Regulatory Focus™ > News Articles > Generic Boniva Approved, Marking Next Big Patent Expiry

Generic Boniva Approved, Marking Next Big Patent Expiry

Posted 20 March 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) approved the first generics version of Roche Holding AG's blockbuster osteoporosis drug Boniva (ibandronate), marking the next big patent expiry for the pharmaceutical industry this year.

The generic ibandronate will be manufactured by Apotex Inc., Orchid Healthcare and Mylan Pharmaceuticals, and will be accompanied by an FDA-required Medication Guide (MedGuide) warning patients about the risks associated with the drug.

Boniva has been associated with a number of risks, including esophagus problems, low blood calcium levels, pain, severe jaw bone problems and thigh bone fractures.

Boniva had sales of $438 billion as recently as 2008, but sales have declined significantly in recent years in response to increased competition and new classes of osteoporosis drugs.

Read more:

FDA - FDA approves first Boniva generics to treat or prevent osteoporosis

Reuters - FDA approves generic Boniva for osteoporosis

MedCity news - Generic Boniva looms but deal gives GSK new piece of osteoporosis market

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