Vioxx vs. Rofecoxib
As explained below, generic drugs are identical to their name-brand counterparts in everything but appearance and inactive ingredients. The information on this web site applies to name-brand Vioxx as well as its generic version, rofecoxib. If you took rofecoxib, or generic Vioxx, your rights and responsibilities, as well as your entitlement to safe, high-quality medication, are the same as those of someone who took the name-brand drug.
Drug Patent Process
When a new drug is first created, the manufacturer holds the patent so that no other drug company may produce the drug. This patent begins with the very first preclinical trials and lasts for 20 years. By the time a drug is available to the public, the patent usually has 7-12 years remaining, during which time a generic version is not available. The justification for this extended patent period is that the original manufacturer of a drug invests the lion’s share of the research money. The exclusive rights to the drug’s profits pay the company back for that initial investment.
Once the original patent on a drug has expired, other manufacturers are free to produce a generic form of the drug. Often, the original manufacturer of a drug will produce a generic version of its own drug, while also continuing to produce the name-brand version.
FDA Guidelines for Generic Drugs
According to FDA guidelines, a generic drug must be equivalent to its brand name version in active ingredients (inactive ingredients may vary), dosage, method of administration, side effects, and safety. While generic drugs vary in appearance from their name-brand cousins, in every other way, they should be considered the same. In other words, any information provided on a name-brand drug also applies to its generic counterpart, and vice versa.
The FDA inspects American drug manufacturers on a rotating basis to ensure that their production meets safety and quality standards. The FDA does not, however, inspect prescription drug manufacturers located outside of the US.
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