11 Most Asked Pharmaceutical Branding Questions Answered
Whether you’ve been involved in pharmaceutical branding for years or you’re new to the game sometimes the answers to the most commonly asked questions can escape you. We’ve we’ve compiled answers for the 11 most frequently asked questions surrounding pharmaceutical branding we receive today to help you with your next branding project:
1. When do pharmaceutical and biotech companies start the name development process for their assets?
Typically, companies start at the beginning to middle of Phase II. The FDA allows manufacturers to submit name candidates upon completion of Phase IIb under an IND review.
2. When do companies start the generic (USAN/INN) development process?
Many companies start late Phase I/early Phase II.
3. How long does it take to gain USAN/INN approval for a non-proprietary name?
18-24 months to receive global acceptance of a generic name.
4. How long does the current FDA brand name review process take?
Under an IND review, sponsors can expect a 180-day name review. Under an NDA name review, sponsors can expect a 90-day review.
5. How many brand name candidates can be submitted to FDA?
Up to two names may be submitted and the name evaluation will occur based on order of name preference.
6. When can manufacturers submit names to EMA?
EMA will accept name submissions 18 months prior to the anticipated submission of the Marketing Authorization Application.
7. How many invented names (brand names) can be submitted to EMA and how long does the review time take?
Up to 4 invented names may be submitted to the EMA and all 4 names will be reviewed concurrently. The review time is normally 3 months.
8. What are the current brand name/invented name rejection rates for FDA and EMA?
Presently, FDA rejects 35-40% of brand name candidates. The EMA is even higher with almost 50% of invented names being rejected.
9. Why should my company brand a clinical trial?
Increased awareness and recall; creates differentiation from competitive trials; increases value to the clinical community, investors and potential partners.
10. How long does it take to develop and validate brand name candidates?
4-12 months depending on geographic interests. The global trademark registration process can take another 6-12 months.
11. Are there guidelines from the global health authorities pertaining to logo development?
Yes, much like naming, the global health authorities have specific criteria for evaluating logo candidates.