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It has the same active ingredient, so it should work the same, but if someone says 'I want Cheerios, not Walmart-os', then why should they not get what they're paying for? (David Maris, pharmaceuticals analyst at Wells Fargo, as quoted in Staying Power, David Crow, Financial Times [Log in required], Aug 22.
Discovering a drug and bringing it to market can take more than 10 years and costs on average $2.6bn per medicine. Typically around five to seven years after, the exclusive rights on the discovery expire, and generic copycat versions quickly flood the market. Prices are slashed to super-cheap, and then for all time and eternity, society benefits greatly. Or, in the words of Pfizer's CEO Ian Read during an investor call: "The price of medicines drop significantly once the patent expires... Today, about nine out of ten prescriptions in the US offer generic drugs, which lead to significantly reduced costs in the healthcare system."
A recent Financial Times analysis doesn't completely agree though. Prices of branded medicines aren't slashed once the patent expires. They actually often sharply increase.
Before companies get to that phase however, a whole slew of other tactics have been used to maintain exclusivity. Many make small changes to a drug, then renew the patent. This is known as evergreening. Others "pay for delay" -- offering financial incentives to the generics producers to bring their alternatives to market more slowly. And once the generics get to market, pharma companies change tactics by attempting to stop patients, doctors and pharmacists from switching.
The end result is price differences between generics and brand medicines which are somewhat strange for a free market: Wellbutrin (bupropion, 150 mg) [Valeant]: $36 per pill versus $0.46 for the generic [bupropion]; Lipitor (atorvastatin 20mg) [Pfizer] 10.49 versus 0.13, Abmien (zolpidem 5mg) [Sanofi] 15.52 versus 0.02, Prozac (fluoxetine 20mg) [Eli Lilly] 11.39 versus 0.03, Xanax (alprazolam 1mg) [Pfizer] 8.14 versus 0.05 and Sarafem (fluoxetine 20mg) [Allergan] $15.98 versus $0.03 per pill.
There must be lot of people who prefer Cheerios over Walmart-os.
(Score: 3, Informative) by Anonymous Coward on Wednesday August 24 2016, @01:54AM
(Score: 0, Troll) by Anonymous Coward on Wednesday August 24 2016, @05:12AM
> The FDA and equivalent organisations around the world I believe are not such idiots as to confuse their left hands with their right, and would have scientists working for them who understand all about chirality!
If only it were so simple!
Lots of medicines are racemic and we often don't know if one or the other or both contribute to medicinal effects (see: ibuprofen).
> generic medicines must have exactly the same active ingredients as their branded counterparts to qualify
Ok; so if I say that the L-entantiomer is active, and R- is inactive, then all that matters from my chemical process is a consistent L- yield. Which means the 'inactive' R- can be present at any level (or none). Except that... like with ibuprofen, we might be wrong, based on initial or in-vitro data, in assuming R- is truly inactive.
It is not unheard of for sources of chemicals to themselves acquire a new source, and alter the L-R ratio. And do you really think that every generic maker in the world is testing every batch with a mechanism that confirms chirality? Much more likely it's a simpler yield test that doesn't distinguish, and if the reaction proceeds apace... who finds out that the output has changed?
"Trust the scientists" unfortunately got us DDT, DEET, BPA and PTFE.
(Score: 0) by Anonymous Coward on Wednesday August 24 2016, @05:45AM
They had fucking better be, or else the FDA or its equivalent regulatory agency would have reason to prevent their products from being imported into their areas of jurisdiction and punish everyone involved in doing so. Unless your regulatory agencies are so captured by special interests that the fox is guarding the henhouse, but that's a different problem.
By the way, trusting the scientists also told us that DDT, DEET, BPA, and PTFE were bad things and needed to be removed.
(Score: 0) by Anonymous Coward on Wednesday August 24 2016, @03:41PM
Consider that the "name brand" maker can also get sloppy or take short-cuts. Let's not pick on just generics.
(Score: 0) by Anonymous Coward on Wednesday August 24 2016, @07:10AM
(Score: 2) by tathra on Wednesday August 24 2016, @01:57PM
different isomoer combinations are noted as different drugs. i give you Dexedrine (d-amphetamine salts) and Adderal (racemic amphetamine salts) as proof of this. the implications are understood and monitored, however this might only be the case where it is known that the different isomers have different effects.