Patent estate

Arcutis Biotherapeutics — Patent Portfolio

1 drug with active patents · 68 active patents · 0 expired · 0 biologics with BPCIA exclusivity

AI-enriched 68/68 patents with grounded plain-English summaries · sourced from FDA Orange Book + Purple Book · updated 2026-05-18

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Strategic Patent Estate Brief
AI-grounded executive summary · generated 2026-05-16

Verdict Arcutis Biotherapeutics' portfolio is moderately strong, with a significant cliff year in 2037 and no revenue at risk in the next 5 years.

Portfolio overview Arcutis Biotherapeutics has a total of 1 drug with patents, out of a total of 1 drugs in their portfolio. The company has 68 active US patents, with an average vulnerability score of 62. Notably, there are no ironclad patents in the portfolio, but 26 patents are considered vulnerable. The company does not have any biologics with BPCIA exclusivity.

Cliff calendar The company faces a significant cliff year in 2037, with 1 drug losing exclusivity, including Daliresp. This year will see the most drugs lose exclusivity, with a total of 1 drugs losing exclusivity.

Most exposed drugs The top drug facing near-term loss of exclusivity is Daliresp, with an earliest active patent expiry date of 2037-06-07, an average vulnerability score of 62, and no annual revenue data available. This drug has 68 patents and is the only drug in the portfolio.

Biologic exclusivity Arcutis Biotherapeutics does not have any biologics in their portfolio, and therefore, there are no biologics with BPCIA 12-year reference product exclusivity.

Strategic implications The company has no revenue at risk in the next 5 years. However, the company should consider lifecycle moves to maintain revenue, such as subQ switches, label extensions, or combination filings, to mitigate the impact of the cliff year in 2037.

Sources: FDA Orange Book · FDA Purple Book · INPADOC family · USPTO · vulnerability scoring. Not legal advice.

Loss of exclusivity calendar · next 12 years

Drugs facing US patent or BPCIA biologic exclusivity loss per year. Click any year to see the broader cliff calendar for the industry.

1 2037

Patent estate by drug

Daliresp (ROFLUMILAST)

Cliff 2037 · 11y
Method of Use 26 Formulation 42
  • US11992480 Vuln 75 2037-06-07
    This patent protects a method of reducing gastrointestinal side effects from a PDE-4 inhibitor, such as roflumilast, by topically administering it with phosphate ester surfactants.
  • US12310956 Vuln 75 2037-06-07
    This patent protects a method of using roflumilast, specifically a topical formulation with certain additives to improve delivery and plasma half-life.
  • US12005051 Vuln 75 2037-06-07
    This patent protects a method of using roflumilast, specifically a topically administered formulation with improved delivery and plasma half-life.
See all 68 patents →

Patent classification breakdown · active patents

By US patent type. Method-of-use patents are most vulnerable to design-around; composition-of-matter patents are the strongest protection.

  • Formulation 42 patents
  • Method of Use 26 patents

Sources

  • FDA Orange Book — small-molecule patents listed against approved NDAs.
  • FDA Purple Book — biologic BPCIA 12-year reference product exclusivity.
  • USPTO Patent Public Search — title, abstract, claim text grounding.
  • AI summaries generated by Drug Landscape, grounded in source claim text.

Patent term extensions (PTR, SPC, pediatric exclusivity) may shift effective expiry. Not legal advice.

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