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Lupin and Natco’s Armodafinil generic approved to treat sleep disorders by FDA Posted 06/01/2017

The US subsidiary of Indian drug manufacturer, Lupin Pharmaceuticals, announced on 29 November 2016 that its Armodafinil tablets had received approval from the US Food and Drug Administration (FDA). Marketing and promotion of the product in the US will begin shortly.

Armodafinil is a generic version of Nuvigil that was first approved by FDA in 2007 [1] and is produced by US company, Cephalon Inc. It is used to promote wakefulness and treat obstructive sleep apnea, narcolepsy or shift work disorder [2]. Lupin’s Armodafinil tablets will be available in 50 mg, 150 mg, 200 mg and 250 mg doses. The originator, Nuvigil, is available in 50 mg, 100 mg, 150 mg, 200 mg and 250 mg doses.

Lupin develops and delivers a wide range of branded and generic drug formulations, and biotechnology products across the globe. In 2015, they announced that they were to acquire US generics makers Gavis Pharmaceuticals and Novel Laboratories (Gavis). This deal was reportedly worth US$880 million, and was the largest buyout by any Indian company [3].

On the same day in November 2016, another Indian pharmaceutical manufacturer, Natco Pharma, announced that their Armodafinil tablets had also received approval from FDA. However, Natco’s tablets have been approved in 50 mg, 150 mg, and 250 mg doses, and not 100 mg and 200 mg. These two Indian pharmaceutical companies will now join other generics manufacturers in producing generic Armodafinil for the US market.

In 2014, Actavis settled a long-standing patent dispute with Cephalon Inc. and was allowed to market 100 mg and 200 mg Armodafinil tablets in the US from 1 June 2016 [4]. However, Mylan was the first company to produce a generic version of Nuvigil in the US. They were awarded 180 days marketing exclusivity for their Armodafinil tablets that have been approved in 50 mg, 150 mg and 250 mg doses [5].

These companies will now battle it out for a share of the potential US$515.6 million US sales that were achieved by Nuvigil for the 12 months that ended in September 2016, according to IMS Health.

Related articles
Indian generics manufacturer Lupin buys 21 brands from Japan’s Shionogi

Lupin and Gavis to divest generics to appease US FTC

References
1. FDA approved labeling text for NDA 21-875/NUVIGIL™ (armodafinil) tablets. Approved labeling dated 15 June 2007. Corpina. Available from: http://corpina.org/wp-content/uploads/2014/01/Armodafinil_FDA_Approval-.pdf
2. Lupin Pharmaceuticals, Inc. Lupin receives FDA approval for generic Nuvigil® tablets [homepage on the Internet]. [cited 2017 Jan 6]. Available from:
 http://www.lupinpharmaceuticals.com/lupin-receives-fda-approval-for-generic-nuvigil-tablets.htm
3. GaBI Online - Generics and Biosimilars Initiative. Lupin to expand US generics business with Gavis acquisition [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jan 6]. Available from: www.gabionline.net/Pharma-News/Lupin-to-expand-US-generics-business-with-Gavis-acquisition
4. GaBI Online - Generics and Biosimilars Initiative. Actavis settles Nuvigil patent litigation, challenges Onglyza patent [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jan 6]. Available from: www.gabionline.net/Generics/News/Actavis-settles-Nuvigil-patent-litigation-challenges-Onglyza-patent
5. Mylan. Mylan launches first generic of Nuvigil® tablets [homepage on the Internet]. [cited 2017 Jan 6]. Available from:
 http://newsroom.mylan.com/2016-06-01-Mylan-Launches-First-Generic-of-Nuvigil-Tablets

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