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Market Exclusivity Strategies for Pharmaceuticals

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Abstract

Drug and biological inventions have shorter periods of exploitation than typical commercial products because their long development cycles subtract from the uniform 20 years-from-filing patent longevity. However, in the US, market exclusivity for new drugs and biologicals need not derive solely from such patents. Understanding how additional exclusivity may be obtained, due to statutory provisions for new products, patent-term restoration for US Food and Drug Administration (FDA) review times, orphan drug designation, paediatric research, and being a first-to-market bioequivalent, is essential to maximize innovator revenues during the lifespan of a given product. Non-patent types of market exclusivity also often have a complex relationship with the part of the statute that theFDArelies upon in order to grant original or supplemental marketing approval.

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Notes

  1. The author has no direct knowledge of the strategic development path for Brevibloc®. The example described represents a theoretical plan that has been created based upon publicly available information.

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Acknowledgements

The author has no conflicts of interest that are directly relevant to the content of this review. No sources of funding were used to assist in the preparation of this review.

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  1. Conatus Pharmaceuticals, 4365 Executive Drive, Suite 200, San Diego, California, 92121, USA

    Cynthia Luchetti

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  1. Cynthia Luchetti
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Correspondence to Cynthia Luchetti.

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Luchetti, C. Market Exclusivity Strategies for Pharmaceuticals. Pharm Med 23, 77–84 (2009). https://doi.org/10.1007/BF03256753

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