The second strategy intended to encourage new antibiotic development has been to provide additional market exclusivity incentives based on regulatory approval.
Offering additional market exclusivity has worked for so-called orphan drugs for rare diseases, but the trade-off has been sky-high prices that have sparked their own controversy.
Yet in the case of supplemental approvals for pediatric use, such studies will lead to six months of additional market exclusivity under the Best Pharmaceuticals for Children Act, which can be extremely lucrative for the sponsor.
For example, estimating patent expiration dates has become a challenge since these dates may change due to litigation, additional patents, exclusivities, and other factors which are difficult to anticipate [ 75, 76].
The arrangement would provide Pfizer 20 additional months of exclusivity to Lipitor, which generated $13 billion in revenue annually.
This allowed a new product fast-track status, priority review, and additional 5-year exclusivity free from generic competition.
No additional period of exclusivity will be granted to a previously licensed biologic product when subsequent applications are made for a new indication, route of administration, dosage form, or dosing strength.
The lawmakers have also reinserted a provision giving 6 additional months of marketing exclusivity to drugs approved for rare diseases, an incentive for drugmakers that had been removed in a previous version.
And Upton made another concession about a month ago when he removed the so-called Open Act, which would have given drug companies an additional six months of exclusivity for orphan drugs.
If the Pharmaceutical Companies submitted studies responding to the PWR, six additional months of marketing exclusivity were received.
