Generic Drugs vs Patented Drugs: What’s the Difference and Are They Equally Effective?
Drugs have brought tremendous benefits to human life. They have reduced mortality and morbidity by saving lives and decreasing the number of patients suffering from various diseases. Drugs play a crucial role in improving public health.
Based on patent duration and drug names, drugs are divided into two types: generic drugs and branded (patented) drugs. When purchasing drugs at a pharmacy or filling a doctor’s prescription, patients are often faced with the question: “Should I use a generic drug or a branded drug?” Many people feel confused when confronted with these two options.
From a price perspective, generic medicines are usually cheaper, leading to the assumption that generics are of lower quality. On the other hand, branded medicines are often perceived as more effective due to their higher prices. This perception causes some patients to hesitate in switching to generics, even though both contain the same active ingredient.
- What Are Generic and Branded Drugs?
- Why Do Branded Drugs Cost More Than Generics?
- Bioequivalence as the Basis for Assessing Drug Effectiveness
What Are Generic and Branded Drugs?
Before discussing the differences and effectiveness of the two further, it is important to first understand what generic and branded (patented) drugs are. When a pharmaceutical company first develops a new drug to treat a disease, the product is marketed under a brand name. This drug is protected by a patent, meaning that only the patent holder has the exclusive right to produce, market, and profit from the drug.
Once the patent expires, other companies may produce and sell the same drug, which is then known as a generic drug. According to the U.S. Food and Drug Administration (FDA), a generic drug is one that is comparable to a branded drug in dosage form, strength, route of administration, quality, performance characteristics, and intended use.
Similarly, the European Medicines Agency (EMA) defines a generic drug as a drug developed to be equivalent to an already approved patented medicine. Generics contain the same active ingredient, are used in the same dosage, and are intended to treat the same condition as the patented drug. However, their brand name, physical appearance (such as color or shape), and packaging may differ from the original.
Why Do Branded Drugs Cost More Than Generics?
Branded drug are protected by patent rights that grant the developer exclusive marketing rights for approximately 20 years. Generic drugs can only enter the market once the patent period has ended. Branded drugs are marketed under a trade name given by the innovator company, while generics are marketed using their chemical or generic name.
Due to trademark regulations, generics cannot replicate the appearance of branded drugs, so they often differ in color, shape, or packaging. Branded drugs are generally more expensive because they include the costs of research, development, and promotion. In contrast, generic medicines are much more affordable since they do not bear the initial research costs and can be produced by multiple manufacturers, creating price competition.
Bioequivalence as the Basis for Assessing Drug Effectiveness
Both generic and branded drugs contain the same active pharmaceutical ingredients and must demonstrate bioequivalence. Bioequivalence is defined as the condition in which two pharmaceutical products are pharmaceutically equivalent and have similar bioavailability (the rate and extent of absorption into the bloodstream) when administered in the same molar dose. This degree of similarity is sufficient to ensure that their effects, in terms of both efficacy and safety, can be considered essentially the same.
Pharmaceutical equivalence means that both products contain the same amount of the same active substance(s), are in the same dosage form, administered via the same route, and meet the same or comparable quality standards. The primary purpose of establishing bioequivalence is to demonstrate that generic medicines are equivalent to branded (patented) drugs so that preclinical and clinical data obtained from the branded medicine can be used as a reference for the generic without the need to repeat the entire process.
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The Role of Validation in Ensuring the Quality of Pharmaceutical Products
In conclusion, patented medicines are not more effective than generic medicines, as both have similar efficacy, mechanisms of action, and side effect profiles. To ensure the safety of drugs, both generic and branded, requires proof through valid scientific data. Every product must undergo a quality verification process to ensure its effectiveness.
This is why laboratory testing is a crucial step before a drug is distributed. IML Research provides drug testing services that include active ingredient analysis, assays, stability, and bioequivalence. The entire process is designed to ensure your product meets applicable regulatory standards. Trust your drug testing to IML Research for accurate, comprehensive, and reliable results.
References:
Dunne, S. S., & Dunne, C. P. (2015). What do people really think of generic medicines? A systematic review and critical appraisal of literature on stakeholder perceptions of generic drugs. BMC medicine, 13, 173. https://doi.org/10.1186/s12916-015-0415-3
Dunne, S., Shannon, B., Dunne, C., & Cullen, W. (2013). A review of the differences and similarities between generic drugs and their originator counterparts, including economic benefits associated with usage of generic medicines, using Ireland as a case study. BMC pharmacology & toxicology, 14, 1. https://doi.org/10.1186/2050-6511-14-1
Pandanwangi TW, S., Agustina, D., & Karsidin, B. (2024). A systematic review of knowledge and perception regarding generic medicines among Indonesians. Journal La Medihealtico, 5(2), 309–322. https://doi.org/10.37899/journallamedihealtico.v5i2.1187
