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The compounds are made public due to FDA regulations. Due to low research and development expenses, as well as a significantly lower burden for approval, the profit margins for generic drugs are higher despite significantly lower prices. Brand Name Drugs This ends when the registered patent expires. Only then can other medicine manufacturers file to create a generic version, with only a 3. This is also the reason why brand name drugs are usually more expensive than generic versions.
A disadvantage of generic drugs is that their appearance may change if the manufacturer supplying your pharmacy changes, although variations in appearance should not affect the effectiveness or safety of the drug. The key to understand is, though the generic name exists, the company who developed the drug, through its patents, receives an exclusivity period where it has the only rights to sell the medication under either the brand or generic name.
During the period of patent protection, the company sets the price to a point where it can recover research and development costs along with other cost, like marketing, while trying to make a profit. At the point where a patent expires and the exclusivity period ends, other manufacturers are allowed to apply to the FDA to sell generic versions under the generic name of a medication. So much so that in a study, it was reported that generics saved the US healthcare system over 3 billion dollars a week.
In order for the FDA to approve a generic version of a brand, the FDA requires that generic medications have the same dosage form, safety, strength, route of administration, quality, performance characteristics and intended use as the brand-name drug.
And, the generic manufacturing, packaging, and testing sites must pass the same quality standards as those of brand name drugs. When it comes to the difference between generic and brand drugs, the generic version of a drug will differ in certain characteristics, such as inactive ingredients including colors and flavorings.
When differences such as certain inactive ingredients e. Even though certain characteristics may differ, such as inactive ingredients, in order for the FDA to approve a generic drug, the differences between a brand and generic drug can not affect performance characteristics, safety or effectiveness.
In the development process of the drug, an active ingredient appears first. The drug is protected by a patent. It is essential to design the patent.
It allows a pharma manufacturing company to sell medicine at higher profits and earn more. Till the drug is covered by the patent, other companies are not allowed to send a similar medicine that contains the key ingredient. Every patent has some definite time. When the patent expires, the drug becomes free. Other companies also get permission to develop medicines using that active ingredient. These medicines are called generic medication. It means you will get different drugs names with the same active ingredients, and this active ingredient is what refers to the generic drug.
Trade laws forbid generic drugs to look exactly like the brand-name drugs but must all have the same active ingredients for the same medicinal effects. These differences often come from non-active ingredients used such as the dyes, fillers, and preservatives, which help to determine the size, shape and color.
If your prescription is for a brand name, but your doctor permits generic substitution, the drug label will indicate the active ingredient.
So despite differences between brand name and generic drugs, active ingredients are the same, effectively. However, talking to your doctor before filling your drug list will guarantee you are getting the right drug.
You are not to assume a drug is the same just by looking; it takes an understanding of active ingredient composition to decide. Generic drugs are cheaper than brand name drugs; will this not affect the quality of the drugs? If you are concerned that generic drugs are cheaper and may affect the quality, you are not alone. The food and drug administration FDA works to make generic drugs as safe and effective as brand name drugs. Imagine the world without enough and affordable essential drugs. It is why generic drugs are allowed to make more drugs available and affordable to people who need them.
Generic drugs are cheaper since the costs of production do not include the cost of development and marketing for the brand name drugs. Usually, new drugs expenses will include the cost of research, patency, development, marketing, and promotion. But none of these costs are involved in generic drugs.
It is why the law allows the brand name company to recoup its investment before allowing generic drug manufacturers to produce and sell the same drug.
In a way, the reason generic drugs are allowed is to bring down cost and make drugs available to more people at affordable prices.
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