Branded generic drugs are new-formulated versions of off-patent drugs, sold by the original manufacturer or by a generic drug company seeking to create a brand name for their generic version. This is in distinction from ordinary generics who do not seek a brand name, and market their generics by their chemical name. The branded generics market is worth two-thirds of the global generics market and was valued at $230.47 billion dollars in 2021. With sales growing at 8.9% CAGR, the market is expected to double in size by 2030.
Branded generics go through the same FDA approval process as other generics do after the original drug patents expires. Companies must submit an ANDA (abbreviated new drug application) to the FDA, proving bioequivalence to the original drug. Authorized generics, however, are created by the original manufacturer, under the same NDA (New Drug Approval) authorization as the original drug, and they may be sold before drug patents expire. In terms of price, both branded generics and authorized generics tend to cost more than ordinary generics, due to the branded generic's long approval process, and the authorized generic's market exclusivity.
The global generics market is primarily driven by the significant increase in cardiometabolic risk factors and in cancer cases thus raising the need for cheaper alternatives. In turn, governments are shifting towards implementing generic drugs in healthcare. In addition, the COVID-19 pandemic led to the implementation of stringent lockdown regulations across several countries, which are now being removed, reopening the market to generic distribution.
However, the main reason the branded generics market is expected to expand is due to Marketing and commercialization, having an enormous effect on the success of new drugs in the market. Marketing a name that consumers can remember easily, rather than a complicated chemical name, sparks loyalty and familiarity, and is why consumers stick to the same brand name. This is why the branded generic market still has a long way to go.
Sample pricing data: CRYSELLE (Norgestimate / Ethinylestradiol) US state tender and private.
Sample US Medicaid / Medicare 2016-2020 consumption data: CRYSELLE (Norgestimate / Ethinylestradiol)
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