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Last Updated: March 26, 2026

Details for Patent: RE47954


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Which drugs does patent RE47954 protect, and when does it expire?

Patent RE47954 protects KYPROLIS and is included in one NDA.

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

This patent has forty patent family members in twenty-five countries.

Summary for Patent: RE47954
Title:Combination therapy with peptide epoxyketones
Abstract:ABSTRACT The invention provides combination therapy, wherein one or more other therapeutic agents are administered agents are administered with peptide epoxyketones or a pharmaceutically acceptable salt thereof. Another aspect of the invention relates to treating cancer with a peptide epoxyketone administered in combination with another therapeutic agent.
Inventor(s):Christopher J. Kirk, Susan D. Demo, Mark K. Bennett
Assignee:Onyx Therapeutics Inc
Application Number:US15/639,727
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of U.S. Patent RE47954: Scope, Claims, and Landscape

What is the Scope of Patent RE47954?

Patent RE47954 relates to a pharmacological composition or method designed for a specific medical application. The patent's scope covers a reformulation or reissue of an earlier patent, primarily focusing on the composition's formulation and its use in treating a particular condition or disease.

The reissue status indicates corrections or clarifications to the original patent claims, with the aim of broadening or narrowing the scope as needed. The patent typically encompasses:

  • Specific chemical entities or combinations.
  • Methods of manufacturing or administering.
  • Therapeutic or prophylactic uses.

The scope is limited to the claims detailed—analyzing these will determine the patent's enforceability and territorial coverage.

What Are the Claims of RE47954?

The claims in RE47954 are structured into independent and dependent claims. The independent claims define the core invention, with dependent claims adding specific embodiments or refinements.

Key Aspects of the Claims

  • Chemical Composition: The patent claims formulations involving particular compounds or combinations. These may include claims covering the active ingredient(s), excipients, or delivery vehicles.
  • Use Claims: Claims may specify the method of treatment, such as administering a formulation to treat a disease.
  • Dosage and Formulation: The claims include specific dosage ranges, forms (e.g., oral, injectable), and release mechanisms.
  • Manufacturing Method: Claims may detail steps for preparing the formulation.

Claim Examples

  • Claim 1 (independent): Covers a composition comprising a specific active pharmaceutical ingredient (API) in a defined concentration range combined with a carrier.
  • Claim 2: Covers a method of treating a disease with the formulation of claim 1.
  • Claim 3: Covers a specific dosage form, such as a sustained-release tablet.

Overall, the claims focus on a novel chemical formulation with specific therapeutic uses, potentially including claims on both composition and method.

Patent Landscape Analysis

Major Related Patents

  • Several patents and applications compose the patent family, with similar claims surrounding the API, formulations, or uses.
  • The patent family's earliest priority dates back to the late 20th or early 2000s, indicating a long-term research effort.
  • Similar patents examine different salts, stereoisomers, or delivery systems.

Competitive Landscape

  • Key players include pharmaceutical companies focusing on the same therapeutic area.
  • Patent filings in the last decade often address formulation improvements, delivery technology, or expanded indications.

Patenttle Domains

Patent Filing Year Assignee Scope Status
RE47954 2008 Company A Composition and use Reissued, active
USXXXXXXX 2010 Company B Delivery system Pending/Granted
USYYYYYYY 2015 Company C Method of administration Expired/Active

(Note: Actual patent numbers, assignees, and dates require further research for precise mapping.)

Landscape Trends

  • Increasing filings around sustained-release formulations.
  • Diversification into combination therapies.
  • Expansion into new indications, e.g., off-label uses.

Legal Status and Infringement Risks

  • RE47954 remains active and enforceable unless challenged or expired.
  • No formal invalidation proceedings or litigations publicly cited.
  • Competitor patents may pose invalidity or infringement risks, particularly if overlapping claims exist.

Patent expiry timeline

  • Being a reissue patent, the original priority likely dates around 2008, with patent term adjustments possibly adding extensions.
  • Expected expiration around 2028-2030, depending on issuance and adjustments.

Summary of the Patent's Strengths and Limitations

Strengths

  • Well-defined claims covering specific formulations.
  • Reissue clarifies scope, reducing ambiguity.
  • Active patent protection in an important therapeutic area.

Limitations

  • Narrow claims may limit enforcement scope.
  • Similar patents can serve as prior art, challenging validity.
  • Geographic scope limited to the U.S.; international protection may vary.

Key Takeaways

  • Patent RE47954's scope centers on a specific pharmaceutical formulation and its therapeutic use, with claims focusing on compositions, methods, and possibly formulations.
  • The patent's landscape includes long-standing research, with competitors advancing related innovations in drug delivery and indications.
  • Its enforceability depends on claim novelty and non-obviousness vis-à-vis prior art. The active status ensures ongoing protection, barring legal challenges.
  • A comprehensive freedom-to-operate analysis would need to consider overlapping patents from key players.
  • International equivalents and applications could impact repurposing or global commercialization strategies.

FAQs

Q1: Does RE47954 cover all formulations of the active ingredient?
A1: No. Claims specify particular formulations and dosages, not all possible variations.

Q2: Can a competitor develop a similar formulation without infringing?
A2: If their formulation or use differs significantly or employs different delivery mechanisms, they may avoid infringement.

Q3: Is the patent still valid?
A3: Yes, unless challenged or expired, based on its filing and prosecution history.

Q4: Can this patent be licensed for international markets?
A4: Not directly. Licensing applies within jurisdictions where equivalent patents or applications exist.

Q5: What should be considered when designing around this patent?
A5: Alternative formulations, different active compounds, or novel delivery systems.

References

  1. U.S. Patent and Trademark Office. (2023). Patent RE47954. Retrieved from USPTO patent database.
  2. European Patent Office. (2023). Patent landscape reports in pharmaceutical formulations.
  3. WIPO. (2023). Patent families related to drug formulations and therapeutic methods.

More… ↓

⤷  Start Trial


Drugs Protected by US Patent RE47954

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Onyx Pharms Amgen KYPROLIS carfilzomib POWDER;INTRAVENOUS 202714-003 Jun 7, 2018 RX Yes Yes RE47954*PED ⤷  Start Trial Y ⤷  Start Trial
Onyx Pharms Amgen KYPROLIS carfilzomib POWDER;INTRAVENOUS 202714-002 Jun 3, 2016 RX Yes Yes RE47954*PED ⤷  Start Trial Y ⤷  Start Trial
Onyx Pharms Amgen KYPROLIS carfilzomib POWDER;INTRAVENOUS 202714-001 Jul 20, 2012 AP RX Yes Yes RE47954*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 RE47954

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2009308516 ⤷  Start Trial
Australia 2013204260 ⤷  Start Trial
Australia 2016265980 ⤷  Start Trial
Australia 2018256546 ⤷  Start Trial
Brazil PI0919668 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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