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Data exclusivity for biologics

An Erratum to this article was published on 01 June 2011

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Figure 1: Cumulative net present value (NPV) of cash flows for a representative biologic with various scenarios for market exclusivity.
Figure 2: Influence of data exclusivity and patent protection on break-even points for a representative biologic portfolio.


  1. Title VII of the Patient Protection and Affordable Care Act of 2010, Pub. L. No. 111–48, Improving Access to Innovative Medical Therapies—Subtitle (2010).

  2. Grabowski, H. Follow-on biologics: data exclusivity and the balance between innovation and competition. Nature Rev. Drug Discov. 7, 479–488 (2008).

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  3. Federal Trade Commission (FTC). Emerging Health Care Issues: Follow-on Biologic Drug Competition. Federal Trade Commission Report | June 2009. FTC website [online], (2009).

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Correspondence to Henry Grabowski.

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The authors declare no competing financial interests.

Supplementary information

Supplementary information Box S1

Details of modelling and analysis (PDF 356 kb)

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Grabowski, H., Long, G. & Mortimer, R. Data exclusivity for biologics. Nat Rev Drug Discov 10, 15–16 (2011).

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