FDA Exclusivity and Patent Protection The absence of patents...

FDA Exclusivity and Patent Protection

The absence of patents does not mean there is no protection from competitors. According to the FDA’s own website “Patents and exclusivity work in a similar fashion.”

Of relevance, exclusivity is available where there are significant changes in already approved drug products (dronabinol) in situations such as a new use or different treatment.

IRX 211 comfortably ticks both these boxes with 1. consumption via inhalation and 2. treatment for pain indication.

From the Chair's statement in the Townhall, shareholders were told to expect IRX 211 - if approved by the FDA - to receive a minimum of 3 years protection.



It means exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not.

It also prevents the submission or effective approval of ANDAs or applications described in Section 505(b)(2) of the Act.

A 505(b)(2) application is one where one or more of the investigations relied upon by the applicant for approval "were not conducted by or for the applicant."

This provision expressly permits the FDA to approve an NDA where some of the data is not developed by the applicant such as published literature or the agency’s finding of safety and effectiveness of a previously approved drug.
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3 years plus protection would be an eternity for a Big Tobacco giant like PMI to entrench first mover advanatge. If you give Usain Bolt a 3 second head start, nobody's going to catch him.

Frequently Asked Questions on Patents and Exclusivity | FDA

Imho & Gltah





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