Medipharm Labs Corp T.LABS

ANDA - 505(b)(2)

[Solid1]

The most important point for me was that Jazz/GW Pharma's exclusive rights to New Chemical Entities (NCEs) expired in September 2023, just as Labs' pharma partner was filing its ANDA.

[alleyesonme]

Keith said on the q1 cc that their busy preparing for the epidiolex launch in the U.S"...fingers crossed we have news of a release date before Y/E...should move the needle...lots of opportunity with dronabinol in the E.U and I'm surprised no DMF for THC which would allow entry into the U.S where a shortage exists.

[Solid1]

I didn't realise that GW Pharma had managed to do that. If Medipharm really does manage to develop a generic of Epidiolex, would they have exactly the same status?  https://www.marijuanamoment.net/cbd-prescription-drug-is-no-longer-a-federally-controlled-substance-dea-says/

[subaru1]

Fingers crossed since 3 years and still waiting that something happen. Already 2 months into the 3 qrt and no news about anything, with the few dollars that they put into the R&D it is not surprising that nothing is happening. Have a good day everyone.

[QContinuum1]

Eye on the ball people.  Epidiolex isn't going anywhere as long at the patent litigation is ongoing.  Guessing about what this or that may or may not mean is not meaningful.  Yes Strachan stated something about ramping up to support this, but they have also stated and confirmed that this is a non-starter as long as the courts are involved.

[Solid1]

The lawsuits relate to a generic drug for the treatment of epilepsy. Jazz has lost important exclusive rights, which means that the same drug can be approved if it is a new treatment. For example, there are enough studies for opiate addiction or something else. In addition, the lawsuits were filed in 2022 and Labs' ANDA was filed in 2023, one year later. 

[QContinuum1]

ANDA has been confirmed by LABS on numerous calls that it is Epidiolex, period.  There is no reason to believe it is anything else and certainly no reason to smudge reality to make it something it isn't. And nothing else you state has been stated by the business as being in flight in any way as it relates to LABS, thus it is pure speculation and hopium; which is fine but as I said, let

[Solid1]

Epidiolex is just CBD. But by God you're a fool 

[QContinuum1]

Apparently the patent office and the current litigation deem otherwise, so who really is the fool, lol Given you're a patent expert, just call up Strachan and tell him what you think, I'm sure Jazz will throw their hands up and say 'we give up, how could we have been so stupid!'.  lol

[alleyesonme]

Actually, litigation is only ongoing with one corp, the other 12 have settled with Jazz gaining marketing/selling approval on the condition of certain, unknown to the public milestones...and yes epidiolex is only CBD, however instead of 100$ a bottle it's 1700-2200$ covered by insurers....so very significant margins to be had....pharma is the diamond jubilee and labs will be partaking no doubt

[Solid1]

Jazz had exclusive rights to the active ingredient CBD for five years, this exclusivity expired in September 2023 (i.e. no patent). CBD cannot be patented. The patents that Jazz currently holds relate to specific treatment methods in the field of epilepsy. So if there is a new treatment option, it can get marketing authorisation...because the active ingredient CBD is no longer exclusive. Quite

[QContinuum1]

Again, the patent lawyers and judge overseeing the case seem to have a different opinion than you. 

[Solid1]

Source please 

[QContinuum1]

The precedings are online.  Go look yourself. But if you want to save yourself some time, just the fact that they are occurring and some parties are settling should be proof enough. 

[Solid1]

 Source... where was the agreement reached? is that what you mean? --> https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=421213

[Solid1]

Jazz has granted production licenses for Epidiolex to Teva, Padagis and Alkem. Teva and Padagis also sell naloxone for opiate overdoses, and recent studies show that CBD enhances this effect. Thanks for the info, it was worth the search