All about Generic Drugs

Generic drugs are copies of branded drugs with the same brand name, dosage form, safety, strength, quality, and characteristics. The FDA standards for generic drugs are same as for the innovator drug. Even the generic medicine manufacturing, packaging, purity, and stability has the same standard as those of the branded drugs.

Generic drugs do not have the same inactive components like the brand name. A generic drug can be marketed after the original manufactured drug patent has expired that usually lasts up to 20 years. Generic medicines are less expensive than the brand name drugs.

Review process of a Generic Drug

Approval of generic drugs like any other drug takes time. The Generic pharmaceutical companies before marketing or sale have to get FDA approval. FDA reviews that the generic drug can substitute the brand name drug that it copies or not. The complexity of the drug and the application completion also aids in approval. FDA has to undergo a vast testing for generic drugs as they are prescription drugs and are bound to have life-saving positive effects.

The profit margin in medicines is not exponentially high but, it’s pretty good to fill the pharmaceutical company’s pocket. For increasing the pharma business and profit, the right marketing strategy is effective. FDA while reviewing the application of generic drug checks whether it is pharmaceutically equivalent” to the brand; capability of manufacture; consistency of the manufacture; active ingredient similarity to the brand; inactive ingredients safety; and the breakdown potential of the drug.

Types of Generic drugs

1. Branded generic drugs

  • Branded generics are generic medicines with a brand name. The brands are developed by a generic drug company or the original manufacturer after the patent expires for the original product. The branded generic name is proprietary of the original pharmaceutical company. They are thus novel dosage forms of products produced by a manufacturer who is not the actual discoverer of the molecule.
  • Branded generics are newly formed pharmaceutical companies who are willing to submit the abbreviated new drug application (ANDA) to the FDA. Many big brand name pharmaceutical companies are acquiring the generic companies to increase their pharma business.

2. Authorized Generics

  • They are the exact copy of the brand name version given by the authorized patent holder. It is a prescription drug produced by a company under a New Drug Application (NDA) and marketed as a generic under a private label. Like the original product, authorized generics are same in color, size, and inactive ingredients.
  • The costs for authorized generics low and similar to other generic medicines. Nevertheless, as there are manufactured after passing the NDA process so they may be a little higher to pocket than other generics. They are just products that are almost same as the original drug whose patent is expired.


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