Understanding Brand Drugs

Understanding “Brand Drugs” and “Generic Drugs”

blog1brand drug is originally discovered and manufactured by a research and development focused biotechnology or pharmaceutical company. After approval by a regulatory body, a brand drug can be exclusively marketed and sold by that company for the duration of the patent protection on the drug. The average duration of initial patent protection is generally around 12 years. Brand drugs are always marketed under a “trade” name rather than the “chemical” name of the drug itself.

generic drug is the chemical equivalent of a brand drug that has an expired patent.
A generic drug is made by drug manufacturing companies that usually do not engage in new drug discovery. They reproduce or basically copy successful brand drugs that patent protection has expired on. They then market them under the chemical name.

In countries like Canada, England, Ireland, France, Germany, Australia, New Zealand and the United States, their respective national regulatory agencies require that all drugs, regardless if brand or generic, must meet standards of safety, strength, purity and effectiveness. Additionally, they must be manufactured in inspected and approved facilities that comply with rigorous standards related to input supply chain, manufacturing process, packaging, labeling, and tracking.

In order to ensure its safety and effectiveness, a generic drug just like the brand drug, has to undergo intensive human testing. This is a rigorous process and deals with two main issues: “Pharmacokinetics“, or the effect of the human body on the drug, and “Pharmacodynamics” or the effect of the drug on the human body. A generic drug can not be approved for sale and marketing in these jurisdictions, unless it is therapeutically equivalent to the brand drug. The term “Bioavailability” is used to describe the amount of a given dose of a drug that reaches the blood after administration. “Bioequivalence” is a term used to describe the expected similarities of two drugs in the human body.
A generic and a brand drug would be said to be bioequivalent if after giving the same dose of both to a patient, via the same route, there was no significant difference in the rate and extent to which the active chemical substance in each drug arrived at the ultimate site of action in the body. In other words, the two drugs would be pharmaceutically equivalent with similar bioavailabilities, and their effectiveness and safety profile would be expected to be essentially the same.

As stated above, for a drug to be marketed under a generic label in these jurisdictions, the manufacturer must comply with stringent regulatory standards. Generic drugs must be therapeutically equivalent to the brand name drug. Other than cost, numerous studies have failed to show any true statistical differences between brand name drugs and generic drugs manufactured in these jurisdictions.

Most employer sponsored plans today, for good reason have mandatory generic substitution. There are very few valid and evidence based reasons clinically for a brand to be preferred over a generic product by an Attending Physician to achieve a therapeutic outcome for a patient. A Multisource Product would have generic versions from more than one manufacturer, in addition to the brand. Single Source Products are usually the brand product from the innovator pharmaceutical company. The price differential can be enormous between Brand and Generic, resulting in excessive costs to both the plan sponsor and the member.
Our mandate is to provide you with quality pharmaceutical products at true lowest net cost through exceptional consumer service and industry leading safety standards. By increasing the Generic Utilization Rate (GUR), Elect Rx is driving your net cost of prescription drug products down. It’s just more common sense, courtesy of ElectRx!