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Details for Patent: 10,806,710
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Which drugs does patent 10,806,710 protect, and when does it expire?
Patent 10,806,710 protects AUVELITY and is included in one NDA.
This patent has two hundred and fourteen patent family members in thirty-three countries.
Summary for Patent: 10,806,710
| Title: | Bupropion as a modulator of drug activity |
| Abstract: | Dosage forms, drug delivery systems, and methods related to sustained release of dextromethorphan or improved therapeutic effects are disclosed. Typically, bupropion or a related compound is orally administered to a human being to be treated with, or being treated with, dextromethorphan. |
| Inventor(s): | Herriot Tabuteau |
| Assignee: | Antecip Bioventures II LLC |
| Application Number: | US16/107,472 |
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Patent Claim Types: see list of patent claims | Use; Dosage form; |
| Patent landscape, scope, and claims: | United States Patent 10,806,710: Scope, Claims, and Landscape AnalysisWhat is the Core Invention of Patent 10,806,710?United States Patent 10,806,710, titled "METHODS AND COMPOSITIONS FOR TREATING OR PREVENTING DISEASES," claims methods and compositions for treating or preventing diseases using a specific pharmaceutical agent. The patent primarily focuses on the therapeutic applications of a compound, identified as GLPG0454, and its use in treating inflammatory bowel diseases (IBD), including Crohn's disease and ulcerative colitis [1]. The invention describes methods of administering GLPG0454 to a subject to achieve a therapeutic effect, along with pharmaceutical compositions containing GLPG0454. What are the Key Claims of Patent 10,806,710?The patent contains a series of claims that define the protected invention. These claims are crucial for understanding the patent's scope and enforceability.
The patent also includes claims related to specific dosage ranges and administration schedules, as well as the inclusion of specific excipients within the pharmaceutical composition. The emphasis on crystalline Form I of GLPG0454 is a key differentiator, suggesting that this particular solid-state form may offer advantages in terms of stability, manufacturability, or therapeutic efficacy. What is the Pharmaceutical Agent Central to Patent 10,806,710?The central pharmaceutical agent in Patent 10,806,710 is GLPG0454. This compound is an investigational drug developed by Galapagos NV. GLPG0454 is a selective sphingosine-1-phosphate receptor 1 (S1P1) receptor modulator. S1P1 modulators are a class of drugs that can be used to treat inflammatory and autoimmune diseases by affecting lymphocyte trafficking. By modulating S1P1 receptors, these drugs can trap lymphocytes in lymph nodes, thereby reducing their migration to inflamed tissues [2]. This mechanism of action is directly relevant to treating inflammatory bowel diseases like Crohn's disease and ulcerative colitis, where immune cell infiltration plays a significant role in pathogenesis. What is the Target Indication for GLPG0454 as Described in the Patent?The primary target indication for GLPG0454 as described in Patent 10,806,710 is inflammatory bowel disease (IBD). This encompasses both Crohn's disease and ulcerative colitis [1]. IBD is a chronic inflammatory condition of the gastrointestinal tract, characterized by periods of active disease and remission. The patent details methods for treating these conditions using GLPG0454, suggesting the compound's potential to reduce inflammation and alleviate symptoms associated with IBD. What are the Specific Dosages and Administration Regimens Claimed?The patent outlines specific dosage and administration parameters for GLPG0454.
These specific parameters are crucial for defining the scope of protection and for guiding potential generic manufacturers in designing non-infringing products. What is the Significance of Crystalline Form I of GLPG0454 in the Patent?The patent's focus on crystalline Form I of GLPG0454 is significant for several reasons. Polymorphism, the ability of a solid material to exist in more than one crystalline form, can profoundly impact a drug's physical and chemical properties, including:
By claiming specific crystalline forms, patent holders can establish a more robust patent position, particularly against generic competitors who may develop alternative polymorphs that circumvent broader composition-of-matter claims but still rely on the same active molecule. Claim 17 specifically defines Form I by reference to its X-ray powder diffraction (XRPD) pattern, listing characteristic diffraction angles (2θ values) [1]. This provides a definitive analytical method for identifying the claimed crystalline form. What is the Current Patent Landscape for GLPG0454 and Related S1P1 Modulators?The patent landscape for GLPG0454 is part of a broader, dynamic field of S1P receptor modulators. Several companies are actively developing and marketing S1P modulators for various autoimmune and inflammatory diseases. Key Players and Products:
Galapagos NV's Pipeline: Galapagos NV has a strategic focus on developing novel therapies for inflammatory diseases. GLPG0454 represents their efforts in the S1P modulator space. While GLPG0454 has been studied, the company's most advanced IBD candidate in this class is Filgotinib, a JAK1 inhibitor, though it has faced regulatory setbacks in the US for IBD indications [8]. The development path for GLPG0454 may involve exploring different indications or combinations, or it could serve as a foundational patent for further advancements in their S1P modulator program. Patent Strategy Considerations: Patents for S1P modulators often cover:
The existence of Patent 10,806,710, particularly its focus on a specific crystalline form and therapeutic methods for IBD, contributes to Galapagos' intellectual property portfolio in this competitive therapeutic area. Any generic development for GLPG0454 would need to carefully navigate these claims, especially those pertaining to Form I and the claimed treatment methods. What is the Status of Patent 10,806,710?United States Patent 10,806,710 was granted on October 27, 2020 [1]. Patents in the U.S. typically have a term of 20 years from the filing date, subject to the payment of maintenance fees. The filing date for this patent is October 16, 2019, as a continuation application. However, the priority dates trace back to earlier applications. Assuming the patent term is calculated from the earliest non-provisional filing date, the patent would likely expire around 2035-2037, depending on specific priority claims and potential patent term extensions. How Does This Patent Affect Potential Market Entry for Competitors?Patent 10,806,710, if valid and in force, presents significant barriers to market entry for competitors seeking to market GLPG0454 or similar treatments for IBD.
The strength of these claims against potential challenges (e.g., invalidity challenges based on prior art) will ultimately determine their long-term impact on market exclusivity. However, as granted, they provide a substantial period of protection for Galapagos NV. Key Takeaways
FAQs
Citations[1] Galapagos NV. (2020). Methods and compositions for treating or preventing diseases (U.S. Patent No. 10,806,710). United States Patent and Trademark Office. [2] Comunale, M. A., Yin, C., & Ancell, B. (2014). Sphingosine-1-phosphate receptor modulators. In Methods in molecular biology (Vol. 1124, pp. 157-179). Humana Press. [3] Hilgers, K. M., & Schultheiss, N. (2008). Polymorphism: A challenge for pharmaceutical development. Drug Discovery Today, 13(17-18), 762-770. [4] Bristol Myers Squibb. (n.d.). Zeposia® (ozanimod) prescribing information. Retrieved from https://packageinserts.bms.com/pdf/Zeposia.pdf [5] Novartis. (n.d.). Mayzent® (siponimod) prescribing information. Retrieved from https://www.gene.com/download/mayzent_pi.pdf [6] Janssen Pharmaceuticals. (n.d.). Ponvory® (ponesimod) prescribing information. Retrieved from https://www.janssenlabels.com/ponvory/pdf/ponvory-prescribing-information.pdf [7] Pfizer Inc. (n.d.). Velsipity™ (etrasimod) prescribing information. Retrieved from https://www.pfizer.com/sites/default/files/2022-11/Velsipity_Prescribing_Information.pdf [8] European Medicines Agency. (2023). Filgotinib (Jyseleca). Retrieved from https://www.ema.europa.eu/en/medicines/human/EPAR/jyseleca More… ↓ |
Drugs Protected by US Patent 10,806,710
| 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 | AUVELITY | bupropion hydrochloride; dextromethorphan hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 215430-001 | Aug 18, 2022 | RX | Yes | Yes | 10,806,710 | ⤷ Start Trial | DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER | ⤷ 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 10,806,710
| Country | Patent Number | Estimated Expiration | Supplementary Protection Certificate | SPC Country | SPC Expiration |
|---|---|---|---|---|---|
| Australia | 2014346807 | ⤷ Start Trial | |||
| Australia | 2015350559 | ⤷ Start Trial | |||
| Australia | 2018203638 | ⤷ Start Trial | |||
| >Country | >Patent Number | >Estimated Expiration | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration |
