AstraZeneca immediately petitioned the F.D.A., arguing that if the correct dose for children with HoFH could not be on the generic label, then it would be illegal and dangerous to approve any generic versions for any use at all. That is because doctors might still prescribe the generic for children with HoFH and choose the wrong dose, posing “substantial safety and efficacy risks.” AstraZeneca was only asking for generic versions to be kept off the market for another seven years for safety reasons.
20 Jul 2016
Crestor is the Top selling brand of AstraZeneca.
Crestor sale was $5 billion of its $23.6 billion total product sales of Astra Zeneca. Patent of Crestor will be expiring shortly. So, Generic drugs will enter the market, will lead to drastic decrease in Crestor Sales.
One of the way, company is trying to avoid the generic competition by getting it approved to treat rare disease. ORPHAN DRUG approval will lead to seven years of additional market exclusivity under the Orphan Drug Act.
In May, AstraZeneca got approval of Crestor to treat children with the rare genetic disease of homozygous familial hypercholesterolemia (HoFH ). That gives it an additional seven-year patent on the drug, but only for that particular — very small — market. However, the designation means that detailed prescription information about using Crestor to treat children in this way must not be included on the label. AstraZeneca’s now focusing on to extend patent for all uses of the drug.