| Drugs sold as a cheaper alternative to brand named | | | | countries. Generics are created by applying reverse |
| products are called generic drugs. Usually, generic drug | | | | engineering to brand named formulations to create |
| companies cannot patent their active ingredients, but | | | | bioequivalent generics thereof. Generics don't need to |
| they can patent their own unique formulation. | | | | undergo clinical trials proving safety and |
| The Food and Drug Administration of the United | | | | effectiveness, which also saves time and money. |
| States of America governs all medications and | | | | Generic drug companies leverage off the marketing |
| according to them the generic drug is identical to the | | | | efforts of the brand name drug, which after a |
| brand named drug, legally. Therefore, the same laws | | | | number of years on the market has become |
| apply to these drugs as their branded counterparts | | | | well-known to healthcare professionals. These same |
| where strength, administration and safety are | | | | professional can now easily switch over their patients |
| concerned. They must contain the same active | | | | from the branded product to the generic medication. |
| ingredient as the branded product and be within | | | | Branded products monopolize the industry while the |
| acceptable bioequivalent ranges. | | | | patent applies and this allows them to price the |
| Once the patent expires on a branded drug, generic | | | | product as they wish to maximize profits. In doing |
| drugs can be introduced into the market. This leads | | | | this, they produce funds to research and create |
| to competition on the market which brings down the | | | | additional drugs, which generic med companies lack |
| price of both the generic and the branded drug. | | | | the funds for. |
| Whilst patents are valid for 20 years on drugs in the | | | | It is legal for generic developers to create a new |
| USA, it is only really active for about a decade as | | | | generic version when either the patent for the |
| developers have to apply for a patent before they | | | | branded product expires, when they can certify the |
| begin with clinical trials. | | | | invalidity of the original patent or in a country where |
| Once a patent no longer protects a drug, drug | | | | the patent is not valid. Not all patents are valid in all |
| companies can develop a similar product for a lot | | | | countries. |
| cheaper. This saves a lot of money for the generic | | | | Market monopoly is removed when a patent expires |
| company and enables them to market the product | | | | and they are generally not renewable. If a brand |
| for a lot cheaper, hence the savings are passed onto | | | | name company changes their formulation drastically, |
| health insurers and patients. Generic meds can be | | | | they have to apply for a new patent. New clinical |
| distributed within developing countries for a lot | | | | trials will have to be performed. While this happens, |
| cheaper than the named brands. | | | | the generic drug can still be sold unless it is removed |
| India is the world leader in generic drug manufacturing | | | | from the shelves by regulators of the FDA. |
| and are distributed from there to many developing | | | | |