From the announcement: "Following notification from a company...

From the announcement:

"Following notification from a company filing an ANDA with a Paragraph IV Certification, the patent owner has 45 days to file a patent litigation suit asserting patents listed in the Orange Book in a United States District Court in order to initiate the litigation process under the HatchWaxman Act."

The date of the paragraph iv submission was June 6, 2018 (#1).

The timing of the notice to the patent holder, from what I can gather, is within 20 days from ANDA "receipt" acknowledgement letter (#2).

So if we add 65 days to the June 6th submission, we get to around August 10th. If I'm correct, any notice of a litigation suit should be known within the next week or so.

Welcoming of any other insights/corrections.


#1 https://www.fda.gov/drugs/developme...dnewdrugapplicationandagenerics/ucm047676.htm

#2
https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM445610.pdf