What's A Generic Drug?

What’s A Generic Drug?

Facts, Figures and Information About Generic Medications

Did You Know 85% of Medications Prescribed Each Year Are Generic?

Generic Medications are The Most Prescribed Drugs In The HealthCare System

At MyFreePharmacy we are here to help and educate consumers when it comes to making decisions about how and where to get their prescriptions. There are a lot of questions and misinformation out there in the industry. There is also a ton of overcharging and crazy inflated prices on the medications many people need to stay alive.

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FREQUENTLY ASKED QUESTIONS

What Is The Definition Of A Generic Drug?

A generic drug is a pharmaceutical drug that contains the same chemical substance as a drug that was originally protected by chemical patents. Generic drugs are allowed for sale after the patents on the original drugs expire. Because the active chemical substance is the same, the medical profile of generics is believed to be equivalent in performance.[1][2] A generic drug has the same active pharmaceutical ingredient (API) as the original, but it may differ in some characteristics such as the manufacturing process, formulation, excipients, color, taste, and packaging.[2]

Although they may not be associated with a particular company, generic drugs are usually subject to government regulations in the countries in which they are dispensed. They are labeled with the name of the manufacturer and a generic non-proprietary name such as the United States Adopted Name (USAN) or International Non-proprietary Name (INN) of the drug. A generic drug must contain the same active ingredients as the original brand-name formulation. The U.S. Food and Drug Administration (FDA) requires generics to be identical to or within an acceptable bioequivalent range of their brand-name counterparts, with respect to pharmacokinetic and pharmacodynamic properties.[3] (The FDA’s use of the word “identical” is a legal interpretation, not literal.)

Biopharmaceuticals, such as monoclonal antibodies, differ biologically from small molecule drugs. Biosimilars have active pharmaceutical ingredients that are almost identical to the original product and are typically regulated under an extended set of rules, but they are not the same as generic drugs as the active ingredients are not the same as those of their reference products.

In most cases, generic products become available after the patent protections afforded to the 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. However, many countries and regions, such as the European Union and the United States,[5] may grant up to five years of additional protection (“patent term restoration”) if manufacturers meet specific goals, such as conducting clinical trials for pediatric patients.[6]

How does FDA ensure generic medicines work the same as brand-name medicines?

Any generic medicine must perform 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 high standards of quality and manufacturing as the brand-name product, and it must be and quality, taken and used in the same way as well. 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.

It is important to note that there will always be a slight, but not medically significant, level of expected variability—just as there is for one batch of brand-name medicine compared with the next batch of brand-name product. This variability can and does occur during manufacturing, for both brand-name and generic medicines. When a medicine, generic or brand-name, is mass produced, very small variations in purity, size, strength, and other parameters are permitted. FDA limits how much variability is acceptable.

For example, a very large research study1 comparing generics with brand-name medicines, found that there were very small differences (approximately 3.5%) in absorption into the body between generic and brand-name medicines. Some generics were absorbed slightly more, some slightly less. This amount of difference is expected and clinically acceptable, whether for one batch of brand-name medicine tested against another batch of the same brand, or for a generic tested against a brand-name medicine.

Why does a generic drug look different from the brand drug?

Generic drugs are approved only after a rigorous review by FDA and after a set period of time that the brand product has been on the market exclusively. This is because new drugs, like other new products, are usually protected by patents that prohibit others from making and selling copies of the same drug.

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

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 substantial discounts, an estimated 80 to 85% less, compared with the price of the brand-name medicine. According to the IMS Health Institute, generic drugs saved the U.S. healthcare system nearly $2.2 trillion from 2009 to 20192.

When multiple generic companies are approved to market a single product, more competition exists in the marketplace, which typically results in lower prices for patients.

Bringing more drug competition to the market and addressing the high cost of medicines is one of FDA’s top priorities. In 2017, FDA announced the Drug Competition Action Plan (DCAP) to further encourage robust and timely market competition for generic drugs and help bring greater efficiency and transparency to the generic drug review process, without sacrificing the scientific rigor underlying our generic drug program.

Why aren’t ALL medicines on your drug list?

Generic medications make up for 85% of the medications dispensed in America each year. Our list accounts for 90% of medications prescribed. Our list has medications grouped in more than 22 therapeutic classes making sure that we have a very well-rounded formulary treating a variety of chronic and acute conditions.

Our Program Is Very Simple, For A Small Monthly Subscription of $19.95, much like joining a gym and being able to use all of the equipment, you get access to ALL or our 605 medications for FREE!

At MyFreePharmacy we have made it our mission to help the uninsured and underinsured (people who have insurance but deductibles are so high they never meet them and they are paying full price for medicine). With decades or relationships, partnerships and buying power, we have pooled our resources and are bringing you the lowest prices on medications in the country.

How To Get Your Medications

E-Prescriptions make it easy for providers to electronically send prescriptions to a your local pharmacy or home delivery service with orders going out as soon as the same day.

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