2023-03-29 06:54:35 ET
Neurocrine Biosciences ( NASDAQ: NBIX ) announced late Tuesday that Teva Pharmaceutical ( NYSE: TEVA ) has agreed to delay the launch of generic versions of its tardive dyskinesia therapy Ingrezza, resolving a patent dispute between the two.
In 2017, the U.S. greenlighted the once-daily medication known as valbenazine in generic terms as the first FDA-approved therapy for movement disorder tardive dyskinesia.
However, a legal battle between Teva and Neurocrine ( NBIX ) started when the former sought to introduce generics of Ingrezza by filing an abbreviated new drug application before the expiry of the company’s Orange Book listed patents.
Under the settlement agreement signed on Tuesday, Neurocrine ( NBIX ) has offered Teva ( TEVA ) the rights to launch its generic versions in the U.S. starting February 01, 2040, or earlier under certain conditions.
The Federal Trade Commission and the Department of Justice have yet to review the agreement.
Similar litigations between Neurocrine ( NBIX ) and three other parties over the market entry of generic Ingrezza are set to go into trial on January 02, 2024.
In the tardive dyskinesia market, Teva ( TEVA ) competes against Neurocrine ( NBIX ) with Austedo, which the FDA approved for adults with tardive dyskinesia in 2017.
Read: Seeking Alpha contributor Sean Daly argues that Neurocrine ( NBIX ) can fund its pipeline development from free cash flow from Ingrezza TD without needing further dilutive financing.
For further details see:
Teva in pact with Neurocrine to delay Ingrezza generics