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Authorized Generic Entry prior to Patent Expiry: Reassessing Incentives for Independent Generic Entry

Author

Listed:
  • Silvia Appelt

    (University of Munich)

Abstract

Originators seek to mitigate the loss of monopoly power by authorizing generic entry prior to patent expiry. Off-patent competition may be adversely affected if authorized generic entry substantially lowers the attractiveness of subsequent generic entry. This study assesses the impact of authorized generic entry on independent generic entry in recent cases of patent expiry in Germany. The results of a recursive bivariate probit regression, accounting for the endogeneity of authorized generic entry, show that authorized generic entry has no significant effect on the likelihood of generic entry. Business scope expansion and rent-seeking motives drive authorized generic entry decisions.

Suggested Citation

  • Silvia Appelt, 2015. "Authorized Generic Entry prior to Patent Expiry: Reassessing Incentives for Independent Generic Entry," The Review of Economics and Statistics, MIT Press, vol. 97(3), pages 654-666, July.
    • Handle: RePEc:tpr:restat:v:97:y:2015:i:2:p:654-666
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    Citations

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    Cited by:

    1. Melissa Newham & Jo Seldeslachts & Albert Banal-Estanol, 2018. "Common ownership and market entry: Evidence from the pharmaceutical industry," Working Papers of Department of Management, Strategy and Innovation, Leuven 623896, KU Leuven, Faculty of Economics and Business (FEB), Department of Management, Strategy and Innovation, Leuven.
    2. Farasat A.S. Bokhari & Weijie Yan, 2020. "Product line extensions under the threat of entry: evidence from the UK pharmaceuticals market," Working Paper series, University of East Anglia, Centre for Competition Policy (CCP) 2020-04, Centre for Competition Policy, University of East Anglia, Norwich, UK..
    3. Izhak, Olena, 2019. "Extra costs of integrity: Pharmacy markups and generic substitution in Finland," DICE Discussion Papers 307, Heinrich Heine University Düsseldorf, Düsseldorf Institute for Competition Economics (DICE).
    4. Victoria Serra-Sastre & Simona Bianchi & Jorge Mestre-Ferrandiz & Phill O’Neill, 2021. "Does NICE influence the adoption and uptake of generics in the UK?," The European Journal of Health Economics, Springer;Deutsche Gesellschaft für Gesundheitsökonomie (DGGÖ), vol. 22(2), pages 229-242, March.
    5. Farasat A. S. Bokhari & Franco Mariuzzo & Arnold Polanski, 2020. "Entry limiting agreements: First‐mover advantage, authorized generics, and pay‐for‐delay deals," Journal of Economics & Management Strategy, Wiley Blackwell, vol. 29(3), pages 516-542, July.
    6. Yong Tan, 2019. "Dynamic Entry With Demand And Supply Side Spillovers," Contemporary Economic Policy, Western Economic Association International, vol. 37(1), pages 86-101, January.
    7. Crea, Giovanni & Galizzi, Matteo M. & Linnosmaa, Ismo & Miraldo, Marisa, 2019. "Physician altruism and moral hazard: (no) Evidence from Finnish national prescriptions data," Journal of Health Economics, Elsevier, vol. 65(C), pages 153-169.
    8. Haruo Kakehi & Ryo Nakajima, 2025. "Role of Pharmacists in Generic Pharmaceutical Adoption," Keio-IES Discussion Paper Series 2025-001, Institute for Economics Studies, Keio University.
    9. Haruo Kakehi & Ryo Nakajima, 2024. "Role of Pharmacists in Generic Pharmaceutical Adoption," Keio-IES Discussion Paper Series 2024-015, Institute for Economics Studies, Keio University.
    10. Serra-Sastre, Victoria & Bianchi, Simona & Mestre-Ferrandiz, Jorge & O’Neill, Phill, 2021. "Does NICE influence the adoption and uptake of generics in the UK?," LSE Research Online Documents on Economics 113639, London School of Economics and Political Science, LSE Library.

    More about this item

    Keywords

    patents; monopoly; generic entry; germany; recursive bivariate;
    All these keywords.

    JEL classification:

    • L12 - Industrial Organization - - Market Structure, Firm Strategy, and Market Performance - - - Monopoly; Monopolization Strategies
    • L41 - Industrial Organization - - Antitrust Issues and Policies - - - Monopolization; Horizontal Anticompetitive Practices
    • I11 - Health, Education, and Welfare - - Health - - - Analysis of Health Care Markets
    • O34 - Economic Development, Innovation, Technological Change, and Growth - - Innovation; Research and Development; Technological Change; Intellectual Property Rights - - - Intellectual Property and Intellectual Capital
    • C35 - Mathematical and Quantitative Methods - - Multiple or Simultaneous Equation Models; Multiple Variables - - - Discrete Regression and Qualitative Choice Models; Discrete Regressors; Proportions

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