The news of AstraZeneca’s failed attempts to delay generic competition for its blockbuster antipsychotic drug Seroquel (quetiapine fumarate) has caused a gold rush among generic companies, who are falling over each other to launch their generic versions.
Iceland-based Actavis, India-based Dr Reddy’s Laboratories and Israel-based Teva Pharmaceuticals (Teva) all announced launch of their generic versions of quetiapine on day one of patent expiry (27 March 2012). Sun Pharma announced approval of its Abbreviated New Drug Application (ANDA) for its generic version of quetiapine on 28 March 2012, and no doubt more generics companies will follow suit.
Quetiapine is indicated in the treatment of schizophrenia and the treatment of moderate to severe manic episodes and bipolar disorders. Generics companies will offer their generic quetiapine in tablet form and at concentrations of 25 mg, 50 mg, 100 mg, 200 mg, 300 mg and 400 mg.
Despite the fact that generics manufacturers are already shipping generic quetiapine into the US, AstraZeneca is not ready to give up the fight for its blockbuster anti-psychotic drug Seroquel (quetiapine fumarate) quite yet.
In the latest turn of events AstraZeneca filed for a temporary restraining order (TRO) seeking to overturn FDA’s 27 March 2012 approval of more than 10 ANDAs for generic quetiapine fumarate tablets and to prevent FDA from granting any further final ANDA approvals for the drug until the court decides the case on the merits.
AstraZeneca’s case was based on the claim that FDA acted improperly in granting the ANDAs, by not providing AstraZeneca timely notice after approving the ANDAs. However, on the very same day (28 March 2012), US District Judge Beryl Howell denied AstraZeneca’s TRO, stating that AstraZeneca had ‘not demonstrated a likelihood of success’.
FDA did not get away without criticism, however. Judge Howell commented in her ruling that FDA was ‘hiding the ball’ and did not provide sufficient time for AstraZeneca to seek judicial review of FDA’s decisions regarding its denial of AstraZeneca’s citizens petitions before ANDAs were approved and generics were being shipped.
In some good news for AstraZeneca, the US District Court for the District of New Jersey upheld the formulation patent protecting AstraZeneca’s extended release version of quetiapine (Seroquel XR). The court also ruled that Anchen, Osmotica, Torrent and Mylan Pharmaceuticals had infringed the Seroquel XR patent, which is due to expire in November 2017.
A similar decision upholding the Seroquel XR patent had been made in The Netherlands on 7 March 2012. However, this must come as a relief for AstraZeneca, after a UK court ruled the Seroquel XR patent to be invalid on 22 March 2012 [1].
Teva will offer generic quetiapine at a significantly lower price than that of the brand-name drug from AstraZeneca. Prices published by Teva UK show that the company will charge GBP 6.08 for its 25 mg quetiapine tablets, compared to GBP 40.50 for the brand-name Seroquel from AstraZeneca.
AstraZeneca are now set to take a substantial hit to their earnings as a result, as 2011 sales of Seroquel are estimated to be around US$1.49 billion.
AstraZeneca has much to lose with the launch of all these generic quetiapines. Seroquel has accounted for almost 16% of AstraZeneca’s annual earnings in the past years. According to IMS Health, US sales of the Seroquel brand in 2011 were US$4.6 billion, while worldwide sales in 2010 were US$5.3 billion [2].
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References
1. GaBI Online - Generics and Biosimilars Initiative. AstraZeneca losing fight against generic quetiapine [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Apr 13]. Available from: http://gabionline.net/Generics/News/AstraZeneca-losing-fight-against-generic-quetiapine
2. GaBI Online - Generics and Biosimilars Initiative. 2012’s biggest patent expiries [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Apr 13]. Available from: www.gabionline.net/Policies-Legislation/2012-s-biggest-patent-expiries
Source: Actavis, Dr Reddy’s, Teva, Sun Pharma
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