Drug product life cycle

To assist the reader with the question of which dissolution test to apply when the first part of this chapter is divided into two primary sections—one dealing with drugs that have few or no solubility problems, in which case developing dissolution tests at all stages of the product life cycle... 

Chiral drug development provides more effective drugs and extends the product life cycle of drugs for longer periods. 

Refer to Section 3.6. Chiral drugs are more effective than racemic mixtures as they can better interact with active sites to alter disease progression. An important example is the case of omeprazole and esomeprazole (Exhibit 3.16). It is also strategically important for pharmaceutical companies to work on chiral drugs to further the product life cycle and compete with generics. 

Some practices utilized by brand firms to delay generic competition have been the target of recent FTC and legislative actions. One concern was the practice of listing several new patents late in the product life cycle in an apparent effort to trigger successive 30-month stays to delay generic competition. To prevent this practice, the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 limited each branded product to one 30-month stay (Padden and lenkins 2004). 

Baichwal A, Neville D. Advanced drug delivery technology infuses new life into product life-cycles. Business Brief Pharmatech 2002 1-5. 

Another aspect of the market for any value-added pharmacy services that must be considered is the competition. When identifying competitors, it is important to acknowledge exactly what services the pharmacy will pursue. When identifying competitors for value-added services, pharmacists often limit their search to other pharmacies and pharmacists. While this may be appropriate for traditional pharmacy goods and services (e.g., dispensing drug products), pharmacists considering new value-added services must cast a much broader net. Many value-added services offered by pharmacists are still at the introductory point of their product life cycles. Few, if any, other pharmacies may offer these services in a particular market. On the other hand, other competitors maybe very well established. For example, while diabetes education services currently are not offered in many community pharmacies, physicians and certified diabetes educators (who can be physicians, nurses, pharmacists, and other health care professionals) have provided this service for a number of years (Zrebiec, 2001). 

Thirty years on from the explosion of commercially successful applications of targeted and controlled release pharmaceutical formulations, it is evident that there remains a need for further refinements and innovations in the field of drug delivery. Many of the larger corporations focus on the use of novel technology for extension of a product life cycle however, in many cases solubility and permeability issues limit the application of such technologies. Additional complications arise due to inter- and intrasubject variability, compliance, and chronobiological variation in disease incidence. 

Various strategies are pursued by pharmaceutical companies to extend the product life cycle. Under the Hatch-Waxman Act, patent term extensions are available for patented drug substances, drug products, method of use, and method of manufacturing to compensate for the time lost in the FDA s regulatory approval process. However, the limitations of the statute of the following aspects have to be considered ... 

Figure 1.1 Typical pharmaceutical product life cycle income potential against time. Figure 1.2 Drugs approved by the U.S. Food and Drug Administration.

The value of the potential income from successful drugs on the day of product launch depends on the complete product life cycle expected for these compounds. Figure 4-1 shows a hypothetical life cycle of R D investment and revenues for an industry. 

That there is wide variation among different compounds in their sales history and product life cycle is undisputed. In that sense, every drug is unusual. Manufacturers do depend on a few big winners to carry the fixed costs of R D and marketing necessary to develop and sell drugs in today s market (159). OTA s analysis is at the industry level, however, and an accurate representation of the pattern of loss of... 

The number of drug information requests is often predictable, based on the product life cycle. The first 6 months following launch generally represent the heaviest call volume. 

---