What are Generic Medicines?
A generic drug is a medication created to be the same as an already marketed brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use. These similarities help to demonstrate bioequivalence, which means that a generic medicine works in the same way and provides the same clinical benefit as the brand-name medicine. In other words, you can take a generic medicine as an equal substitute for its brand-name counterpart.
After patent expiry a medicine is sold under its molecule name, known as generic medicine
They are exactly same in its efficiency & strength
Generic Vs Branded
Generic medicinescontains the same active ingredient as that of branded medicine;
Generic medicines is identical in strength to that of branded medicine,
Dosage form, and route of administration of Generic medicine is same as that of branded medicine;
Generic Medicine has the same indications, dosing, and labeling as Branded Medicine;
Generic Medicine provides the same efficacy and safety profile to patients (“bioequivalent”) as branded medicine,
Are Generic Medicines safe?
Generic medicines have to be safe and effective to be approved by the FDA. The FDA also requires generic drug manufacturers to:
meet the same batch-to-batch requirements for strength, purity, and quality as the original manufacturer; and
follow the same strict “Good Manufacturing Practices” rules.
Why do generic medicines often cost less than the brand-name medicines?
Generic drugs are approved only after a rigorous review by FDA and after a set period of time that the brand product has been on the market exclusively. This is because new drugs, like other new products, are usually protected by patents that prohibit others from making and selling copies of the same drug.
Generic drugs tend to cost less than their brand-name counterparts because generic drug applicants do not have to repeat animal and clinical (human) studies that were required of the brand-name medicines to demonstrate safety and effectiveness. This abbreviated pathway is why the application is called an “abbreviated new drug application.”
The reduction in upfront research costs means that, although generic medicines have the same therapeutic effect as their branded counterparts, they are typically sold at substantial discounts, an estimated 80 to 85% less, compared with the price of the brand-name medicine.