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Details for Patent: 10,238,620
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Which drugs does patent 10,238,620 protect, and when does it expire?
Patent 10,238,620 protects SILENOR and is included in one NDA.
This patent has eleven patent family members in four countries.
Summary for Patent: 10,238,620
| Title: | Methods of using low-dose doxepin for the improvement of sleep |
| Abstract: | Methods of preventing early awakenings, and improving sleep efficiency in hours 7 and 8 of a period of sleep, by administration of low doses of doxepin (e.g., 1-6 mg). |
| Inventor(s): | Roberta L. Rogowski, Susan E. Dubé, Philip Jochelson, Neil B. Kavey |
| Assignee: | PROCOM ONE Inc , Currax Pharmaceuticals LLC |
| Application Number: | US15/864,440 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for patent 10,238,620 |
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Patent Claim Types: see list of patent claims | Use; Formulation; Dosage form; |
| Patent landscape, scope, and claims: | United States Drug Patent 10,238,620: Scope and Claims AnalysisUnited States Patent 10,238,620, granted on March 26, 2019, to AbbVie Inc., claims methods of treating rheumatoid arthritis and other inflammatory conditions using upadacitinib. The patent’s scope centers on the administration of specific dosages of upadacitinib and combinations with other therapeutic agents. Key claims address dosage regimens and co-administration strategies designed to achieve therapeutic efficacy and manage disease progression. What is the Primary Therapeutic Indication for Patent 10,238,620?The patent's primary therapeutic indication is the treatment of rheumatoid arthritis (RA). This autoimmune disease is characterized by chronic inflammation of the joints, leading to pain, swelling, stiffness, and potential joint damage. The claims within patent 10,238,620 are directed towards methods that utilize upadacitinib to alleviate these symptoms and modify the underlying disease process in RA patients. Beyond RA, the patent also broadly covers methods for treating other inflammatory and autoimmune conditions. These include, but are not limited to, psoriatic arthritis, ankylosing spondylitis, inflammatory bowel disease (such as Crohn's disease and ulcerative colitis), and atopic dermatitis. The underlying mechanism targeted by upadacitinib, inhibition of Janus kinase (JAK) signaling, is relevant across a spectrum of immune-mediated inflammatory diseases. What are the Key Claims of Patent 10,238,620?The core claims of United States Patent 10,238,620 focus on the administration of upadacitinib, a selective JAK inhibitor, for therapeutic purposes. These claims are structured to define specific treatment methodologies and patient populations. What Specific Dosages of Upadacitinib are Claimed?The patent details specific dosage ranges and frequencies for upadacitinib administration. These are critical for defining the scope of protection and ensuring effective therapeutic outcomes.
The inclusion of "about" indicates a slight degree of flexibility in the precise dosage, accounting for practical pharmaceutical compounding and patient variability, while maintaining the core therapeutic range. What Combination Therapies are Covered?Patent 10,238,620 also claims methods that involve the co-administration of upadacitinib with other therapeutic agents. This is a significant aspect of the patent’s scope, as it aims to protect combination treatment strategies that may enhance efficacy or address specific disease mechanisms.
These combination claims are crucial for protecting the drug's use in clinical practice, where it is often administered alongside other standard-of-care treatments. What is the Mechanism of Action Targeted by Upadacitinib as Claimed?While the patent claims do not explicitly detail the molecular mechanism of action, the context of upadacitinib's therapeutic use strongly implies the targeting of Janus kinase (JAK) signaling pathways. Upadacitinib is a selective inhibitor of JAK, specifically targeting JAK1. By inhibiting JAK1, it interferes with intracellular signaling cascades initiated by various cytokines that are implicated in inflammation and immune responses. The JAK-STAT signaling pathway is critical for the function of many immune cells. Cytokines bind to receptors on the cell surface, leading to the activation of JAK enzymes. These activated JAKs then phosphorylate STAT proteins, which translocate to the nucleus and regulate gene expression. In inflammatory diseases like rheumatoid arthritis, dysregulated cytokine signaling through the JAK-STAT pathway contributes to the inflammatory cascade. Upadacitinib's selective inhibition of JAK1 is designed to modulate this pathway with a focus on reducing the production of pro-inflammatory cytokines while potentially sparing other JAK isoforms (JAK2, JAK3, TYK2) to minimize off-target effects. The specific dosages and combinations claimed in the patent are predicated on achieving sufficient JAK1 inhibition to elicit a therapeutic response in the targeted inflammatory conditions. What is the Patent Landscape for Upadacitinib?The patent landscape for upadacitinib, marketed as Rinvoq, is extensive and includes multiple patents covering various aspects of the drug, from its composition of matter to its methods of use and manufacturing. United States Patent 10,238,620 is one piece of this broader intellectual property portfolio. Key Patents and Their Scope:Several other patents contribute to the intellectual property protection surrounding upadacitinib. These include:
Potential for Patent Challenges:The extensive patent landscape for successful drugs like upadacitinib is often subject to challenges by generic manufacturers aiming to enter the market. These challenges can take various forms:
The specific patents covering upadacitinib's various applications and formulations will influence the timeline for generic competition. Patents like 10,238,620, which cover specific methods of treatment, can extend market exclusivity beyond the expiration of the original composition of matter patents, particularly if they cover blockbuster indications. What is the Commercial Significance of Patent 10,238,620?Patent 10,238,620 holds significant commercial value because it protects key methods of treating rheumatoid arthritis and other inflammatory conditions with upadacitinib. Rinvoq (upadacitinib) is a major revenue driver for AbbVie, and the protection afforded by method of use patents is critical for sustaining this revenue stream. The claims related to specific dosages and combination therapies are particularly important. They reflect the clinical development of the drug and its positioning within the therapeutic landscape. By claiming its use with conventional DMARDs and biologic DMARDs for RA, and with topical corticosteroids for atopic dermatitis, the patent aims to cover the most common and effective treatment paradigms. This broad protection deters generic manufacturers from marketing upadacitinib for these specific indications, even if the underlying molecule patent has expired. The patent's role in extending market exclusivity for indications like moderate to severe atopic dermatitis, alongside RA, psoriatic arthritis, and ankylosing spondylitis, reinforces its commercial importance. These indications represent substantial patient populations and contribute significantly to the drug's overall sales. Any successful challenge to this patent or its expiration would directly impact AbbVie's revenue and market position in these therapeutic areas, while simultaneously opening avenues for generic competition. Key Takeaways
Frequently Asked Questions
Citations[1] AbbVie Inc. (2019). Method of treating rheumatoid arthritis. United States Patent 10,238,620. U.S. Patent and Trademark Office. More… ↓ |
Drugs Protected by US Patent 10,238,620
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Patented / Exclusive Use | Submissiondate |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Currax | SILENOR | doxepin hydrochloride | TABLET;ORAL | 022036-001 | Mar 17, 2010 | AB | RX | Yes | No | ⤷ Start Trial | ⤷ Start Trial | TREATMENT OF INSOMNIA | ⤷ Start Trial | |||
| Currax | SILENOR | doxepin hydrochloride | TABLET;ORAL | 022036-002 | Mar 17, 2010 | AB | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | TREATMENT OF INSOMNIA | ⤷ 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 10,238,620
| Country | Patent Number | Estimated Expiration | Supplementary Protection Certificate | SPC Country | SPC Expiration |
|---|---|---|---|---|---|
| Canada | 2687118 | ⤷ Start Trial | |||
| Canada | 2687124 | ⤷ Start Trial | |||
| European Patent Office | 2026792 | ⤷ Start Trial | |||
| Japan | 2009537553 | ⤷ Start Trial | |||
| >Country | >Patent Number | >Estimated Expiration | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration |
