Mylan/King Merger Brings Another Twist To Levothyroxine Generics
This article was originally published in The Pink Sheet Daily
Executive Summary
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
You may also be interested in...
Mylan Levoxyl Generic Clears FDA As ANDA Supplement
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.
King Denied Injunction In Levothyroxine Suit Against FDA; Mylan Faces Exclusivity Loss
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.
Synthroid, Levoxyl Generics Clear FDA; Sandoz Has Broadest Line
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.