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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 |
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Patent Claim Types: see list of patent claims | |
| Patent landscape, scope, and claims: | Analysis of United States Drug Patent 11,129,833Patent 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:
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:
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.
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.
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.
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:
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:
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:
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:
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:
What are the potential challenges and considerations?Despite the patent's strengths, several challenges exist:
The patent provides a strong foundation, but successful commercialization will depend on overcoming these scientific, clinical, and economic hurdles. Key TakeawaysPatent 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 QuestionsWhat 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] More… ↓ |
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 |
