Teva Pharmaceutical Industries Limited announced the launch of a generic version of Lialda®1 (mesalamine) delayed-release tablets, 1.2 g, in the U.S.
Mesalamine delayed-release tablets are indicated for the induction of remission in adults with active, mild to moderate ulcerative colitis and for the maintenance of remission of ulcerative colitis.
“The launch of mesalamine is a significant addition to Teva’s generic portfolio,” said Brendan O’Grady, Executive Vice President and head of North America Commercial at Teva. “With more than a million people in the U.S. estimated to suffer from inflammatory bowel diseases, including ulcerative colitis,2 this is an important and more affordable generic treatment option for our customers.”
Mesalamine further enhances Teva’s already-comprehensive anti-inflammatory portfolio. With nearly 600 generic medicines available, Teva has the largest portfolio of FDA-approved generic products on the market and holds the leading position in first-to-file opportunities, with over 100 pending first-to-files in the U.S. Currently, one in seven generic prescriptions dispensed in the U.S. is filled with a Teva generic product.
Mesalamine Delayed-Release Tablets, 1.2 g had annual sales of approximately $1.11 billion in the U.S., according to IMS data as of January 2018.
About Mesalamine Delayed-Release Tablets
Mesalamine delayed-release tablets are indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis and for the maintenance of remission of ulcerative colitis.
Important Safety Information
Mesalamine delayed-release tablets are contraindicated in patients with known hypersensitivity to salicylates or aminosalicylates or to any of the ingredients of mesalamine delayed-release tablets.
Renal Impairment, including minimal change nephropathy, acute and chronic interstitial nephritis, and, rarely, renal failure, has been reported in patients given products that contain mesalamine or are converted to mesalamine. Mesalamine has been associated with an acute intolerance syndrome that may be difficult to distinguish from an exacerbation of ulcerative colitis.
Some patients who have experienced a hypersensitivity reaction to sulfasalazine may have a similar reaction to compounds that contain or are converted to mesalamine. Mesalamine-induced cardiac hypersensitivity reactions (myocarditis and pericarditis) have been reported with mesalamine delayed-release tablets and other mesalamine medications. There have been reports of hepatic failure in patients with pre-existing liver disease who have been administered mesalamine.
Pyloric stenosis or other organic or functional obstruction in the upper gastrointestinal tract may cause prolonged gastric retention of mesalamine which would delay mesalamine release in the colon. The most common adverse reactions (incidence greater than or equal to 2 %) in clinical trials were ulcerative colitis, headache, flatulence, liver function test abnormality, and abdominal pain.
For more information, please see accompanying full Prescribing Information.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading global pharmaceutical company that delivers high-quality, patient-centric healthcare solutions used by millions of patients every day. Headquartered in Israel, Teva is the world’s largest generic medicines producer, leveraging its portfolio of more than 1,800 molecules to produce a wide range of generic products in nearly every therapeutic area. In specialty medicines, Teva has a world-leading position in innovative treatments for disorders of the central nervous system, including pain, as well as a strong portfolio of respiratory products. Teva integrates its generics and specialty capabilities in its global research and development division to create new ways of addressing unmet patient needs by combining drug development capabilities with devices, services and technologies. Teva’s net revenues in 2017 were $22.4 billion. For more information, visit www.tevapharm.com.
