Study: FDA finds competitive generic therapies launch faster than other generics

A study by US Food and Drug Administration (FDA) officials published in JAMA Internal Medicine earlier this week found that competitive generic therapies (CGTs) approved by the US Food and Drug Administration (FDA) were launched faster than traditional generics. This swift launch enables these products to compete more quickly with brand-name drugs, the authors said.

The study authors attributed the faster CGT entry “to the use or lose” nature of CGT exclusivity.

Between 2018 and 2022, FDA approved 127 CGTs, of which, 106 (or 83%) were launched within 75 days. In contrast, for non-CGTs, only 50% were launched within six months of approval, as noted by FDA's Kevin Kho and colleagues.

Regarding non-CGT approvals, the authors referred to an FDA report titled "Marketing of First Generic Drugs Approved by U.S. FDA from January 2010 to June 2017," published in November 2021. This report indicated that among 387 companies that submitted Paragraph IV (PIV) certifications challenging patents on branded drugs, only 50% entered the market within six months of approval.

The CGT designation was established under the FDA Reauthorization Act of 2017 (FDARA) and establishes a new process to designate and expedite the development of drugs for which there is inadequate generic competition.

The CGT pathway differs from the traditional generic drug approval program; for non-CGT products, FDA grants 180 days of marketing exclusivity to the first filer of a “substantially complete” Paragraph IV certification.

For products with a competitive therapy designation, applicants must market the product within 75 days of receiving approval or they forfeit exclusivity.

The authors evaluated generic drug products approved with CGT exclusivity eligibility from 1 October 2017 through 31 December 2022.

The study revealed that generic competitors reduce prices by an average of 31% compared to the brand price while in contrast, the reduction for competitive generics (CGTs) is even smaller at 26.8%. The authors explain this difference by noting that CGTs are typically lower-revenue drugs.

These competitive generics were used for various therapeutic purposes, including treating cardiovascular disease, endocrine disorders, diabetes, metabolic conditions, infectious diseases, psychiatric disorders, and other medical issues.

Data were obtained from the IQVIA National Sales Perspectives (NSP), which covered the period from 2017 to 2024. The NSP tracks the volume of prescription drug products distributed by manufacturers and distributors to various retail and non-retail outlets, capturing approximately 90% of the pharmaceutical market.

JAMA study

Study: FDA finds competitive generic therapies launch faster than other generics

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