Selecting the right name for a pharmaceutical product is a critical step in commercialization, one that extends beyond marketing into regulatory approvals, trademark clearance, and market positioning. The first priority is typically securing a nonproprietary (INN/USAN) name, but delaying proprietary (brand) name development too long can create costly challenges.
Working with brand naming agencies early ensures that name development aligns with regulatory requirements, market strategy, and business objectives. Here’s why Phase 2b or early Phase 3 is the ideal time to begin proprietary naming, and why waiting too long can put your launch at risk.
Phase II: Nonproprietary Naming, Clinical Trial Branding, and Early Proprietary Naming Considerations
Nonproprietary Naming Typically begins in Phase I or II
Before focusing on a proprietary brand name, companies must secure a nonproprietary (INN/USAN) name, typically submitted in early Phase II. This is a critical regulatory milestone since every product must have a nonproprietary name before market entry.
At this stage, companies are still gathering early clinical data, making it too soon for proprietary name development. However, discussions around long-term positioning and regulatory strategy should begin to ensure a smooth transition into Phase 2b or Phase 3 brand naming.
Clinical Trial Branding Begins in Phase II
Clinical trial branding typically begins in Phase II, as companies need an identity for trial recruitment, stakeholder engagement, and internal alignment. A strong trial name can:
- Support investigator and patient recruitment
- Create awareness among key stakeholders
- Lay the foundation for future commercialization
Phase 2b or Early Phase 3 is the Best Time to Begin Proprietary Naming
By Phase 2b, companies have a more complete understanding of:
- The drug’s mechanism of action and differentiation
- More robust clinical data to inform branding decisions
- The competitive landscape, including potential regulatory or trademark conflicts with existing or recently submitted names
At this point, brand naming consultants can provide valuable support in:
- Regulatory screening and name safety evaluations
- Linguistic and commercial preference research
- Trademark clearance and risk mitigation
Understanding Regulatory Timelines for Proprietary Naming
Securing a proprietary brand name is not a quick process. A typical timeline includes:
- Name safety and commercial testing: 8+ months
- Regulatory submission and review: 3-9 months
- Trademark filing and registration: 4+ months
Phase III: The Final Window for Naming
Naming in early Phase 3 is not necessarily a bad thing—in fact, many companies start the proprietary naming process in Phase 2b and finalize it in early Phase 3. However, waiting until mid or late Phase 3 can create unnecessary risks.
At this stage, the focus should be on:
- Finalizing the nonproprietary (INN/USAN) name
- Submitting the proprietary name for regulatory review
- Ensuring trademark clearance to avoid last-minute conflicts
The Importance of a Backup Name
In addition to timing your submission correctly, it’s vital to have a backup name option. First-pass regulatory approval is never guaranteed 100%, so it’s critical to have a backup name ready in case of rejection. While a name may pass initial screenings, there is always the risk of a competing name being submitted around the same time—one that hasn’t been publicly disclosed yet but could still lead to rejection.
EMA name submission, FDA approval, and global regulatory clearance all require rigorous evaluations. Partnering with brand naming consultants ensures a smoother approval process and avoids costly delays.
Key Takeaways
- Secure your nonproprietary name (INN/USAN) in Phase I or early Phase II
- Consider clinical trial branding to enhance visibility and recruitment (begins in Phase II)
- Start proprietary naming in Phase 2b or early Phase 3 to avoid last-minute challenges
- Factor in regulatory review timelines (12+ months total)
- Work with experienced brand naming agencies for regulatory expertise
Next Steps
If your company is preparing for FDA, EMA, or any global name submission, our team can help.
For more information, Contact Brandsymbol or check out the various regulatory name submission guidance documents, which provide key regulatory insights for naming success.