Generic drug companies may be eligible for R&D tax credits for performing qualified research activities. For example, the following activities may be eligible for R&D tax credits:

  • Performing technical research including quality, reliability and effectiveness of generic drugs

  • Performing technical research and/or development including strengths, dosage forms, routes of administration, and indications to generic products

  • Performing technical research including value-added generics, hybrid generics, or new therapeutic entities (NTE) formulations  

  • Developing and/or designing enhanced generic product production processes

  • Developing biosimilars in compliance with governmental standards of quality, safety, and efficacy

  • Developing techniques for the assessment of bioequivalence (e.g. range of dosage forms, delivery systems) 

  • Developing an array of delivery technologies (e.g. extended-release, drug device combinations, alternative dosages) 

  • Developing fixed combinations of commonly co-prescribed medicines (e.g. diuretic/potassium conserving and non-steroidal/proton pump inhibitor) to improve patient compliance

  • Designing cost reduction processes pursuant to government safety and efficacy regulations  

  • Designing packaging and dispensing systems to improve efficiency, reduce waste, avoid dosing errors, or promote patient safety  

  • Quality testing assurance to meet bioequivalent standards pursuant to health authority regulations and/or licensing

 

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