Yes, my understanding is that the sponsor had to do new clinical studies to secure approval of the new indication. If a sponsor does new clinical studies essential to approval after an original approval, it meets the basic requirements for 3-year exclusivity under the Hatch-Waxman Act.
An innovator could, if it wished, continue to seek new indications. However, once the first indication is no longer subject to exclusivity, any future indications will be less valuable unless the innovator alters the dosage form or some other aspect of the drug product (e.g., strength) because a generic application could now be approved for the original NDA that no longer enjoys exclusivity.
Also, technically, later 3-year exclusivity periods do not "extend" the prior exclusivity, but stand on their own.
Yes, you are correct, once the NP exclusivity expires, the new indication exclusivity will remain.
______________________________________________
Michael A. Swit, Esq.
Special Counsel, FDA Law Practice
Duane Morris LLP
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maswit@duanemorris.com Note: all postings by me on this forum represent my personal views and are not necessarily those of my clients or my law firm. Further, my comments are not intended as legal advice but as the sharing of general knowledge and do not create an attorney-client relationship with any reader.
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Original Message:
Sent: 10-10-2014 16:32
From: Charissa Lewis
Subject: 505(b)(2) exclusivity
Upon reviewing the Orange Book patent and exclusivity information for Zorvolex (DICLOFENAC, there are two exclusivity periods one for NP (new product) and one for I-692 (new indication). It appears that an additional 10 months exclusivity has been added for the new indication. Does the extension of the 3 year exclusivity for this indication indicate that a new clinical study was submitted and approved approximately 10 months after the original application was approved?
Could a sponsor strategically perform studies for new indications to extend the 3 years of exclusivity? If so, does this need to be completed before the initial 3 years of exclusivity expire or can this go on indefinitely?
Is it a correct assumption that once the NP exclusivity expires, only the indication exclusivity is preserved?
Thank you in advance for your comments.
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Charissa Lewis
Henderson NV
United States
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