Question

1) What is the definition of a generic drug?

2) What is the difference between a generic drug and an over the counter (OTC) drug?

3) Why are generic drugs important to the healthcare system?

4) What is “Pay to Delay”?   What is “Ever-greening”? Give an example for each

Answer 1

1. Generic drug is the pharmacologic salts having the same action as that of the branded drugs by not having any brand or the proprietary name. These are having bioequivalent to the branded drugs in their release profile in blood. They are regulated under ANDA (abbreviated new drug application in U.S). In generic drugs the clinical trials are not conducted but the bioequivalence studies are performed in closed comparison to the branded drugs. Hence generis medications are cost saving then the branded medications.

2. Generic drugs are not only having the brand name but may have the same pharmaceutical salt name/ drug name. They may or may not be prescribed by the physicians. But the OTC drugs (over the counter drugs), are non-prescription medications which may be generic or the branded medications. The condition is for their purchase there is no use of prescription. Hence these medications are for the common illness and hence are the major part of the self medications.

3. Generic drugs are very important to the healthcare system as they are cost effective and are assessable to the common population.

4. “Pay-for-delay” is a business strategy utilized by the pharmaceutical companies to pay off to the generic medication manufacturers for the delaying their production, to have the exclusive command on the market to avoid the generic competitors. Example AbbVie's monopoly for adalimumab   

Ever-greening is the strategy in which the patent holder attempts to exploit the loopholes in the patent laws as well as associated regulatory guidelines to maximize their monopoly in the pharmaceutical market. Example SA Pharmaceuticals have recently filed for patent protection of the new molecule for cure of panic disorder.