What are Generic Medicines


The generic term for a medication is the name of the active ingredient it contains. This is the ingredient that actually does the work of controlling your asthma or reducing your risk of heart disease.

There is only one generic name for each medication. But several different brands may be available. The brand name is usually the largest writing on the packet. Nurofen, for instance, is the brand name for the generic medication ibuprofen.

Generic medications are available for older drugs, and are commonly offered by your pharmacist as a cheaper alternative to the original branded medication. These drugs are tested to contain exactly the same active ingredients, so they produce the same effects.

However, there are a few rare exceptions, such as in some epilepsy medications, where drug levels may differ slightly between brands. So in such cases, doctors can choose to prescribe the branded version for its specific clinical benefits.

Why are generics cheaper than brand-name medications?


Generic makers don’t face the same costs as manufacturers of brand-name drugs. That’s because the brand-name maker often invented the drug, a process that can cost hundreds of millions of dollars. This is the rationale behind drug patents: They give pharmaceutical companies a period of years when only they can make money on a product in which they have made a large investment. That investment also includes advertising: all those TV commercials and billboards at bus stops.

For a generic manufacturer, no such investment is required — not in development and not in marketing. The drug’s formula is known, the clinical trials are complete; the generic maker’s only requirement is to demonstrate to regulators that its version is as good and effective in humans as the original.

That is an enormous economic advantage for these companies, which is why their drugs can be much cheaper.

Are generic drugs as effective as brand-name drugs?


Yes. A generic drug is the same as a brand-name drug in dosage, safety, strength, quality, the way it works, the way it is taken and the way it should be used.

FDA requires generic drugs have the same high quality, strength, purity and stability as brand-name drugs.

Not every brand-name drug has a generic drug. When new drugs are first made they have drug patents. Most drug patents are protected for 20 years. The patent, which protects the company that made the drug first, doesn't allow anyone else to make and sell the drug. When the patent expires, other drug companies can start selling a generic version of the drug. But, first, they must test the drug and the FDA must approve it.

Creating a drug costs lots of money. Since generic drug makers do not develop a drug from scratch, the costs to bring the drug to market are less; therefore, generic drugs are usually less expensive than brand-name drugs. But, generic drug makers must show that their product performs in the same way as the brand-name drug.

How are generic drugs approved?


Drug companies must submit an abbreviated new drug application (ANDA) for approval to market a generic product. The Drug Price Competition and Patent Term Restoration Act of 1984, more commonly known as the Hatch-Waxman Act, made ANDAs possible by creating a compromise in the drug industry. Generic drug companies gained greater access to the market for prescription drugs, and innovator companies gained restoration of patent life of their products lost during FDA's approval process.

New drugs, like other new products, are developed under patent protection. The patent protects the investment in the drug's development by giving the company the sole right to sell the drug while the patent is in effect. When patents or other periods of exclusivity expire, manufacturers can apply to the FDA to sell generic versions.

The ANDA process does not require the drug sponsor to repeat costly animal and clinical research on ingredients or dosage forms already approved for safety and effectiveness. This applies to drugs first marketed after 1962.

What standards do generic drugs have to meet?


Health professionals and consumers can be assured that FDA approved generic drugs have met the same rigid standards as the innovator drug. To gain FDA approval, a generic drug must:

contain the same active ingredients as the innovator drug(inactive ingredients may vary)

be identical in strength, dosage form, and route of administration

have the same use indications

be bioequivalent

meet the same batch requirements for identity, strength, purity, and quality

be manufactured under the same strict standards of FDA's good manufacturing practice regulations required for innovator products

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