| Brand name |
Risperdal |
| Generic name |
risperidone |
| Developer/Original owner |
Janssen Pharmaceutica (a subsidiary of Johnson & Johnson) |
| Key patents that originally protected Risperdal |
- US 5,285,223 – “Method of treating psychotic disorders with risperidone” (filed 1990, issued 1993)
- US 5,383,245 – “Risperidone and its salts” (filed 1991, issued 1994)
- US 5,411,876 – “Formulation of risperidone” (filed 1992, issued 1994)
- US 5,447,772 – “Risperidone as an anti‑nausea agent” (filed 1992, issued 1994)
|
| Primary exclusivity |
The original patents gave Janssen a 10‑year data exclusivity period (from first FDA approval in 1999) and 4‑year market exclusivity (1999‑2003). |
| Patent expiration dates |
Most of the foundational patents expired between 2007‑2009. The 10‑year data exclusivity ended in 2009. |
| Generic approval |
- 2009 – First generic risperidone (generic name “risperidone” in tablet form) approved by the FDA.
- 2010 – First generic oral solution approved.
|
| Current generic landscape (2026) |
> 30 generic manufacturers worldwide. In the U.S. the leading generic providers are Teva, Mylan (now Viatris), Sandoz, and Apotex. Prices vary but generic risperidone is typically < $2 per tablet (vs. $10‑$30 for brand). |
| Patent litigation history |
Janssen pursued several post‑approval patent challenges against generics, notably: - Janssen v. Teva – 2009–2011 – resolved via settlement and a 5‑year “patent hold” on the generic, delaying its launch.
- Janssen v. Mylan – 2011 – resulted in a $2 billion settlement and a 10‑year extension on a “formulation” patent (later found invalid by the Supreme Court in 2013 in Mylan v. Teva).
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| Why generics appeared when they did |
The expiration of the last meaningful patents and the end of the 10‑year data exclusivity unlocked the market for generics. The settlements and court rulings also created a “patent hold” period for certain generic entries, delaying their entry until 2010‑2011. |
| Current patent situation (if any) |
Janssen has no active patents covering the core molecule. However, some companies hold formulation or delivery‑system patents (e.g., a novel sustained‑release matrix) that can be used to keep certain product lines exclusive. These are often “evergreen” and can be renewed for 6–10 years. |