In a perfect world, we could take our time to meet challenges. Brand-name drugmakers, however, do not have that luxury. A new report, however, suggests some must believe otherwise. After surveying big pharma for its 'Combatting Generics' study, Cutting Edge finds that 66 percent do not begin counter-generics planning until at least two years after a product has launched.
Although product teams often feel that they should not be planning for generics until well after a successful launch and period of brand maturation, veteran brand managers consistently report that teams start counterinsurgency planning far too late in a drug’s life, according to the executive summary. (You can take a peek by starting here).
The research firm then goes on to say something recognizable: "The internal workings of pharmaceutical companies sometimes encourage the lack of planning." Compounding the problem is a high turnover rate among brand managers. A newbie may arrive with just a couple of years of patent protection and no generic strategy, which means little chance to do anything other than react.
However, Cutting Edge did find that some companies do consider generics problems relatively early – 23 percent do conduct generics planning while drugs are still in clinical trials, and another 11 percent initiate a generic strategy during launch. Just the same, many wait until patent expiration is too close to explore their options.
A majority of drugmakers report they first consider generics within four years of patent expiration. Since R&D options can take at least that long to execute, Cutting Edge notes that drugmakers with a lifecycle management strategy that begins at least four to six years before patent expiration gives themselves the best chance to prolong brand life.
Hat tip to in-PharmaTechnologist
3 Comments
This was the issue that got me involved in topics pharma.
There are some notable exceptions to procrastinating. As reported both in the Justice Department summary and by FDA, Warner-Lambert anticipated Neurontin's going off patent when it was first launched. That was central in the off-label scam - they were saving those indications for what FDA called "son of Neurontin" and which we now know as Lyrica. I always thought there was a kind of demonic genius there.
From company's perspective, of course, two bad they got bused for $430 million in civil and criminal penalties, but it was actually s small price to pay given Neurontin sales and share prize when Pfizer bought them out. In this case, crime clearly paid.
In general, companies have been able to delay a generic for two-three years _after_ patent expiration through provisions in Hatch-Waxman - a series of legal motions (only the _other_ lawyers are greedy!) which keep generics at bay. That has tightened up some, but not a heck of a lot.
I am going to guess that there is a little disinformation in the Cutting Edge report - in part to sell their own services.
...got the summary...and now Cutting Edge solicitations for more and more and more. Whatever is worthwhile about their info, I'm sure bein' detailed!
Hopefully, they'll send pizza with report.
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