Many companies have been caught off-guard by the extent to which generic competition has eaten away at their sales. Genentech says it managed to be caught off-guard by a lack of it, leading to a shortage of the injectable version of its osteoporosis drug Boniva when demand outstripped its supply.
The company has been working to address the production shortfall and a July 31 FDA update says the company expects to deliver some of the injectable form to wholesalers this week. Genentech believes that it will resume continuous supplies by the middle of September.
In June, the Roche ($RHHBY) division said the injectable form of Boniva would be in limited supply for some weeks because the company had missed its forecast on demand for the product. At the time, the company offered no explanation how that happened.
In email to FiercePharmaManufacturing this week, Genentech spokesman Chris Vancheri said: "As you may know, Boniva lost its patent protection in March (2012) and we expected generic competition to enter the market. Thus, demand for Boniva Injection was expected to significantly decline throughout the year. Our supply forecasts reflected this assumption. Therefore, when a generic product did not enter the market, we experienced a stock out due to actual demand exceeding our forecast. Patient safety is of the utmost importance to Genentech, and we are working as fast as we can to address the temporary stock out of Boniva Injection."
Roche did lose patent protection on the solid dose form of the drug in March and several companies were approved to produce it, including Apotex, Mylan ($MYL) and Orchid Pharmaceuticals. But it wasn't until May that a lawsuit over its patent was decided against Roche. An Express Scripts ($ESRX) patent list, however, indicates that the patent on the injectable version of the drug, prescribed for patients who have difficulty swallowing pills, does not lapse until 2023.
- get FDA shortage information
- see Express Scripts patent list
- read the FDA notice of generics
- check out the patent suit ruling
Missed forecast by Roche leads to Boniva shortage
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