Pseudo Generics

Medicines are classified into branded drugs and generic drugs based upon the development or research for discovery new molecule. When a pharmaceutical company develop a new molecule, a exclusive rights is provided to company by government for certain period of time to cover expenses and investment involve during research for development of that molecule.

The pharmaceutical company market this researched molecule by fixing a brand name which is different from its International Non proprietary Name (INN) or common name (generic name). This product is known as branded drug.

After expiry of exclusive rights time period, other pharmaceutical companies have allowed to manufacture this molecule and sell into market. These products are known as generic drugs which are bio equivalent of branded medicines which means rate and extent of availability after administration in the same dosage form, same route of administration are similar to such a degree that their effects, with respect to both efficacy and safety with branded drugs.

Generic drugs consist of same active pharmaceutical ingredient but may contain different inactive ingredients (binders, bulking agent, lubricants, excipients etc) which may alter colour and size of generic drugs from branded drugs.

To avoid competition generated by generic version of branded molecule, innovator pharmaceutical company manufacture a replica of own branded drugs which consist of same active pharmaceutical ingredients and same inactive ingredients. This generic version of Innovator Company to prevent competitors to enter into market of that molecule is known as Pseudo Generics.

Pseudo generic medicines have similarity in looking, size and color of branded medicine manufactured by same company. Pseudo generics are almost similar bio equivalence as of branded medicines as manufactured under same conditions, equipment, accordingly same master formula etc.

There may be changes of difference in bio equivalence properties of generic versions and branded medicine because inactive ingredients used in generic versions may alter absorption, availability of active ingredients into body, safety profile and efficacy. But that is not in case of Pseudo generic drugs as they contain similar active and inactive ingredients as of branded drugs.

Pseudo Generics deter other generics from making the investment required to enter, and slows the process of entry by competing generic firms. Patent medicine producer has a first mover advantage as they generally launch pseudo generic before expiry of patent and maintain their domination in generic market also.

Consumers have to pay more even after expiry of patent because the difference in cost between a pseudo-generic and true generic product can be up to 40 per cent. Launch of pseudo generics produce anti- competitive effect and prevent true generic to enter into markets.

Hope above information is helpful to you...
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