Patent estate

BRISTOL — Patent Portfolio

1 drug with active patents · 10 active patents · 0 expired · 0 biologics with BPCIA exclusivity

AI-enriched 10/10 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 BRISTOL portfolio is moderately strong with a significant cliff year in 2035 and no revenue at risk in the next 5 years.

Portfolio overview The BRISTOL portfolio consists of a total of 3 drugs, with 1 of them having patents. The portfolio has a total of 10 US patents, all of which are active. The average vulnerability score is 47, indicating a moderate level of vulnerability. The portfolio has 4 ironclad patents and 4 vulnerable patents. There are no biologics in the portfolio.

Cliff calendar In 2035, 1 drug will lose exclusivity, including Augtyro. This marks a significant cliff year for the company. Additionally, there are no other notable cliff years in the near future.

Most exposed drugs The top drug facing near-term loss of exclusivity is Augtyro, with an earliest active patent expiry date of 2035-01-23 and an average vulnerability score of 47. Augtyro generates $200 million in annual revenue. This drug is facing significant vulnerability, with 10 patents and a high vulnerability score.

Biologic exclusivity There are no biologics in the portfolio, so there is no BPCIA 12-year reference product exclusivity to consider.

Strategic implications The company has no revenue at risk in the next 5 years. However, the loss of exclusivity for Augtyro in 2035 will require the company to consider lifecycle moves, such as subQ switches, label extensions, or combination filings, to maintain revenue and competitiveness.

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 2035 1 2036

Patent estate by drug

Augtyro (REPOTRECTINIB)

Cliff 2035 · 9y
Composition of Matter 4 Formulation 2 Method of Use 4
  • US12310968 Vuln 75 2036-07-20
    This patent protects the use of a specific diaryl macrocycle compound in the treatment of disease in mammals, particularly humans.
  • US12310968 Vuln 75 2036-07-20
    This patent protects the use of a specific diaryl macrocycle compound in the treatment of disease in mammals, particularly humans.
  • US11452725 Vuln 75 2036-07-24
    This patent protects the use of a specific diaryl macrocycle compound in the treatment of disease in mammals, particularly humans.
See all 10 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.

  • Composition of Matter 4 patents
  • Method of Use 4 patents
  • Formulation 2 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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