- The United States District Court for the District of Delaware ruled that Alvogen's generic version of Suboxone Film did not infringe upon three patents ('514, '150, and '497) held by Indivior PLC.
- As of March 22, the Food and Drug Administration has not given marketing authorization to Alvogen's copycat of the opioid addiction treatment. And Indvior warned in a statement that any launch of the generic alternative would be considered "at risk," allowing Indivior to sue for damages.
- The patent decision will likely hurt Invidior's business, as the film is responsible for a large portion of the company's revenue. The company said the ruling would result in a "rapid and material loss of market share."
Suboxone (buprenorphine and naloxone), a medication-assisted therapy (MAT) for opiate addiction, is highly prescribed. Available in film and tablet form, it is a partial opiate receptor agonist that replaces the opioid and helps treat addiction.
In a February financial statement, Indivior said Suboxone Film had an average market share of 57% in 2017. This was lower than it was in 2016, which the company said was due to price-sensitive payers selecting cheaper oral tablets over Indivior's sublingual film.
The company said in the earnings statement that its revenues "are expected to be primarily derived from sales of Suboxone Film and Sublocade and any decrease in sales due to competition or supply or quality issues could significantly affect the results of operations and prospects."
With so much of its $1 billion in total revenues on the line, Indivior responded to the court's decision by saying it will appeal the ruling. But it acknowledged that if Alvogen moves forward with an "at-risk" launch, Invidior "may have increased difficulty successfully defending its intellectual property against future ANDA filers."
In previous lawsuits, the court determined Actavis and Par infringed Invidior's '514 patent, and as a result, Actavis and Par are currently barred from launching a generic product until April 2024. But Actavis was already granted tentative FDA approval in October 2017 for at least its 8 mg/2 mg generic, and in November 2017, the company received tentative approval for its 12 mg/3 mg generic.
Teva Pharmaceutical Industries Ltd. and Dr. Reddy's are also involved in lawsuits with Indivior on patents covering generic Suboxone Film. There was a non-infringement ruling for both of these firms, although Indivior is appealing. Novartis AG's Sandoz has abandoned its generic version and Mylan filed a petition seeking an inter partes review (IPR) of the '514 and '497 patents, but ended up settling.
In addition, Indivior has asserted two new Orange-Book listed patents (the '454 and '221 patents) against Alvogen and certain other ANDA filers claiming infringement (including Dr. Reddy's, Actavis, Par and Teva). The '221 patent covers the uniform distribution of the active drug across a polymer film.
Indivior's patent challenges are happening across the backdrop of the opioid crisis. The National Institute on Drug Abuse estimates that 115 Americans die from overdosing on opioids daily. The government has been calling for more options for treating addiction. Currently, there are only four FDA-approved drugs that are indicated for opioid-use disorder — two opioid replacement therapies and two opioid receptor antagonists.