Fair Prescription Drug Competition Act

The Senate and House of Representatives are both considering bills that would prevent NDA holders from marketing authorized generic versions of their drug during a generic manufacturer’s 180-day exclusivity. The nearly-identical bills, S.373 and H.R.741, concern any version of an NDA holder’s drug that the NDA holder introduces on the market after receiving notice of a pending ANDA with a Paragraph IV certification alleging invalidity or noninfringement. An exception in the bill would allow an NDA holder some involvement in the release of an authorized generic drug if the first ANDA filer, eligible for 180-day exclusivity, would be marketing, selling, or distributing the drug. After the 180-day exclusivity period concludes, or after the first ANDA filer forfeits the exclusivity period, the NDA holder could again introduce new versions of the drug.

If this new measure becomes law, it would give first-filing ANDA applicants a 180-day period to start competing with the NDA holder in which even the NDA holder could not introduce a new version of the drug. The exclusive nature of this half-year right to introduce new versions would increase the incentive for potential ANDA filers to challenge patent validity or scope. With no new NDA holder competition, an ANDA filer may introduce its generic product at a price equal to or only slightly lower than the NDA holder’s brand price. Thus, this bill would incentivize patent challenges at some expense to generic drug consumers, both monetarily and regarding variety of generic drug options. However, consumers might also see earlier initial introduction of generic drugs. The bill would disadvantage NDA holders, both in increased patent challenges and in missed opportunity to establish a position in the generic market. First-filing ANDA applicants would realize greater profits in exchange for their patent challenges.