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Almost 90% of prescriptions filled in the United States are for generic drugs according to the Food and Drug Administration (FDA). Brand name drugs are released first and generic drugs are copies of them. For example, the generic version of the erectile dysfunction drug Viagra is sildenafil. The generic version of the pain killer Vicodin is hydrocodone and acetaminophen. Due to patent protection, you may not be able to get a generic version of a brand-name drug until a period of time after the brand-name drug is released.
Are generic drugs the same as brand name drugs?
According to the FDA, generic medicines work in the same way as brand-name medicines and use the same active ingredients. The active ingredient makes the medicine effective against the illness or condition it is treating.
In addition, to receive FDA approval, generic drugs must
- Be the same strength
- Be same dosage form (tablet, capsule, etc.)
- Have the same route of administration (oral, topical, injectable, etc.)
- Have the same quality and effectiveness as the brand name drug.
The generic manufacturer must also prove that the generic drug is the bioequivalent to the brand name drug and that it is as safe as the brand name drug. However, generic drugs may look different than brand name drugs. Differences in size, shape, and color of the tablet or capsule do not impact how the drug works, according to the FDA.
The FDA allows for slight variation between brand name and generic drugs. As a rule, the difference between generic and brand name drugs can be about the same as the difference from one brand name drug to another brand name of the same drug.
What about inactive ingredients in generic drugs?
Generic drugs may have different inactive ingredients than its brand name counterpart. Inactive ingredients help a drug taste better or dissolve faster, according to the FDA. If you experience a reaction when switching from a brand name drug to a generic drug, let your health care provider know. Your health care provider may report this reaction to the FDA.
Why do generic drugs cost less than brand name drugs?
Generic drugs can cost 80% to 85% less than an equivalent brand name drug, according to the FDA. Lower price doesn’t mean inferior. The cost of the brand name or “innovator” drug is partially to help the company that developed the drug recoup the costs of bringing a new drug to market. The FDA grants a period of exclusive marketing rights up to seven years to drug developers.
Generic drugs must go through a rigorous review process to receive FDA approval. However, generic drugs tend to cost less because they don’t have to repeat the studies and clinical trials that were required of brand-name drugs to prove safety and effectiveness. Generic drugs use the data from their brand-name counterparts when developing their drug. Generic drug companies also generally don’t have to pay for advertising and marketing. Lastly, generic drugs may cost less because multiple generic companies may be approved to market a single product. This creates competition in the marketplace, which may lower generic drug prices. The FDA estimates that generic drugs save American consumers three billion dollars a week.
Are generic drugs regulated?
Like brand name drugs, the Food and Drug Administration (FDA) regulates generic drugs. The FDA monitors reactions and adverse events for all drug products in the United States. The FDA investigates reactions and may impose changes on how the product is used or manufactured.
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