Generic drugs are chemically the same as their name-brand counterparts. When the patent runs out on a drug, other pharmaceutical companies begin to produce it under a generic name. The generic drugs go through the same regimen of tests and procedures as name brand drugs and must pass all the requirements of the FDA. Generic drugs usually cost less than brand-name drugs. They have the same chemical components as the brand name medications and are expected to work in much the same way.
Pharmaceutical Patents
A pharmaceutical patent is applied for when a chemical compound has been produced. A drug will go through several years of research and development. It must also go through at least seven years of testing to meet FDA guidelines. Patents can remain in effect for up to 20 years. Because of the many years taken up by research, development and testing, manufacturers may only have a few years to recover their investment once the drug is sold publicly. After the patent expires, other pharmaceutical companies may produce the same drug under generic names.
Efffectiveness
Because generic drugs have the same basic chemical make up as brand name drugs, their effectiveness should be similar. The generic drugs must go through similar testing by the FDA as their predecessors. These tests make sure that the generic drug has the same compounds and amounts as the brand names they are named after. Effectiveness of any drug can be influenced by the companies manufacturing techniques and the qualities of the materials that are used.
Research and Development
Generic drugs are required to go through tests and meet guidelines put in place by the FDA. Some testing may be required by the FDA, but for the most part, inconsistencies and flaws have already been noted and corrected by the company that patented the brand name drug. Because the drugs are second generation, most of the research and development that was put into creating them was already accomplished by the original manufacturer.
Ingredients
Even though generic drugs are based on the same chemical compound as a name-brand drug, there may be some differences. The chemical structure of the generic compound must be the same as the original for the product to be a generic drug. Fillers or bonding agents may be added to change a capsule form to a tablet form.
Cost Effectiveness
Because most of the cost of developing and testing the drug was placed on the original manufacturer, a generic drug will not have to be priced to reflect those investments. Most of the cost that generic manufacturers incur are associated with the manufacturing of the drug. The brand name manufacturing companies not only pay costs associated with the patenting process, but also invest large amounts of money in the research and development of the drugs.
