Generic Crestor launched in US

The day of reckoning is here for AstraZeneca as cheap generic rivals to blockbuster cholesterol drug, Crestor (rosuvastatin) were launched yesterday in the US.

Despite a last-ditch court battle, a group of generics firms including Sun Pharma and Teva are now free to market cut-price rivals to the drug, worth $2.8 billion in US sales to AZ in 2015.

Allergan had already been marketing a rival since May following a patent litigation settlement with AZ.

AZ had launched a lawsuit against the US Food and Drug Administration attempting to block rivals by making them list any orphan drug indications on the label.

In 2014, AZ tested the drug in children with the rare disease, homozygous familial hypercholesterolaemia and managed to get it approved in the orphan indication.

The Anglo-Swedish company had argued this would mean rivals would have to abide by a market exclusivity period keeping them off the shelves until 2023.

Unsurprisingly the attempt failed, given that Japan’s Otsuka had unsuccessfully lost a similar case when trying to block competition for its schizophrenia drug, Abilify (aripiprazole).

The FDA argued that the case “is a transparent and manifestly premature attempt by one of the world’s largest drug companies…to block generic competition”.

It said the case is not about the medical needs of the paediatric population but AZ’s desire to “extend its virtual monopoly on one of the world’s most popular medicines.”

But AZ has been preparing for this moment for decades, licensing older drugs to other pharma companies to boost cash reserves so it can focus on rebuilding its pipeline.

It has had some successes too – such as the approval of lung cancer drug Tagrisso (osimertinib) and ovarian cancer drug Linparza (olaparib).

This week, AZ’s Qtern diabetes combination pill, Qtern (saxagliptin+dapagliflozin) was approved in the EU, although it was rejected late last year by the FDA.

The company is striving to meet a sales target of $45 billion by 2023, set by CEO Pascal Soriot after it successfully fought off Pfizer’s takeover bid.

 

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