I would recommend David Healy's publications on psychopharmacology and Grace Jackson's Rethinking Psychiatric Drugs.  

Dear Barry

Many thanks to you for making the effort and time to provide me with helpful feedback.

Merry Christmas to you and your family.

Kind regards

Panos

Policies are different in some countries, like Brazil, more than 20% of all drug sales are generic.

Kenneth C. Shadlen. The politics of patents and drugs in Brazil and Mexico: the industrial bases of health policies

http://eprints.lse.ac.uk/27051/1/politics_of_patents_and_drugs_in_Brazil_and_Mexico_%28LSERO%29.pdf

In the US it is really simple guys so let's not get too political.  We have a system that is designed to protect the drug developers and for very good reasons, it costs millions and even more to bring a drug to market.  So these drugs go through stringent (though some would say not stringent enough) testing on animals and human beings and to protect them they are assigned patent rights in the US and if they file in other countries there too.  And there is a portion of our government that is created to monitor and assign and "prosecute" the patents on these chemicals.  Depending on whether the drug is considered to be of a "chemical" nature or a "biologic" nature.  It can take many years to get a patent and what usually happens is the drug manufacturers take out patents on various methods of drug delivery and on several forms ie capsuls, caplets, liquid, iv only, patches etc.  In fact to extend the initial patent, near the end of the first set, the manufacturers make tiny changes in the initial compound and it starts all over.  But eventually they wear off and we are left with generic drugs.  I for example take paroxatine with is the generic form of a drug labeled "Paxil" that is off patent.  But there are loads of new paroxatine based anti-depressants just out on patent that are being used for not depression but some other disorder that would have been considered "off label"  (not the main disorder or disease initially intended to be treated).

Getting back to your question.  Non patented drugs do not go through the FDA.  They are overseen by the same organization that handles vitamins etc.  There is not a patent on the formula.  Anyone can make the same thing, call it something different and market it.  These are not routinely observed in testing for efficacy or safety.  The safety testing done is similar to food testing but is relaltively minimal and efficacy is a matter of the fine print on the label.  So for example, there are loads and loads of non patented weight loss formulas which along with a low calorie diet and 40-45 minutes of exercise a day will take off about 1 to 2 lbs a week if you stick to it religiously.  Course you could do the same thing without the pill.  Lots of small manufacturers like to do things and call them food "additives" in order to side step the much longer process.  So there was a weight loss remedy that involved sprinkling something on your food.  I think it eventually got taken off the market because it really was a drug.

Hope that helps.  There is a difference between generic and non pattented.  One is a physiologically active drug that is off patent that is the patent has expired.  The other is something you can buy over the counter and it may or may not have any efficacy.  Aspirin for example is a generic, you can buy it over the counter, but it is not a non-patented drug.  In this case, many manufacturers have their brand name versions of the generic drug but it is still quite physiologically active.  Same for Ibuprofen, etc.

It is all about money.  Which is why you can buy the same exact patented drug cheaper in Europe than Canada and much cheaper than in the US.  Our lobbiests for the big Pharma companies do a better job of protecting their profits than those in other countries.  The amazing thing is that many of these are not US companies and the same drug which sells for $5.00 in the UK may sell for hundreds here.  Yet one more reason to be a Democrat (liberal)

In U.S. patented drugs are most likely new drugs or formulations (of old drugs) discovered within the last twenty years. There are non-expired, valid patents protecting the drugs or formulations. In contrast, non-patented drugs are drugs or formulations discovered more than twenty years ago. Their patents have expired or been invalidated.

FDA maintains an "Orange Book," which is a collection of approved drugs currently under patent protection. That would be the place for anyone who wants to know whether a known medication is still protected by a patent or patents.

I don't want to disagree Feng, but most of the generic drugs are still very much valid pharmacologically.  One could hardly call aspirin an invalid compound.  It is still the most widely used pain and fever medication on the planet.  But it may be that there are new formulations or drugs that operate on different mechanisms that may be desirable and let's face it at some point most manufacturers have similar products and this keeps the pressure on to open up the initial formulation to improvements or at least differences and the initial drug just gets too cheap to bother with the extreme costs of maintaining patents especially world wide.  At one time I consulted for an emerging drug development company working on oral and transdermal insulin.  Insulin is insulin, what was patented was the mechanism of delivery.  But even in early stage research, the patents would cost hundreds of thousands of dollars a year to maintain.  And that wasn't even global.  Plus patent protection in the Far East is a laugh.  By the time you have the patent in countries from India eastward, someone had already stolen the technology and there were no courts to fight it off.  All of this is factored into the price of new drugs in Western Pharmacological development.  Some countries have gotten a bit better, but China has ubiquitously stolen intellectual property of all types for many many years.

So many many times, manufacturers stop prosecuting the patents because it just isn't worth it but the product is still good.  See Prevacid for example

Dear Alexandra,

Thank you so much for making the time and effort to provide with fruitful feedback.

May I ask you for a couple of clarifications because I am not a specialist in this area, please?

Back to your feedback, Paxil is an off-patent medication, right?

Paroxatine is a generic medication (like an aspirine), but here, Paroxatine is the generic version of the off-patent PAXIL, correct?

What are the fine differences between an off-patent medication and a generic medication? (do they have a time-window between the off-patent drug and the generic drug? I do not know, but please let me know).  You cannot purchase the off-patent over the counter, but you can do so with a generic, correct?

How come the medication in EU is cheaper than CAN, which is turn cheaper than in the USA? 

I would appreciate your feedback.

Many thanks

Panos

Paxil is the original patented medication.   You can still get prescriptions filled for the original drug from the original manufacturer.  But it is still much more expensive than the generic so most insurance companies won't pay for a "name brand" drug when there is a generic available.  What is off patent is the ingredient paroxetine.  Paroxetine is the generic off patent. When the drug manufacturers use let's say a smaller dosage of paroxetine in another formulation, they can repatent a new drug even if the main active ingredient is still paroxetine.  Sometimes however, there may be a difference in how the generic and the name brand acts in patients.  

I have ADD and take a generic form of Adderall.  I have been told by my Psychiatrist though that there can be a difference in efficacy so if I had had that effect, he would have prescribed the name brand Adderall in lieu of the generic.  The difference in price is huge in this case.  The generic is less than $100 for a 30 day supply, the name brand is almost $400.  And other than formulation, they have exactly the same active ingredient.

Not exactly like aspirin because you still need a prescription but it is the generic form.  I am not sure there is a difference between off patent and generic, I would have to look that up, but the big difference is between over the counter and prescription.  I am just looking at an over the counter allergy medication.  Manufacturer is Top Care (actually that is probably just the distributor), active ingredient is loratadine which was once a patented product.  This is now not only and off patent but in this case it is so widely used they probably reduced the strength to allow it to be an over the counter drug and it is now in almost all anti-histamine type drugs widely used for allergy symptoms.  This is a further price drop because most of the over the counter drugs are less than $10 for about a 30 day supply.  

So what a whole lot of it boils down to is marketing.  I remember when Prevacid came off patent.  The manufacturer skipped the generic stage and went straight to the over the counter medication (there was a lot of legal maneuvering).  What they did was slightly reduce the active ingredient but keep the prescription name brand label.  Because it is over the counter, it is available to everyone.  And I sometimes think most of the US has acid reflux.  With a little advertising, they have far exceeded their original prescription drug money especially when the active ingredient became available to almost any other manufacturer.

The price difference between countries has absolutely nothing to do with cost of manufacturing and I can't even see how much it would have to do with cost of development because for example Glaxo is an EU based company but it's drugs are wildly more expensive in the US.  The reason is that they make more profit here and have the best lobbiests to keep the price up.  The major health insurance in other countries is some form of government/private plan and these plans negotiate pricing way down.  But in the US, the GOP (Republicans-Conservatives etc) have kept the drug companies very happy by making government sponsored health care watered down or non existent.  And even our Social Security Program which has a government sponsored  Medicare plan is not permitted to collaborate with Medicaid (another health care plan for low income individuals) to negotiate rates.  So between the drug manufacturers, the private insurance plans (which only cover a portion of the prescription and non of the over the counter drug costs), and health care providers, the only people who get screwed are the people.

So all this stuff is totally about that good old idea PROFIT and MONEY at one level or the other and because of our recent decisions in the supreme court allowing private companies to put unlimited monies directly into elections, this is all going to get worse before it gets better.

I know it is all very confusing.  

1) "Their patents have expired or been invalidated;" not the drugs themselves.

2) The early prosecution of a new U.S. non-provisional patent application only costs about ten thousand dollars (about $5k for USPTO fees and $5k for lawyer fees), not "hundreds of thousands dollars." In fact, the registration fee for a provisional patent application is about $125 for a small entity applicant if the inventor writes the application him- or herself (no requirement for writing patent claims at this stage).

3) Generic drug is the counter part of brand name drug, while patented drug is the counter part of off-patent or non-patented drug. In most cases, generic drug is manufactured in India, the pharmacy of the world which has special patent rules to prevent the ever-greening strategies of Big Pharma to extend their drug patents.

4) As to the demand for generic medication, the main driver is to lower the healthcare cost for any affected country. India, for example, has a significantly large portion of indigent population who cannot afford paying the sticker price of patented drugs (most of which are marketed by Big Pharma). Remember, patent is a time-limited monopoly, which leads to whatever price the patent owner wants to charge the consumer of the patented drug. Accordingly, in order to deal with the healthcare demands in India, the Indian government would force the owner of the patented drug either to drastically lower the drug price or to face the invalidation of their drug patents or loss of patent protection. The losers of this battle are the western pharmaceutical companies (lost patent right in India). The winners are the poor patients worldwide (and the Indian generic drug industry).

India became a world leader in generic drug manufacture[1] by removing patentability for pharmaceutical products in 1972.[2] In 2005 in order to comply with its obligations as a WTO member, India reintroduced patent protection on pharmaceutical products.[3] Because the generic knockoffs of AIDS drugs made by Indian manufacturers were used to treat patients in about two hundred countries and the new changes in Indian patent law might adversely impact the Indian generic drug industry, a New York Times editorial predicted in 2005 that future patent disputes would become “a crucial battleground for the health of hundreds of millions of people in India and worldwide.”[4] To shed more light on the current Indian patent law[5] and its impact on public health in India and other poor countries, analysis of Indian patent cases identified factors important to the Indian patent law, including compulsory licenses[6] and the Section 3(d) inventive step requirement[7]. In particular, it appears that when dealing with pharmaceutical patents, the Indian patent system performs a balancing act of protecting the rights of patent right holders while safeguarding the public interest.[8]

[1]. See Yusuf K. Hamied, Indian Pharma Industry: Decades of Struggle and Achievements (Apr. 2, 2005) at 3, Arvind Gupta, http://www.arvindguptatoys.com/arvindgupta/avra-hamied.pdf.

[2]. See P. NARAYANAN, PATENT LAW 7 (3d ed. 1998, Eastern Law House, 1998), at 543, 546.

[3]. See George K. Foster, Opposing Forces in a Revolution in International Patent Protection: the U.S. and India in the Uruguay Round and its Aftermath, 3 U.C.L.A. J. INT’L L. & FOR. AFF. 283 (1998).

[4]. Editorial, India’s Choice, N.Y. TIMES, Jan. 18, 2005, http://www.nytimes.com/2005/01/18/opinion/18tues2.html.

[5]. The Patents Act, No. 39 of 1970 (Universal 2005)(amended 2005).

[6]. Id. § 84.

[7]. Id. § 3(d).

[8]. Philippe Baechtold & Tomoko Miyamoto, National Strategies and Policies for Innovation: A View from China and India, WIPO MAGAZINE (July 2007), http://www.wipo.int/wipo_magazine/en/2007/04/article_0007.html.

Ok Feng, now I feel obligated to explain some more stuff that probably no one but us thinks is useful.  In 2011 76% of all the drugs in the world had a generic equivalent (most commonly known as a copy cat drug because it is exactly like its branded equivalent)  Branded is just what it sounds like, it is a drug researched, developed, manufactured and marketed by large (usually manufacturers).  India's drug business has been almost exclusively generic because patents until 2006 have been process not product based.  This is changing now and because of a lot of labor things, major US and European Drug Companies are looking to purchase Indian ones if they have a large generic base.  Biologic generics don't exist much because they are not copy cats.  And then there are drugs that groups of individuals force into generic distribution.  

But here is a list of a large %j of the world's largest pharmaceutical companies and they are not Indian.  Most come from Germany, the US and England though a few are from other EU countries:  Bayer; Schering Pharma; Boehringer Ingelheim, Roche, Merck, Glaxo Smith Kline; Astrozeneca, Abbott, Johnson and Johnson (huge over the counter and household products); Pfizer, Eli Lilly, Novartis, Aventis, Sumitomo (Japanese), Alcon, Briston Meyers Squibb, Novo Nordisk, Ailead, Bakter, Allergen.  Indian companies include FarrAPC, Glenmark, Sun

I had forgotten how many of these I have had dealings with over the years either in Internal Control Development, Patent application, Grant Application, Research and Development Process Development.

Now that we have just about covered all the general knowledge about this, maybe we should just let it go with the exception of the realization that this is one of the most profitable, perhaps filled with nasty business practices and not nearly as humanistic as their websites might otherwise indicate.