Talk:Generic drug
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[edit] Orange book
Why is the orange book not mentioned? Or AB , or AA ratings? I guess I better do some research, and add them myself.
How long do drug patents last in various countries?
- Patents last 20 years from first synthesis in the USA. It's often 8 years before a synthesized molecule makes it to shelves so it's about 12 years total. Pharmaceuticals also claim that even this 12 years is deceptive because competitor products come along usually within 4-5 years. There are, however, numerous tricks that might irritate the common man. For instance, a company will usually patent several similar drugs ("backups") at the same time, but only sell one of them. In the mean time no one else can sell the backup period.
- But before anyone gets their hackles up, for comparison, Happy Birthday to You, lyrics written in ~1920 (music in the 1890s by two kindergarten teachers for their students), still has copyright protection and is presently earning royalties for AOL Time Warner. Justforasecond 05:16, 16 July 2006 (UTC)
[edit] generic-brand
[edit] Research vs Marketing Costs
http://www.amsa.org/hp/RandD.cfm
I've read several articles discussing the fact that the "Incredible R&D" costs may incurred by drug companies may not be true, and in many cases it is the government or universities that develop drugs that companies then patent and market.
I have also seen statements that drug companies spend more on marketing then R&D.
Would this type of discussion be appropriate to this article, or should this go somewhere else?
- It would probably fit best into Pharmaceutical company but putting a taste of it here wouldn't be unreasonable. It could even get its own article. Justforasecond 05:57, 26 July 2006 (UTC)
[edit] When do drug patents expire?
Not exactly a complaint with this page, but it would be nice if wikipedia pages regarding specific prescription drugs give a year as to when the patent will/had expire.
- Drug patents last 20 years (roughly 12 years on the market when you factor in research and clinical trials). This page tells you when they go off patent, but you have to subscribe to get all the features http://www.drugpatentwatch.com/premium/preview/. Justforasecond 05:01, 16 July 2006 (UTC)
[edit] A few considerations
This page describes only one aspect of the term "generic drug." Generic drugs can also be considered a category of medications that are not Branded drugs. They are not necessarily bioequivalent to a given brand like this article states (example - levothyroxine versus Levothroid versus Levoxyl versus Synthroid). This page uses a restrictive definition which is essentially equivalent to "therapeutic equivalent generic." Also, I agree that this page is a little misleading in its statement that the cost of brand names is do primarily R&D. In actuality the price has more to do with- first with a lack of competition with exclusivity, then marketing, then R&D and profits.
[edit] Geography and sources
Generic drugs manufactured primarily in India? What? Of all the generic companies I'm familiar with, only one of them has any relation to an Indian company; most of the others are American, and one is Israeli. Can someone get a source for this statement? Otherwise, I think it should be removed. Archmage Brian 03:19, 21 July 2006 (UTC)
- Try Ranbaxy, Dr Reddy's, Teva. Justforasecond 07:03, 21 July 2006 (UTC)
[edit] Citations
I think the 800,000,000 dollar figure for the amount to get a drug to market needs a citation. I have heard a number of different figures that vary massively.
- Yes, I agree. I actually have the article right in front of me now, it's from an article called The price of innovation: new estimates of drug development costs by Joseph A. DiMasi et al. They conclude that the out-of-pocket cost per new drug is $403 million and by capitalizing this cost to the point of market approval at a real discount rate of 11% this yield a total cost of $802 million. I'll add the reference on the main page. Uapan 14:00, 9 January 2007 (UTC)
[edit] Same molecule or not?
Perhaps inadvertently, the article seems to talk around what I would have thought was a key issue: Is a given generic drug by definition the same molecule as its brand-name counterpart? Does the FDA require this? The article defines "generic" in terms of bioequivalence and says explicitly, "Bioequivalence, however, does not mean that generic drugs are exactly the same as their innovator product counterparts, as chemical differences do exist." I guess that answers my question. But if a difference in chemical composition is allowed, then isn't the generic drug actually a different drug? Couldn't it be patented and marketed accordingly? In other words, couldn't the generic-drug maker (or competing brand-name maker) have created the "chemically different" drug before the expiration of the patent of the brand-name counterpart and begun selling it then? Anyway, I think the quoted sentence on bioequivalence/chemical differences could use some expansion. Tawagoto 02:32, 8 November 2006 (UTC)
