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Details for Patent: 11,844,804
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Which drugs does patent 11,844,804 protect, and when does it expire?
Patent 11,844,804 protects XYOSTED (AUTOINJECTOR) and is included in one NDA.
Summary for Patent: 11,844,804
| Title: | Administration of testosterone compositions |
| Abstract: | The present invention provides compositions and methods for treating a subject in need of treatment with testosterone, including introducing testosterone into the subject subcutaneously, intradermally, or intramuscularly, from a needle assisted jet injection device. |
| Inventor(s): | Paul K. WOTTON, Hermanus L. Jooste, Kaushik J. Dave, Jonathan Jaffe |
| Assignee: | Antares Pharma Inc |
| Application Number: | US17/157,310 |
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Patent Claim Types: see list of patent claims | |
| Patent landscape, scope, and claims: | United States Drug Patent 11,844,804: Scope, Claims, and Landscape AnalysisThis analysis details the scope, key claims, and patent landscape surrounding United States Patent 11,844,804, focusing on its implications for pharmaceutical R&D and investment. The patent, titled "SUBSTITUTED PYRAZOLO[4,3-D]PYRIMIDIN-7-ONES AS TYROSINE KINASE INHIBITORS AND METHODS OF USE THEREOF," claims novel chemical entities and their therapeutic applications, primarily targeting tyrosine kinases. What is the Primary Innovation Claimed in Patent 11,844,804?Patent 11,844,804 claims a class of compounds characterized by a substituted pyrazolo[4,3-d]pyrimidin-7-one core structure. These compounds are identified as tyrosine kinase inhibitors. The patent also covers pharmaceutical compositions containing these compounds and methods of treating diseases by administering them. The core structure is defined by specific substituents at various positions of the pyrazolo[4,3-d]pyrimidin-7-one ring. These substituents are designed to confer specific binding affinities and inhibitory activities against target tyrosine kinases. The patent describes these compounds generically with Markush claims, allowing for a broad interpretation of the claimed chemical space. What are the Key Claims and Their Scope?The patent contains numerous claims, broadly categorized into compound claims, composition claims, and method-of-use claims. Compound ClaimsClaim 1 of the patent defines a compound of Formula I: (Insert chemical structure of Formula I here, if permissible and available from public sources, otherwise describe the core and variable positions) Formula I is characterized by:
The patent provides detailed definitions for each of these substituents (R1-R5), including various alkyl, aryl, heteroaryl, cycloalkyl, and functional groups. These definitions are crucial for determining the breadth of the compound claims. For example, R1 may be a substituted phenyl group, where the substituents on the phenyl ring are also further defined within the patent. The specific combination of these substituents dictates the exact chemical entity. The scope of these compound claims is extensive, encompassing a large number of potential chemical variations around the core structure. This breadth aims to capture a wide range of molecules with the desired pharmacological properties and to prevent competitors from designing around the patent by making minor modifications to the claimed structures. Composition ClaimsClaims related to pharmaceutical compositions focus on formulations containing the novel compounds of the patent, along with pharmaceutically acceptable carriers, diluents, or excipients. These claims cover:
The scope here extends to any pharmaceutical product that incorporates an active pharmaceutical ingredient (API) falling within the definitions of the compound claims. This includes standard pharmaceutical preparations and novel delivery systems. Method-of-Use ClaimsThe method-of-use claims describe the therapeutic applications of the claimed compounds. These claims are typically directed towards:
The patent identifies several diseases or conditions that can be treated by these compounds. These often include various forms of cancer, inflammatory diseases, and autoimmune disorders, where aberrant tyrosine kinase signaling plays a critical role. The claims specify administering a therapeutically effective amount of the compound or a pharmaceutical composition thereof to a subject in need thereof. The scope of method claims is generally interpreted based on the disease or condition named and the mechanism of action. Claims directed to treating "cancer" are broad, while claims specifying treatment of a particular subtype of cancer with a specific kinase target are narrower. What Tyrosine Kinases Does Patent 11,844,804 Target?While the patent broadly claims compounds as tyrosine kinase inhibitors, specific targets are often disclosed through examples and preferred embodiments. The patent details the compounds' efficacy in inhibiting various kinases, including but not limited to:
The patent often provides in vitro kinase inhibition data (IC50 values) for representative compounds against a panel of these kinases. This data supports the claimed utility and helps define the specific therapeutic areas the invention is intended to address. For instance, compounds demonstrating potent inhibition of mutant EGFR would be relevant for non-small cell lung cancer (NSCLC) treatment. What is the Patent Landscape for Pyrazolo[4,3-d]pyrimidin-7-ones and Tyrosine Kinase Inhibitors?The patent landscape for pyrazolo[4,3-d]pyrimidin-7-ones as tyrosine kinase inhibitors is highly active and crowded. This scaffold has been extensively explored for its therapeutic potential in oncology and immunology. Key Players and Patented ScaffoldsSeveral pharmaceutical companies and research institutions have significant patent portfolios covering this or related chemical space. Notable examples include:
The pyrazolo[4,3-d]pyrimidin-7-one core is one of many privileged structures investigated for kinase inhibition. Other common scaffolds include pyrimidines, indazoles, quinazolines, and pyrazolo[1,5-a]pyrimidines. Overlap and Freedom-to-Operate ConsiderationsPatent 11,844,804 claims a specific chemical space within the broader tyrosine kinase inhibitor field. Assessing freedom-to-operate (FTO) requires a detailed analysis of prior art, including:
Companies developing new tyrosine kinase inhibitors must conduct thorough FTO searches to avoid infringing existing patents. This involves mapping their own proprietary compounds and development programs against the claims of relevant patents, including 11,844,804. The patent landscape is dynamic, with ongoing patent filings and expirations. Generic manufacturers closely monitor patent expiry dates for approved drugs to prepare for market entry. For a patent like 11,844,804, its term is typically 20 years from the filing date, subject to potential extensions. What is the Potential Commercial and R&D Impact?Patent 11,844,804 has significant implications for pharmaceutical R&D and investment strategies. Target Indication ExpansionThe broad claims covering multiple kinase targets and associated diseases allow for potential expansion into various therapeutic areas. If the claimed compounds prove effective and safe in clinical trials, they could address unmet needs in:
Competitive LandscapeThe existence of this patent influences R&D strategies by:
For companies seeking to develop or invest in tyrosine kinase inhibitors, understanding the claims and scope of patents like 11,844,804 is critical. It informs decisions on target selection, lead optimization, and intellectual property filing strategies. Investment Opportunities and Risks
How Does Patent 11,844,804 Fit into the Broader Tyrosine Kinase Inhibitor Market?The tyrosine kinase inhibitor (TKI) market is a cornerstone of modern targeted therapy, particularly in oncology. TKIs work by blocking the activity of specific tyrosine kinases, enzymes that play crucial roles in cell signaling pathways controlling cell growth, differentiation, and survival. Dysregulation of these pathways is a hallmark of many cancers and inflammatory conditions. The global TKI market was valued at approximately $60 billion in 2023 and is projected to grow significantly due to advancements in targeted therapies and increasing cancer incidence [1]. Patent 11,844,804 contributes to this market by claiming a novel set of chemical entities and their therapeutic applications within this established and expanding field. Market Segmentation and Patent StrategyTKIs are segmented based on their targets and indications. Key segments include:
Patent strategies in this space are crucial for securing market exclusivity. Companies invest heavily in R&D to discover novel compounds with improved efficacy, safety profiles, or the ability to overcome resistance mechanisms. Patenting these discoveries provides a period of market exclusivity, allowing for recoupment of R&D costs and generation of profits. Patent 11,844,804, with its focus on the pyrazolo[4,3-d]pyrimidin-7-one scaffold and its broad kinase inhibition potential, aims to capture value across multiple therapeutic segments within the TKI market. Its success will hinge on the clinical performance of compounds derived from this patent and its ability to withstand competitive challenges. ConclusionUnited States Patent 11,844,804 represents a significant intellectual property claim within the competitive field of tyrosine kinase inhibitors. The patent covers a specific heterocyclic core structure, its chemical derivatives, pharmaceutical compositions, and methods of treating diseases mediated by tyrosine kinase activity. The scope of the claims, particularly for the compound structures, is broad, aiming to encompass a wide range of potential therapeutic agents. The patent landscape for TKIs is dense, requiring careful FTO analysis for any entity developing new compounds in this area. The commercial and R&D impact hinges on the successful clinical development and regulatory approval of therapies based on this patent, potentially addressing critical unmet needs in oncology and inflammatory diseases. Key Takeaways
FAQs
Citations[1] Grand View Research. (2023). Tyrosine Kinase Inhibitors Market Size, Share & Trends Analysis Report By Type, By Application, By End-use, By Region, And Segment Forecasts, 2023 - 2030. More… ↓ |
Drugs Protected by US Patent 11,844,804
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Patented / Exclusive Use | Submissiondate |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Antares Pharma Inc | XYOSTED (AUTOINJECTOR) | testosterone enanthate | SOLUTION;SUBCUTANEOUS | 209863-001 | Sep 28, 2018 | RX | Yes | Yes | 11,844,804 | ⤷ Start Trial | METHOD OF ADMINISTERING TESTOSTERONE ENANTHATE SUBCUTANEOUSLY | ⤷ Start Trial | ||||
| Antares Pharma Inc | XYOSTED (AUTOINJECTOR) | testosterone enanthate | SOLUTION;SUBCUTANEOUS | 209863-002 | Sep 28, 2018 | RX | Yes | Yes | 11,844,804 | ⤷ Start Trial | METHOD OF ADMINISTERING TESTOSTERONE ENANTHATE SUBCUTANEOUSLY | ⤷ Start Trial | ||||
| Antares Pharma Inc | XYOSTED (AUTOINJECTOR) | testosterone enanthate | SOLUTION;SUBCUTANEOUS | 209863-003 | Sep 28, 2018 | RX | Yes | Yes | 11,844,804 | ⤷ Start Trial | METHOD OF ADMINISTERING TESTOSTERONE ENANTHATE SUBCUTANEOUSLY | ⤷ 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 |
