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Lupin’s generic diabetes drug approved and asthma drug launched in US Posted 04/09/2020

In August 2020, India-based generics maker Lupin announced that it has received approval from the US health regulator to market a generic diabetes drug in America. Following previous US Food and Drug Administration (FDA) approval, it has also now launched generic tablets for the treatment of asthma in the US market.

Lupin announced the tentative approval from FDA for Empagliflozin tablets, for diabetes treatment in strengths of 10 mg and 25 mg. This product is a generic version of Jardiance tablets produced by Boehringer Ingelheim Pharmaceuticals, Inc. The drug is indicated to improve glycemic control in adults with type 2 diabetes mellitus, as an adjunct to diet and exercise. According to IQVIA MAT March 2020 data, the drug had annual US sales of approximately US$4,368.

In addition, Lupin has launched its 600 mg Zileuton extended-release tablets for asthma treatment. These are a generic version of Chiesi USA Inc's Zyflo CR extended-release tablets in the same strength. The tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and children of 12 years or older. According to IQVIA MAT June 2020 data, Zileuton extended-release tablets had annual US sales of approximately US$40 million.

The successful approval and launch of these generic drug products follow Lupin’s success with its etanercept biosimilar which is now approved in Japan [1, 2] and Europe [3].

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Lupin to launch etanercept and pegfilgratim biosimilars the US

Glenmark and Lupin gain FDA approval for nervous system agents

FDA approves Lupin’s generic clobazam and Dr Reddy's launches follow-on sevelamer carbonate

References
1. GaBI Online - Generics and Biosimilars Initiative. Japanese approval for Lupin’s etanercept biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Sep 4]. Available from: www.gabionline.net/Biosimilars/News/Japanese-approval-for-Lupin-s-etanercept-biosimilar 
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars highlights: 2019 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Sep 4]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-highlights-2019  
3. GaBI Online - Generics and Biosimilars Initiative. EC-approval-for-etanercept-biosimilar-Nepexto [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Sep 4]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-etanercept-biosimilar-Nepexto 

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