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Applied Clinical Research, Clinical Trials and Regulatory Affairs (Discontinued)


ISSN (Print): 2213-476X
ISSN (Online): 2213-4778

Review Article

The Breakthrough Hatch Waxman Amendment – A Shared Benefit for Innovations and Subsequent Innovations

Author(s): Sandeep Kumar Dhiman, Anju Dhiman*, Shelly Khurana, Vikram Gummadi and Anjali Saharan

Volume 4 , Issue 2 , 2017

Page: [86 - 90] Pages: 5

DOI: 10.2174/2213476X04666170519125451

Price: $65


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 prices.

Keywords: ANDA, certification, generic, Hatch Waxman, drug, paragraph, USFDA.

Graphical Abstract

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