NEW YORK, May 2, 2013 /PRNewswire-iReach/ -- For the first quarter of the 2013 calendar year, the FDA's Center for Drug Evaluation and Research (CDER) has approved nine new molecular entities. A total of 39 novel new medicines were approved in 2012, the highest total in sixteen years. Our conclusions are based on a comparison of the average number of letters and syllables in tandem with POCA (Phonological Orthographic Computer Analysis) for the combined proprietary drug names approved in 2012 and 2013. Two of the approved NME's in 2012, choline C-11 and raxibacumab, were approved with the non-proprietary name in place of a proprietary name. The average for both number of letters and number of syllables has increased in the first quarter of 2013. The average number of letters increased from 7.2 to 7.7. The average number of syllables increased from 2.9 to 3.2.
The comparison of POCA ratings includes a merged (M) average of the distinct orthographic (O) and phonetic (P) ALINE algorithms as well as the individual similarity ratings derived from all drug products listed within the Orange Book (as of April 16th, 2013). Although the average percentage of similarity for the most similar names remained consistent at 62% (merged) and 63% (orthographic) from 2012 to 2013, the phonetic average for the most similar names increased in 2013. For 2013 Q1 approvals, we note that the number of names where similarity is greater or equal to 60% is in decline based on the merged and orthographic similarity measures.
While it remains early in the calendar year of 2013, the trend to create names which can establish points of difference related to the number and type of letters, i.e., ascending and descending letter characteristics, is logical in the context of known FDA Division of Medication Error Prevention and Analysis (DMEPA) proprietary name review criteria.
These insights and related trends confirm the importance of initiating the pharmaceutical trademark process early combined with the rigorous pursuit of a orthographically diverse spectrum of names. Most pharma industry professionals agree that the dual challenges of regulatory approval and legal trademark registration in the pharma space plays a preeminent role in every aspect of the pharmaceutical trademark development process. Combined with these challenges is a rapidly expanding global marketplace, where many pharmaceutical companies are compelled to file a greater number of trademark applications to address the risk of not having an approvable trademark by the planned product launch date in critical markets.
For more information visit www.brandpersand.com. To request a copy of the complete 2012/2013 US/FDA Approved NME Drug Name Analysis report containing the individual POCA ratings in tandem with analysis of letter, phonetic and orthographic attributes for all recently approved NME proprietary names, contact Clement Galluccio at +1 (800) 663-2104 or email@example.com.
Clement Galluccio Brandpersand, (800) 663-2104, firstname.lastname@example.org
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