Orphan Drug Development

The Orphan Drug Act was passed in 1983 under IRC Section 45C to incentivize pharmaceutical companies to develop treatments for rare diseases, defined as conditions affecting fewer than 200,000 people in the United States. Once a company receives orphan drug designation from the FDA, the Orphan Drug Tax Credit (ODTC) allows companies to claim 100% of qualified clinical testing expenses (QCTEs, employee wages, raw materials & supplies, and third-party contracting costs) involved in clinical trials between the time of designation and FDA approval.

Companies can recoup a federal tax credit equal to approximately 25% of the total R&D QCTEs per year. For additional information regarding this and the associated tax benefits, see our detailed article about the ODTC. The ODTC applies to clinical testing expenses only; the R&D costs associated with discovery and preclinical phases should be claimed with the standard R&D Tax Credit. 

Example activities that qualify:

• Finalizing drug formulation for effectiveness and strength
• Hiring a third-party contractor to recruit, screen, and enroll clinical trial participants
• Addressing low solubility, bioavailability, and/or dissolution rate issues
• Analyzing clinical trial results (e.g. pharmacokinetics, pharmacodynamics, etc.)
• Applying for FDA and other regulatory agency approval
  

Do you have these job titles on your payroll, or do you hire third-party contractors to do these jobs?

• C-suite
• Clinical Pharmacologists
• Clinical Trial Coordinators
• Data Managers
• Pharmacists
• Physicians
• Principal Investigators
• Research Coordinators
• Research Nurses

Use our R&D Tax Calculator to estimate your potential benefit, and partner with Strike to claim your tax benefits with no up-front costs. Contact one of our experts today.