There are common misconceptions about the quality of generic and branded medicines, and it&39;s essential to clarify their differences. Both types of medications are prescribed by doctors and contain the same active drug but may differ in other ingredients.
Branded Medicines:
- Branded medicines are the first of their kind; they are developed and invented by the pharmaceutical company. This process involves extensive research, testing, development, production, and marketing.
- To market and sell a branded medicine, the pharmaceutical company must meet FDA requirements by submitting a New Drug Application. This application provides data to establish the drug&39;s efficacy, quality, and clinical safety, often requiring numerous studies.
- Upon FDA approval, the pharmaceutical company obtains a patent, granting it exclusive rights to manufacture and sell the drug. This exclusivity allows the company to recoup its research and development expenses and make a reasonable profit. The patent prevents other companies from producing or selling the drug without permission. Once the patent expires, other companies can apply to the FDA to manufacture and sell generic versions of the drug.
Generic Medicines:
- Generic drugs are copies of branded medicines. In the USA, over 80% of prescriptions are filled with generic brands, a number expected to grow as more drug patents expire.
- To gain FDA approval to produce and sell generic drugs, manufacturers must demonstrate bio-equivalence and bio-availability, meeting the FDA&39;s strict standards for identity, strength, quality, purity, and potency.
Differences between Generic and Branded Medicines:
- Cost: The primary difference is cost. Branded medicine manufacturers incur extensive development costs, while generic medicine manufacturers mainly face production and marketing expenses. Therefore, generic medicines are generally more affordable than their branded counterparts.
- Competition: Multiple generic companies may produce the same drug under its brand name, leading to increased competition and lower prices. In fact, generics have significantly contributed to cost savings in healthcare.
- Inactive Ingredients: Generic medicines must contain similar active ingredients to the branded medicine since they treat the same condition. However, differences in inactive ingredients (excipients) can affect how the drug is absorbed. This can lead to variations in tolerability and, in some cases, allergies.
- Appearance: Generic drugs may differ in appearance, such as shape, size, and color, but their effectiveness remains comparable to branded medicines.
- Naming Conventions: Branded medicine names are capitalized, while generic medicine names are not capitalized.
In summary, the primary distinction between generic and branded medicines is cost, with generics being more affordable due to lower development expenses. Both types of medicines must meet FDA standards for safety and efficacy, but variations in inactive ingredients can affect how they are absorbed. Despite differences in appearance, generic drugs are equivalent in effectiveness to their branded counterparts, contributing significantly to cost savings in healthcare.