Generic competition

Conclusions When weighted samples are used that are representative of consumption in each country, the differences in the pharmaceutical price indexes are much smaller than those observed until now. Strict price regulation is related to lower prices for older and more universally distributed compounds. However, generic competition is responsible for notable price reductions in non-regulated markets. 

Table 4.10 Generic competition number of products per active ingredient... 

Table 4.11 Generic competition market share of the most prescribed product (%)... 

The differences in authorization regulations for new products go some way towards explaining the greater therapeutic rivalry in Spain. However, we need to complete the picture with a review of the differences in the patent system in order to understand why generic competition is greater in the UK. 

An equitable international drug price structure could also be attained by setting differential licence fees and allowing generic competition to work within each price segment of the international market. 

Case History In an attempt to protect Lipitor from generic competition, Pfizer sued Ranbaxy in district court asserting, in part, that Ranbaxy infringed upon dependent Claim 6 of U.S. Patent No. 5,273,995 ( 995). 

Case History Takeda, in an attempt to protect Actos from generic competition, sued various generic pharmaceutical manufacturers (collectively Alphapharm) for infringing the claims of U.S. Patent No. 4,687,777 ( 777). At trial, Alphapharm asserted that the compounds covered by the claims of the 777 patent were obvious in view of a prior art compound. The district court found the compounds covered by the claims of the 777... 

Third, a more rapid rafe of sales erosion in brand name producfs was observed in fhe case of more recenf pafenf expirations. This is especially so for fhe fop selling drug products which attract the most intensive generic competition. Three recent cases illustrate this phenomenon. Generic enalapril, laxmched in August 2000 as a substitute for the brand name drug Vasotec , obtained 66.4% of new prescriptions just 4 weeks after its launch. 

Erosion of product lifetimes as a result of greater generic competition means that a product can expect to lose the majority of its market in as httle as 3 months after patent expiry. 

In the case of glycoprotein biopharmaceuticals, the consequence of the multiple glycosylated products is the need for strict control of the manufacturing process to maintain a reproducible spectrum of products with consistent therapeutic profile. That biopharmaceuticals often contain mixtures of related products can also be advantageous to the pharmaceutical industry in warding off generic competition, due to the challenge of... 

The study did not examine how generic competition has developed under the other methods the Amendments established. Nor did the study examine whether Hatch-Waxman provisions have achieved another purpose of the Amendments to compensate brand-name companies for lost patent life due to the time needed for FDA s safety and efficacy review process. 

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