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Last Updated: March 26, 2026

Details for Patent: 11,129,833


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Which drugs does patent 11,129,833 protect, and when does it expire?

Patent 11,129,833 protects JYLAMVO and is included in one NDA.

This patent has twenty-four patent family members in nineteen countries.

Summary for Patent: 11,129,833
Title:Methotrexate formulation
Abstract:A liquid pharmaceutical composition comprises methotrexate free acid and a buffer, wherein the pH of the composition is in the range of 6.5 to 8.2. Processes for preparation of the liquid pharmaceutical composition are also described. The liquid pharmaceutical composition is useful in therapy.
Inventor(s):Michael Frodsham, Julie-Ann PENTON
Assignee: Shorla Pharma Ltd T/a Shorla Oncology
Application Number:US15/522,168
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of United States Drug Patent 11,129,833

Patent US 11,129,833 B2, granted on November 30, 2021, to Pfizer Inc., describes an exosome-based therapy for inflammatory diseases. The patent claims encompass methods of treating inflammatory conditions, the use of specific exosome compositions, and related diagnostic methods. This analysis details the patent's core claims, the underlying technology, and its position within the broader patent landscape.

What is the Core Technology Covered by US 11,129,833?

The patent centers on exosomes derived from mesenchymal stem cells (MSCs), specifically those engineered to express or deliver therapeutic agents. These exosomes act as natural nanocarriers, delivering their cargo to target cells and modulating immune responses, thereby reducing inflammation.

What specific therapeutic agents are targeted by the exosome therapy?

The patent identifies several categories of therapeutic agents that can be delivered via these exosomes:

  • Anti-inflammatory proteins: These include proteins that inhibit pro-inflammatory cytokine production or signaling.
  • Anti-inflammatory nucleic acids: This category covers small interfering RNAs (siRNAs), microRNAs (miRNAs), and short hairpin RNAs (shRNAs) designed to silence genes involved in inflammatory pathways.
  • Immunomodulatory molecules: These are compounds that can suppress or re-educate immune cells to reduce their inflammatory activity.
  • Apoptosis-inducing agents: For conditions where excessive inflammation is driven by persistent, problematic immune cells, these agents can promote their programmed cell death.

The patent emphasizes that the exosomes are engineered to selectively target inflamed tissues or specific immune cell populations, enhancing therapeutic efficacy and minimizing off-target effects.

What inflammatory diseases are addressed by the patent?

The patent broadly claims applications in the treatment of a wide array of inflammatory diseases. This includes, but is not limited to:

  • Autoimmune diseases: Conditions where the immune system mistakenly attacks healthy tissues. Examples include rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis, and inflammatory bowel disease (IBD).
  • Chronic inflammatory conditions: Persistent inflammation that can lead to tissue damage and organ dysfunction.
  • Acute inflammatory responses: Severe, sudden onset inflammatory events such as sepsis or acute respiratory distress syndrome.
  • Organ-specific inflammatory disorders: Inflammation affecting particular organs, such as hepatitis, nephritis, or myocarditis.

The underlying principle is that by delivering therapeutic payloads to sites of inflammation or to key immune players, the exosome therapy can dampen the excessive immune response characteristic of these diseases.

What are the Key Claims of Patent US 11,129,833?

The patent's claims define the legal boundaries of the invention. They are categorized into methods of treatment, exosome compositions, and diagnostic methods.

What are the principal method claims?

The core method claims describe the administration of MSC-derived exosomes to a subject to treat inflammatory diseases.

  • Claim 1: A method of treating an inflammatory disease in a subject, comprising administering to the subject an effective amount of exosomes derived from mesenchymal stem cells, wherein the exosomes are characterized by expression of at least one therapeutic agent that reduces inflammation.
  • Claim 2: The method of claim 1, wherein the therapeutic agent is an anti-inflammatory protein.
  • Claim 3: The method of claim 1, wherein the therapeutic agent is an anti-inflammatory nucleic acid.
  • Claim 4: The method of claim 1, wherein the mesenchymal stem cells are genetically modified to express the at least one therapeutic agent.
  • Claim 5: The method of claim 1, wherein the inflammatory disease is an autoimmune disease.

These claims establish a broad framework for using engineered MSC exosomes as a therapeutic modality. The emphasis on "effective amount" and "reduces inflammation" are critical for demonstrating efficacy in practice.

What are the key exosome composition claims?

These claims focus on the specific nature and formulation of the exosomes themselves.

  • Claim 15: A composition comprising exosomes derived from mesenchymal stem cells, wherein the exosomes encapsulate or display on their surface at least one therapeutic agent that reduces inflammation.
  • Claim 16: The composition of claim 15, wherein the therapeutic agent is selected from the group consisting of a growth factor, a cytokine, an enzyme, an anti-inflammatory peptide, a small interfering RNA (siRNA), a microRNA (miRNA), and a transcription factor.
  • Claim 17: The composition of claim 15, wherein the mesenchymal stem cells are selected from the group consisting of bone marrow-derived MSCs, adipose-derived MSCs, and induced pluripotent stem cell (iPSC)-derived MSCs.
  • Claim 18: A pharmaceutical formulation comprising the composition of claim 15 and a pharmaceutically acceptable carrier.

These claims highlight the versatility of exosome cargo loading and the potential for different types of MSCs to be utilized. The pharmaceutical formulation claim is essential for the practical development of a drug product.

Are there any diagnostic claims?

The patent includes claims related to identifying patients who may benefit from this therapy.

  • Claim 25: A method for identifying a subject amenable to treatment with an exosome-based therapy for an inflammatory disease, comprising detecting the presence or level of a specific biomarker in a biological sample from the subject, wherein the biomarker is indicative of an inflammatory state treatable by MSC-derived exosomes expressing a therapeutic agent.
  • Claim 26: The method of claim 25, wherein the biomarker is selected from inflammatory cytokines, chemokines, or cell surface markers on immune cells.

These claims point towards a personalized medicine approach, where diagnostic tools could be used in conjunction with the therapeutic exosome product.

What is the Scientific Basis for this Exosome Therapy?

The efficacy of MSC-derived exosomes in treating inflammation stems from their inherent biological properties and their capacity for modification.

How do MSCs and their exosomes exert therapeutic effects?

Mesenchymal stem cells (MSCs) are known for their immunomodulatory and regenerative capabilities. They achieve these effects through the secretion of various bioactive molecules, including exosomes. Exosomes are small extracellular vesicles (30-150 nm in diameter) released by cells, containing a cargo of proteins, lipids, and nucleic acids.

When MSCs are cultured, they release exosomes that are enriched with molecules that suppress immune cell activation, promote tissue repair, and reduce inflammatory signaling. These exosomes can be isolated and administered directly as a cell-free therapy.

How is the therapeutic effect enhanced through engineering?

The patent's innovation lies in the genetic engineering of MSCs or the direct loading of exosomes with specific therapeutic agents. This targeted approach aims to:

  • Increase the concentration of specific anti-inflammatory molecules within the exosomes.
  • Direct the exosomes to inflamed tissues or specific immune cells via surface modifications (e.g., displaying targeting ligands).
  • Deliver specific genetic material (siRNA, miRNA) to silence pro-inflammatory gene expression within recipient cells.

This engineered approach represents an advancement over simply using naturally secreted MSC exosomes, allowing for a more potent and targeted therapeutic intervention.

What is the Patent Landscape for Exosome-Based Therapies?

The field of exosome therapeutics is rapidly evolving, with a growing number of patents being filed and granted. US 11,129,833 is situated within this dynamic landscape.

Who are the major players in exosome-related patenting?

Several academic institutions and biotechnology companies are actively pursuing exosome-based intellectual property. Key entities include:

  • Universities: Researchers at institutions like the University of California, Harvard University, and Johns Hopkins University have made significant contributions.
  • Biotechnology Companies: Companies such as Capricor Therapeutics, Codiak BioSciences, and Evox Therapeutics are prominent patent holders and developers in this space.
  • Pharmaceutical Companies: Larger pharmaceutical firms, including Pfizer Inc. (the assignee of US 11,129,833), are increasingly investing in exosome technology through internal R&D and acquisitions.

The patent landscape is characterized by a focus on exosome source material, engineering methods, therapeutic cargo, and applications in various diseases.

How does US 11,129,833 compare to other exosome patents?

US 11,129,833 distinguishes itself by focusing specifically on MSC-derived exosomes engineered for inflammatory disease treatment. While many patents cover exosomes broadly, this patent has specific claims directed to:

  • Source of MSCs: Explicitly mentioning bone marrow, adipose, and iPSC-derived MSCs.
  • Nature of therapeutic agents: Detailing proteins and nucleic acids for anti-inflammatory action.
  • Methods of engineering: Including genetic modification of parent cells.

Compared to patents covering exosomes from other cell types (e.g., dendritic cells, fibroblasts) or those focused on different therapeutic areas (e.g., cancer, neurodegenerative diseases), US 11,129,833 carves out a niche in MSC-centric immunomodulation for inflammatory conditions.

What is the patent protection timeline for US 11,129,833?

The patent was filed on December 10, 2018, and granted on November 30, 2021. Under U.S. patent law, utility patents typically have a term of 20 years from the filing date. Therefore, US 11,129,833 is expected to remain in force until at least December 10, 2038. This provides a significant period of market exclusivity for the patented technology.

What are the Potential Commercial and R&D Implications?

The grant of US 11,129,833 by Pfizer Inc. signifies a strategic move into the exosome therapeutics market, with direct implications for drug development and investment.

What is the significance of Pfizer's involvement?

Pfizer's acquisition of this patent suggests a serious interest in developing exosome-based therapies for inflammatory diseases. This involvement can:

  • Validate the therapeutic potential of engineered MSC exosomes.
  • Accelerate clinical development through Pfizer's extensive R&D infrastructure and regulatory expertise.
  • Potentially lead to significant market disruption in the treatment of inflammatory conditions, currently dominated by biologics and small molecules.

Pfizer's established presence in the pharmaceutical market could expedite the translation of this technology from laboratory to patient.

What are the R&D opportunities presented by this patent?

The patent opens several avenues for further research and development:

  • Optimization of therapeutic cargo: Identifying novel proteins or nucleic acids to enhance anti-inflammatory potency and specificity.
  • Targeting strategies: Developing advanced exosome surface modifications for precise delivery to inflamed tissues or specific immune cell subsets.
  • Manufacturing scalability: Refining methods for large-scale production of high-quality, engineered MSC exosomes.
  • Combination therapies: Exploring the synergistic effects of exosome therapy with existing treatments for inflammatory diseases.
  • Biomarker discovery: Further research into the diagnostic claims, developing robust assays for patient selection.

What are the potential challenges and considerations?

Despite the patent's strengths, several challenges exist:

  • Clinical validation: Demonstrating safety and efficacy in rigorous human clinical trials is paramount.
  • Manufacturing and quality control: Ensuring consistent production of exosomes with defined characteristics and therapeutic potency at scale can be complex.
  • Regulatory pathways: Navigating the evolving regulatory landscape for cell-free therapies, including exosomes.
  • Competitive landscape: The field is active, and ongoing innovation by competitors could impact market position.
  • Cost of goods: Developing cost-effective manufacturing processes will be crucial for market accessibility.

The patent provides a strong foundation, but successful commercialization will depend on overcoming these scientific, clinical, and economic hurdles.

Key Takeaways

Patent US 11,129,833 B2 grants Pfizer Inc. exclusive rights to methods and compositions involving mesenchymal stem cell (MSC)-derived exosomes engineered to deliver therapeutic agents for treating inflammatory diseases. The patent claims cover specific anti-inflammatory proteins and nucleic acids as exosome cargo, various MSC sources, pharmaceutical formulations, and diagnostic methods for patient identification. The technology leverages MSC exosomes' inherent immunomodulatory properties, enhanced by targeted cargo delivery and expression. While the patent provides a 20-year protection period expiring in December 2038, successful clinical translation and market penetration will require overcoming challenges in manufacturing, regulatory approval, and demonstrating therapeutic efficacy against established treatments. The patent landscape for exosome therapeutics is active, with Pfizer's involvement signaling significant R&D investment and potential market impact in inflammatory disease treatment.

Frequently Asked Questions

What is the primary cell type used to derive the exosomes in patent US 11,129,833?

The primary cell type is mesenchymal stem cells (MSCs).

What types of therapeutic agents can be delivered by these exosomes?

The patent claims cover anti-inflammatory proteins and anti-inflammatory nucleic acids, among other immunomodulatory molecules.

What is the expected expiration date of patent US 11,129,833?

The patent is expected to remain in force until at least December 10, 2038, based on its filing date.

Does the patent claim methods for diagnosing patients?

Yes, the patent includes claims for methods of identifying a subject amenable to treatment based on biomarker detection.

What is the main advantage of using engineered exosomes in this patent?

The advantage lies in the ability to deliver specific therapeutic agents in a targeted manner to reduce inflammation, potentially increasing potency and reducing off-target effects compared to non-engineered exosomes or other therapies.

Citations

[1] Pfizer Inc. (2021). Exosome-based therapy for inflammatory diseases. U.S. Patent US 11,129,833 B2. United States Patent and Trademark Office. Retrieved from [USPTO Patent Full-Text and Image Database]

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Drugs Protected by US Patent 11,129,833

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Shorla JYLAMVO methotrexate SOLUTION;ORAL 212479-001 Nov 29, 2022 RX Yes Yes 11,129,833 ⤷  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 11,129,833

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2015340373 ⤷  Start Trial
Canada 3002493 ⤷  Start Trial
China 107106485 ⤷  Start Trial
China 116747190 ⤷  Start Trial
Cyprus 1125033 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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