"4. For small molecule products, the period of data protection – five years in the United States – is less important, because the regulatory approval standard for generics requires a generic to have the identical active ingredient. This requirement allows for patents to predictably provide effective market exclusivity – that is, patents on the innovator’s product
will cover the generic product as well. In addition, the U.S. Hatch-Waxman Act provides patent term restoration to compensate new drug and biologic developers for periods of lost effective patent life consumed by the regulatory approval process. Through term restoration, a patent covering the product or its use or manufacture may be extended up to 14
years post-FDA approval. Thus, studies show that the interplay of these extended patent rights and the stringent regulatory standard for approval of generics combine to provide innovator products protection against premature generic competition for, on average, 12 years."