Dr Reddy’s Debuts Daraprim Rival In US
Also Introduces Naloxone With CGT Exclusivity And First Generic Ziprasidone
Dr Reddy’s has launched the first generic version of Daraprim in the US. The company has also introduced naloxone with 180 days of exclusivity under the FDA’s Competitive Generic Therapy pathway, as well as the first US generic of ziprasidone mesylate.
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Dr Reddy’s enjoyed a strong showing in Europe in the fiscal fourth quarter amid a string of launches and a ramp-up in France, Italy and Spain, with the Indian firm anticipating continued momentum in the region by leveraging its global portfolio. The firm’s China growth strategy is 'still valid', management maintains.
Daraprim, which saw its price jacked up by 4,000% by former drug company executive Martin Shkreli, now has a competitor with the US Food and Drug Administration’s approval of the first generic version of the nearly seven-decade-old drug used to treat a life-threatening parasitic infection known as toxoplasmosis.
Teva has received FDA approval for the first US generic naloxone nasal spray after a 30-month stay linked to ongoing patent litigation expired. Launch plans have not yet been revealed. Meanwhile, the Israeli firm has also introduced the first generic version of VESIcare in the US.