UK-based pharmaceutical company Indivior has launched a generic version of its Suboxone (buprenorphine and naloxone) sublingual film in the US for the treatment of opioid dependence.
Novartis subsidiary Sandoz will market and distribute the authorised generic drug on behalf of Indivior.
The prescription medicine is available in four dosage strengths and is indicated for use as part of a complete treatment plan, including counselling and psychosocial support.
Indivior CEO Shaun Thaxter said: “We are making an authorised generic of our Suboxone Film brand product available to patients and providers immediately, giving them yet another option of medication-assisted treatment for opioid dependence.
“In addition, we expect this launch will create the opportunity to maximise the value of our Suboxone Film franchise.”
The launch comes soon after the US Supreme Court rejected Indivior’s request and upheld the Court of Appeals for the Federal Circuit’s decision to allow launch of cheaper generic versions of the product from other companies.
In November last year, the US Court of Appeals lifted a preliminary injunction that had prevented Indian drug maker Dr. Reddy’s from marketing its generic version.
Later, the US District Court for the District of New Jersey dissolved the temporary restraining order against Alvogen Pine Brook and confirmed the lifting of injunction against Dr. Reddy’s.
The latest Supreme Court decision upholds these rulings, allowing Dr. Reddy’s and Alvogen to sell or import their generic Suboxone sublingual film products in the country.
IQVIA reported that Suboxone generated around $2bn in US sales for the period ending December 2018. Reuters noted that Indivior could lose nearly 80% of its Suboxone film market share upon commercial launch of the generic versions.