An Examination of Factors that Influence Patent Exclusivity Retention of Brand Drugs

IPD has released a new Data STACK Trend Report: “An Examination of Factors that Influence Patent Exclusivity Retention of Brand Drugs.”

In this report, we analyzed 141 brand drugs across 40 manufacturers that either:
- Faced first-time generic entry from January 2018 through June 2024;
- Lacked generic competition as of June 2024 despite having no unexpired patents or exclusivity remaining; or
- Whose manufacturer launched an early authorized generic (AG) through an out-licensing agreement or in-house during the period reviewed.

We analyzed the 141 brand drugs by complexity. There were 106 low-to-moderate-complexity drugs and 35 high-complexity drugs. Only 21 of the high-complexity drugs have experienced a loss-of-exclusivity (LOE) event or early AG launch, while the remaining 14 are still single-source brands. On average, the low-to-moderate-complexity LOE drugs retained approximately 11.2 years of exclusivity, while the high-complexity LOE drugs retained 18.8 years.

Among the gross sales categories reviewed for the low-to-moderate-complexity LOE drugs, the $1B+ (“blockbuster”) category had the highest maximum patent protection period (18.9 years); however, actual exclusivity was only 11.7 years, equating to a 62% exclusivity retention rate. The high-complexity blockbuster drugs also had the highest maximum patent protection period (22 years), with actual exclusivity of 18.5 years, equating to an 84% retention rate.

A formulation patent was identified as the key patent more frequently than any other patent type, followed by composition-of-matter patents, and dosing and method-of-use patents.