I think the 20 days notice period starts from 2nd August, and 45...

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pkm60

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08/08/18

22:59

Post #: 34817757
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Originally posted by long_haul ↑

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

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I think the 20 days notice period starts from 2nd August, and 45 days litigation period from the notice date.
ACR is looking very confident of winning the litigation though, since they and a other company have already received a favourable outcome on 1 of 8 patents

ACR Price at posting: 21.0¢ Sentiment: None Disclosure: Not Held
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