> The first generic drug approved gets 6 months of exclusivity where no other generic drug can be approved by the FDA.
Not quite. The first patent that files a lawsuit challenging a patent on the non-generic drug and wins said lawsuit gets 180 days exclusivity.
This rule was established to incentivize generic companies to challenge drug patents and get their products to market sooner.
In the case where the patents aren't being challenged, there's no exclusivity for generic drugs.
In practice, this 180 day exclusivity is a very big deal to generic companies, because typically the first to market among the generics will have a big edge in capturing the market (once a drug has a generic, pharmacies will typically automatically fill prescriptions for the brand name drug with the equivalent generic unless the doctor specifies not to).
You can get 180 exclusivity even if you don't challenge the validity of the patent.
From the FDA guidance[1 - page 6]:
When filing an ANDA, the sponsor can do one of the following 4 things to gain 180 exclusivity: (1) indicate no patent exists in the Orange Book (paragraph I cert), (2) that the patent has expired (paragraph II cert), (3) that the patent will expire on said date (paragraph III cert) or (4) that the patent is invalid, unenforceable or will not be infringed (paragraph IV cert)
But you are correct in that it's the status of the patent and how it relates to the filing that drives the 180 day exclusivity. My comment was a simplification, since I can't think of anyone who would file and not do that.
Not quite. The first patent that files a lawsuit challenging a patent on the non-generic drug and wins said lawsuit gets 180 days exclusivity.
This rule was established to incentivize generic companies to challenge drug patents and get their products to market sooner.
In the case where the patents aren't being challenged, there's no exclusivity for generic drugs.
In practice, this 180 day exclusivity is a very big deal to generic companies, because typically the first to market among the generics will have a big edge in capturing the market (once a drug has a generic, pharmacies will typically automatically fill prescriptions for the brand name drug with the equivalent generic unless the doctor specifies not to).