What Is Meant By A Generic Drug
Generic drugs, also known as non-proprietary drugs, are those medications which are not patented. Off-patented drugs are the ones which were not patented ever or which have expired patents. To understand what does a generic drug really mean, let’s take the example of Paracetamol. Paracetamol was first produced by Sterling Winthrop Co. in 1953 and was granted a patent for the brand name, ‘Paracetamol’ by the FDS in United States. With a grant of patent, the brand name of the drug became a registered trade mark and only Sterling Winthrop Co. had the rights to use this brand name to sell the drug in the market. A patent remains active for 20 years. During this time period if any other company tries to use the brand name, Paracetamol to sell the drug it would be charged for violation of copy rights of Sterling Winthrop Co. The patent for Paracetamol has expired long ago. With the expiration of the patent, Sterling Winthrop Co. lost the exclusive rights to use the bran name and other companies got the liberty to manufacture the product and market it and they did so! Now Paracetamol has become a generic drug as it’s not property of any particular company. Many branded drugs are now available as generic drugs as their patents are expired.
Production of Generic Drug
Generic drugs can be produced:
1. When the patent is expired.
2. When the patent is affirmed as invalid and bogus.
3. In a state or territory where there is no law to protect law.
4. When no patent has been granted to any company for a certain drug.
How does a generic drug get approval?
The patents are issued by FDA. Once the patent gets expired FDA reviews the drug and allows the manufacturing of the generic drug under the Drug Price Competition and Patent Term Restoration Act of 1984.
Common Myths about Generic Drugs – Busted!
The term generic is considered equal to inferior and substandard. Most of us have some misconceptions about generic drugs. It is believed that generic drugs are not effective, have inferior quality, and should not be used for longer periods. FDA’s Director Generic Drugs have busted these myths by declaring them safe. Generic drugs are as efficient as their branded versions, their strength, purity, and stability is not inferior by nay standards. Generic drugs gets thoroughly tested and examined by FDA before coming into the market.
generic version of ulcer drug
Generic drugmaker Ranbaxy Pharmaceuticals Inc. said Monday it received US market approval for a generic version of Robinul, a treatment for ulcers.
Top-selling generic drugs
Behind every new branded drug is a generic copycat ready to start selling a nearly exact yet much cheaper version virtually the day patent protection ends.
generic medications
As Obama noted at Tuesday’s town hall meeting in New Hampshire, shorter exclusivity periods for drug companies would speed the introduction of cheaper generic medications and ultimately save consumers money.
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