A generic drug is a medicine created to be the equivalent to an already marketed brand-name drug in dosage form, safety, strength, route of administration, feature, physical characteristics, and intended use. The similarities between generic drug and brand-name medicine helps to demonstrate bio-equivalence, which shows that a generic medicine works in the same way and gives the same clinical benefit as its brand-name type. In other words, generic medicine can be taken as an equal substitute for its brand-name equivalent. FDA Generic Drugs program conduct inspections of manufacturing plants every year and monitor the drug safety after it has been approved and marketed.
Even though generic drugs and brand-name drugs share the same active ingredients, safety, strength, efficiency and the intended use, the trademark laws in the United States do not allow them to have the same look exactly like other drugs which is already on the market.
Cost difference between Generic medicine and Brand-name medicine
Companies that develop new drugs, like other new products are protected by patents that restrict other companies from manufacturing and marketing the same drug. The patent protects the company’s investment in developing the drugs by giving the sole right to market the drug till the patent is in effect. FDA allows certain period of marketing exclusively the brand-name medicine till the patents and marketing exclusive rights expire. After that, it approves the generic version of the same drug. Generic drugs cost less than their brand-name equivalent because they do not need to repeat animal and clinical studies that were required for brand-name drugs to demonstrate its safety and efficiency. This is also known as “abbreviated new drug application.” The competition between the brand-name drug and multiple generic drugs is the main reason for low-cost generic drug.
Demonstration of ANDA
ANDA must demonstrate the generic medicine is equivalent to its brand-name counter part by the following ways.
- Contain the same active ingredients as the brand-name drug. Active ingredients make the drug effective against the disease or condition it is treating. Inactive ingredients may vary.
- Be identical in strength, dosage form and route of administration. If the brand-name drug is a capsule and is taken orally, so is the generic.
- Treat the same medical condition.
- Be absorbed into the bloodstream at a similar rate and over the same period of time.
- Meet the same requirements for identity, strength, purity and quality.
- Be manufactured under the same strict standards that FDA demands of brand-name drugs.
FDA will make sure that the medicines both generics and brand- name sold in the United States are safe and effective by conducting testing in its laboratories or through research contract and grants. Also FDA encourages physicians and consumers to notify FDA of any adverse side effects when using the drugs and medical devices which FDA regulates by reporting them at MedWatch.
Liberty Management Group , a leading FDA consulting firm in the United States provides assistance with drug establishment registration, drug listing and label review.
Sudha S
Regulatory Consutltant
Mail : office@libertymanagement.us