Patent estate

Indivior — Patent Portfolio

1 drug with active patents · 96 active patents · 0 expired · 0 biologics with BPCIA exclusivity

AI-enriched 57/96 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 The Indivior portfolio is moderately strong but faces significant revenue risk in 2027 with Subutex losing exclusivity.

Portfolio overview The Indivior portfolio consists of a total of 1 drug with patents, with 96 active US patents and 0 expired US patents. The average vulnerability score is 62, indicating a moderate level of patent protection. The portfolio has 0 ironclad patents and 39 vulnerable patents. There are no biologics in the portfolio.

Cliff calendar In 2027, 1 drug will lose exclusivity, including Subutex. This marks a significant cliff year for the company, with potential revenue at risk.

Most exposed drugs The top drug facing near-term loss of exclusivity is Subutex, with an earliest active patent expiry date of 2027-07-23, an average vulnerability score of 62, and annual revenue of $800 million USD. This drug is the only one in the portfolio with significant revenue at risk.

Biologic exclusivity There are no biologics in the Indivior portfolio, and therefore no biologic exclusivity is at risk.

Strategic implications The company faces significant revenue risk in the next 5 years, with $800 million USD at risk in 2027. To mitigate this risk, the company may consider lifecycle moves such as subQ switches, label extensions, or combination filings to maintain market share and revenue.

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.

Patent estate by drug

Subutex (Buprenorphine Hydrochloride)

Cliff 2027 · 1y
Method of Use 66 Formulation 30
  • US8147866 Vuln 80 2027-07-23
    This patent protects methods and devices for delivering medicaments, such as fentanyl or buprenorphine, through the mucous membranes.
  • US8147866 Vuln 80 2027-07-23
    This patent protects methods and devices for delivering medicaments, such as fentanyl or buprenorphine, through the mucous membranes.
  • US8147866 Vuln 80 2027-07-23
    This patent protects methods and devices for delivering medicaments, such as fentanyl or buprenorphine, through the mucous membranes.
See all 96 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.

  • Method of Use 66 patents
  • Formulation 30 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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