No. New drugs are developed under patent protection, and most drug patents are protected for 20 years after FDA filing. However, it may take many years to research and get the brand name drug to market. When the patent gets closer to expiration, other drug companies apply to the FDA for approval to start selling the generic version of the drug.
A generic drug can be “tentatively approved” by the FDA prior to patent expiration for the brand product. Multiple companies can manufacture and sell generic versions of the brand name product. However, some drugs may never have a generic because manufacturers may deem these products unprofitable or too difficult to manufacture.
You can search for generic equivalents by using the Electronic Orange Book on the FDA and search by the active ingredient name. A full list of products will appear, including generic and proprietary names, and the name of the manufacturer. If the “TE” (therapeutic equivalence) code beings with the letter “A”, then that product is therapeutically equivalent to its reference-listed drug (RLD), which is the proprietary drug. For example, there are multiple ibuprofen products that are considered therapeutically equivalent to Motrin (the RLD).
Since there is a lag time after generic products are approved and when they appear in the “Orange Book,” you should also consult the most recent monthly FDA generic approvals at First Generic Drug Approvals.
