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Generic drugs - Frequently Asked Questions

Amazing fact about generic drugs

In 2015, generic drugs made up 88% of prescriptions filled and 28% of total drug spending.  This year, the percent of prescriptions increased to 89% while the percent of overall spending dropped to 27%, according to the report by the Generic Pharmaceutical Association.

What is a generic drug?

In many instances, consumers have a choice between brand name drugs and generic drugs. A brand name drug is a medication manufactured by a drug company that has developed and patented the drug. After the drug patent expires, other manufacturers who can meet the FDA production standards may produce and market an equivalent product. These medications, known as generic drugs, are chemically and therapeutically equivalent to their brand name counterparts.

For more than 25 years, America’s generic pharmaceutical industry has been providing Food and Drug Administration (FDA) approved generic versions of brand medicines at a savings to consumers of 30% to as much as 90%. By asking your doctor or pharmacist if there is a generic version of your prescription, you can reduce your health care costs while receiving the same quality of care.

Millions of Americans are using generics to treat a variety of medical conditions, including high cholesterol, infections, heart disease and cancer. Generics are rigorously tested by the FDA and must prove that they are the same medicine with the same active ingredient, strength and dosage as their brand-name counterpart. Today, there are thousands of generic drugs available and all are manufactured and inspected under the same strict quality guidelines as a brand.

What do the experts say about generic drugs ?

Experts Agree — Generics offer the  same safety and effectiveness as brands

According to Dr Bill Thomas (from AARP):

Are generic drugs just as good as their brand name equivalent? Watch the latest Excellent short video comparing brand and generic drugs from Dr Bill Thomas who explains why generic drugs are just as good as brand drugs, even though they are often over 80% cheaper.

According to the FDA:

“Generic drugs…are just as safe and just as effective as their brand-name counterparts, and they are a cost effective way of achieving substantial savings.”

“A generic drug is identical or bio-equivalent to a brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use.”

According to the American Medical Association (AMA):

“One of the primary ways physicians can practice cost-effective prescribing is by offering patients a generic medicine when one is available.”

According to the managing editor of Best Buy Drugs, sponsored by Consumer Reports:

“Switching to generic whenever possible is, quite simply, one of the clearest paths to reducing health care spending in the years ahead.”

What is the difference between generic and brand drugs? Why does the generic drug look different to the brand drug?

A generic drug is basically a copy of a brand name drug. It is the same medicine with the same active ingredients as the brand name drug, but usually made by another company. A generic drug is the same as a brand-name drug in:

  1. quality
  2. dose
  3. safety
  4. strength
  5. the way it should be used
  6. the way it works
  7. the way it is taken

The differences between a brand and generic drug are the colour, name, packaging and much lower price. Generic drugs look different because certain inactive ingredients, such as colors and flavorings, may be different. These ingredients do not affect the effectiveness, performance and safety of the generic drug.

Generic drugs have to look different because trademark laws in the U.S. prohibit a generic drug looking exactly the same as other drugs already on the market.

Why are generic drugs cheaper?

Since generic drug makers do not develop a drug from scratch, the costs to bring the drug to market are much lower than the brand version. The research, development, marketing, testing and advertising costs are all much higher for a brand drug. However a generic drug must still perform in the same way as the brand-name drug.

All our USA generic drugs that we ship are fully approved by the FDA.

Where do you get your generic prescription drugs from?

Some are manufactured by the same pharmaceutical companies that make brand drugs; others are produced by pharmaceutical companies specializing in the manufacturing of generics. All our prescription drug manufacturers must meet rigid FDA, WHO and GMP approval rules before there generic drug is allowed on the market.

We can supply you with generic drugs from some of the world’s largest drug manufacturers including Merck, Novartis, Pfizer, GSK, Ranbaxy and Teva.

Are the generic drugs that you sell safe?

Yes – all of US produced drugs are FDA approved. Those drugs manufactured by non-US companies are from the worlds largest pharmaceutical and have all been approved by the relevant countries World Health Organisation (WHO) and follow strict Good Manufacturing Practice (GMP) guidelines. Before allowing a drug on the market, the FDA says that all drugs (brand and generics) must work well and be safe.

Generic drugs use the same active ingredients as brand-name drugs and work the same way, meaning they have the same risks and benefits as the brand-name drugs.

Who determines if I can take a prescription generic drug?

By law, pharmacists must fill prescriptions as prescribed by your physician. If your physician has written the prescription for a brand drug with “no substitutions” allowed, then the pharmacist cannot substitute the brand for a generic version. Although not every brand drug has a generic equivalent, you may request a generic substitution as long as your prescription allows for it.

If you want to start taking advantage of the massive cost savings made by switching to generic drugs, ask your pharmacist and physician about your generic options.

Does every brand-name drug have a generic drug?

No. When new drugs are first made they have drug patents. The patent protects the company that first made the drug and usually lasts around 17 years. The patent doesn’t allow anyone else to make and sell the drug. It is only when the patent expires that other drug companies can start selling the generic version of the drug. But, first, they must test the drug and the FDA must approve it. However, approximately 80% of all brand drugs now have a generic equivalent and many brand drugs even have multiple generic versions by different manufacturers.

How does the FDA ensure that generic drugs are as safe and effective as the brand drug?

All generic drugs are put through a strict and rigorous, multi-step review process that includes a review of scientific data on the generic drug’s ingredients and performance. Just like with brand drugs, the FDA also periodically inspects the manufacturing plant to monitor drug quality – even after the generic drug has been approved.

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. However, there are many worldwide manufacturers such as Teva Pharmaceuticals that only develop and sell generic drugs.

See here for more essential information on Indian generic drug companies.


Generic Drugs - Other Help Links and Resources

Generic Drug Information Center - Our own information center providing key information about generics such as key facts, myths and new releases
FDA Generic Drugs Homepage - Questions,answers and facts about generic drugs
Generic Pharmaceutical Association (GPhA) - The nation's leading trade association for generics
Consumer Reports Guide to buying generic drugs - An excellent independent report on shopping for generic drugs


Patent Expirations
Drugs@FDA
- FDA's searchable database of approved medicines. Use this database if you are searching for available generics.
FDA Electronic Orange Book - The FDA's official book of approved drugs, which includes patent dates.


Related legislation:
Amendment to Allow for Importation of Prescription Drugs

Affordable Medicine Safety and Access Act
Importation of Prescription Drug Bill #H.R.1
Prescription Drug Parity for Americans Act
Save Our Seniors Act


FDA Statements:
Personal Importation Policy

Statement on Vermont's Lawsuit on Importing Prescription Drugs from Canada
Consumer Education: Buying Medicine from Outside the United States


Brochures
Generic Medicines:Improving Lives for Less
- Learn more about the benefits of generic medicines by downloading PDF versions of the GBHA brochure.


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