Bringing Generic Opana ER to Market: FTC Challenge to “No-AG Commitment” Deals

Yesterday, the FTC filed a complaint against Endo Pharmaceuticals and others for the use of pay-for-delay settlements to keep generic versions of certain drugs off the market.  Sometimes called reverse payment deals or pay-to-go-away settlements, these agreements resolve patent disputes by essentially paying the generic drug maker to not only stop litigating but to commit to a delay in bringing a generic entrant to market.  The "no-AG commitment" wrinkle, reported to be included in about half of all pay-for-delay deals, is when a potential generic entrant bargains for exclusivity when generic entry does occur (when the first generic entrant does not have to compete against any product other than generics placed in the market by the branded drug producer) — this time the exclusivity is guaranteed by the branded maker agreeing not to market a generic version of its own drug.  

The "no-AG commitment" agreements are interesting because, in tandem with a pay-for-delay settlement, they can be seen as designing a system of brokered exclusivity in the market on a sequential basis, without having to implicate the exchange of cash or compensation, often a trigger for antitrust scrutiny and concern.  It might be seen as a form of temporal market allocation, if you will, — "First you have a monopoly, then I'll have a monopoly, etc. We'll take turns!"

There is case law indicating that these kinds of deals may be considered reverse payments and anti-competitive. It will be interesting to see the FTC attempt to expand Actavis in this way.

But what really caught my eye was the name of the lead opioid restricted from generic competition in the market: Opana ER. The lidocaine patch Lidoderm is also involved. But the newly announced litigation on behalf of America's Opana ER consuming public should make us think hard about Opana ER's place in the opioid marketplace.  

Opana (Oxymorphone), of course, is twice as strong as OxyContin, with a powerful sedative effect.  One theory for Opana's wild rise in popularity for recreational drug use is to view it as a work around for hard-to-defeat reformulated OxyContin.  Popularly known as "stop signs" or "the O bomb" or "the new blues" — Opana abuse is the scourge of rural communities, surpassing meth in many places. Interestingly, a number of deaths previously ascribed to heroin abuse may actually be heroin and Opana abuse. We find this out, of course, only when detailed post-mortem blood work is done, with surprising results.  As an injectable drug – cooked to defeat the extended release coating and then injected — Opana abuse has also become a marker for the spread of HIV in some communities. One measure of the spread of the injectable drug abuse epidemic is the measure of new HIV cases. The development of new HIV cases apparently related to injectable drug abuse is staggering in places like Indiana.

Opana ER has its legitimate uses, of course, for round-the-clock treatment of moderate to severe pain. But I have to wonder how much of its current supply for prescription use ends up in pharmaceutical drug diversion and why so few are talking about that.


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