On 28 September 2010, Sun Pharma announced that it had received tentative approval from the FDA for its Abbreviated New Drug Application (ANDA) for a generic version of sanofi-aventis’s Rilutek tablets 50 mg.

The generic riluzole hydrochloride tablets are indicated in the treatment of amyotrophic lateral sclerosis. Rilutek has annual sales of approximately US$50 million in the US.

Then on 29 September 2010, the company announced that it had received tentative approval from the FDA for its ANDA for a generic version of Astra Zeneca’s blockbuster cholesterol treatment Crestor.

The generic rosuvastatin calcium tablets are indicated for treatment of hypertriglyceridemia (high cholesterol) and approval covers 5 mg, 10 mg, 20 mg and 40 mg tablet forms of the medication. This is a big one for Sun Pharma, as Crestor has annual sales of approximately US$3.4 billion in the US.

These tentative approvals, however, mean that the generics cannot yet be marketed in the US because of existing patents and/or exclusivity rights.

Patents supporting Crestor, one of Astra Zeneca's biggest money-spinners, began expiring in 2006. However, so far, Astra Zeneca has managed to block companies marketing generic versions and has won court battles upholding its patent protection until 2016.

Related articles

What is ‘tentative approval’ and how does it affect generics?

Sun Pharma adds generic tamsulosin and rivastigmine to portfolio

Generics lose battle against AstraZeneca’s Crestor (rosuvastatin)

References

Sun Pharma Press Release. Sun Pharma announces USFDA tentative approval for generic Rilutek. 28 September 2010.

Sun Pharma Press Release. Sun Pharma announces USFDA tentative approval for generic Crestor. 29 September 2010.