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Endo’s Par Opts For Authorized Generic As It Debuts Lubiprostone In US

Multiple ANDA Sponsors Waiting In The Wings

 
• By Dean Rudge

Endo’s Par has introduced the first generic version of Mallinckrodt’s chronic idiopathic constipation medicine Amitiza, realizing the terms of a settlement agreement announced more than six years ago.

Racing
Endo's Par has a settlement that put it years ahead of ANDA rivals. • Source: Shutterstock

Endo’sPar Pharmaceutical unit has introduced the first generic version of Mallinckrodt’s Amitiza (lubiprostone) 8mcg and 24mcg soft gel capsules in the US, an authorized generic, years ahead of several potential abbreviated new drug application rivals.

More than six years ago, before Endo acquired Par and Mallinckrodt acquired Amitiza developer Sucampo, Par and its Anchen Pharmaceuticals subsidiary agreed to settle Paragraph IV ANDA

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