Orphan Drug Tax Credit Application Form

Streamline Your Orphan Drug Tax Credit Claims with Paperform

The Orphan Drug Tax Credit Application Form is designed for pharmaceutical companies, biotechnology firms, and research organizations seeking to claim federal tax credits for qualified clinical testing expenses related to drugs designated for rare diseases or conditions. This comprehensive template helps you document eligibility, calculate credits, and maintain IRS compliance throughout the approval process.

Why This Form is Essential for Your Organization

The Orphan Drug Tax Credit under IRC Section 45C provides a powerful incentive for companies developing treatments for rare diseases affecting fewer than 200,000 Americans. This credit can offset 25% of qualified clinical testing expenses—but claiming it requires meticulous documentation and compliance. Our template ensures you capture all necessary information while maintaining audit-ready records.

Key features of this template include:

• Rare disease designation verification to confirm FDA Orphan Drug status
• Qualified clinical testing cost tracking with detailed expense categorization
• Credit calculation worksheets that automatically compute eligible amounts
• Recapture provisions documentation to manage credit adjustments upon non-approval
• Multi-year tracking capabilities for ongoing clinical trials
• Supporting documentation uploads for invoices, contracts, and FDA correspondence

Perfect for Pharmaceutical and Biotech Companies

This form is specifically tailored for:

• Pharmaceutical manufacturers conducting clinical trials for orphan drugs
• Biotechnology companies developing treatments for rare diseases
• Contract research organizations (CROs) managing clinical testing on behalf of sponsors
• Tax and finance teams responsible for R&D tax credit compliance
• CFOs and controllers overseeing tax strategy and financial reporting
• Tax consultants specializing in pharmaceutical industry credits

How Paperform Enhances Your Tax Compliance Workflow

With Paperform's powerful features, your orphan drug credit applications become part of a seamless financial workflow:

Automated calculations ensure accurate credit computations based on qualified expenses, eliminating manual spreadsheet errors. Conditional logic displays relevant fields based on drug designation status, trial phase, and approval outcomes, creating a tailored experience for each submission.

Payment integration isn't needed here, but Paperform's calculation engine is perfect for complex tax formulas—automatically computing credit amounts, recapture obligations, and carryforward provisions based on IRS rules.

Integrate with Your Existing Financial Systems

Connect this form to your existing tech stack using Stepper (stepper.io), Paperform's AI-native workflow automation platform. When a tax credit application is submitted, Stepper can automatically:

• Route submissions to your tax advisory team for review
• Update your financial management system with credit estimates
• Sync data to Excel or Google Sheets for further analysis
• Create tasks in project management tools for documentation gathering
• Send notifications to stakeholders when credit calculations are complete
• Archive submissions in your document management system

For ongoing clinical trials spanning multiple tax years, use Stepper to create approval workflows that route submissions through your finance, legal, and scientific teams before final filing.

Maintain Compliance and Audit Readiness

The Orphan Drug Tax Credit comes with specific IRS requirements, including the potential for credit recapture if the drug doesn't receive final FDA approval or loses its orphan designation. This template helps you document all necessary information to support your credit claims and prepare for potential audits.

Key compliance features:

• FDA orphan drug designation number tracking
• Clinical trial phase documentation (Phase I, II, III)
• Qualified vs. non-qualified expense segregation
• Recapture event monitoring and documentation
• Historical credit tracking for carryforward and carryback provisions

Designed for Finance and Tax Professionals

The form speaks the language of tax compliance and pharmaceutical finance, with terminology and structure that aligns with IRS Form 8820 (Orphan Drug Credit) requirements. This makes it easy for CFOs, tax managers, and external advisors to review submissions and ensure accuracy before filing.

Whether you're a mid-sized biotech company filing your first orphan drug credit claim or an established pharmaceutical manufacturer managing multiple designations, this template provides the professional foundation you need.

Secure, Compliant Data Management

Paperform is SOC 2 Type II compliant with robust security controls, role-based permissions, and data residency options—critical for protecting sensitive financial and proprietary drug development information. While Paperform is not HIPAA compliant, this form focuses on financial and tax data rather than protected health information.

For teams managing multiple drug programs or client projects, Agency+ features let you organize forms by drug candidate, therapeutic area, or reporting period, keeping everything structured as your pipeline grows.

Get Started in Minutes

This template is ready to use immediately, or customize it to match your organization's specific tax credit calculation methodology, internal approval workflows, or additional documentation requirements. With Paperform's doc-style editor, you can easily add fields for specific therapeutic areas, adjust calculations for your corporate structure, or embed guidance from your tax advisors.

Start capturing qualified clinical testing expenses accurately and position your organization to maximize available tax credits while maintaining full IRS compliance—all through one intelligent, integrated form.