This information is based on information from the U.S. Food and Drug Administration (FDA)
Q1 : What is a generic drug?
When a brand-name drug's patent protection expires, generic versions of the drug can be approved for sale. The generic version works like the brand-name drug in dosage, strength, performance and use, and must meet the same quality and safety standards. All generic drugs must be reviewed and approved by FDA.
According to FDA a generic drug is identical, or bioequivalent to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. Although generic drugs are chemically identical to their branded counterparts, they are typically sold at substantial discounts from the branded price. According to the Congressional Budget Office, generic drugs save consumers an estimated $8 to $10 billion a year at retail pharmacies. Even more billions are saved when hospitals use generics.
Q2 : What is a brand name drug?
A brand name medication can only be produced and sold by the company that holds the patent for the drug. Brand name drugs may be available by prescription or over-the-counter. For example: Valsartan, a medication used to treat high blood pressure, is sold by prescription only by Novartis Pharmaceuticals under the brand name Diovan. Loratadine, a medication used to treat allergies, is sold over the counter by Schering-Plough HealthCare Products under the brand name Claritin.
Q3 : Why do a generic drug look different?
Generic drugs look different because certain inactive ingredients, such as colors and flavorings, may be different. These ingredients do not affect the performance, safety or effectiveness of the generic drug. They look different because trademark laws in the U.S. do not allow a generic drug to look exactly like other drugs already on the market.
Q4 : Why Do Brand Name Drugs cost more?
When a pharmaceutical manufacturer develops a new drug, it obtains a patent for that drug. The patent protects the developer's investment in developing the drug, and no one else can legally sell the exact same drug for a period of time. It will be protected for up to 17 years. That patent-protected drug is the innovator drug. When we purchase it, we are also paying for the research costs, the costs incurred in proving it is safe, the costs to market and transport the drug, and a premium if it is the only available drug for a certain symptom, disease or condition. Those costs can make drugs very expensive for us to purchase. The developer considers much of the price a way to recoup its development costs. Once that patent-protected time has passed, any other company can manufacture and sell a drug with the same ingredients as the branded one.
Q5 : Why Are Generic Drugs Less Expensive Than Brand Name Drugs?
Since generic drug companies do not have to develop a medication from scratch, it costs significantly less to bring the drug to the market. Once a generic medication is approved, several companies can produce and sell the drug. This competition helps lower prices. In addition, many generic drugs are well-established, frequently used medications that do not require expensive advertising.
Q6 : About generics How Much Can I Save if I Switch to a Generic Drug?
Generic medications can save you up to 80% on the cost of a prescription when compared with the brand name drug. Most often, the savings range from 30% to 50%. According to the National Association of Chain Drug Stores, the average retail price of a generic prescription drug in 2007 was $34.34. The average retail price of a brand name prescription drug was $119.51. Many commonly used brand name medications have readily available generic versions. For example: The average retail price of 20mg Pravachol, a drug used to treat high cholesterol, is $132 for a 30-day supply. The same amount of pravastatin, the generic version of Pravachol, can be purchased at Wal-Mart, Target, and other large chain stores for $4, a savings of more than $1,500 a year. The average retail price of 500mg Glucophage, a drug used to treat type 2 diabetes, is $204 for a 90-day supply. The same amount of metformin, the generic version of Glucophage, can be purchased at chain stores for $10, a savings of more than $750 a year. At Prescription Giant (US) metformin (500mg) 100 tabs costs only $6.33 while at Australian online pharmacy 100 tabs same strength costs $11.51. See Legitimate pharmacies for further details.
Q7 : How does FDA ensure that my generic drug is as safe and effective as the brand-name drug?
All generic drugs are put through a rigorous, multi-step review process that includes a review of scientific data on the generic drug's ingredients and performance. FDA also conducts periodic inspections of the manufacturing plant, and monitors drug quality - even after the generic drug has been approved. If generic drugs and brand-name drugs have the same active ingredients,
Q8 : Does every brand name drug have a generic drug?
No. Brand name medications typically are given patent protection for approximately 17 years. This provides protection for the pharmaceutical company that paid for the research, development, and marketing expenses of the new drug. The patent does not allow any other company to make and sell the drug. However, when the patent expires, other pharmaceutical companies, once approved by the FDA, can start making and selling the generic version of the drug. Because of the patent process, medications that have been on the market for less than 17 years do not have a generic equivalent being sold.
Q9 : Is my generic drug made by the same company that makes the brand-name drug?
It is possible. Brand-name firms are responsible for manufacturing approximately 50 percent of generic drugs.
Q10 : Are generic drugs always made in the same kind of facilities as brand-name drugs?
Yes. All generic drug manufacturing facilities must meet FDA's standards of good manufacturing practices. FDA will not permit drugs to be made in substandard facilities. FDA conducts about 3,500 inspections a year to ensure standards are met. FDA makes it tough to become a generic drug in America so you can feel confident about taking your generic drugs. But then the disadvantages are that more varieties of generics are available abroad so some people tend to buy from foreign pharmacies.
Q11 : Why is the name of generic medications different from their brand name counterpart ?
The FDA insists that a generic drug must be given a new name.
Q12 : Do I have a choice brand name or generic?
Your insurance company maintains a list of preferred drugs, called a formulary, that helps you understand pricing. If the choice is not clear, check with your insurance company to determine whether the branded or generic will cost you less. The best way to be sure you are getting exactly the drug you need, branded or generic, is to consult with your doctor. When your doctor prescribes a drug for you, ask if there is a generic equivalent. If there is, then ask which form of the drug makes the most sense for you. If you are curious about the availability of generic versions of the drugs you currently take, the FDA maintains a reference called the Orange Book.
Your doctor, however, may prescribe a similar medication to treat your condition that does have an available generic equivalent. For example, if you are taking Lipitor (Atorvastatin), which is still on patent protection, for high cholesterol , your doctor can switch you to simvastatin, the generic version of Zocor.
Q13 : Can I Still Save on Generic Drugs?
Yes. Most health plans with drug coverage pay for medications based on a drug formulary. A drug formulary is a list of preferred prescription drugs, both generic and brand name. Each time you have a prescription filled you are responsible for copay, which is your share of the cost of the prescription. Drugs on a health plan formulary are usually grouped into tiers, and your copay is determined by the tier of your medication. A typical drug formulary includes three tiers. The first tier has the lowest copay, and it usually includes generic medications. Medications in tier 2 and tier 3 are brand name drugs with higher copays. For example: In a large health plan in the Northeast, Zoloft, a medication used to treat depression, is in tier 3 and has a copay of $55 for a 30-day supply. The generic version of Zoloft, sertraline, is in tier 1 and is $10 for a 30-day supply, an annual savings of $540.
Q14 : Can I Get a Generic Version of Any Medication?
No. The U.S. Food and Drug Administration (FDA) provides patent protection for pharmaceutical companies that pay for the research, development, and marketing expenses of a new drug. When the patent expires, other pharmaceutical companies, once approved by the FDA, can start making and selling the generic version of the drug. According to the FDA, 8,730 of the 11,487 drugs listed in the FDA's Orange Book (a list of all products that have been approved by the FDA) have generic counterparts. Generics are readily available to treat many common health conditions, and almost 50% of all prescriptions in the U.S. are filled with generic drugs.
Q15 : Can I Change My Treatment to Include a Generic Medication?
Yes. Depending on your health condition and the drugs that are available to treat that condition, your doctor may be able to switch you to a similar medication that has a generic version. Some of the most common health conditions, including high cholesterol, depression, allergies and diabetes, have generic medications available. Example: Lipitor, a medication used to treat high cholesterol, is still on patent protection and does not have a generic version. It has an average retail price of about $142 for a 30-day supply. If it is safe and appropriate, your doctor may switch you to pravastatin, the generic version of Pravachol, which costs $4 for a 30-day supply at Wal-Mart, Target and Costco, an annual savings of more than $1,600.
Q16 : I Know That I Can Save Money on Generic Drugs. But Are They Safe?
Yes. Generic drugs must use the same active ingredients as the brand name version of the drug. A generic drug must meet the same quality and safety standards. The FDA requires that a generic drug be the same as a brand name drug in dosage, safety, strength, the way it works, the way it is taken, and the health conditions it treats.
Q17 : Generic drugs often cost 30% to 50% less than brand name drugs. Why are some healthcare providers reluctant to recommend or prescribe generic medications?
Despite the fact that the active ingredient in a generic medication is the same as in the brand name counterpart, small differences could effect how the generic medication works in your body. This may be due to how the generic medication is produced or the type and amount of inactive materials present in the medication. For some people, these slight differences may cause the drug to be less effective or lead to side effects. Several health-related organizations, including the Epilepsy Foundation of America and the American Thyroid Association, have raised concerns about the mandatory use of generic medications proposed by some states or required by health plans to save money. An example of the controversy about generic versus brand name medication is the drug levothyroxine, used to treat people with a low thyroid condition (hypothyroidism). Since many people with low thyroid are sensitive to very small changes in the dose of their medication, switching between brand name and generic versions of levothyroxine can cause symptoms of too little thyroid medication or side effects from too much medication. Before switching to a generic drug, speak with your healthcare provider and make sure that you are both comfortable with the change.
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