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Sleep News Blog

Prescription Sleep Medicine

The Brands That Are Considered Generic Brand Drugs Will Be Checked by the FDA

Posted by sleepyguy in Prescription Sleep Medicine on September 05th, 2010

Generic drugs are medications that are manufactured and distributed without a patent. The generic version can carry a patent on the constitution, but not the active ingredient. The history of generic drugs products began during the 1970s when Al Williams left his job as a label lines manager and began his own business called Keynote Marketing.

He manufactured 20 ‘no name’ generic drugs under an ordinary white label and sold them to grocery chains in the USA. Shortly after, the major chain stores followed suit and began introducing their own ‘white label’ products, which were made by various manufacturers.

When it comes to medication, the main criterion is that the generic must contain the exact active ingredient as the branded formula. The FDA insists that generics are compliant with the bioequivalent range of the branded version with regards to pharmacodynamic and pharmacokinetic properties. This basically means that a generic drug must be identical in its strength, intended use, method of administration, dose, safety and efficacy.

Generic medications are made available when the patent acquired by the original company has expired. When they become available to the public, competition in the market place leads to substantially cheaper prices for the generic and the original branded product. In America, it usually takes 20 years for a patent to expire.

Generics save insurance companies and patients a lot of money. As already mentioned, this is due to stiff competition among drug producers. Because there are fewer expenses in making the generic version, companies can pass these savings onto the consumer while still making a healthy profit.

Third world and other developing countries are even able to afford generics because they are so cheap. Thailand recently imported millions of blood-thinning generic tablets at a cost of only 3 (USA) cents per pill. This included shipping from the manufacturer in India.

Generic companies are able to take advantage of any preceding marketing strategies and campaigns devised for the branded drug. This will include advertising promotions, giving away free samples, and drug presentations. There are hundreds of generic drugs that have been in use for more than 10 years.

Some people are still suspicious about generics. Claims have been made that they are manufactured in sub-standard facilities, and that they are inferior to the branded versions. Neither of these statements is true. The FDA demands exactly the same requirements of all drug manufacturers, irrespective of whether they make branded products or generics.

In fact, numerous manufacturers make both generic and branded versions of drugs. According to the FDA, half of all generics are made by brand-name companies. And yet claims are still made that generics are inferior. This cannot be so because the FDA tests generics to ensure they are as effective and work just as quickly as the original brand.