The U.S. Food and Drug Administration (FDA) has given final approval for Zydus Cadila to market Mesalamine Delayed–Release Tablets USP, a generic version of Lialda, in the U.S. to treat ulcerative colitis (UC).
The announcement follows news in May that Zydus had won a court battle over Shire’s patent for Lialda. The U.S. Court of Appeals for the Federal Circuit ruled that Zydus’ proposed generic version of Lialda does not infringe upon Shire’s patent covering the drug.
Zydus, owned by India’s Cadila Healthcare, was the first company that questioned Shire’s rights to Lialda by filing an abbreviated new drug application with the FDA for a generic version of Lialda in 2010, according to reporting by Law360.
Mesalamine is a compound that has been around for years and is not patent protected. Shire’s patent covers the release mechanism, allowing the drug to travel through the intestines untouched until it reaches the colon. U.S. Patent No. 6,773,720 protects this delayed-release mechanism.
Lialda, developed and commercialized by Shire, is currently approved for the induction of remission in patients with active mild-to-moderate ulcerative colitis. It can also be used for the maintenance of remission. The recommended dosage for the induction of remission in adult patients with active mild to moderate UC is two to four 1.2–gram tablets taken once daily with a meal for a total daily dose of 2.4 grams or 4.8 grams.
The recommended dosage for the maintenance of remission is two 1.2–gram tablets taken once daily with a meal for a total daily dose of 2.4 grams.
According to Zydus estimates, brand sales for Mesalamine Delayed-Release Tablets USP, 1.2 grams, could be as high as $1.1 billion. The generic version of Lialda will be produced at the Moraiya plant in Ahmedabad, India.
UC is an inflammatory bowel disease (IBD) that causes long–lasting inflammation and ulcers in the digestive tract. The disease affects the innermost lining of the large intestine and rectum. Symptoms usually develop over time rather than suddenly. UC can be debilitating and lead to life–threatening complications. While currently there is no cure, treatment can reduce signs and symptoms of the disease.