Generic Drugs: What You Need to Know

A generic drug is a medication manufactured to be the same as an already available brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use. These similarities help to prove bioequivalence, which means that a generic medicine works in the same way and supplies the same clinical benefit as the brand-name medicine.

Key takeaways:

In other words, you can take a generic medicine in the same manner and way you would a brand-name medication. A little-known fact about generics is that legally there can be a 10% difference in strength when compared with brand-name medications (stronger or weaker). This does not interfere with the drug’s effectiveness.

Ensuring generic drug quality

Any generic medicine needs to act the same in the body as the brand-name medicine. It must be the same as a brand-name medicine in dosage, form and route of administration, safety, effectiveness, strength, and labeling (with certain limited exceptions). It must also meet the same lofty standards of quality and manufacturing as the brand-name product This standard applies to all generic medicines.

Generic medicines use the same active ingredients as brand-name medicines and work the same way, so they have the same risks and benefits as the brand-name medicines. The FDA Generic Drugs Program conducts a rigorous review to ensure generic medicines meet these standards, in addition to conducting inspections of manufacturing plants and monitoring drug safety after the generic medicine has been approved and brought to market.

A generic drug may have certain minor differences from the brand-name product, such as different inactive ingredients.

Generic drug appearance

Trademark laws in the United States dictate that a generic drug cannot appear exactly the same as drugs already on the market. Generic medicines and brand-name medicines share the same active ingredients, but other characteristics that do not affect the performance, safety, or effectiveness of the generic medicine, such as colors and flavorings, may be different.

Cost of generic drugs

Generic drugs tend to cost less than their brand-name counterparts because generic drug applicants do not have to repeat the animal and clinical (human) studies that were required of the brand-name medicines to prove safety and effectiveness. This simplified pathway is why the application is called an “abbreviated new drug application.”

The decrease in upfront research and development costs means that, although generic medicines have the same therapeutic effect as their branded counterparts, they are typically sold at large discounts (an estimated 80 to 85% less) compared with the price of the brand-name medicine.

Prescribed a brand-name but given a generic?

Most state pharmacy laws and insurance guidelines state that if a box saying “Dispense as Written” is not marked on the prescription, then the pharmacy must dispense a generic equivalent unless the patient specifies that they want the brand-name medication. In the United States, most insurances are more willing to cover a generic unless there is a medical reason the patient cannot take the brand or no generic is available yet.

Generic medications are wonderful alternatives to their branded equivalents. The introduction of generic medications into the market made access to affordable medicine a reality in the United States. It is always the decision of the insurance company or the patient as to the coverage and payment for a branded medication but there is a trivial difference in the therapeutic effect. Generics are extremely competitive and cost effective.

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