About generic drugs
A new drug is a new drug that is manufactured and sold for the first time after researching and developing new active ingredients and usage methods, and is also called the real product.
Generic drugs are developed by other pharmaceutical companies using the same active ingredients after the expiration of the patent period of the new drug, and after passing rigorous tests on the assumption that the efficacy and safety are equivalent to the new drug, It is a drug. Approved by the government.
New and generic drugs have the same efficacy and safety, but some have improved size and flavor by using state-of-the-art technology to make them easier to swallow. There are also tablets with the name of the medicine printed on them to prevent mistakes.
“Generic” is a word that means “generic” in English. In Europe and the United States, where the penetration rate of generic drugs is extremely high, generic names are often used instead of product names when prescribing, so generic drugs are called generic drugs. It has become a common term around the world and has come to be called “generic medicine” in USA.
The LifetimePills.com handles a large number of generic drugs. We carefully select recommended products that are both effective and safe, and offer them at low prices, so please use them.
Difference from new drug
The active ingredients, amounts, efficacy and safety of new and generic drugs are the same. Let me explain what is different.
The difference is ease of drinking and price.
Generic drugs are developed using the same active ingredients in the same amount. However, there are differences in taste, shape, color, additives, etc.
For example, you can coat the medicine to reduce the bitterness, or change the size to make tablets that are easy to swallow. Others are in the form of jellies or sheets that melt in the mouth.
Of course, not only the medicines for drinking but also the medicines for external use have been improved. Some nasal drops are designed to stay in the nasal passages for extended periods of time by adding viscous properties, and some patches are designed to reduce sticky rashes.
Drugs developed with various ingenuity in this way are called “advanced generics.”
The biggest difference is the difference in cost. Compared to new drugs, development time and development costs can be significantly reduced. As a result, the selling price can be reduced.
Generic drugs are widely used around the world because of many of these benefits.
Original drug and generic drug (generic drug)
First, there are two types of drugs: original drugs and generic drugs.
[Original drug]
It is a newly developed drug and is also called a new drug.
Example: Viagra, Cialis, etc.
[Generic drug]
It is a drug that is manufactured with the same main ingredients as the original drug and has the same effect, and is generally called a generic drug.
Example: Kamagra Gold, Tadarise, etc.
The development of a new generic drug requires a huge cost of tens of billions of yen and a long development period of several years to several decades.
Therefore, the selling price of the drug substance is high. This is inevitable.
In comparison, generic drugs (generic drugs) are sold at overwhelmingly low prices.
At the same time as the development of the drug substance, we obtained a patent for raw materials and manufacturing methods, but when this patent period expires, we will be able to manufacture drugs with the same principal components.
Of course, since it is manufactured with the same main ingredients, no new research and development is required. The manufacturing cost is overwhelmingly low, and the selling price is considerably lower than that of the drug substance.
Even from the general public, it is very grateful to be able to buy medicines with the same effect at a low price.
Market Share of generic drugs
Worldwide, generic drugs are widely used in developed countries in Europe and the United States, such as the United States, Germany, and the United Kingdom. In terms of market share, generic drugs account for 30-40% and generic drugs 60-70%.
This is because “generic drugs” have recently become known, but somewhere in my mind, I misunderstand that “the higher the price, the more effective it is.” That’s not it?
As mentioned above, it is no exaggeration to say that “misunderstanding = loss” because both the drug substance and the generic drug have the same effect.
Today, I think it’s wise to abandon the weird brand orientation after learning about generics.
Efficacy / safety and quality
New and generic drugs are basically the same in terms of efficacy and safety.
The new drug is a drug that has established efficacy and safety over an exclusive sales period of 20 to 25 years. Generic drugs are developed based on the active ingredients and manufacturing methods of new drugs, and are approved for manufacturing after passing many rigorous tests.
The development of generic drugs goes through various stages from basic research to clinical trials.
First, we will investigate the sales of new drugs and the trends of patients with indications. Based on the active ingredients of new drugs that are judged to be developable as a result of basic research, we will consider whether we can develop drugs of equal or better quality. After that, a clinical trial will be conducted.
How the medicine dissolves is important for the effect of the medicine. The effect depends on where it melts.
We are conducting elution experiments to measure the dissolution rate of new drugs and generic drugs using acidity and alkalinity.
By conducting a bioisostere test in the approval review of generic drugs, the behavior of blood concentration can be adjusted so that the efficacy and safety are the same even if the ingredients and compounding amounts of the new drug and the additive are different. You can change it. We are checking if it is equivalent to the original medicine.
The bioisostere test is a test conducted to prove that a generic drug is therapeutically the same as a new drug, and is also called a BE test.
This is a study of regular administration of new and generic drugs to healthy adults to see if there is a statistical difference in blood levels between the two.
We also carry out accelerated tests to estimate the stability of the distribution period in a short period of time, and stability tests of long-term storage tests to estimate long-term quality stability.
Generic drugs are manufactured and marketed only after they have passed various studies, studies and trials and have been approved by the state. From this, it can be said that there is no difference in the efficacy, safety and quality of the drug substance and the generic drug.
Reason for cheap
The biggest feature of generic drugs is their low selling price.
It can be purchased at a cost of 30-70% compared to new drugs. The price is cheap so the quality is not bad. Now, let me explain why the selling price is low.
First, the development cost of a new drug is said to be 20 to 30 million dollar over a long period of 9 to 17 years.
Even if an ingredient that seems to be effective is found, it seems that it is often interrupted during development due to poor compatibility with the human body at the development stage and high toxicity.
It is said that less than 1/4000 of the ingredients under development are actually approved as new drugs.
As you can see, there are significant risks in developing new drugs.
Also, the process up to release is very time consuming as it requires a huge amount of material to be submitted after a lot of review. Therefore, the selling price of new drugs is high.
On the other hand, the development process for generic drugs is very different. Since it is developed using ingredients with established efficacy and safety, the period can be shortened to 3 to 4 years and the development cost can be significantly reduced.
As you can see by comparing these, generic drugs are of the same quality and can be sold at a lower price. Since the development cost is reduced, it is possible to engage in drug research, improve the drug substance, and manufacture value-added drugs.
It is a generic drug manufactured based on a new drug developed with labor and a large amount of cost, but if it is improved, manufactured and sold immediately after the new drug is sold, only cheap generic drugs will be sold. .. It will be over. Pharmaceutical companies that develop new drugs are patented to ensure that the efforts of long-term R & D companies that have invested heavily are not wasted.
You have the right to prevent other pharmaceutical companies from imitating manufacturing methods that use the same ingredients for a period of time. The pharmaceutical company that develops the new drug must recover the development costs during the exclusive sale of this patent.
After the expiration of the patent, other pharmaceutical companies will be able to develop medicines using the same active ingredients and manufacturing methods, and generic medicines will be born.
When developing a generic drug, you can omit the clinical trials that are being conducted during the development stage of the new drug.
Generic drugs based on these are available at low prices, which can significantly reduce development costs compared to new drugs.