Mylan/King Merger Brings Another Twist To Levothyroxine Generics
This article was originally published in The Pink Sheet Daily
Mylan's launch of a generic version of the thyroid hormone levothyroxine will not be affected by the proposed acquisition of Levoxyl-manufacturer King Pharmaceuticals, Mylan maintained during a July 26 conference call
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Mylan is the only company cleared to market generics equivalent to all three market-leading levothyroxine brands: Synthroid, Unithroid and Levoxyl. Mylan’s Levoxyl generic will compete with Levo-T and Unithroid for King’s levothyroxine market share.
A D.C. federal judge declines to stay or temporarily revoke FDA approval of supplemental NDAs allowing Alara’s Levo-T and Jerome Stevens’ Unithroid to claim equivalence to Levoxyl. Mylan also is protesting FDA approval of the supplemental NDAs because the company believes it is entitled to 180-day generic exclusivity for Levoxyl.
Mylan receives the first ANDA approval for Abbott’s market-leading levothyroxine brand Synthroid. Sandoz, through a partnership with Mova, will market a levothyroxine tablet rated bioequivalent to both Synthroid and King’s Levoxyl. The approvals follow FDA’s decision to reject an Abbott citizen petition.