Yes. Companies involved in developing a generic medicine can qualify for the R&D Tax Incentive.

The following types of medicines could qualify for the R&D Tax Incentive:

  • Pharmaceutically equivalent products
  • Pharmaceutically alternative products
  • Therapeutically equivalent products
  • Interchangeable pharmaceutical products

Eligible R&D activities in respect of generic medicine development can include:

  • An activity in respect of analysis or characterisation of the properties of a pharmaceutical product with the purpose of determining the excipients and other ingredients to be utilised in the formulation of the multisource pharmaceutical product:
    • Compatibility tests between the active pharmaceutical ingredients (APIs), excipients and other ingredients
    • Dosage form design

 

  • Laboratory-scale reformulation through experimentation on the APIs, excipients and other ingredients
    • pilot-plant-scale reformulation
    • The activities, tests, design and formulation of multisource pharmaceutical products

 

  • Determination of analytical and stability testing methods if those methods are determined in conjunction with –
    • the activities, tests and design of multisource pharmaceutical products
    • the formulation of APIs, excipients and other ingredients; or
    • the activities, tests and design of multisource pharmaceutical products and the reformulation of APIs, excipients and other ingredients

Will the development of a Generic Medicine qualify for the R&D Tax Incentive?