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Alvogen Launches Generic Equivalent to Suboxone® (Buprenorphine/Naloxone) Sublingual Film

20 febbraio 2019 | 15.55
LETTURA: 2 minuti

PINE BROOK, New Jersey, Feb. 20, 2019 /PRNewswire/ -- Global pharmaceutical company, 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: "We are excited to launch this important product that will empower patients suffering from opioid dependence. The launch demonstrates a significant commitment from our teams to bringing affordable generic medicines to the market."

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. 

Please click here for full Prescribing Information including Medication Guide.

About Alvogen

Alvogen is a global, privately owned pharmaceutical company focused on developing, manufacturing and selling generic, brand, over-the-counter medicines (OTC) and biosimilar products for patients around the world.  The company has commercial operations in 35 countries with 2,800 employees and operates four manufacturing and development hubs in the U.S., Romania, Korea and Taiwan. North America is Alvogen's single largest market and other key markets include: South Korea, Russia, Taiwan, Romania, Hungary, Ukraine, Japan and China.

Learn more about Alvogen on www.alvogen.com

Media Contact

Halldor Kristmannsson Global Corporate Marketing & CommunicationsTel: (+354) 522 2900Email: halldor.kristmannsson@alvogen.com 

 

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