ADDERALL XR - ADHD
Sales of ADDERALL XR for the three months to March 31, 2009 were $295.8 million, an increase of 13% compared to the same period in 2008 (2008: $261.5 million). Product sales grew due to price increases, which offset the negative impact of significantly higher sales deductions in Q1 2009, declining US prescriptions (down 5% compared to Q1 2008), and wholesaler de-stocking.
The increase in sales deductions in Q1 2009 to 37% of gross sales (2008: 24%) results from two factors: (i) a higher Medicaid rebate reserve on wholesale and retail pipeline inventory, as a consequence of shipment of authorized generic ADDERALL XR to Teva in April 2009 and the impact of including these shipments in the Medicaid rebate calculation pursuant to the Deficit Reduction Act of 2005; and (ii) a reserve on pipeline inventory for larger rebates offered to managed care organizations from April 1, 2009.
On April 2, 2009 Teva announced that it had commenced commercial shipment of its generic version of ADDERALL XR. As anticipated and reflected in our 2009 guidance framework, sales of ADDERALL XR will decrease significantly due to generic competition.
VYVANSE - ADHD
Sales of VYVANSE for the three months to March 31, 2009 increased by 114% to $116.6 million (2008: $54.4 million), with VYVANSE's average share of the US ADHD market for Q1 2009 increasing to 11.5% (2008: 6.1%). US prescriptions of VYVANSE increased by 102% in Q1 2009 over the same period in 2008, due to the increase in average share and 8% growth in the US ADHD market.
On February 24, 2009 Actavis Elizabeth LLC ("Actavis") brought a lawsuit
against the FDA seeking to overturn the FDA's decision granting new chemical
entity exclusivity to VYVANSE. Shire believes the FDA's decision was correct.
VYVANSE has new chemical entity exclusivity through
|SOURCE Shire Plc|
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