Mumbai-headquartered pharma firm Lupin is eyeing the lucrative US eye drug market, literally. For

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second time this year, Lupin has been sued for wanting to sell generic copies of an eye drug.

The $5.2 billion Allergan sued Lupin last week for wanting to sell its proposed generic Bimatoprost Ophthalmic Solution (0.01 per cent) that US-based company sells in the name of Lumigan.

Allergan estimates that Lumigan franchise product net sales would be between $610 million and $630 million in 2011, and this obviously attracted the attention of Lupin. Last financial year, Lupin raked in over $220 million in US generic sales.

In August 2010, the United States food and drug administration (FDA) approved Lumigan (bimatoprost ophthalmic solution 0.01 per cent) as a first-line therapy indicated for reduction of elevated intra-ocular pressure in patients with open-angle glaucoma or ocular hypertension.

Allergan’s suit filed in Texas Eastern District Court comes after Lupin and Lupin Pharmaceuticals, acting jointly, submitted an abbreviated new drug application to the USFDA.

Allergan believes that by submitting this application, Lupin committed an act of infringement of “the 504 patent”, which protects Lumigan till June 13, 2027, according to the copy of the suit with Financial Chronicle.

While none from Lupin was available for a comment, analysts pointed that Allergan is sure to face generic competition in its eye products such as Lumigan that account for 25 per cent of its eye business.

In first week of October, Allergan received a letter of intimation on behalf of Lupin about its generic product. Lupin is understood to have told Allergan that “the 504 patent” is invalid, or will not be infringed by its own offering.

It is understood that Lupin may have filed the application with a Paragraph IV certification, which is why Allergan was notified. As is the norm, after the notice, the branded company has 45 days to file a patent infringement action against the generic company. After the suit has been filed, the FDA cannot approve of the application until the generic company defends the suit or until 30 months, whichever comes first.