Generic Pharmaceutical Drugs
A generic drug is a medication created to be the same as an existing approved brand-name drug in dosage form, safety, strength, route of administration, quality, and performance characteristics.
When a drug company first invents a drug, only that company is allowed to make that drug in the same country for a certain number of years and known as an innovator drug. The same drug can be manufactured by other companies after a certain period of time. These drugs are called generic drugs. FDA estimates that innovator firms manufactured over 50% of generic products
Generic medicines work the same as brand-name medicines
A generic medicine works in the same way and provides the same clinical benefit as its brand-name version. This standard applies to all FDA-approved generic medicines. A generic medicine is the same as a brand-name medicine in dosage, safety, effectiveness, strength, stability, and quality, as well as in the way it is taken and should be used.
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 make sure generic medicines meet these requirements. In addition, FDA conducts 3,500 inspections of manufacturing plants a year, ensuring compliance with the agency’s regulations on good manufacturing practices.
FDA staff also continually monitor drug products to make certain the medicines at all levels of the supply chain, from active pharmaceutical ingredients (API) to products being sold to consumers, are safe, effective, and high quality. In the event of reports of negative patient side effects or other reactions, the FDA investigates and, when appropriate, may require changes in how a medicine (both brand-name and generic versions) is used or manufactured.
Generic drugs must meet high standards to receive FDA approval
FDA requires drug companies to demonstrate that the generic medicine can be effectively substituted and provide the same clinical benefit as the brand-name medicine that it copies. The abbreviated new drug application (ANDA) submitted by drug companies must show the generic medicine is the same as the brand-name version in the following ways:
- The active ingredient in the generic medicine is the same as in the brand-name drug/innovator drug.
- The generic medicine has the same strength, use indications, form (such as a tablet or an injectable), and route of administration (such as oral or topical).
- The inactive ingredients of the generic medicine are acceptable.
- The generic medicine is manufactured under the same strict standards as the brand-name medicine.
- The container in which the medicine will be shipped and sold is appropriate, and the label is the same as the brand-name medicine’s label.
Approved generic medicines are generally only sold after patents and exclusivities protecting the brand-name version end
Patents and exclusivities are forms of protection for drug makers that may affect how and when a generic drug is approved and can be sold. New brand-name drugs are usually protected by patents (issued by the U.S. Patent and Trademark Office) that prohibit others from selling generic versions of the same drug. Periods of marketing exclusivity for brand-name drugs can also impact the approval of generic drugs.
FDA must comply with the delays in approval that the patents and exclusivities impose. Once these patents and marketing exclusivities expire (or if the patents are successfully challenged by the generic drug company), the generic drug can receive full approval and can be sold.
Generic medicines cost less than brand-name medicines
Generic medicines tend to cost less than their brand-name counterparts because they do not have to repeat animal and clinical (human) studies that were required of the brand-name medicines to demonstrate safety and effectiveness. In addition, multiple applications for generic drugs are often approved to market a single product; this creates competition in the marketplace, typically resulting in lower prices.
The reduction in upfront research costs means that, although generic medicines have the same therapeutic effect as their branded counterparts, they are typically sold at substantially lower costs. When multiple generic companies market a single approved product, market competition typically results in prices about 85% less than the brand-name. According to the IMS Health Institute, generic drugs saved the U.S. health care system $1.67 trillion from 2007 to 2016.
Are Generic drugs equal to brand drugs?
- In terms of active ingredients brand name drugs and their generics are identical.
- As the generic pills are made by a different company, they may look different but inside is exactly the same active ingredient, which works in exactly the same way as Brand name drugs.
- The foremost difference between brand-name drugs and generic drugs is that generics are always much less expensive.
- By purchasing generic drugs instead of name-brand medication savings of up to 80% can be made.
- Though generic drugs have the same active ingredient and work in exactly the same way as the brand drugs, the look of the generic drug is not the same as the brand name products. Moreover, if the same brand name pill is manufactured in a different country, it may look different.
- For example, Celexa 20 mg is a peach-colored pill in the US, yet the Canadian pill is white and a little bit smaller than the US pill. Both pills are Celexa 20 mg, both have the same active ingredient, and both are made by the same company.
- The manufacturer decided to make the Canadian drugs a different color for whatever unknown reason.
- When it comes to the comparison of 2 different Generics, they will look different if they are made by 2 different companies.
Are Generic Drugs Safe?
- Generic drugs when compared to their brand-name counterparts are just as safe and effective. These drugs are manufactured and exported in bulk by the companies that go into the making of the world’s best-selling brands in the US and Europe.
- Same rigid standards are maintained by the generic drugs as the brand name drug, as dictated by the U.S. Food and Drug Administration. 45% of U.S. prescriptions today are filled with generic drugs.
- In simple terms, a generic drug is a branded drug that uses a different name.
- Prilosec is the brand name for generic omeprazole which helps people with reflux disease. A drug used by diabetes patients (Metformin), is the generic name for the brand Glucophage.
- “The US Food and Drug Administration (FDA)considers a generic drug to be “alike, or bioequivalent, to a brand name drug in dosage form, safety, strength, route of administration, performance characteristics and the domain of usage..”
- But generic drugs cost less than their branded counterparts, and with the skyrocketing costs of healthcare, choosing generic drugs may be one way to keep costs lower.
What are the differences between Generic and Branded drugs?
- The difference lies in pricing. Beyond the pricing, there are other differences.
- First of all, generic versions are not there for all innovator drugs. Generic versions do not exist for all those recently developed drugs which are probably still patented, so to get the benefits of those drugs, you’ll need to use the branded versions.
- Also, “bio” equivalent means only that the active ingredients need to be the same.
- As per the requirement of U.S. Trademark laws, the drugs need to look different, so the generic version may be a different color, a different shape, have a different taste, or contain inactive ingredients that are different.
- Several problems have been reported by people who changed use from the branded drug to its generic, and vice versa. In most cases, the root cause of the problems found to be from the variation in the inactive ingredients.
- The number of active ingredients included in the different versions found to be a problem by different users. Adverse reports are rare.
- During the time of purchase, we pay for the costs associated with research, safety compliance, market transition, transport, and a premium if it is the only specific drug for a certain symptom or disease.
- Those costs can make drugs very expensive for us to purchase. The developer thinks much of the price is a valuable approach to recover its advancement costs.
- The drug can be manufactured and sold by any other company with the same ingredients as the branded one on the expiration of the patent protection.
- As insisted by the FDA, a generic drug must be given a new name. The generic drug manufactured by the company didn’t incur the costs of the original research, testing or marketing, the cost is lower
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