Patent Protection for Drugs
A company developing a new drug may obtain a patent for the drug itself, its synthesis, its use, and even the method of distribution and release into the bloodstream. Therefore, a company often owns more than one patent for the same drug. Patents grant the company exclusive rights to the drug for 20 years. Additional patents may sometimes be applied for to extend the term. Typically, about 10 years elapse between the discovery of the drug (when the patent is issued) and the time the drug is approved for use in humans, leaving the company with only half the patent term for its exclusive marketing. The FDA may choose to expedite the approval process for drugs to treat Acquired Immunodeficiency Syndrome (AIDS), cancers, and other life-threatening conditions when there is currently no effective treatment.
After the patent expires, a generic version of an FDA-approved drug can be manufactured and sold by other companies. Typically, they sell the product at a lower price than the original branded version because the generic drug manufacturer does not have to recover the original costs associated with developing the drug and usually invests much less in marketing campaigns. A generic drug can be marketed under its generic name or under a trade name (branded generic drug), but not under the name used by the original patent-holding company.
Not all drugs that are not covered by patent protection have generic versions. Sometimes, it is too difficult to reproduce a drug or there is not adequate evidence to show that the generic acts exactly like the brand-name drug. Sometimes, the market for the drug is so tight that producing another version would be economically unviable.
Generic drugs that do not require a prescription
Generic drugs corresponding to certain non-prescription drugs (over-the-counter drugs) are often sold, generally at a lower price, under a brand name of drug manufacturing chains or cooperatives. These drugs are evaluated at the ministerial level in the same way as prescription drugs and must meet the same requirements.
Pharmacists may recommend over-the-counter generics that have the same efficacy as the original. However, a consumer may prefer one product over another because of appearance, taste, texture or other characteristics.
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Generic drugs manager fdf corresponding to certain non-prescription drugs (over-the-counter drugs) are often sold, generally at a lower price, under a brand name of drug manufacturing chains or cooperatives. These drugs are evaluated at the ministerial level in the same way as prescription drugs and must meet the same requirements.
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