Mumbai-headquartered drugmaker Lupin has been sued by Allergan in a US court over its

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plans for a generic version of Allergan’s Acular LS solution.

Lupin is planning to come out with generic copies of Allergan’s Acular LS solution, in a move that indicates its growing interest in the billion-dollar US eye drug market.

This is the third instance in the past nine months, when innovator company, Allergan has sued Lupin in a US court over generics of eye drugs.

This time, Lupin is planning to launch the generic version of the prescription eye medicine that is covered by at least one patent (no. 338) expiring in May 2027.

The worldwide opthalmology drugs market is expected to reach a size of $19.8 billion by the year 2014 growing at a CAGR of 4 per cent from 2009-2014. The US opthalmic drug market has crossed $5 billion in 2008 and has of late attracted the attention of generic firms.

Through its latest generic drug application, Lupin is planning to sell its proposed generic product (ketorolac tromethamine 0.4 per cent) in ophthalmic solution that is used as an eye-inflammation treatment.

In mid-November 2011, Allergan received a letter on behalf of Lupin where the Mumbai-headquartered firm said it was seeking approval to make and sell generic version of Allergan’s Acular LS® product prior to the expiration of the patent.

A copy of Allergan’s suit was accessed by Financial Chronicle. A Lupin spokesperson was not available for immediate comment. Acular LS ophthalmic solution is indicated for the reduction of ocular pain and burning/stinging following corneal refractive surgery. Acular LS was approved by the US Food and Drug Administration in 2003.

It is understood that Lupin has filed the application with a Paragraph IV certification. Hence Allergan has been notified. As is the norm, after the notice, the branded company has 45 days to file a patent infringement action against the generic company.

Since the suit has been filed, the FDA cannot approve of the application until Lupin successfully defends the suit or until 30 months, whichever comes first.

In November 2011, Lupin was sued for wanting to sell generic copies Bimatoprost Ophthalmic Solution( 0.01 per cent), which is sold as Lumigan by Allergan.

Earlier that year (in April and May), Japan’s Senju Pharmaceutical and Kyorin Pharmaceutical along with US-based Allergan sued Lupin alleging patent violation in case of 0.3 per cent Gatifloxacin opthalmic solution.