Talk:Generic drug

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?

How long do drug patents last in various countries? — Preceding unsigned comment added by 69.22.126.93 (talk • contribs) 21:53, 14 September 2004 (UTC)

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)

If I recall correctly, the ordinary term of a pharmaceutical patent in the U.S. and many other countries is 20 years after the patent is applied for, not 20 years after the drug is first synthesized. The application for a patent may be long after the original synthesis/invention, if the invention has not been publicly disclosed, so the period from invention to patent expiration may be much longer than 20 years. I believe that this is also the case for other utility patents, not just drugs (and the chemical compound of a drug may not necessarily need to be a new chemical compound in order for a patent to be granted, provided there is something new and inventive about its use as a drug). As far as I know, there is no limit on how long an invention can be kept as a trade secret before it is patented, although it can be risky to try to keep an invention a secret. Public disclosure can result in the loss of the ability to patent the invention, and the rules for what constitutes public disclosure can be tricky. In the U.S. there is a one-year grace period on public disclosure, but that does not exist in most other countries. There are various other legal considerations, and IANAL and TINLA. There is also some danger that someone else could get a patent on an invention if the original inventor does not apply for a patent before the other person does. Regarding "Happy Birthday to You", that was a matter of significant dispute (and was a matter of copyright, not patents). In 2016, a U.S. federal district court ruled that the song is in the public domain, and that may be the final settlement of the matter (please see the article about the song on Wikipedia). —BarrelProof (talk) 22:34, 15 May 2019 (UTC)

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)

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)

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.— Preceding unsigned comment added by Cbamity (talk • contribs) 04:05, 26 April 2006‎

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)

Teva is the largest worldwide and actually the one from Israel mentioned by Archmage Brian. -- Alfie (talk) 11:10, 15 June 2008 (UTC)

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)

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)

“[…] as chemical differences do exist.” is a rather confusing expression for the non-expert. Actually the “active moiety” may be identical (then it’s called a “pharmaceutical equivalent”), or a different salt or ester (a “pharmaceutical alternative”). Details are given in 21CFR320.1. http://edocket.access.gpo.gov/cfr_2008/aprqtr/21cfr320.1.htm Actually both salts and esters are cleaved in the stomach and only the base finally enters the systemic circulation. If I remember it correctly there were a couple of innovators filing lawsuits against their competitors from the generic industry, but never succeeded in demonstrating a difference in bioavailabilty (i.e., bioinequivalence). I will try to alter the sentence in the article. -- Alfie (talk) 01:38, 15 June 2008 (UTC)

Tone: NPOV

I agree that this article doesn't have a neutral point-of-view. It seems to present the debate on the role of generics primarily from the drug developers' POV. I have changed the introduction, but the rest of the article needs work. Especially the section on Reasons for a Cheaper Price. For instance, just the word cheaper rather than lower reveals an attitude. Ben 09:58, 17 April 2007 (UTC)

I've made extensive changes, and I feel the article now satisfies NPOV. For that reason, I've removed the tag. -Rustavo^{Talk/Contribs} 17:43, 19 June 2007 (UTC)

The introduction still seems to be drug company POV. E.g. "In some countries, like Brazil, more than 20% of all drug sales are generic." By using a developing nation "like Brazil" as an example, it gives the impression that generics are for who are living in a country "like Brazil". France used "only" 21.5% [1] and considered itself behind European standards. "The FDA's use of the word "identical" is very much a legal interpretation, and is not literal." sounds like FUD. I am going to change Brazil to France and {citation needed} to the "FUD". --Timtak (talk) 00:41, 13 April 2015 (UTC)

Reason for low price

The following is not true, in my opinion:

The principal reason for the relatively low price of generic medicines is that these companies incur fewer costs in creating the generic drug, and are therefore able to maintain profitability while offering the drug at a lower cost to consumers.

A company can't manufacture a drug more cheaply just because it didn't invent it. Invention costs should have either been recovered during the life of the patent, or written off. The real reason that generics are cheaper is that they are subject to competition, so monopoly pricing doesn't apply. Horatio 23:15, 21 September 2007 (UTC)

Added Link near the end of the economics section

I added some to the discussion of price competition between generics to include competition between generics and name-brand drugs and linked to step therapy. Theophan (talk) 17:31, 11 July 2008 (UTC)

Broken weblinks in references

FDA redesigned their website without automatic redirects (pros at work). Since June 2009 most links are broken. I'm a little short in time, but we have to fix it. Some references to old/new links are given here. -- Alfie^±Talk 10:08, 9 July 2009 (UTC)

45% difference

I removed the sentence ‘This interpretation allows for up to a 45% difference in bioavailability between different generic formulations.’ The 45% difference is an often quoted, but also common misinterpretation of the concept of bioequivalence. Although the acceptance range for bioequivalence is 80%–125% of the reference (where the 90% confidence interval of the test formulation has to be included), it's not possible in the real world to approve a generic product with such a difference. The bioavailability of the reference product in the study is by definition 100%, therefore the maximum theoretical possible differences would be −20% or +25%. Approval of a generic product with such a difference would only be possible

1. for an infinite number of subjects in the BE study, and
2. an intra-subject coefficient of variation of zero.

Each condition is not possible, even more both of them. See also ref. #22 in the article Orange Book Preface.
A survey [http://www.accessdata.fda.gov/scripts/oc/scienceforum/sf2006/Search/preview.cfm?keyword=A&abstract_id=897&type=category&backto=search Nwakama et al.; Generic Drug Products Demonstrate Small Differences in Bioavailability Relative to the Brand Name Counterparts: A Review of ANDAs Approved 1996 – 2005. 12th Annual FDA Science Forum, April 2006: Board A-18]
showed following differences (far below 10%):

• AUC_∞: 3.12% (±2.66%)
• AUC_t: 3.19% (±2.72%)
• C_max: 4.50% (±3.57%)

-- Alfie^±Talk 13:38, 10 August 2009 (UTC)

You correctly identify a misconception, but not one that relates to the wording used. The language was quite deliberate. "...a 45% difference in bioavailability between different generic formulations." This sentence shows not that Innovator : Generic can be 45% different, but that Generic A : Generic B, can.

In this context, citing FDA data to support FDA policy is probably inappropriate.

Further, while the data used in this study may be the most current, I would argue that it's age brings into question it's relevance. Portions of the data used are now 15 years old. Generic drug manufacture has grown significantly since then, both in volume produced, and volume of manufacturers. Generic price wars, international manufacture and the FDA's reliance on approval at introduction over ongoing quality control will likely impact future studies.

Participants in this study were healthy individuals and the results are based on a single dose.

Given the source of the study, it's limitations and it's age, suggesting a potential 45% difference between Generic A and Generic B is valid in an introductory paragraph.66.57.60.49 (talk) 00:54, 13 August 2009 (UTC)

Sorry for the late response, I didn't have this page on my watchlist. Bioequivalence is a concept based on the population mean, its confidence interval and some regulatory goalposts (80%-125%). As said above a difference of the mean of -20% or +25% (generic/innovator) is theoretical, because it would imply an infinite number of subjects and a variance of zero. The rules are not FDA's policy, but law in the US. Quoted data are relevant, because rules for ANDAs haven't changed since 1995. Not all studies were single dose. Single dose studies are more sensitive in detecting differences between formulations than studies in steady state. Not all studies were performed in healthy subjects, because it is unethical to study some drugs (eg, antineoplastics, antipsychotics) in healthy subjects. Such drugs were studied in patients. The only reason why bioequivalence studies are generally performed in healthy subjects is to reduce variability (and therefore reduce the sample size given the same expected difference of test/reference). However, FDA's guidances call for a study population matching the drug's target population (sex, age, ethnicity). Since FDA's showed a difference of ANDAs of ±5% (test/reference), one can expect a difference between generics of ±10%. →Alfie^±Talk 14:57, 24 January 2010 (UTC)

Patently missing

2 things. One, when did generics start appearing? And why not before? Two, tho I can't cite, I've seen news reports of major brands extending patent protection by making claims on the shape & color of the pill. This (in a way I don't understand) locks out the generics while a judge studies the issue... These things need inclusion. TREKphiler ^{hit me ♠} 02:10, 16 October 2009 (UTC)

Fixed a Math Error

This article had a minor error suggesting that 80%-125% was a range that had deviation of 45%, I changed it to 25%, since the width of the range is not its deviation from the standard.Fireemblem555 (talk) 06:47, 24 January 2010 (UTC)

Disallowed

While it may differ by jurisdiction, in the U.S., frex, in some places, pharmacists may be prohibited from subsituting a generic even if a patient specifically requests it. TREKphiler ^{any time you're ready, Uhura} 15:41, 10 April 2011 (UTC)

Outside US?

This article is very US-centric. There's no explanation how patents apply on international level, etc. Litawor (talk) 10:15, 14 March 2012 (UTC)

I came here with the same complaint. I would love for someone to propose a source which talks about this internationally. Blue Rasberry (talk) 20:00, 17 April 2013 (UTC)

Not sure I'm doing this correctly, but this reference could be of help here. It gives a broad, international and non-US centric view: http://www.biomedcentral.com/2050-6511/14/1 Sprocketito (talk) 14:56, 13 August 2013 (UTC)

Are generics really the same as branded drugs?

Is there ANY place/way for this "idea" in this article? http://management.fortune.cnn.com/2013/01/10/generic-drugs-quality/

Maybe it's already covered under "bioequivalence"...?

I earlier tried adding: According to CNN, "Consumers are told that generics are just like their name-brand counterparts. More medical professionals are starting to say that's not the case." [5] but it was reverted... Curious1i (talk) 01:40, 27 March 2013 (UTC)

I work for a consumer organization which gives health information and we often publish statements saying that generic drugs are equivalent to branded drugs. Often we get our information from medical specialty professional organizations. I am not sure what the final authority on these matters are, but Fortune magazine is not it even though it may be all right to include in this case. The right source is probably a medical organization and there might even be variation in the quality of generic drugs from country to country; I am not sure. If anyone knows of any international study in equivalency standards of generic drugs to any branded drugs then I would like to see it. Blue Rasberry (talk) 20:03, 17 April 2013 (UTC)

Opinions on stating whether a drug is available in generic form

I have been considering whether Wikipedia articles on various drugs should state whether the drug which is the subject of the article is available in a generic form. The biggest problem with this is that this can happen at different times in different countries, and I am not sure where to look to find out where it is generic. I am often interested in older drugs which could conceivably be off-patent everywhere. Is there such thing as a list of drugs which are available in generic forms worldwide? Has anyone seen any source which lists which drugs are available as generic in various countries? Blue Rasberry (talk) 20:09, 17 April 2013 (UTC)

They should and many do. Good question. I'd say one reliable thing to do to get info is to look up the patents. Because patent holders are sure to lie/mislead about whether stuff is patented. Patent pending and all. There are several great, free, complete US patent databases on the 'net, (optimistic but not sure about the rest of the world, sorry) and thanks (*cough*) to intellectual property treaties like the TPP and others already in effect, availability of generics is becoming more and more uniform. But there are a handful of countries where, by law or by practice, generics are available even when a medication is still protected by patent in most places. India is most well-known. I'm adding some rough relevant content now... --Elvey^(t•c) 05:32, 1 July 2015 (UTC)

Sourced content

I just restored this: Anticompetitive tactics and payoffs to generic drug manufacturers also often keep a generic drug off the market years after the underlying drug patent has expired, and it's common for generic drugs that do reach the market to be unfairly priced. It's common for manufacturers, wholesalers, or drugstores to jack up prices. The largest generic drug manufacturers are owned by giant pharmaceutical companies that develop and make name-brand drugs. Re. "the cited reference does not say anything about manufacturers, wholesalers, and drugstores raising prices in response to patent term restoration" umm... but the cited reference does say stuff about manufacturers, wholesalers, and drugstores raising prices. So don't remove properly sourced content and make a straw man argument in an attempt to justify it. Re. "not true - the largest generic manufacturers like Teva and Mylan are independent are not owned by branded pharma companies (see corresponding articles))" Umm. It's fully sourced content from a reliable source. Re. "it's illegal to do this and has been punished by heavy FTC fines" - well again, It's fully sourced content from a reliable source. And since you admit it has been punished by heavy FTC fines, you're implicitly admitting that it happens. So don't remove properly sourced content and make a bogus argument in an attempt to justify it. --Elvey^(t•c) 05:32, 1 July 2015 (UTC)

Market and regulation by country?

A best way to organize content, after general concepts, is by country. The sales, regulations, etc. are different, and result in very distinct scenarios. --Krauss (talk) 02:49, 29 March 2014 (UTC)

New article - FDA citizen petition

There was a paragraph in this article about the FDA citizen petition process. I just created an article for that and cut the content here to paste it there. The concept can expand at that article, as this part of United States regulation is WP:UNDUE for expansion in this article about generic drugs in general. Blue Rasberry (talk) 17:11, 8 March 2017 (UTC)

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Addition of a term - Branded Generic

A term 'Branded Generic' can be added in the article along with its meaning. -- Dr. Abhijeet Safai (talk) 06:03, 24 February 2021 (UTC)