Nippon Shinyaku Co., Ltd. — Patent Portfolio
1 drug with active patents · 15 active patents · 0 expired · 0 biologics with BPCIA exclusivity
Verdict Nippon Shinyaku Co., Ltd.'s portfolio is at risk of significant revenue loss in 2026 due to the loss of exclusivity for Cytarabine, with no ironclad patents and a high average vulnerability score of 51.
Portfolio overview Nippon Shinyaku Co., Ltd. has a relatively small portfolio with a total of 2 drugs, of which only 1 has patents. The company has a total of 15 US patents, all of which are active, with no expired patents. The average vulnerability score of 51 indicates a high level of patent vulnerability. The company has no ironclad patents and no vulnerable patents, and no biologics with BPCIA exclusivity.
Cliff calendar In 2026, 1 drug will lose exclusivity, including Cytarabine. This marks the beginning of a significant cliff year for the company.
Most exposed drugs The top drug facing near-term loss of exclusivity is Cytarabine, with an earliest active patent expiry date of 2026-06-07, an average vulnerability score of 51, and no annual revenue data available. This drug has 15 patents and is the only drug in the portfolio with patents.
Biologic exclusivity Nippon Shinyaku Co., Ltd. has no biologics in its portfolio, and therefore has no BPCIA 12-year reference product exclusivity to consider.
Strategic implications The company's revenue at risk in the next 5 years is $0, indicating that there are no biologics with BPCIA exclusivity in the portfolio. However, the loss of exclusivity for Cytarabine in 2026 may prompt the company to consider lifecycle moves such as subQ switches, label extensions, or combination filings to maintain revenue.
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
Cytarabine (Cytarabine)
Cliff 2026 · 0y-
US7850990
Vuln 63
2027-01-23
This patent protects compositions that deliver non-antagonistic combinations of two or more agents, such as antineoplastic agents, like Cytarabine.
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US7850990
Vuln 58
2027-07-23
This patent protects compositions that deliver non-antagonistic combinations of two or more agents, such as antineoplastic agents, together.
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US9271931
Vuln 58
2027-07-23
This patent protects compositions that deliver non-antagonistic combinations of two or more agents, such as antineoplastic agents, together.
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.
- Other 7 patents
- Method of Use 6 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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