Pharmaceutical drug discovery and development is an extensive, investment incurring,
and unpredictable process that may take 8-12 years to make a drug reaching to market place.
Originator companies generally ensure patent rights over the drug molecules discovered and developed
by them at an early drug development stage. This is an effort to inhibit other competitor
companies from synthesizing, use in manufacture, or sell these molecules at a later stage. This will
also allow the originator company to ensure exclusive profit gains if the drug molecule succeeds
to become a blockbuster drug. This security on exclusivity is rationalized to allow the originator
company to as recuperate investment and realize benefits as the process of discovery and development
of new drug needs a lot of investment in people, efforts, time and financial fronts.
Through an Abbreviated new drug application (ANDA) process, applicant may get FDA approval
for a generic drug without performing full clinical trials if the proposed drug product is bioequivalent
to the innovator drug product. USFDA approves the generic drugs if they demonstrate
to have the same quality, purity, strength and stability as that of innovator drugs. A paragraph IV
certification is submitted by the generic drug applicant in case they wish to market the generic
version of the drug before expiry of the originator’s patent rights. Submitting a Paragraph IV certification
would mean that generic applicant claims that it is justified to place generic drug early on
the market because its drug does not infringe the patent in question or the patent in question is invalid.
In case of successful proceedings over the claims the generic drug applicant is rewarded for
a ‘Para IV filing’ by granting a marketing exclusivity for 180 days. Exclusivity means that no
company is allowed to launch its product during this period. As a result, there is ‘No Competition’
in the market. As the first mover, this helps the generic manufacturer to have an advantage. It can
garner a market share. This is a valuable opportunity for generic drug manufacturer to maximize
profit margins without any competition. This provision in the act has promoted healthy competition
and helped public health sector with drugs becoming available to public at relatively lower
Keywords: ANDA, certification, generic, Hatch Waxman, drug, paragraph, USFDA.
Rights & PermissionsPrintExport