The End is Near

But evergreening will save us! A recent report has indicated that sales of atypical antipsychotics may be enjoying their apex now, but not for long.

“Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that generic competition will end the robust growth of the schizophrenia drug market. Atypical antipsychotic sales will decrease from $5.4 billion in 2005 to $4.8 billion in 2015. All five currently on-patent agents -- Janssen's Risperdal and Risperdal Consta (risperidone), Eli Lilly's Zyprexa (olanzapine), AstraZeneca's Seroquel (quetiapine), Pfizer's Geodon/Zeldox (ziprasidone), and Bristol-Myers Squibb/Otsuka's Abilify (aripiprazole) -- will lose patent protection in the United States by 2015.

Risperidone is the first to face generic competition, in 2008 in the United States, 2007 in Europe, and 2006 in Japan. "Generic competition's effect on the Risperdal brand will be most profound in the U.S. market -- we forecast that 80% of patients will be on a generic form of the molecule in 2010, and the price of the generic will be 10% of the brand that year," said Nitasha Manchanda, Ph.D., analyst at Decision Resources. "Risperdal Consta, the depot form of the drug, remains on patent until 2013; however, its use will be too low to preserve franchise sales. In 2015, approximately 70% of drug-treated patients will be treated with a generic antipsychotic."

Of course, there is hope for the manufacturers. Evergreening. The term, as many of my readers know, loosely means to extend the patent life of a drug as long as possible. Antipsychotic drug manufacturers can follow standard practices, including the following:

1) Getting their products approved for new indications. After all, atypical antipsychotics are now being rebranded as “broad spectrum psychotropic agents.” Not that it matters that the atypicals show no substantial improvement in efficacy or safety over existing products in the areas in which they will be marketed.

2) Increase marketing. Even when generic competition arrives, a marketing blitz can buy time.

3) Release in extended release format. This is becoming a time-honored classic.

4) Reformulate the existing product molecule just enough to remarket it as a brand new product. It doesn’t work all the time (as seems to be the case with Effexor), but it sometimes works wonders (Celexa/Lexapro or, better yet, Prilosec/Nexium). From a Merck/Medco 2001 Report: “Food and Drug Administration (FDA) approvals of the last decade highlight the prevalence of evergreening strategies. During the 1990s, the FDA approved a total of 857 New Drug Applications; 60% were for drugs containing existing active ingredients. Nearly half (426) were “new formulations” or “new fixed combinations” of existing drugs. An additional 10% were existing products marketed by a new manufacturer.”

5) Drag patent issues out in court as long as possible to prevent release of generic forms of medication

6) Pay generic drug manufacturers to not create generic versions of your drug.

None of the above is likely to actually yield substantial benefit for patients. One could argue that extended release pills enhance compliance, which then enhances outcomes, but I’m not familiar with any data to support such an assertion.

An interesting brief article about some of the above tactics, go here. Or just tool around the PharmaGossip site for a plentitude of examples.