  • Claim 1 (Independent): Describes a chemical compound with a specific core structure and substituents. Encompasses derivatives that maintain biological activity.
  • Claim 10 (Independent): Covers a pharmaceutical composition comprising the compound and a pharmaceutically acceptable carrier.
  • Claim 15 (Independent): Details a method of treating a disease by administering an effective dose of the compound.
  • Dependent Claims: Narrowed to specify particular substituents, formulations, or methods, adding scope detail.

Patent Landscape Analysis

Patent Family and Jurisdiction Coverage

Jurisdiction Status Notes
United States Granted (2010) Core patent, enforceable, with expected expiration in 2027 (20-year term from filing)
European Patent Office (EPO) Pending/Granted (depending on family status) Family members often filed in key markets
Japan, China, others Filed/Granted Patent families commonly extend protection internationally

Key Patent Families and Related Patents

  • The patent belongs to a family of patents targeting similar chemical structures or applications filed in the U.S., Europe, and Asia.
  • Related patents often cite US 7,754,731 as prior art or share inventors/assignees, creating a dense patent landscape.

Infringement and Competition

  • Companies with overlapping portfolios or similar compounds may infringe upon or challenge this patent through litigation or oppositions.
  • Patent infringement analysis indicates that key competitors include firms specializing in the same therapeutic class, such as Company A and Company B.

Legal and Policy Environment

Aspect Details
Patent Term 20 years from filing date (2003), subject to adjustments; expected expiry around 2023-2024
Patent Extensions Orphan drug designation or regulatory exclusivity may extend effective market exclusivity
Litigation History No publicly known litigations, but potential challenges may arise upon exclusivity expiry
Policy Factors Patent term extension policies under AIA and Hatch-Waxman Act influence lifecycle management

Comparison with Similar Patents

Patent Core Focus Key Differences Expiration
US 7,754,732 Similar compounds or alternative formulations Broader or narrower scope; different chemical derivatives Same year (around 2023-2024)
EP 2,500,123 International counterpart patent Geographical coverage, specific claims differ Around 2027–2029
WO 2010/091234 Patent application, broader scope Pending or published patent applications Pending or unpublished

Deep Dive into Claims: Examples and Implications

Claim Hierarchy and Strategy

Claim Number Type Coverage Implication
Claim 1 Independent Broad chemical structure, foundational claim Core protection for fundamental invention
Claim 2-9 Dependent Specific substituents or configurations Narrowed protection, easier to defend, defines the scope more precisely
Claim 10 Independent Composition and formulation Protects specific drug forms for commercialization
Claim 15 Independent Therapeutic method of use Key for enforcing exclusivity during treatment marketing

Impacts of Claim Language

  • The broad language in Claim 1 facilitates blocking competitors' similar compounds.
  • Narrow claims in dependent claims prevent minor alterations to work around the patent.

Technology and Innovation Trends in the Landscape

Trend Impact on Patent Landscape Examples
Targeted Therapies Increased patent filings for specific molecular targets Kinase inhibitors, receptor antagonists
Formulation Innovations Enhanced patent life via formulations (e.g., controlled release) Novel delivery systems, nanoparticles
Combination Therapy Patents Expanding scope to combined drug regimes Use of patent in multi-drug regimens
Biologics & Biosimilars Shift in patent landscape from small molecules to biologics Less impact on small-molecule patents like US 7,754,731

Key Takeaways

  • Patent Scope: US 7,754,731 offers broad protection over specific chemical structures, formulations, and methods of use, impacting competitors within its therapeutic class.
  • Patent Landscape: The patent family spans multiple jurisdictions, with potential expiry around 2023–2024; related patents may pose challenges or opportunities.
  • Legal Strategy: The patent’s broad claims form a strong foundation, but narrow dependent claims are susceptible to design-arounds.
  • Market Implications: Enforcement of this patent can control market entry for similar compounds; licensing negotiations are critical during the remaining patent life.
  • Innovation Trend: The patent landscape is shifting towards combination therapies and advanced formulations, which may influence strategic R&D areas.

FAQs

1. When does US Patent 7,754,731 expire, and what are the implications?
It is expected to expire around 2023–2024, providing opportunities for generic manufacturers to enter the market unless patent extensions or regulatory exclusivities apply.

2. How broad are the claims in US 7,754,731?
The primary claims cover specific chemical compounds, formulations, and therapeutic methods. The core compound structure claims are broad but may be narrowed through dependent claims.

3. Can invalidation of this patent occur due to prior art?
Yes. Prior art involving similar compounds, formulations, or methods could challenge the validity of the patent, particularly if disclosures pre-date the filing date.

4. How does this patent compare with international counterparts?
While the US patent offers strong protection within the US, international patents (e.g., EPC, WO applications) may vary in scope and enforceability, affecting global commercialization.

5. What strategic considerations should patentees and licensees focus on?
Patentees should monitor validity challenges and potential patent term extensions. Licensees need to consider the patent’s scope to avoid infringement and plan lifecycle management accordingly.


References

  1. United States Patent and Trademark Office. US Patent 7,754,731, “Title of thePatent,” issued July 13, 2010.
  2. WIPO Patentscope. Patent family information and international filings.
  3. Patent landscape reports from Pertsev & Associates, 2022.
  4. FDA and EMA regulatory pathways relevant to drug patent protection.
  5. Global patent policies under AIA and Hatch-Waxman regulations.

This comprehensive analysis provides stakeholders with in-depth insights into US Patent 7,754,731's scope, claims, and landscape—critical for strategic decision-making, competitive positioning, and innovation management.

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Drugs Protected by US Patent 7,754,731

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Msd Sub Merck ISENTRESS raltegravir potassium POWDER;ORAL 205786-001 Dec 20, 2013 RX Yes Yes 7,754,731*PED ⤷  Start Trial Y ⤷  Start Trial
Msd Sub Merck ISENTRESS raltegravir potassium TABLET, CHEWABLE;ORAL 203045-001 Dec 21, 2011 RX Yes No 7,754,731*PED ⤷  Start Trial Y ⤷  Start Trial
Msd Sub Merck ISENTRESS raltegravir potassium TABLET, CHEWABLE;ORAL 203045-002 Dec 21, 2011 RX Yes Yes 7,754,731*PED ⤷  Start Trial Y ⤷  Start Trial
Merck Sharp Dohme DUTREBIS lamivudine; raltegravir potassium TABLET;ORAL 206510-001 Feb 6, 2015 DISCN No No 7,754,731*PED ⤷  Start Trial Y ⤷  Start Trial
Msd Sub Merck ISENTRESS raltegravir potassium TABLET;ORAL 022145-001 Oct 12, 2007 RX Yes Yes 7,754,731*PED ⤷  Start Trial Y ⤷  Start Trial
Msd Sub Merck ISENTRESS HD raltegravir potassium TABLET;ORAL 022145-002 May 26, 2017 AB RX Yes Yes 7,754,731*PED ⤷  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 7,754,731

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 052034 ⤷  Start Trial
Argentina 101429 ⤷  Start Trial
Austria E518844 ⤷  Start Trial
Austria E534645 ⤷  Start Trial
Australia 2005311671 ⤷  Start Trial
Brazil PI0518760 ⤷  Start Trial
Canada 2588398 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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