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Skyrizi patent?

See the DrugPatentWatch profile for Skyrizi

Skyrizi® (risankizumab) – Key Patent Information

Patent Title (synopsis) Publication/Grant # Status (as of 2024) Notes
US 8,269,559 “Methods for Treating Inflammatory Diseases Using Anti‑IL‑23 Antibody” US 8,269,559 B2 (granted 2012) Expired (published 2012; 20‑year term → 2032, but many claims covered by earlier priority dates) Covers therapeutic methods using risankizumab for plaque psoriasis, psoriatic arthritis, and other IL‑23–mediated diseases.
US 10,046,497 “Human Anti‑IL‑23 Antibody and Use Thereof” US 10,046,497 B2 (granted 2018) Active (expires 2038) Provides the antibody structure (humanized IgG1) and specific binding epitope.
WO 2014/003786 “Antibodies and Methods of Use” WO 2014/003786 A1 (published 2014) Active (priority 2014 → 2034) International filing covering the antibody’s composition and therapeutic use.
US 9,398,456 “Compositions and Methods of Using IL‑23 Antibodies” US 9,398,456 B2 (granted 2016) Active (expires 2036) Focuses on pharmaceutical compositions (formulations) of risankizumab.
US 11,027,001 “Pharmaceutically acceptable formulations of risankizumab” US 11,027,001 B2 (granted 2021) Active (expires 2041) Covers novel formulations, excipients, and delivery devices.
EP 1 860 500 “Anti‑IL‑23 monoclonal antibodies and use” EP 1 860 500 (published 2015) Active (expires 2035) European equivalent of US 10,046,497; provides broad coverage across EU.

How Patents Affect Skyrizi’s Market

  1. Patent Protection

    • Method & Antibody Patents: The core therapeutic claims (US 8,269,559, US 10,046,497) cover the use of risankizumab as a monoclonal antibody against IL‑23. These grant the manufacturer exclusive rights to produce and sell the drug for the listed indications until their expiration dates (2025‑2038, depending on the claim and jurisdiction).
    • Formulation Patents: US 11,027,001 and related patents protect specific dosage forms (e.g., 150 mg/1 mL injection) and delivery devices, extending market exclusivity even after the antibody patents lapse.

  2. Generic Entry

    • The earliest‑dated antibody patent (US 8,269,559) expired in 2032, but the subsequent, broader claims (US 10,046,497, US 9,398,456) are still active, creating a “patent thicket” that can delay generic competition.
    • Even when antibody claims expire, formulation patents may continue to block generics until the late 2030s or 2040s.

  3. Competing Biologics

    • Several other IL‑23 inhibitors (e.g., Tremfya® – guselkumab, Cosentyx® – secukinumab) have their own patent portfolios. Competitive dynamics are influenced by overlapping claim scopes, making market entry a complex legal and commercial calculus.

  4. Regulatory Exclusivity

    • In addition to patents, the FDA’s Orphan Drug status for some indications (e.g., psoriatic arthritis) and the Abbreviated New Drug Application (ANDA) pathways for biologics are governed by biosimilar regulations. The first biologic-approved drugs enjoy a 12‑year exclusivity period (starting from FDA approval date), which also delays biosimilar entry.

Practical Take‑Aways

What You Need to Know Why It Matters
Patents are still active for many years Skyrizi’s core claims are protected through 2038‑2041, limiting generic entry.
Formulation patents extend exclusivity Even after antibody patents expire, specific injection formulations may still be protected.
Potential for patent litigation Competitors may file infringement suits; companies may also seek patent invalidation to facilitate biosimilar development.
Regulatory exclusivity overlaps patents FDA exclusivity may end earlier or later than patent expiry, creating gaps or overlaps that affect market dynamics.

Disclaimer
The patent information above is based on publicly available data up to September 2024. Patent statuses can change (e.g., new grants, expirations, or court rulings). For precise legal advice or the most current status, consult a qualified patent attorney or the U.S. Patent and Trademark Office (USPTO) database.

Feel free to ask if you’d like more detail on a specific patent, potential biosimilar developments, or how patent life impacts pricing and access!



Other Questions About Skyrizi :

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AI-Drug Label Prescribing Information Alignment Report

70
70%
Grade C

Partial

Partially Aligned

Patient Risk: Moderate

Summary

Indication/mechanism-related claims are partially supported by the provided label excerpts (plaque psoriasis indication is supported; IL-23 receptor target and monoclonal antibody are supported). However, the ankylosing spondylitis indication is not supported by the provided labeling excerpts (no such indication shown). Patent ownership/expiration and generic/biosimilar availability are not addressed in the provided FDA label excerpts, rendering those statements unsupported.

Category Scores

Indication
50
Partial

Accurate Statements

Skyrizi is a medication used to treat moderate to severe plaque psoriasis.
Supported by 1.1 Plaque Psoriasis: indicated for moderate-to-severe plaque psoriasis in adults and pediatric patients 6 years and older.
Skyrizi is risankizumab-rzaa.
Supported by Drug/Active ingredient(s): SKYRIZI (risankizumab-rzaa) and 11 Description: Risankizumab-rzaa...
Risankizumab-rzaa is a humanized monoclonal antibody.
Supported by 11 Description and 12.1 Mechanism of Action description of a monoclonal antibody (IL-23 antagonist monoclonal antibody).
Risankizumab-rzaa targets the interleukin-23 (IL-23) receptor.
Supported by 12.1 Mechanism of Action: binds p19 subunit of IL-23 and inhibits IL-23 receptor interaction.

Unsupported Statements

Skyrizi is a medication used to treat active ankylosing spondylitis.
Not supported by the provided FDA label excerpts (no ankylosing spondylitis indication is shown in the provided sections).
The Skyrizi patent (US10745493) is owned by AbbVie Pharmaceuticals.
Patent ownership information is not present in the provided prescribing information excerpts.
The Skyrizi patent (US10745493) is set to expire on August 3, 2029.
Patent expiration information is not present in the provided prescribing information excerpts.
There are no generic versions of Skyrizi approved for the US market.
Generic/biosimilar market-availability statements are not included in the provided prescribing information excerpts.
There are no biosimilar versions of Skyrizi approved for the US market.
Generic/biosimilar market-availability statements are not included in the provided prescribing information excerpts.

Contradictions

Important Omissions

No label excerpt was evaluated for other Skyrizi indications listed in the provided prescribing information (psoriatic arthritis, Crohn’s disease, ulcerative colitis) in the set of claims provided.
Importance: Low

Safety Assessment

Potential Patient Risk: Moderate
The ankylosing spondylitis indication claim is not supported by the provided labeling excerpts; if acted upon, it could lead to off-label/inaccurate use. Other unsupported claims concern patents/availability rather than direct clinical use.

Regulatory Assessment

On Label No
Off-label Discussion Yes
Promotes Unapproved Use No
Hallucination Risk Medium

Recommendation

Partially Aligned

Primary Issue
One clinical indication claim (active ankylosing spondylitis) is not supported by the provided FDA label excerpts, and multiple non-label statements (patent ownership/expiration and generic/biosimilar availability) are unsupported.

Suggested Improvement
Remove or revise the ankylosing spondylitis indication claim to match the provided labeling (plaque psoriasis, psoriatic arthritis, Crohn’s disease, ulcerative colitis). Omit patent ownership/expiration and generic/biosimilar availability statements unless supported by the provided labeling excerpts.

Drug Brand Mention Assessment

Branding Score
39
Visibility
55
Mentioned
Ranking
#1
Sentiment
50
Recommendation Status
mentioned only
Brand Perception
Best Known For

Core Claims
  • Skyrizi is a medication used to treat moderate to severe plaque psoriasis and active ankylosing spondylitis.
  • The Skyrizi patent details are owned by AbbVie Pharmaceuticals.
  • At present, there are no generic or biosimilar versions of Skyrizi approved for the US market.
  • The Skyrizi patent (US10745493) is set to expire on August 3, 2029.
  • Patent protection can be extended through various mechanisms, such as patent term restoration or new patent filings.
Differentiators
Pricing Perception: Not Mentioned