Regulatory Affairs

Indivior files patent lawsuits against Teva, Dr Reddy's and others

Published 06 April 2018

Indivior has filed patent lawsuits against Dr. Reddy's, Actavis, Par, Alvogen and Teva for infringement of United States Patent No. 9,931,305 (the '305 patent) relating to their respective proposed generic versions of the company's Suboxone (buprenorphine and naloxone) sublingual film product.

These lawsuits allege that the aforementioned companies infringe the '305 patent, which was issued on April 3rd and has been submitted for listing in the FDA's Orange Book.

The '305 patent claims film compositions having a substantially uniform distribution of active drug. Indivior has been involved in patent infringement litigation involving other, earlier issued patents covering SUBOXONE® Film with these same companies relating to their proposed generic products.

Indivior CEO Shaun Thaxter said: "The '305 patent, along with the other new Orange Book patents that we secured (the '454 and '221 patents), demonstrates our commitment to innovate and generate new intellectual property for the SUBOXONE® Film.

“As a follow-on to our '514 patent, we believe this new patent is strong and we are asserting it to protect our intellectual property rights."

Indivior is a global specialty pharmaceutical company with a 20-year legacy of leadership in patient advocacy and health policy while providing education on evidence-based treatment models that have revolutionized modern addiction treatment.

The name is the fusion of the words individual and endeavour, and the tagline "Focus on you" makes the Company's commitment clear. Indivior is dedicated to transforming addiction from a global human crisis to a recognized and treated chronic disease.

Building on its global portfolio of opioid dependence treatments, Indivior has a strong pipeline of product candidates designed to both expand on its heritage in this category and address other chronic conditions and co-occurring disorders of addiction, including alcohol use disorder and schizophrenia.

Source: Company Press Release