I just received a bottle of Cefuroxime pills, the generic version of Ceftin, which was prescribed for a sore throat (“Whooo! That’s a live one you got there!” the doctor said on peering into my esophagous).
Are generic drugs the same, just non-branded (i.e., the exact same chemical composition), or are they a different drug with the same effects? There must be some difference for generics to be sold more cheaply than name brands, but they can’t be adequately substituted (as is Walgreen’s policy without explicit instructions to the contrary) if the differences are notable.
Probably need a pro to weigh in on this but generics are the same chemical composition for the active drug, just not a brand name. I do not know if they contain the same inert ingredients or if there are different standards for consistency, efficacy, etc. Generally a generic can’t be offered (in practical terms) until the original patent expires.
For example, I take a thyroid hormone and I have read that the generics are not as consistent as far as dosage level, which is important especially for this drug, and you don’t save much going to a generic for this drug, so the recommendation is to go with the name brand. (Although recently it came out that one of the name brand manufacturers also had significant quality problems with dosage level, so go figure.)
Generally, when a pharmacutical company invents a new drug, they patent it, and then have the exclusive right to sell it in the countries it is patented in for a certain length of time. (Ten years in the US, I think.) Once the patent expires, any company can make the same drug. The no-name (generic) companies will make the drug for dirt cheap (they are still subject to government standards, of course). Meanwhile, the pharmacutical company which invented it will still sell it for more money under the brand name. There is a psychological effect that people are more willing to trust a brand name that they are heard of, thus they get away with selling it for more. AFAIK, there is no difference between brand name and generic drugs.
Generics have the exact same chemical composition as the brand-name drug. They’re only available in the US (and the rest of the Western world, AFAIK) after the patent expires on the name-brand drug, which. IIRC, is 14 years after the original drug company patented it. In other countries, most notably India, only the process of making the drug can be patented, so other drug companies come up with a slightly different set of reactions to make the same end product, which is why generics are available immediately over there. As you can imagine, this doesn’t fill pharmaceutical companies with delight.
Quality control issues, like dosage level consistency, are a different story. Name brand drugs are made by Big Pharma (eg Merck, Pfizer, Novartis, etc.), which theoretically will have better quality control than the no-name companies that make generics. This isn’t always the case in practice (witness Schering’s troubles at their manufacturing plants recently). IANAD, but I think that in most cases, there’s no practical difference between generics and name-brands.
What happens is that when the branded drug’s patent expires, another manufacturer can manufacture that drug. It can then be sold more cheaply than the original brand largely because the manufacturing company doesn’t have to recoup all the R&D and marketing costs that the original pharmaceutical company did.
Sounds like a UL to me. There are literally thousands of generic drug manufacturers. It would be far more expensive to buy them all off than to simply compete with their product.
Sounds like a UL to me. There are literally thousands of generic drug manufacturers. It would be far more expensive to buy them all off than to simply compete with their product.
Generic drug substances are chemically identical to their name brand counterparts. However, the various inert ingredients (called excipients) can be (and usually are) different from the original’s excipients.
Generic manufacturers must perform in-life testing to establish the equivalency of their drugs to the original, as well as safety and stability testing. However, all of this is somewhat more cut-and-dried, not to mention cheaper, than the work done on the orginal drug (a “New Chemical Entity,” as FDA calls it).
While many generic drugs are made by companies that specialize in them, there are many large drug manufacturers that have generic drug subsidiaries. They compete in this market, but because they have access to the original drug source and all of their research and secrets, they can even undercut the generic manufacturers, while the parent company reaps the wealth of people who insist on buying “the real stuff.”
It’s not so far-fetched to “buy off” generic manufacturers. Not all of the manufacturers have the expertise or the resources to produce all drugs and dosage forms; if only one company has gotten to the point where they represent a credible threat, it’s definitely possible that the larger company will buy the rights to their work, an agreement not to manufacture, or maybe the whole company.
Finally, I’ve seen many drugs get their patent life extended by the introduction of minor variations; first you patent the drug itself, then you patent the process for making it, then you patent the vehicle it’s compounded in, then you patent its use in treating one medical condition, then another condition… In this way, you can make generic versions of the drug economically nonfeasible for decades, if you’re lucky.
Nametag - (unless I misunderstood what you meant - then ignore this):
In a sense, this is true, since the limits and specifications are already set, but ANY drug must follow the same feasibility/stability/registration/CTM pathway as the original, AND perform exactly the same way as the original. If potency of the original is 98.3% at the T=2 year stability time point, than the generic must be 98.3% +/- [I don’t know the range off-hand] at the same time point. If water content by Karl Fischer at 2 years is no more than 4% in the original, than the generic must also not contain more moisture than that. Tablet compression or capsule fill weight must be the same, impurities must be the same (and at the same levels), hardness must be the same, etc. It is my understanding that the generic drug is not “allowed” to out-perform the original, since then it is techically a better, and “new” drug substance, however it is also not allowed to be much worse. So, basically, they must be essentially identical in all ways.
(Funny thing - I just today handed in final reports for a generic drug being prepared for FDA revision in time to be available as soon as the original patent expires in 6 months…that project is following me!!! :)).
Oh, Hell no! The generic must merely meet specifications – reasonable specifications, I might add, NOT those of the original drug. Hell, the originating manufacturer’s specifications are a trade secret.
The bioequivalency standard is usually 85-115%; the potency specification is usually 90-110% of labeled concentration; other specs are similar. Most definitely, the generic does NOT have to have the same impurity profile; as long as bioequivalency and safety are shown, the drug can be made by a completely different synthetic pathway and have entirely different impurities and excipients. The drug does need to have equivalent performance characteristics, but not anywhere near as specifically as you have stated.
However, that’s not what I was talking about. The sentence you quoted was about how much less investigation a generic requires; given that the drug itself is already approved, I don’t need to determine whether the drug is safe, because I know it’s safe. All I have to do is prove my copy is as safe as the original; knowing the answer makes the testing easier to design. I don’t need to figure out whether the product can be made into a stable dosage form; it’s been done once already, so I just figure out how.
It’s been mostly said already, but one point is incorrect: Pattent protection is currently 17 years in the US from the time of patent, not the time of marketing. If a drug takes ten years to reach market (not entirely out of bounds), then it’s only protected for the remaining seven years, during which time it must recoup not only it’s own development costs, but also part of the development costs of the 5000 or so other compounds that didn’t make it to market (for various and sundry reasons). This is why big Pharma fights patent protection so fiercely: Without exclusivity, they can’t stay in business to research and create new drugs.
The tactics Big Pharma will use to stave-off the advent of a generic are myriad, and ‘buying off’ a generic manufacturer isn’t entirely out of the question, although in many such ‘buy-off’ cases, it’s more a case of the big boys partnering with the generic. This allows the generic to submit their aNDA more quickly, without threat of a fight, and with more assurance that the FDA will accept their application, while to some degree protecting the big guy’s revenue stream.
Sorry Nametag - I am just a summer student and know very little of the details, but that is basically how it was explained to me by my boss - I suppose he was summing up, and I took it a bit too literally
The other thread contains my .02 on generic/brand, IIRC.
Soooo- one interesting thing about the manufacturers is, sometimes they are making the generics too. One example springs right to mind - Xanax is a branded product by Upjohn/Pharmacia. The generic a lot of pharmacies stock is made by a company called Greenstone. Greenstone is a wholly owned company of Upjohn/Pharmacia. Therefore, where Greenstone is your generic, you’re getting pills made by the brand-name manufacturer.
The really really interesting thing I’ve noticed is lately when the generics do get out, the brand name drug price usually goes up, not down. They know there’s all sorts out there, including the ones for whom “only brand” will do.
Be sure and check out that other thread for the real lowdown on brand/generic. I won’t repeat my post here.