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Related Concept Videos

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In many practical and theoretical contexts, the exact value of a definite integral may be inaccessible. This limitation typically arises when the antiderivative of a function is either unknown or cannot be expressed in a closed mathematical form. Alternatively, it can occur when a function is defined not by a formula but by a finite set of empirical data points, such as those collected during experiments. In these cases, approximate integration techniques provide a valuable solution.One of the...
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Linearization is a mathematical technique used to approximate complex, nonlinear functions with simpler linear models in the vicinity of a chosen reference point. The method is based on the idea that, although a function may be difficult to evaluate exactly, its behavior near a specific input value can often be closely approximated by the tangent line at that point. This approach is particularly useful when small deviations from a known value are involved.Consider the square root function, for...
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Related Experiment Video

Updated: Feb 1, 2026

Generic Protocol for Optimization of Heterologous Protein Production Using Automated Microbioreactor Technology
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A Method for Approximating Future Entry of Generic Drugs.

Reed F Beall1, Jonathan J Darrow1, Aaron S Kesselheim1

  • 1Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.

Value in Health : the Journal of the International Society for Pharmacoeconomics and Outcomes Research
|December 4, 2018
PubMed
Summary

A new method accurately predicts market exclusivity for top-selling drugs with active ingredient patents. However, it overestimates exclusivity for drugs relying solely on secondary patents, impacting generic entry timing predictions.

Keywords:
FDAdrug costsdrug legislationdrug regulationgeneric drugspharmaceutical patents

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Area of Science:

  • Pharmaceutical Sciences
  • Intellectual Property Law
  • Health Economics

Background:

  • Accurately predicting generic drug entry is crucial for market analysis and healthcare policy.
  • Understanding drug patent lifecycles and regulatory exclusivities informs market exclusivity periods.

Purpose of the Study:

  • To develop and validate a method for approximating the generic entry timing of top-selling drugs.
  • To assess the accuracy of predicted market exclusivity periods against actual data.

Main Methods:

  • Identified key patents using US Food and Drug Administration (FDA) patent register and extensions.
  • Determined other regulatory exclusivities associated with each drug.
  • Categorized patents as active ingredient or secondary.
  • Tested the prediction method against a database of 170 top-selling drugs with known generic entry dates (2000-2012).

Main Results:

  • The method predicted a median market exclusivity of 12.5 years, matching the actual median.
  • For drugs with active ingredient patents, predictions closely matched actual exclusivity (median 12.25 vs. 13.0 years).
  • For drugs with only secondary patents, predictions substantially overestimated actual exclusivity (median 16.0 vs. 8.25 years).

Conclusions:

  • The developed procedure reasonably approximates market exclusivity for drugs with active ingredient patents.
  • The method significantly overestimates market exclusivity for drugs protected solely by secondary patents.
  • Refinements are needed for accurate prediction of generic entry for drugs with secondary patent protection.