A generic drug is a pharmaceutical drug that is equivalent to a brand-name product in dosage, strength, route of administration, quality, performance, and intended use. The term may also refer to any drug marketed under its chemical name without advertising, or to the chemical makeup of a drug rather than the brand name under which the drug is sold.
New drugs, like other new products, are developed under patent protection. The patent protects the investment in the drug’s development by giving the company the sole right to sell the drug while the patent is in effect. When patents or other periods of exclusivity expire, manufacturers can apply to the FDA to sell generic versions. The ANDA process does not require the drug sponsor to repeat costly animal and clinical research on ingredients or dosage forms already approved for safety and effectiveness.
A drug company develops new drugs as brand-name drugs under patent protection. This in turn protects the investment in the drug’s development by giving the drug company the sole right to manufacture and sell the brand-name drug while the patent is in effect.
When patents or other periods of exclusivity expire, other manufacturers can submit an abbreviated new drug application (ANDA) to the FDA for approval to market a generic version of the brand-name drug.
Although generic drugs are chemically identical to their branded counterparts, generic drugs are typically sold at a cheaper price than the brand-name drug because the drug has not been developed from scratch, and the costs to bring the drug to market are less.
Are generic drugs as safe as brand-name drugs?
Yes. The FDA must first approve all generic drugs. The FDA requires that generic drugs must be as high in quality, and as strong, pure and stable as brand-name drugs. Generic drugs use the same active ingredients as brand-name drugs and work the same way. They have the same risks and the same benefits as the brand-name drugs.
Generic Drug Cost
Generic drugs are non-branded drugs that are marketed once the patent on a branded drug has expired.
When a pharmaceutical company first develops a drug, it applies for a patent. This means that only the company that has developed the original molecule can manufacture and market the drug during its patent protection period. Once the patent protection expires after a fixed number of years, other pharmaceutical companies are then allowed to also manufacture the drug. At this point, the drug is referred to as a generic drug.
This generic drug must contain the same active ingredient as the original branded formulation, as well as being similar or “bioequivalent” in terms of dosage and performance. Bioequivalence between the two drugs means there is either no significant difference between them in terms of the rate and extent of absorption or if there is a difference, it is either intended or not medically significant.
Furthermore, generic manufacturers save on marketing costs because many of the drugs have already been marketed through the media and drug representatives and are already well known to patients and consumers.
The cure for high drug prices – same medication, same pharmacy, lower price
Health professionals and consumers can be assured that FDA-approved generic drugs have met the same rigid standards as the innovator drug. To gain FDA approval, a generic drug must:
** Contain the same active ingredients as the innovator drug(inactive ingredients may vary)
** Be identical in strength, dosage form, and route of administration
** Have the same use indications
** Be bioequivalent
** Meet the same batch requirements for identity, strength, purity, and quality
** Be manufactured under the same strict standards of FDA’s good manufacturing practice regulations required for innovator products
Cheap generic drugs are good for when you’re between jobs, between insurance, or if you’ve just got a prescription drug plan that is costing you too much money. You might find, as Wise Bread did, that a generic version of your medication actually causes fewer side effects in addition to being more cost-effective.
You can use Consumer Report’s Best Buy drugs to help you locate some generics that might work for you, and then speak to your doctor about them.
Rising cost of prescription drugs is becoming harder to accept. Especially for senior people and those who are chronically ill. Online Pharmacy is dedicated to provide world class generic drugs to patients and clients, with superior quality and professionalism at most affordable price.
Our Generic drugs have exactly same active ingredients as the branded drugs. The quality, purity and potency etc. of the ingredients used in our generic drugs are same because they are made by the manufacturers who export the bulk drugs to the world’s leading pharmaceutical companies, Europe and other parts of the world. Our generic drugs are identical in potency, dosage forms, routes of administration, bio equivalent with name brand drugs.
Generic drugs, manufactured in World Class Facilities
Our generic drugs are manufactured in facilities that have been approved by all of the following regulatory authorities:
Pharmacy employs a panel of doctors to review your prescription on the basis of the medical information that you have provided. Once your prescription is approved by our physicians and our highly trained and qualified pharmacist. We will ship the drugs to you.
We offer 100% guarantee on top-quality of the product, we offer a money-back guarantee in case the product doesn’t work for you or you may be somehow dissatisfied by its performance.
In most cases, generic products become available after the patent protections afforded to a drug’s original developer expire. Once generic drugs enter the market, competition often leads to substantially lower prices for both the original brand-name product and its generic equivalents. In most countries, patents give 20 years of protection.
What we do when we authorize a generic prescription medicine for supply?
A generic prescription medicine is only allowed to be supplied if we consider that the evidence shows that the generic medicine is bioequivalent to the original medicine.
We look at the:
** The quality of the ingredients and the final product
** The combination of ingredients used to make the final medicine product
** The safety information obtained from laboratory studies and clinical trials on the original medicine
** We also look at how long the active ingredient remains stable at particular temperatures
If necessary, we also make available information on the use of the generic prescription medicine, for example, warnings about using the product and drinking alcohol. These can be found in the Product Information and the Consumer Medicines Information, available from pharmacists and the website.
Do generics take longer to work?
No. Generic drugs work in your body in the same way and in the same amount of time as brand-name drugs
Are brand-name drugs manufactured in better facilities than generic drugs?
No. Both brand-name and generic drug facilities must meet the same standards; the FDA won’t permit drugs to be made in substandard facilities. The FDA conducts about 3,500 inspections a year to ensure standards are met. In fact, brand-name firms are linked to an estimated 50% of generic drug production. They frequently make generic copies of their own or other brand-name drugs, then sell them with a generic name.
What is the price difference between generic and brand-name drugs?
In 2008, the average price of a brand-name drug was $137.90, while the average generic prescription cost $35.22, according to the National Association of Chain Drug Stores. In addition to the savings on the price difference, there is also a savings on your copayment for using a generic drug over a brand-name drug.
If generic drugs are just as good as brand-name drugs, why do generics cost less?
When a company develops a new drug and submits it for FDA approval, a 20-year patent is issued, preventing other companies from selling the drug during the life of the patent. As a drug patent nears expiration, any drug manufacturer can apply to the FDA to sell its generic version. Because these manufacturers didn’t have the same development costs (such as years of expensive research), they can sell the drug at a discount. Once generics are allowed, the competition keeps the price down. Today, almost half of all prescriptions are filled with generics.
Why do some generic drugs look different from their brand-name versions?
All drugs have inactive ingredients such as dyes, fillers and preservatives. These ingredients often determine the size, shape and color of the drug. Trademark laws do not allow a generic drug to look exactly like its brand-name version. A generic drug must duplicate the active ingredient and it must be equally effective, but the color, shape, and other inactive ingredients may be different.
How do I get generic drugs?
Talk with your doctor and pharmacist. Explain that you want the most effective drug at the best price. Ask your doctor to write prescriptions for generic drugs whenever possible.
What’s the bottom line on generics?
You can use generics with confidence. Although they may look different from their brand-name versions, generics are safe and effective. As always, any medication changes must be discussed with your physician and pharmacist.
Are generic prescription medicines effective?
A generic prescription medicine works in the same way as the existing medicine. What matters is the active ingredient, which is the same in the generic brands and the existing brand. All medicines will have the same potential health benefits and the same potential side effects. Some active ingredients are only effective for some patients and this will be the case whether you use the original or a generic medicine.
How do I know that generic prescription medicines are as safe as possible?
Generic prescription medicines meet the same standards of quality, safety and effectiveness as the original brand. As with all medicines and medical devices the continually monitors safety once they are on the market.
If they are the same, why do they sometimes look or taste different?
Although they work the same and have the same active ingredient, generic prescription medicines may not look the same as the original medicine. All medicines contain inactive ingredients (excipients) as well as active ingredient(s), and these inactive ingredients are often different in the generic medicine. Inactive ingredients have a number of different functions, including providing color and taste. Generic tablets or capsules can also be a different size or shape from the original medicine. Please let your doctor or pharmacist know if you have any allergies just in case the generic medicine contains the substances you are allergic to in the inactive ingredients.
Generic drugs are usually sold for significantly lower prices than their branded equivalents. One reason for this is that competition increases among producers when a drug is no longer protected by patents. Companies incur fewer costs in creating generic drugs only the cost of manufacturing, without the costs of development and testing and are therefore able to maintain profitability at a lower price.