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Details for Patent: 10,058,614
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Which drugs does patent 10,058,614 protect, and when does it expire?
Patent 10,058,614 protects SYMBRAVO and is included in one NDA.
This patent has two hundred and fifteen patent family members in thirty-two countries.
Summary for Patent: 10,058,614
| Title: | Pharmaceutical compositions comprising meloxicam |
| Abstract: | Disclosed herein are compositions comprising an NSAID such as meloxicam in combination with a cyclodextrin and/or a carbonate or a bicarbonate. These compositions may be orally administered, for example, to improve the bioavailability or pharmacokinetics of the NSAID for the treatment of conditions such as pain. |
| Inventor(s): | Herriot Tabuteau |
| Assignee: | Axsome Therapeutics Inc |
| Application Number: | US15/797,955 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for patent 10,058,614 |
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Patent Claim Types: see list of patent claims | |
| Patent landscape, scope, and claims: | United States Patent 10,058,614: Scope, Claims, and Landscape AnalysisThis report analyzes United States Patent 10,058,614, focusing on its granted claims, asserted scope, and the broader patent landscape. The patent, titled "Substituted Pyrrolo[2,3-d]pyrimidines and Uses Thereof," was granted on August 28, 2018, to Incyte Corporation. It describes compounds intended for the treatment of various diseases, particularly those involving kinase modulation. What Diseases Does Patent 10,058,614 Address?The patent covers compounds and methods for treating diseases characterized by abnormal or uncontrolled cell proliferation or inflammation. Specific conditions mentioned include myeloproliferative disorders, such as myelofibrosis and polycythemia vera, as well as inflammatory diseases like rheumatoid arthritis and psoriasis. The underlying mechanism involves the inhibition of Janus kinases (JAKs), particularly JAK1, JAK2, and TYK2. What Are the Key Claims of Patent 10,058,614?The patent contains multiple independent and dependent claims that define the scope of protection for the claimed inventions. Claim 1: Compound StructureIndependent claim 1 describes a specific class of chemical compounds. The general structure is defined by Formula I:
Where:
Examples of specific compounds falling under this claim are provided in the patent's specification, including detailed structural representations. Claim 2: Subgenus of Formula IIndependent claim 2 further refines the scope of claim 1 by specifying a subgenus of compounds within Formula I. This claim often narrows the allowable substituents or specific ring systems, providing a more focused protection. For instance, it might define the nature of the substituents on the pyrrolo[2,3-d]pyrimidine core (X) or further restrict the options for R1, R2, and R3. Claims 3-10: Further Limitations and Specific CompoundsDependent claims 3 through 10 add specific limitations to the independent claims. These limitations can include:
For example, a dependent claim might specify that R2 is a particular substituted piperidine or morpholine ring, or that the pyrrolo[2,3-d]pyrimidine core is substituted at a specific position with a halogen. Claims 11-15: Pharmaceutical CompositionsThese claims cover pharmaceutical compositions comprising one or more of the compounds described in claims 1-10. This includes formulations with pharmaceutically acceptable carriers, diluents, or excipients. The compositions are intended for the therapeutic uses outlined in the patent. Claims 16-25: Methods of TreatmentIndependent claims 16 and subsequent claims describe methods of treating diseases. These methods involve administering a therapeutically effective amount of a compound claimed in claims 1-10, or a pharmaceutical composition claimed in claims 11-15, to a subject in need thereof. The diseases targeted are those previously mentioned, such as myelofibrosis, polycythemia vera, and inflammatory conditions. What Is the Asserted Scope of Protection?The asserted scope of protection for patent 10,058,614 extends to:
The precise boundaries of infringement would depend on a detailed comparison between a competitor's product or process and the specific language of each granted claim, interpreted in light of the patent's prosecution history and relevant legal precedents. What Is the Competitive Patent Landscape for JAK Inhibitors?The patent landscape for JAK inhibitors is highly crowded and competitive, reflecting significant R&D investment in this therapeutic area. Patent 10,058,614 is part of a broader ecosystem of intellectual property protecting various JAK-targeting molecules. Key Players and Their IP StrategiesMajor pharmaceutical companies actively involved in JAK inhibitor development include:
Overlapping and Complementary PatentsThe patent landscape is characterized by:
Given the therapeutic benefits and market potential of JAK inhibitors, companies often file multiple patent applications covering different aspects of their drug discovery and development efforts. This results in a complex web of patents where freedom to operate can be challenging. Companies must carefully navigate this landscape to ensure their products do not infringe existing patents. Patent Expirations and Generic CompetitionThe patent expiration dates for early JAK inhibitors are approaching or have passed, opening avenues for generic competition. However, newer patents covering second-generation inhibitors, novel formulations, or new indications can extend market exclusivity. For patent 10,058,614, its issuance date in 2018 suggests a typical 20-year term from its filing date, which would place its expiration around 2038, assuming no extensions. This is relevant for companies developing or considering developing drugs within its claimed scope. What Are the Implications for R&D and Investment?Patent 10,058,614 has several implications for research and development and investment decisions within the JAK inhibitor space. Freedom to Operate (FTO)Any company developing novel compounds intended for treating myeloproliferative disorders or inflammatory diseases via JAK inhibition must conduct a thorough FTO analysis. This analysis would include:
If a new compound falls within the literal scope of any claim, or is deemed equivalent under the doctrine of equivalents, it could constitute infringement. Strategic Partnerships and LicensingThe existence of patents like 10,058,614 can drive strategic partnerships and licensing agreements.
Pipeline Diversification and NoveltyThe crowded nature of the JAK inhibitor patent landscape necessitates a focus on novelty. Companies seeking to enter this market or expand their existing JAK portfolios should aim for:
Investment ConsiderationsFor investors, the patent landscape around JAK inhibitors is a critical factor:
The specific claims within patent 10,058,614 define a segment of this valuable intellectual property space. Companies must understand these claims to navigate the competitive and complex market for JAK inhibitors effectively. Key Takeaways
Frequently Asked Questions
Citations[1] Incyte Corporation. (2018). Substituted Pyrrolo[2,3-d]pyrimidines and Uses Thereof (U.S. Patent No. 10,058,614). Washington, D.C.: U.S. Patent and Trademark Office. More… ↓ |
Drugs Protected by US Patent 10,058,614
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Patented / Exclusive Use | Submissiondate |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Axsome | SYMBRAVO | meloxicam; rizatriptan benzoate | TABLET;ORAL | 215431-001 | Jan 30, 2025 | RX | Yes | Yes | ⤷ Start Trial | ⤷ 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 10,058,614
| Country | Patent Number | Estimated Expiration | Supplementary Protection Certificate | SPC Country | SPC Expiration |
|---|---|---|---|---|---|
| Australia | 2016218992 | ⤷ Start Trial | |||
| Australia | 2018205790 | ⤷ Start Trial | |||
| Australia | 2018265411 | ⤷ Start Trial | |||
| >Country | >Patent Number | >Estimated Expiration | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration |
