US generic drugmaker Mylan (Nasdaq: MYL) and its subsidiary, Mylan Pharmaceuticals have entered into a settlement agreement with Somaxon Pharmaceutical (Nasdaq: SOMX) that will resolve their ' patent litigation in connection with Mylan Pharmaceuticals' Abbreviated New Drug Application for doxepin hydrochloride tablets, 3mg and 6mg, which is the generic version of Somaxon's Silenor, indicated for the treatment of insomnia characterized by difficulty with sleep maintenance.
Somaxon, which also settled with Par Pharmaceuticals, saw its shares leap 146% on the news. Silenor is the only source of revenue for the company and the drug is expected to generate sales of about $2.8 million to $2.9 million in the second quarter, the company said.
According to the terms of the accord, Mylan has the exclusive right to sell an authorized generic version of Silenor in the USA and its territories for 180 days beginning on January 1, 2020. In certain limited circumstances, Somaxon's license to Mylan would become effective prior to January 1, 2020. Mylan's right to sell the authorized generic product could extend for as long as 360 days, and after such period Mylan will have the right to sell a generic version of Silenor under its own ANDA.
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
7 day trial access
Become a subscriber
Or £77 per month
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze