IMHO, the generics are done. The more that I think about it, I really believe that the generics will dismiss their suits for little to no settlement. First, IMHO the AVNR patents are solid.
Moreover, Nuedexta is only approved for PBA. Any and all future AVNR indications for ALS, ALZ dementia, MS pain, Neuropathic pain will have their own separate 3-year exclusivity periods, likely some new patents with any differing formulas much less any inclusion of DDex with patent protection until 2035.
Just for kicks, however, assume generics could sell 80,000 scripts per month, the script volume at their pricing is simply not financially workable AND would be HUNDREDS of MILLIONS LESS than the TREBLE DAMAGE infringement claims AVNR much less BIIB, MRK or NOVARTIS will have against them after BIG PHARMA BUYS OUT AVNR (i.e., at AVNR's or Big Pharma's pricing NOT the generics).
For example, you simply can't sell 1M Nuedexta scripts annually for $10 with a $2 margin and net $2M in profit - BUT OWE AVNR or BIG PHARMA $540 MM (e.g., $180M TIMES 3 TREBLE DAMAGES = $540MM because 6600 of your 80,000 monthly scripts were for anything other than PBA and violated separate exclusivity periods and/or patents for other new indications. ANY off label and you are out of business.
Nuedexta for PBA is not an aspirin type drug and the fact that there are many other continuing and different indications coming with additional exclusivity periods and patent protections is a complete deal breaker for them.
In fact, Generics can not afford to win. It is a proverbial LOSE and LOSE. The cheapest and only out will be to settle and dismiss the suits. IMHO, of course.
Just might be what a little bit of the term loan could be used for. Let them save face a little, but they will still duck and run.
I don't think Avanir will be going back to do another Phase 3 diabetic neuropathic pain now that they have invested the time and money in the large Phase 2 PRIME study in central neuropathic pain.
I think they are committed to submitting an NDA application for pain first for MS central neuropathic pain. But there may be foot dragging for patent protection.
This does not mean that off-label pain for MS neuropathic pain, diabetic neuropathic pain and numerous other pain syndromes can not occur while the studies continue.
Don't think so.
Diabetic neuropathic pain is the Gorilla in the Jungle. It will include some DDex to 2035. MS is merely another cost-effective layering of indication after indication to meet specific patient needs.
"ANY off label and you are out of business."
I imagine the same rules apply to generics as to brand name drug makers. The companies can not market the drug for off-label indications.
But they can provide the drug to pharmacies who then sell it to whomever has a prescription from a physician, whether the use is off-label or not.
If it were as overwhelmingly likely that Avanir will win its patent case as you portray, Avanir should have little incentive to settle with the generics and the generics should have had little incentive to challenge Avanir's patents.
And since, as I recall, it costs about $5 million to bring these suits and go to trial, I doubt the generics have undertaken this patent challenge if they think they will most likely be settling for only slightly more than their legal expenses.
Perhaps the bulk of the legal expenses is incurred once the case goes to trial and perhaps the generics plan to try to settle for a small amount before going to trial.
If Avanir were to win the patent infringement lawsuit, hopefully the generics would have to pay Avanir's legal fees to discourage nuisance patent challenges. But I don't know if that is generally true.
I think Avanir has a good case and should not settle if they have to pay any more than a few hundred thousand dollars.
"I think Avanir has a good case and should not settle if they have to pay any more than a few hundred thousand dollars."
I am glad that we all agree that the PATENTS are STRONG although I would pay a few million to resolve the issue in the interest of the shareholders!
The fact that the current patent is for PBA only is a deal breaker for the generics. There will likely be no more 20/10 approvals without other patent filings or Ddex. Generics are done. The exclusivity periods for EACH and EVERY indication will kill them along with Ddex and other patent filings.
Cut and run. done.
For illustration purposes only, the example is that 6600 of the 20,000 weekly scripts (i.e. 26,000 of the 80,000 monthly scripts violate any exclusivity periods or other patent protections for any other future indications:
Such as Nuedex for MS PAIN, Nuevo for Alz dementia, Nuedextra Plus for Neuropatic Pain etc. with Ddex and/or with any other new approved FDA formulas and indications.
Doesn't matter if the original patent is null and void but keep pumping. You better consider any/all research costs for AVNR as well. When they take the patent N from AVNR then AVNR is done with research for all the other stuff. Keep pumping like a good puppet. It is entertainment.
Wow, you really are FOS but nice pump. Who is winning in the race for the Pump Puppet throne at this stage? PINOCCHIO TS/BS has some very strong competition. Open up and swallow guys we just can't get enough! Pump it pump it pump it!