Generic Pharmaceutical Drugs : Pharmaguideline

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Generic Pharmaceutical Drugs

Branded and generic drugs are technically same but in appearance and pricing. Their similarities and differences are described here in detail.
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.
Few key points on Generic Drugs:
  • Are protected and successful alternatives to brand name prescriptions
  • Reduction in the cost of prescription drugs can help both consumers and the government.
  • Are presently utilized in 50% of all prescriptions dispensed
  • Save an average of $50 for every prescription sold
Generic Pharmaceutical Associate (GPhA) estimates that 56% of Rx filled by generic products

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.

Are there differences between Generic and Branded drugs?
  • Yes. 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.

Assuring the quality of Generic Drugs:
Generic drugs undergo tight review by the U.S. Food and Drug Administration to fulfill approval standards. The sole responsibility of the generic manufacturer to prove its drug is the same (bioequivalent) as the brand-name drug. Generic drugs can differ from brand-name drugs in size, shape, and color.
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Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of pharmaguideline.com, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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