Lannett announced the launch of Levothyroxine Sodium Capsules USP, an authorized generic of Tirosint®.

Levothyroxine sodium is indicated for the treatment of hypothyroidism – as replacement therapy in primary, secondary, and tertiary congenital or acquired hypothyroidism. It is also indicated as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.

“Currently, we believe we are the sole provider of all 12 currently marketed dosage strengths for generic Levothyroxine Capsules,” said Tim Crew, CEO of Lannett. “We expect another supplier to enter the market with a subset of dosage strengths, in due course. Thereafter, we would be 1 of only 2 suppliers of the generic alternative for an extended period of time, given our understanding of the intellectual property estate associated with Tirosint.”

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The generic product is available as 13mcg, 25mcg, 50mcg, 75mcg, 88mcg, 100mcg, 112mcg, 125mcg, 137mcg, 150mcg, 175mcg, and 200mcg strength capsules.

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Lannett launches authorized generic of Tirosint® (levothyroxine Sodium Capsules). [press release]. Philadelphia, PA: Lannett Company, Inc; November 3, 2020.