Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

FDA Working to Lift Barriers to Generic Drug Competition
Posted on June 21, 2017 by FDA Voice
By: Scott Gottlieb, M.D.

Too many patients are being priced out of the medicines they need. While FDA doesn’t have a direct role in drug pricing, we can take steps to help address this problem by facilitating increased competition in the market for prescription drugs through the approval of lower-cost, generic medicines.

https://blogs.fda.gov/fdavoice/index.php/2017/06/fda-working-to-lift-barriers-to-generic-drug-competition/





This concept is crucial to the future of Elite. There will hopefully be multiple successful branded products along the way, but ultimately, I think this company will be primarily a generic ADF manufacturer. The question is how is the ADF market going to develop? It is easy to foresee a time when every prescription opioid will be an ADF. I just don't know what it will take to get there. A minimum requirement will be an abundance of available generic ADFs of all shapes and sizes, but that market will never develop organically if it is continuously choked off by non-ADF generics at a fraction of the cost. If Dr. Gottleib is serious about both generic competition and a vigorous ADF market, then there are definite actions he needs to take encourage generic ADF's and discourage non-ADF generics.


Elite has virtually complete packages for ELI-201 and ELI-202, presumably naltrexone ADF versions of Percocet and Norco. They were put on the back burner and replaced with ANDA's for non-ADF generic versions. According to Nasrat, this was specifically because of the FDA's attitude about acetaminophen as an acceptable abuse-deterrent for snorting. Maybe things will be seen differently under new leadership, and maybe the Gottleib era is the right time to dust off ELI's 201 and 202. Along with SequestOx, Elite would have an ADF pipeline of the three biggest-selling immediate-release opioids. That would be a pretty big deal no matter what, but it would be gigantic in some future market where we laugh about how we used to have teenagers snorting pills all the time- even long after it was a really easy thing to prevent. If there is a potential role for ADF's to save lives, then it's not in saving those who are already addicted and abusing pills. Those people move to heroin. If an ADF is going to save a life, it's going to be by preventing kids from partying with crushed Percocet, Norco, or Roxy, which in many is the first step toward addiction and injection abuse. Dr. Gottleib has in his power to push things in that direction.

Over the last decade alone, competition from safe and effective generic drugs has saved the health care system about $1.67 trillion. When generics are dispensed at the pharmacy, the immediate savings to each of us are clear. We could see even greater cost savings if we helped more safe and effective generic drugs get to market sooner, after patent and statutory exclusivity periods have lapsed, by addressing some of the scientific and regulatory obstacles to generic competition across the full range of FDA-approved drugs. These barriers may delay and, in some cases, ultimately deny patient access to more affordable drugs.

Dr. Gottleib, would you please check on the obstacles and barriers preventing approval of our generic Percocet and Norco?

We know that sometimes our regulatory rules might be “gamed” in ways that may delay generic drug approvals beyond the time frame the law intended, in order to reduce competition. We are actively looking at ways our rules are being used and, in some cases, misused.

Time to put up or shut on this one. Where is generic OxyContin? The Supreme Court refused to hear Purdue's appeal in November, clearing the way for the handful of companies with successful Paragraph IV challenges to receive approval for their ANDA's for generic OxyContin. Since then, Purdue has continued to sue everyone they can, and they've had good success at getting some new patents included in old suits, including the reinstated case against Collegium's Xtampza. They clearly have not given up on defending OxyContin against generics, which is why I was somewhat surprised when Nasrat said we will file an ANDA soon. Whatever communication has taken place between Purdue and the FDA, eight months have gone by since the court decision and we are still without any generic approvals. There must be a reason, and Dr. Gottleib definitely knows the reason. Question is does he agree with it? He can show some much-desired independence from Big Pharma by approving generic OxyContin, including PuraCap's Epic ANDA.


https://investorshub.advfn.com/boards/read_msg.aspx?message_id=128027166

One example of such gaming is the increasing unavailability of certain branded products for comparative testing. To perform the studies required to develop a generic alternative to a branded drug, a generic sponsor generally needs 1,500 to 3,000 doses of the originator drug. I understand that generic sponsors are willing to buy these products at fair market value; but, in some cases, branded companies may be using regulatory strategies or commercial techniques to deliberately try to block a generic company from getting access to testing samples.

Yes, hello, is this Pzfizer? Nasrat Hakin here. Could you send me over 3 cases of your finest Troxyca?