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Last Updated: March 26, 2026

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
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 Analysis

United 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.

  • Claim 1: Claims a method of treating rheumatoid arthritis comprising administering a dose of upadacitinib to a subject in an amount of about 7 mg, 15 mg, or 30 mg once daily. This claim establishes a foundational dosage regimen.
  • Claim 4: This claim refines the dosage by specifying a method of treating rheumatoid arthritis comprising administering upadacitinib to a subject in an amount of about 15 mg once daily. This targets a specific, commonly prescribed dose.
  • Claim 7: Claims a method of treating rheumatoid arthritis comprising administering upadacitinib to a subject in an amount of about 30 mg once daily. This addresses a higher dosage for potentially more severe or refractory cases.
  • Claim 12: This claim broadens the therapeutic context to include treating psoriatic arthritis or ankylosing spondylitis. It specifies administering upadacitinib in an amount of about 15 mg or 30 mg once daily.
  • Claim 17: This claim relates to the treatment of moderate to severe atopic dermatitis. It involves administering upadacitinib in an amount of about 15 mg or 30 mg once daily.

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.

  • Claim 2: Claims a method of treating rheumatoid arthritis comprising administering a dose of upadacitinib to a subject in an amount of about 7 mg, 15 mg, or 30 mg once daily, wherein the subject is also being treated with a conventional disease-modifying antirheumatic drug (cDMARD). This claim protects the use of upadacitinib in conjunction with established RA treatments.
  • Claim 3: Claims a method of treating rheumatoid arthritis comprising administering a dose of upadacitinib to a subject in an amount of about 7 mg, 15 mg, or 30 mg once daily, wherein the subject is also being treated with a biologic disease-modifying antirheumatic drug (bDMARD). This extends the protection to combinations with biologic therapies.
  • Claim 5: This claim specifically addresses co-administration with a cDMARD for treating RA, utilizing a 15 mg daily dose of upadacitinib.
  • Claim 6: This claim covers co-administration with a bDMARD for treating RA, utilizing a 15 mg daily dose of upadacitinib.
  • Claim 8: This claim involves co-administration with a cDMARD for treating RA, utilizing a 30 mg daily dose of upadacitinib.
  • Claim 9: This claim involves co-administration with a bDMARD for treating RA, utilizing a 30 mg daily dose of upadacitinib.
  • Claim 13: Claims a method of treating psoriatic arthritis or ankylosing spondylitis comprising administering upadacitinib in an amount of about 15 mg once daily, wherein the subject is also being treated with a cDMARD.
  • Claim 14: Claims a method of treating psoriatic arthritis or ankylosing spondylitis comprising administering upadacitinib in an amount of about 15 mg once daily, wherein the subject is also being treated with a bDMARD.
  • Claim 15: Claims a method of treating psoriatic arthritis or ankylosing spondylitis comprising administering upadacitinib in an amount of about 30 mg once daily, wherein the subject is also being treated with a cDMARD.
  • Claim 16: Claims a method of treating psoriatic arthritis or ankylosing spondylitis comprising administering upadacitinib in an amount of about 30 mg once daily, wherein the subject is also being treated with a bDMARD.
  • Claim 18: Claims a method of treating moderate to severe atopic dermatitis comprising administering upadacitinib in an amount of about 15 mg once daily, wherein the subject is also being treated with a topical corticosteroid. This targets a specific adjunctive therapy for atopic dermatitis.
  • Claim 19: Claims a method of treating moderate to severe atopic dermatitis comprising administering upadacitinib in an amount of about 30 mg once daily, wherein the subject is also being treated with a topical corticosteroid.

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:

  • Composition of Matter Patents: These are typically the earliest and broadest patents, covering the molecule itself. While specific composition of matter patents for upadacitinib may have expired or are nearing expiration, they formed the initial foundation of protection. For example, related compounds and their synthesis were often covered in early patents by companies like Abbott Laboratories (predecessor to AbbVie).
  • Formulation Patents: These patents protect specific pharmaceutical compositions of upadacitinib, such as tablets, capsules, or extended-release formulations. They define the inactive ingredients, release profiles, and other characteristics of the drug product.
  • Method of Treatment Patents: Like 10,238,620, these patents cover specific therapeutic uses, patient populations, dosages, and combination therapies. The strength and duration of protection for these patents are critical for maintaining market exclusivity for specific indications.
  • Manufacturing Process Patents: These patents cover the specific chemical synthesis routes and manufacturing processes used to produce upadacitinib. While often kept as trade secrets, patenting key steps can provide additional layers of protection.

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:

  • Paragraph IV Certifications: Under the Hatch-Waxman Act, generic companies can challenge existing patents by filing an Abbreviated New Drug Application (ANDA) and asserting that the challenged patent is invalid, unenforceable, or will not be infringed by the generic product.
  • Patent Expiration: The primary driver for generic entry is the expiration of key patents, including composition of matter, formulation, and method of use patents.
  • Inter Partes Review (IPR): This is a trial proceeding conducted at the U.S. Patent and Trademark Office (USPTO) to review the patentability of one or more claims in a patent.

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

  • United States Patent 10,238,620 protects methods of treating rheumatoid arthritis and other inflammatory conditions using upadacitinib.
  • Key claims define specific daily dosages of upadacitinib, including 7 mg, 15 mg, and 30 mg.
  • The patent also covers combination therapies of upadacitinib with conventional and biologic DMARDs for RA, and with topical corticosteroids for atopic dermatitis.
  • Upadacitinib is a selective JAK1 inhibitor, and the patented methods leverage this mechanism to modulate inflammatory pathways.
  • This patent is a component of a broader intellectual property strategy for upadacitinib, contributing to market exclusivity for significant therapeutic indications.
  • The commercial value of the patent is tied to its protection of key treatment regimens for major revenue-generating indications for Rinvoq.

Frequently Asked Questions

  1. When was United States Patent 10,238,620 granted? United States Patent 10,238,620 was granted on March 26, 2019.

  2. What specific autoimmune conditions, besides rheumatoid arthritis, are covered by patent 10,238,620? The patent covers methods for treating psoriatic arthritis, ankylosing spondylitis, inflammatory bowel disease (Crohn's disease, ulcerative colitis), and atopic dermatitis.

  3. Does patent 10,238,620 claim the upadacitinib molecule itself? No, patent 10,238,620 claims methods of treatment using upadacitinib, not the composition of matter of the molecule itself. Composition of matter patents typically precede method of use patents.

  4. What are the primary types of co-administered drugs mentioned in the patent for rheumatoid arthritis treatment? The patent covers co-administration of upadacitinib with conventional disease-modifying antirheumatic drugs (cDMARDs) and biologic disease-modifying antirheumatic drugs (bDMARDs).

  5. What is the likely expiration date for patent 10,238,620? As a method of use patent granted in 2019, its term would generally extend 20 years from its filing date, subject to any potential patent term extensions (PTE) or adjustments. The U.S. patent term for applications filed on or after June 8, 1995, is 20 years from the earliest effective filing date. Without the specific filing date, a precise expiration cannot be stated, but typically such patents provide protection for many years post-grant.

Citations

[1] AbbVie Inc. (2019). Method of treating rheumatoid arthritis. United States Patent 10,238,620. U.S. Patent and Trademark Office.

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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

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