Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) has launched the generic equivalent of Lovenox (enoxaparin sodium injection) in seven injectable dosage strengths in the US. Enoxaparin Sodium Injection, USP is used for prophylaxis of deep vein thrombosis (DVT) in patients undergoing abdominal surgery, hip or knee replacement surgery, or in medical patients with severely restricted mobility during acute illness; and also for the treatment of acute DVT. Lovenox had annual sales of $1.8 billion in the US, according to IMS data as of November 2014. Under a licensing agreement, Teva has partnered with Chemi SPA to leverage their internal research based technology in the development and manufacture of Enoxaparin Sodium Injection, USP.
Teva has also launched the generic equivalent to Zyvox (linezolid) injection. which is used for the treatment of infections caused by Gram-positive bacteria. Zyvox injection had annual sales of $464 million in the US, according to IMS data as of October 2014.
Teva Global Generic Medicines president and CEO Siggi Olafsson said, “Teva is committed and focused on building a stronger generic injectable business globally. With the launch of Enoxaparin Sodium Injection, USP and Linezolid Injection, accompanied by the reintroduction of three generic injectable products, we are leveraging the strength of our internal and external resources to deliver the right portfolio as part of our growth strategy. As the number one generics company in the world, we can quickly bring a range of high-quality, cost-effective generic injectable treatments to patients within the doctor’s office, hospital, or clinic.”
Teva said that it is continuing to invigorate its injectable business in the US with a selective reintroduction of older generic injectable products as well as continued investment in newer, higher-value generic injectable products. Teva added that it is also progressing in building its R&D capabilities in complex, generic injectables including drug-device combinations, complex drug delivery, and complex molecules. This month, Teva has launched Nafcillin for Injection, USP and is reintroducing into the market Leucovorin Calcium for Injection (100 mg/vial), Methylprednisolone Acetate Injectable Suspension, USP (40 mg/mL), and Ondansetron Injection, USP (2 mg/mL).
As of January 22, 2015, Teva had 120 product registrations pending FDA approval, including 29 tentative approvals. Collectively, these 120 products had U.S. sales in 2014 exceeding $86 billion. Of these applications, 87 were “Paragraph IV” applications challenging patents of branded products; 42 of these pending ANDAs are potential first-to-file opportunities.
Published by Globes [online], Israel business news - www.globes-online.com - on February 18, 2015
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