Replies to post #276861 on Amarin Corp Plc (AMRN)

[circuitcity]

Thanks alm2, I am convinced and on board now. Continue with your thinking, amrn can even apply for injunction until H’s V is out, right? Because hoping JT to have any knowledge on H’s move maybe a too much expectation.

[sts66]

Ok, you mostly convinced me Hikma won't launch, but "If they win they will be selling forever so a few months makes no difference" is not accurate IMO - there's a reason generics rush to get their ANDAs filed and approved, they get 6 months of exclusivity, so it's worth something to them. What threw me off when I first started reading the this page is "wait, DRL *and* Hikma were involved in the court case, who gets the exclusivity?", but the 2nd paragraph makes it clear - whomever is first to get their ANDA approved gets the 180 days, so DRL now has a bit less incentive to help finance the appeal.

https://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/small-business-assistance-180-day-generic-drug-exclusivity

The statute provides an incentive of 180 days of market exclusivity to the "first" generic applicant who challenges a listed patent by filing a paragraph IV certification and running the risk of having to defend a patent infringement suit. The statute provides that the first applicant to file a substantially complete ANDA containing a paragraph IV certification to a listed patent will be eligible for a 180-day period of exclusivity beginning either from the date it begins commercial marketing of the generic drug product, or from the date of a court decision finding the patent invalid, unenforceable or not infringed, whichever is first. These two events - first commercial marketing and a court decision favorable to the generic - are often called "triggering" events, because under the statute they can trigger the beginning of the 180-day exclusivity period.

In some circumstances, an applicant who obtains 180-day exclusivity may be the sole marketer of a generic competitor to the innovator product for 180 days. But 180-day exclusivity can begin to run - with a court decision - even before an applicant has received approval for its ANDA. In that case, some, or all, of the 180-day period could expire without the ANDA applicant marketing its generic drug. Conversely, if there is no court decision and the first applicant does not begin commercial marketing of the generic drug, there may be prolonged or indefinite delays in the beginning of the first applicant's 180-day exclusivity period. Approval of an ANDA has no effect on exclusivity, except if the sponsor begins to market the approved generic drug. Until an eligible ANDA applicant's 180-day exclusivity period has expired, FDA cannot approve subsequently submitted ANDAs for the same drug, even if the later ANDAs are otherwise ready for approval and the sponsors are willing to immediately begin marketing. Therefore, an ANDA applicant who is eligible for exclusivity is often in the position to delay all generic competition for the innovator product.