Any drug developed and marketed by a pharmaceutical company is protected by a patent property and authorization for placing on the market (AMM).
The patent provides the exclusive property of its marketing to its expiration. This patent has a limited duration of 20 years from the date of filing of the application for registration at the Institute of Intellectual Property. The term of protection of data AMM following the filing of the patent property is 10 years. When intellectual property rights have expired and AMM , we say that the invention "falls into the public domain." A specialty that has the same quantitative composition and qualitative in vigorous substances , the same pharmaceutical form , and is active for the same indications as the original , can then be developed and marketed by another laboratory. It's called generic.
Since 1996 , the Public Health Code (Article L. 5121-1) defines the generic "means specialty generic another specialty , a specialty that has the same quantitative composition and qualitative in active substances , similar pharmaceutical outline , and whose bioequivalence by means of the indication medicinal item for consumption has been demonstrated by apposite bioavailability studies. "Clearly , a generic drug is a drug that contains the same molecule as the drug known as" princeps "(original) to treat the same disease.
Which guarantees the quality of the generic drug?
The generic drug also must obtain an authorization for placing on the market (AMM) which guarantees its quality , safety and efficacy. It is produced by a pharmaceutical laboratory approved by the public authorities.
The generic is recorded by the Agency for Safety of Health Products , while being exempted from pharmaco-toxico-clinical , since they have already been made to the original product called "originator". Regularly publishes the official directory specialties entitled to be called "generics".
Because of this shortened course , the generic price is expected to be lower than the original drug.
How do you recognize a generic drug?
It is recognizable by its name. This may be the International Nonproprietary Name (INN). The INN is a unique international name given by WHO. The credits can also have a proper name followed by the suffix "GS".
Warning: A generic drug is several different names. For example: the word "aspirin" is the International Nonproprietary Name (INN) of aspirin widely used. But its chemical name is "acetylsalicylic acid" and its various specialties (drugs) are sold Aspro ®.
