Indivior announced the settlement agreement on Monday, May 14. It will now be submitted to the US Federal Trade Commission and the US Department of Justice for review.
Indivior produces and owns the patents for Subutex (buprenorphine) and Suboxone (buprenorphine and naloxone), which are both substitution drugs for opiate addiction.
Par, part of Endo International, sought to produce and sell generic versions of the Suboxone drug. Par filed an Abbreviated New Drug Application (ANDA) at the US Food and Drug Administration, to obtain approval to market the generic drug.
In response, Indivior filed a patent infringement complaint against Par at the US District Court for the District of Delaware.
Under the agreement reached between the parties, Par will not market its generic version of Suboxone until 2023. Other terms of the settlement have not been made public.
Shaun Thaxter, CEO of Indivior, said the company is “pleased” to have amicably settled the matter.
Indivior has been involved in a number of disputes centring on its Suboxone drug.
Earlier this year the Delaware district court found that a drug developed by generics maker Alvogen does not infringe three patents relating to Suboxone. Indivior said it intends to appeal against the ruling.
In September last year, Indivior settled a Suboxone dispute with Mylan. Indivior had sued Mylan at the US District Court for the Northern District of West Virginia after Mylan filed an ANDA to obtain approval for its generic version of Suboxone.
In the same month, Indivior suffered a loss at the Delaware court. The court ruled that proposed generic products by Dr. Reddy’s, Watson (Actavis) and Par do not infringe the same three patents Indivior asserted against Alvogen.
Did you enjoy reading this story? Sign up to our free daily newsletters and get stories sent like this straight to your inbox.
Suboxone, ANDA, Indivior, Par, Endo International, settlement, patent infringement, generics manufacturer