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Margins
Generic: Margins in the generic segment for the second quarter of 2008 and the first six months of 2008 were 45% and 47%, respectively, compared to 49% and 47%, respectively, in the prior year periods.
Proprietary: Margins in the proprietary segment for both the second quarter of 2008 and the first six months of 2008 were 69%, down from 78% and 72% in the prior year periods, respectively, principally due to higher product amortization.
Update on R&D Activities
Research and development expenses totaled $81 million for the second quarter of 2008, compared to $66 million in the prior year period. R&D for the first six months of 2008 totaled $145 million, compared to $129 million for the prior year period. The increases reflect greater investment in generic and bio-generic development activities, both in the U.S. and Europe, as well as in proprietary development activities in the United States and the impact of foreign currency exchange.
Generic Products
At June 30, 2008, the Company had approximately 70 Abbreviated New Drug Applications, including tentatively approved applications, pending at the U.S. Food and Drug Administration (FDA) targeting branded pharmaceutical products with an estimated $29 billion in sales. The Company also had approximately 350 product registrations, representing 89 molecules, pending with regulatory bodies in Europe and ROW.
During the second quarter of 2008, the Company received two generic product approvals in the U.S. from the FDA, and approximately 20 approvals, representing 13 molecules, from regulatory bodies in Europe and ROW.
Proprietary Products
The Company currently has an extensive proprietary clinical development
program that includes four products in Phase III studies and
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