FDA

The U.S. FDA offers a 180-day exclusivity period to cialis generic drug manufacturers in specific cases. During this period, one (or sometimes several) generic manufacturers can produce the generic version of any drug. This exclusivity period is just used when a generic manufacturer argues a patent is invalid or just isn't violated inside the generic manufacture of a drug, as well as the period provides for a reward with the generic manufacturer who will be willing to risk liability in the court as well as tariff of patent court litigation. There is often contention around these 180-day exclusivity periods just because a generic producer does not have to make the drug during this period and can file a credit application first to avoid other generic producers from selling the drug.

Primary location: Bethesda United States