Akorn submits ANDA for difluprednate ophthalmic emulsion

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Akorn submits ANDA for difluprednate ophthalmic emulsion

Generics/News | Posted 06/02/2015 0 Post your comment

US generics maker Akorn has confirmed that it has filed an abbreviated new drug application (ANDA) with the US Food and Drug Administration (FDA) seeking approval to market difluprednate ophthalmic emulsion 0.05%.

The product is a generic version of Alcon Laboratories (Alcon)’s Durezol, which is a topical corticosteroid indicated for the treatment of inflammation and pain associated with ocular surgery as well as the treatment of endogenous anterior uveitis.

Alcon filed a lawsuit against Akorn in the US District Court of New Jersey on 14 January 2015 seeking to prevent Akorn from commercializing its ANDA product prior to the expiration of its US patent on Durezol, which is expected to be in May 2019.

Akorn believes it may be a first applicant to file an ANDA for generic difluprednate ophthalmic emulsion, which would entitle the company to 180 days of generics market exclusivity.

For the 12 months ending 30 November 2014, Durezol had total US sales of approximately US$131 million, according to IMS Health data.

In 2013, generic eye drug specialist Akorn bought Hi-Tech Pharmacal (Hi-Tech) in order to expand into oral liquids and ointments, including cold and cough treatments. The acquisition of Hi-Tech was also hoped would strengthen Akorn’s position as the third largest company in the US market for generic ophthalmic drugs [1].

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. Akorn to buy Hi-Tech Pharmacal for US$640 million [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Feb 6]. Available from: www.gabionline.net/Pharma-News/Akorn-to-buy-Hi-Tech-Pharmacal-for-US-640-million

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Source: Akorn