Patent estate

AM REGENT — Patent Portfolio

1 drug with active patents · 24 active patents · 0 expired · 0 biologics with BPCIA exclusivity

AI-enriched 24/24 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 AM REGENT portfolio is moderately strong, with a significant cliff year in 2027 and no revenue at risk in the next 5 years.

Portfolio overview The AM REGENT portfolio consists of a total of 2 drugs, with 1 of them having patents. The portfolio has a total of 24 US patents, all of which are active. The average vulnerability score is 75, indicating a moderate level of vulnerability. The portfolio has 2 ironclad patents and 20 vulnerable patents. There are no biologics in the portfolio.

Cliff calendar In 2027, 1 drug will lose exclusivity, including Injectafer. This marks a significant cliff year for the company. Additionally, the company should be aware of the potential loss of exclusivity for other drugs in the future.

Most exposed drugs The top drug facing near-term loss of exclusivity is Injectafer, with an earliest active patent expiry date of 2027-01-08 and an average vulnerability score of 75. This drug has a patent count of 24 and is currently generating revenue. The annual revenue for Injectafer is not available.

Biologic exclusivity There are no biologics in the portfolio, and therefore, 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 Injectafer in 2027 will require the company to consider lifecycle moves, such as subQ switches or label extensions, to maintain 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

Injectafer (FERRIC CARBOXYMALTOSE)

Cliff 2027 · 1y
Method of Use 20 Composition of Matter 4
  • US11478502 Vuln 88 2027-01-08
    This patent protects a method of treating iron-related conditions using a single unit dosage of at least 0.6 grams of elemental iron via an iron carbohydrate complex.
  • US11478502 Vuln 88 2027-01-08
    This patent protects a method of treating iron-related conditions using a single unit dosage of at least 0.6 grams of elemental iron via an iron carbohydrate complex.
  • US11478502 Vuln 88 2027-01-08
    This patent protects a method of treating iron-related conditions using a single unit dosage of at least 0.6 grams of elemental iron via an iron carbohydrate complex.
See all 24 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 20 patents
  • Composition of Matter 4 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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