| According FDA (U.S. Food and Drug administration, to get FDA approval, a generic drug must: contain the same active ingredients as the brand name drug (inactive ingredients may vary), be identical in strength, dosage form and route of administration; have the same use indications, be bioequivalent; comply with the same batch requirements for identity, strength, purity and quality; be manufactured under the same rigid standards of FDA's good producing practice regulations mandatory for brand name drugs. To put it differently, their pharmacological effects are identical to those of their brand name versions.
A great many people have doubts about the potency of generic medications, since the latter are frequently considerably cheaper than brand name versions. They wonder if the quality and potency have been ignored to produce cheaper products. Generic medications are mandatory to be as secure and effective as brand name medications.
Actually, the lower price of generic drugs is explained by the fact that the producers have not had the expenses of manufacturing and promoting a new drug to the market. When a company introduces a new drug to the market, the business has already spent substantial money on research, development, marketing and promotion of the medication. The manufacturer that manufactures the drug is granted a patent - an exclusive right to sell the drug as long as the patent is in force. By the end of the expiration date of the patent, producers can ask the FDA for a permit to produce and sell generic versions of the drug. Without the startup expenses on manufacturing of the medication, producers can afford to make and sell it at a lower price. Because of the competition on the market the price can also reduce.
The standards for all drug producing facilities are the same, and many companies make both branded and generics. In fact, 50% of generic drug manufacture is estimated to be made by branded manufacturers.
At times, generic versions of a drug have different colors, flavors, or combinations of inactive ingredients in comparison with branded medications. According to the U.S. Trademark law, generic drugs are not allowed to look exactly like branded drugs. Still, active ingredients in both preparations must be identical, ensuring that both have the same medicinal effects.
The same variations are also seen between brand name drugs sold in different countries. A drug can be a bolus in the USA, but a pill in Canada, for example, even though it is made by the same brand name company. |
