Esperion reaches settlement restricting Renata’s U.S. generic NEXLETOL and NEXLIZET launch
- Esperion (NASDAQ:ESPR) reached a settlement with Renata and an affiliate over U.S. generic versions of NEXLETOL and NEXLIZET.
- Renata agreed not to market the generic drugs before April 19, 2040, subject to limited exceptions under the agreement.
- Patent litigation continues against Aurobindo, MSN Pharmaceuticals and Sandoz.
Esperion Therapeutics (NASDAQ:ESPR) entered into a settlement agreement with Renata and an affiliate resolving patent litigation concerning proposed generic versions of NEXLETOL and NEXLIZET in the United States.
Under the agreement, Renata agreed not to market generic versions of either medicine in the U.S. before April 19, 2040, unless certain limited circumstances specified in the settlement occur.
The agreement resolves litigation related to Renata’s Abbreviated New Drug Applications (ANDAs), which seek regulatory approval to market generic versions of NEXLETOL and NEXLIZET before the expiration of applicable patents.
Esperion said Renata is the sixth generic drug applicant to reach a settlement concerning the patents covering the two medicines.
However, the company’s broader patent litigation remains ongoing.
Esperion continues to litigate against Aurobindo Pharma and an affiliate, MSN Pharmaceuticals and an affiliate, and Sandoz.
The remaining litigation means the timing of potential generic competition in the U.S. remains uncertain.
Esperion said the settlement with Renata does not resolve the outstanding cases, and the outcome of the remaining patent disputes could affect whether generic versions of NEXLETOL or NEXLIZET enter the U.S. market before April 19, 2040.
NEXLETOL and NEXLIZET are Esperion’s cholesterol-lowering medicines, making the timing of potential generic competition an important consideration for the company’s commercial outlook.
