Glenmark advances in the US and Europe

March and April have proved to be busy months for the India-based firm, Glenmark Generics. On 11th April, Glenmark reported that it had settled pending patent litigation with GlaxoSmithKline regarding Glenmark's generic equivalent of the pharmaceutical giant's atovaquone and proguanil hydrochloride product, Malarone. Glenmark believes it is the first company to file an ANDA with a Paragraph IV certification for this product, and so will be entitled to the 180-days marketing exclusivity allowed under the Hatch-Waxman Act, once approval for its version is given. The patent litigation commenced in August 2009 in the US District Court for the District of Delaware; the settlement will enable Glenmark to launch its version in the third quarter of 2011, well before the expiration of the three patents in the FDA's Orange Book covering the product. All three expire on 25th November 2013, but all three have additional paediatric exclusivity periods until 25th May 2014. A paediatric dosage version of the product forms part of GlaxoSmithKline's NDA, but Glenmark is not challenging this version. Following on from its US approval for ropinirole in February 2010, on 7th April 2010, Glenmark announced that it had gained UK approval for the drug. The product, a generic equivalent of GlaxoSmithKline's Requip, is indicated for the treatment of restless legs syndrome.

Asides from its entanglements with GlaxoSmithKline, Glenmark has also had two other ANDAs approved in March and April in the US. On 26th March, its ANDA for 0.005% calcipotriene ointment was approved. The product, a generic equivalent of Leo Pharmaceuticals' Dovonex ointment, is indicated for the treatment of plaque psoriasis in adults. Leo's version is no longer marketed in the US, having been discontinued for reasons of commercial viability in April 2007. Glenmark appears to have the only marketed ointment version of the drug in the US; however, the fact that the branded version was discontinued for commercial reasons raises questions. Leo currently markets topical cream and solution variants of Dovonex; three generic versions of the topical solution variant are also marketed, by Tolmar, Hi-Tech Pharmacal and Nycomed. A few days later, on 1st April, Glenmark announced FDA approval for its 7.5 mg and 15 mg moexipril hydrochloride tablets. The product is a generic version of Schwarz Pharmaceuticals' Univasc, used in the treatment of hypertension. Branded revenues for the drug appear to be relatively small, and Glenmark's version joins long-established versions marketed by Teva Pharmaceutical Industries, Paddock Laboratories and Apotex. Glenmark noted that this approval complemented an approval for moexipril hydrochloride and hydrochlorothiazide, which was gained on 17th March 2010. On 31st March, Glenmark reported that NDAs for oxycodone hydrochloride capsules and liquid solution had been submitted by its partner, Lehigh Valley Technologies, to the FDA. The FDA has now begun reviewing the applications. Plenty of versions, both branded and generic, of oxycodone are currently marketed in the US, but these appear to all be in tablet form, which would perhaps explain why Lehigh has filed an NDA rather than an ANDA. Glenmark's partnership with Lehigh goes back to 2006, with an agreement covering two unnamed liquid generic pharmaceutical products. This was then extended some months later with an agreement covering another seven products for the US market.

However, the period has not been all plain sailing for Glenmark. On 16th March 2010, the FDA announced that it had ordered the firm to stop marketing unapproved nitroglycerin tablets. The FDA sent a warning letter requiring the tablets to be removed as part of the FDA's Unapproved Drugs Initiative, and gave Glenmark 15 days to respond with a discontinuation plan, and 90 days from the date of the letter to cease manufacturing. It is likely that Glenmark's ultimate response will be to file an ANDA for its version, in order to be able to bring it back to the market.

Ian Platts – Editor, World Generic Markets