How to select generic drug product for development?

For develop generic drug product following eight point to be consider.

  1. Patent expiration, exclusivity and legal issues.
  2. Active Pharmaceutical ingredients (API) availability.
  3. Sales and potential market share/volume.
  4. Technology. 
  5. Formulation.
  6. Experience.
  7. Timing.
  8. Cost.
  1. Patent expiration, exclusivity and legal issues:
    • The expiration date of the patents for Active ingredients, Formulation composition and Process. The generic firm must be considered.
    • Any exclusivity that the innovator firm has filled, the generic firm must be considered.
    • Legal issue must be considered. e.g.: Narcotic drugs
  2. Active Pharmaceutical ingredients (API) availability:
    • DMF availability
    • Impurity profile and stability
    • Potential Polymorphic forms
    • Commitment for physical specifications e.g. Bulk density and Particle size distribution
    • Statement of non-patent infringement
    • Cost of API and Impurities.
  3.  Sales and potential market share/volume:
    • The selection of generic drug product for development is to be estimated sales volume of the branded product and other generic drug product manufacturers.
    • Potential market share that the firm to be expect after approval.
  4. Technology:
    • Availability of technology and cost of acquiring technology for development and manufacturer of generic drug product will also impact on the choice of generic drug.
    • e.g. If the technology required fluidized bed processor, Hot melt extrusion or any special equipment then it must be considered weather equipment available or required to acquired.
  5. Formulation:
    • Formulation considerations include the availability of active ingredients, special excipients and any critical process in the innovator formulation.
  6. Experience:
    • The expertise of the research and development employees, employed by the company.
  7. Timing:
    • The predicted profitability of the generic product with required will require strategic planning for the subsequent lunch timing, which must take into account the expected generic price knowledge of anticipated competition.
  8. Cost:
    • Cost of active pharmaceutical ingredient(s) (API).
    • Cost of excipients.
    • Cost of packing materials.
    • Special equipments required for development and Manufacturing.
    • Cost for analysis. (Method development, routine analysis and Validation).
    • Facility requirements e.g. Low Relative Humidity.
    • Special bioequivalence (BE) related study. e.g. BE study type and Population.

Firm must be considering the cost for develop a generic drug product.


Find below excel sheet for exercise  ⇓

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