Marketing generic competitors

Furthermore, 51.04 per cent of products on the market are generic or have a generic competitor. In recent years the NHS has encouraged a policy of generic prescription, not only when there is a generic version of the relevant active ingredient but even before the generic version reaches the market. 

A pharmaceutical product has a limited life cycle and once the patent expires, generic competitors rapidly enter the market. There are a number of strategies that companies can adopt to try to extend patent life. These include line extensions, reformulations, combination products or switching to over-the-counter (OTC) sales. In the United States, but at this point not the European... 

Generic policies are effective instruments when a patent expires. In the United States of America the average whole sale price falls to 60% of the price of the branded medicines when one generic competitor enters the market, and to 29% when 10 competitors. To introduce and expand the use of generic medicine products, it is important that (1) supportive regulations exist, (2) reliable quality assurance is in place. 

While TRIPS does not require countries to grant patents on new uses of existing medicines, the U.S.-Morocco, U.S.-Australia, and U.S.-Bahrain FTAs do, enabling companies to extend patent terms on existing products, thereby "evergreening" their monopolies (MSF 2004), and indefinitely keeping generic competitors out of the market. 

Where it is not possible to reformulate or develop combination products, the response in the marketplace to the loss of a patent can be very dramatic. In the UK particularly, and to an increasing extent in the US, the entry and penetration of generic competitors into the market can be very swift. In other European countries there tends to be much more brand loyalty and the penetration of the market by generic competitors is much slower. As example of how rapidly the market in the UK can change following patent loss is given by (enalapril) Innovace (Figure 10.10) where, within a few months, prescription volumes for the branded product had fallen to a fraction of their pre-patent loss level. 

From a commercial standpoint. The Orange Book is significant in two ways (1) it identifies generic competitors (if any) for branded products in the United States, and (2) it provides market exclusivity and patent expiration data associated with new drug approvals. Both of these factors are important in assessing company and product vulnerability. 

The end of the effective patent life does not always mark the end of exclusive marketing for the NCE. Some compounds may not have generic competitors for several years after the patent expires, either because of delays in FDA approval of generic versions or because the total market for the drug is too small to induce generic manufacturers to enter the market. Occasionally a process patent issued after the original patents will protect a product for some time. 

Third, information on the brand or generic name under which each product is marketed is useful for our study. In the English information we cannot distinguish the various generic products that offer the same active ingredients. The data for all the competitors that offer these products are grouped together. 

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