Teva Pharmaceutical Industries, a leading global pharmaceutical company, announced the launch of the generic equivalent of Lovenox (enoxaparin sodium injection) in seven dosage strengths in the United States. Enoxaparin s 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 approximately $1.8 billion in the United States, 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 recently 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 approximately $464 million in the United States, according to IMS data as of October 2014.
“Teva is committed and focused on building a stronger generic injectable business globally,” said Siggi Olafsson, president and chief executive officer, of Teva Global Generic Medicines. “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 continues to invigorate the injectable business in the United States with a selective reintroduction of older generic injectable products as well as continued investment in newer, higher-value generic injectable products. Additionally, Teva has progressed in building its research and development 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 US 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.
Enoxaparin sodium injection USP, is indicated for prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE) in patients undergoing abdominal surgery who are at risk for thromboembolic complications; undergoing hip replacement surgery, during and following hospitalization; undergoing knee replacement surgery; or who are at risk for thromboembolic complications due to severely restricted mobility during acute illness.
Inpatient treatment of acute DVT with or without PE, when administered in conjunction with warfarin sodium.
Outpatient treatment of acute DVT without PE, when administered in conjunction with warfarin sodium. Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction, when concurrently administered with aspirin.
Treatment of acute ST-segment elevation myocardial infarction (STEMI) managed medically or with subsequent percutaneous coronary intervention.