Research & Development
Teva Launches of a Generic Version of Delzicol Delayed-Release Capsules in the United States
16 May 2019 - - Israeli generic drug specialist Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) (TASE: TEVA) TODAY announced the launch of a generic version of Delzicol (mesalamine) delayed-release capsules, 400 mg, in the US, the company said.

Mesalamine Delayed-Release Capsules are an aminosalicylate indicated for the treatment of mildly to moderately active ulcerative colitis in patients five years of age and older, and for the maintenance of remission of ulcerative colitis in adults.

Teva EVP and Head of North America Commercial, Brendan O'Grady said, "Ulcerative colitis is a chronic inflammatory bowel disease and we're proud to provide another treatment option for patients."
Mesalamine Delayed-Release Capsules further enhance Teva's already-comprehensive portfolio of medicines to treat gastrointestinal disorders.

With nearly 500 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 US.

Currently, one in eight generic prescriptions dispensed in the US is filled with a Teva generic product.

Delzicol delayed-release capsules have annual sales of approximately USD 130m in the US, according to IMS data as of February 2019.

Mesalamine Delayed-Release Capsules are indicated for the treatment of mildly to moderately active ulcerative colitis in patients five years of age and older and for the maintenance of remission of ulcerative colitis in adults.

Mesalamine Delayed-Release Capsules are contraindicated in patients with known or suspected hypersensitivity to salicylates or aminosalicylates or to any of the ingredients of Mesalamine Delayed-Release Capsules.

Renal impairment, including minimal change nephropathy, acute and chronic interstitial nephritis, and renal failure, has been reported in patients taking 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.

Hypersensitivity reactions have been reported in patients taking sulfasalazine. Some patients may have a similar reaction to mesalamine or to other compounds that contain or are converted to mesalamine. There have been reports of hepatic failure in patients with preexisting liver disease who have been administered mesalamine.

The most common adverse reactions in clinical trials were eructation, abdominal pain, constipation, dizziness, rhinitis, back pain, and rash in adults; and nasopharyngitis, headache, abdominal pain, dizziness, sinusitis, rash, cough, and diarrhea in pediatrics.

Teva Pharmaceutical Industries is in generic and specialty medicines with a portfolio consisting of over 35,000 products in nearly every therapeutic area.
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