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As per Renub Research analysis United States Generic Drugs Market is anticipated to be more than USD 210 Billion by the year 2024. It has approximately 80% share of total dispensing prescriptions. Now most of the physicians and hospitals like prescribe generic drugs as compared to branded drugs.
What is a Generic Drug?
It is a Pharmaceutical drug that has the same chemical composition as patented drug. It has the same Active Pharmaceutical Ingredient (API) as original, but may have different manufacturing process, excipients, color, taste and packaging. It is only allowed when the patent(s) of on original drug is expired.
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Generic Drugs Market in United States
In 2007, the Food and Drug Administration (FDA) launched the Generic Initiative for Value and Efficiency (GIVE) to increase the number and a variety of generic products by modernizing and streamlining approval process for generic drugs in US. For making a generic drug, pharmaceutical companies are required to file an Abbreviated New Drug Application with FDA.
Why Generic Drugs are more affordable than Branded Drugs?
A branded drug has to go through many phases before coming into the market; initial phase is drug discovery, target identification and validation then Primary Screening, Secondary Screening, Lead Optimization, Pre-Clinical Animal Studies and various other tests. As new drug development is a complex process and involves various R & D of chemicals, but clinical trials and regulatory processes are also required to be approved for human use of drugs.
How Drugs Development Process Works?
According to some studies only 5 out of 5000 preclinical drugs are tested on the human for medical use out of those 5 drugs only 1 is approved by FDA. There are various stages involved in drug development.
Drug Discovery and Target Validation: In this stage drug development company chooses a molecule, such as a protein or gene and test it with a drug. After testing multiple drugs only a few are selected for next stage.
Preclinical Testing: It is divided into subcomponents: in vitro and in vivo testing. In vitro testing examines drug molecules interactions in test tubes in the lab setting. In vivo testing involves test is being done on animal models and other living cell cultures. These tests may take several years before going to next stage.
Investigational New Drug Application Filing: At this stage an application is submitted to FDA before beginning human clinical trials. At this point FDA will scrutinize the outcomes of preclinical testing, side effects and other safety measures for an experimental drug. When IND got approved by FDA then it can move onto human trials. After IND approval a patented drugs' 20 year exclusivity period begins.
