Alvogen, has launched its generic equivalent to Suboxone® sublingual film (buprenorphine hydrochloride/naloxone hydrochloride) in the U.S., which will be available in 2mg/0.5 mg, 4mg/1mg, 8 mg/2mg, and 12 mg/3mg strengths.
The launch took place, pursuant to a 31 January 2019 agreement between Alvogen and Indivior, following the issuance of a mandate from the U.S. Court of Appeals for the Federal Circuit vacating the preliminary injunction that had previously been granted enjoining Dr. Reddy’s Laboratories from marketing its product.
Lisa Graver, President of Alvogen Americas, commented:
Suboxone sublingual film is indicated for treatment of opioid dependence. U.S. sales for Suboxone were approximately $1.1 billion in 2018, based on Indivior SEC Filings.
Alvogen currently has 75 products in development and pending FDA approval for the U.S. market. Annual brand sales for filed products and those under development have current brand sales exceeding $35 billion, according to IMS IQVIA (2018).
*Suboxone is a registered trademark of Indivior UK LLC.