United States Generic Drugs Market is anticipated to be more than USD 210 Billion by the year 2024

United States Generic Drugs Market is so huge that nearly 80% of dispensing prescriptions accounts generic drugs. According to FDA in the United States 9 out of 10 prescriptions filled are for generic drugs. Most of the physicians and hospitals are now prescribing generic drugs than that of the brand-name drugs. Generic Drugs are those drugs which have same active component as patent drugs in same outline & equal amounts. US Generic Drugs Market is projected to exceed USD 210 Billion by 2024. Generic drugs are also called as Off-Label 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.

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 the approval process for generic drugs in US. For making a generic drug, pharmaceutical companies are required to file an Abbreviated New Drug Application (ANDA) 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.

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Phase 1 Clinical Studies: At this stage testing involves a small group of healthy people from a dozen to a few in numbers and safety is taken as a primary concern. Now all the side effect of drug, how a drug is absorbed and elimination from the body is tested.

Phase 2 Clinical Studies: After getting positive outcomes from Phase1, Phase 2 begins in this phase the number of patients grows from a few dozen to 100 or more patients who are suffering from disease. Safety is also a big concern at this point and short term side effects are also monitored closely.

Phase 3 Clinical Studies: At this stage the number of patients for drug testing grow from a few hundred to thousands. It is the longest and costliest of all components of development process.

New Drug Application Filing: At this point application is filed to FDA, with all the research and safety data of initial stages having tens of thousands to 100,000 or more pages. After getting affirmation from FDA, Prescription Drug User Fee Act (PDUFA) date is set 10 months.

PDUFA Date and Decision: FDA will wait for PDUFA date for its decision. FDA has 3 choices: it can approve a drug, it can deny a drug or it can request additional information by sending a Complete Response Later (CRL). If a drug is approved by FDA, now it becomes immediately available for commercial production.

Phase 4 Clinical Studies: After 8 steps an approved drug can used for medical purpose, but it doesn't mean it is not under scrutiny of FDA, FDA can request long-term safety measures, side effect and adverse effect of drug.

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