Thursday, March 08, 2018 1:33:34 PM
Look at the "Intellectual Property" section above on this page. IMUN bought or licensed most or all of the existing patents on Naltrexone's uses at a low dose (typically defined as 1.5 mg - 4.5 mg po qd, but I'm not certain on the exact wording as I haven't read the patent applications. But clinically that's the dosing range and use that defines the use of Naltrexone at a "low" dose). It also bought the existing patents on OGF/Metenkephalin's uses.
Is Lodonal chemically or physically different from generic LDN that you can get from a compounding pharmacy? I don't know, but probably not in any significant way, if the compounding pharmacy knows what it's doing.
The great advantage of Lodonal is the patent protection and ownership/licensing that IMUN has to those patents. I'm no lawyer, but I think if IMUN wanted to, it could send cease and desist letters to compounding pharmacies asking them to stop compounding Naltrexone in 1.5 mg - 4.5 mg doses. I don't think it would do that, though, simply not to alienate the existing LDN user base.
Could patients just get a Rx for regular, generic 50 mg Naltrexone and home-brew their own low doses? Sure, but in many cases I imagine they would not, simply for convenience's sake.
But here is the main benefit of patent protection: if and when Lodonal gets FDA, NHS, or EU approval for X, Y or Z indications, brand-name Lodonal, not generically compounded LDN, is what will be on the national health plans' or pharmacy benefit managers' formularies. In other words, prior to patent expiration, only brand-name Lodonal, not generically compounded LDN, is what will be paid for by health insurance or national health plans.
I also would not be surprised to see IMUN rolling out combination capsules or packages of Lodonal and MENK. That's not something that any compounding pharmacy can do.
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