They've been doing it since I was a medical student. Drug companies' patents run out, so they make a new formulation of it and extend the patent.
It is a shell game, and the FDA has played along up to now. I call it the XP version of the drug - for eXtend Patent. These XP drugs are sometimes better, but usually not much. Here are some ways they have done this:
Use an isomer
Many molecules come in Left and Right hand shapes called stereoisomers (trust me on this one), and usually one of the hands does most of the work. The drug companies have been re-marketing the active component as a new drug - and have gotten away with it.
- Nexium - Nexium is the Left-handed isomer of the drug Prilosec. Prilosec was the greatest thing in the world until it went off patent, so then came Nexium. Mysteriously (through drug reps wearing short skirts and direct to consumer marketing), the drug became a blockbuster, even as Prilosec went both generic and OTC at the same time.
- Lexapro - Related to Celexa (for depression) - very successful as well.
- Xopenex - The active component of albuterol (for asthma). Supposedly less side effects, but this is possibly due to just using a lower dose.
Use a Metabolite
Some drugs are not effective until they are broken down by the body. There are often several active metabolites from a single drug.
- Clarinex - This is the anti-Nexium. Unlike Nexium, Clarinex is another molecule altogether. It is a metabolite of Claritin, the blockbuster allergy drug. Just like Nexium, Clarinex came on the market just as Claritin went generic and OTC. Clarinex flopped. What is the difference? Marketing.
- Allegra - Metabolite of Seldane, the allergy drug that caused heart problems.
Change the dosage schedule
A twice a day drug becomes once a day, and the patent is extended.
- Cardizem - used for blood pressure, it went from 4 to 2 to 1 time per day, each time extending the patent. Overall was a big winner for them.
- Coreg - Newest boy on the block. Coreg CR is being pushed heavily as the twice-daily Coreg went generic.
- Effexor - Again, went from twice to once a day and became a much better seller at the new dose. There is a new version of Effexor called Pristiq that is a metabolite. Would it surprise you if I told you the patent for Effexor is running out?
- Ambien - I thought Ambien was a great drug...until the reps told me it didn't last long enough and my patients needed Ambien CR. This drug went from once a day to once a day (extended), and kept the patent alive. Cool trick!
- LOTS of others.
Mix with other drugs
If patent expires, the drug can be mixed with other drugs whose patents have not expired, extending the life of the generic. This is more convenient for the patient and could be less expensive than giving the two drugs separately, but that may not be the case if the generics are cheap enough.
- Glucovance - Diabetic drug that was mix of two meds. More potent together, but both meds available separately.
- Vytorin - The famous combination of Zocor (generic now) and Zetia (not generic). Works well for lowering LDL a bunch, although the jury is still out as to whether this means people actually live longer.
I am sure there are other examples of this game, but you understand my point. The best marketers are able to get doctors to prescribe and consumers to buy the "NEW AND IMPROVED" version of a drug, even if they liked the "OLD AND WAY WORSE" version. It is the same ploy used by paper towel, laundry detergent, and shampoo manufacturers (My Pantene shampoo has "Amino Proteins" in it - kind of like having "letter words" as amino acids make up proteins).
The tactic is blatantly obvious, but has been winked at by the FDA...up to now. Recently the FDA has rebuffed some XP attempts. From the WSJ:
Rolling out an extended-release version of a drug a year or two before it goes generic is one of the oldest pages in the pharma brand-extension playbook. But, at least in the case of GlaxoSmithKline, the FDA doesn’t seem to be playing by the book.
Over the weekend, the agency approved Requip XL, an extended-release version of Glaxo’s drug for Parkinson’s. But the approval came only a long delay, and a generic version of regular Requip, or ropinirole, hit the market last month, the WSJ reports.
My Favorite quote is at the end of the article:
“Requip CR did not make it to market. Why? Not because it’s not safe. Not because it’s not efficacious. The FDA said, ‘Yeah, you’ve got all that. But tell me why you’re better than [Requip].’ Well, that was an unprecedented question from the FDA,” Christopher Viehbacher, president of North American pharmaceuticals, said at an investor conference last month, according to a transcript.
Why is it better? It is Requip XP! It's new and improved! It's Requip 2.0!
Anything for the shareholders.
I can't believe I am saying it, but Thank you, FDA.