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Lupin, the third largest Indian pharmaceutical company by value, is strengthening its position in the US market through aggressive first-to-file launches. In recent months, it launched about half a dozen, with 180-day exclusivity.
The latest one is ciprofloxacin oral suspension, generic equivalent of Bayer's Cipro Oral Suspension, indicated for treatment of infections, with annual US sales of $9 million. Last year, Lupin had 31 approvals in the US, the largest number by an Indian pharma company. It expects to launch 25-30 products yearly, with a focus on obtaining marketing exclusivity in the US by being the first to file for regulatory approvals. Key generic drug launches such as Glumetza, Ranexa and Trizivir were all with marketing exclusivity.
A spokesperson said there was less competition for areas such as oral contraceptives, ophthalmic, derma, complex injectables and inhalation, where the barriers to entry are high and the number of players few. "So, if one has the relevant technological competencies, be it in research, manufacturing or is vertically integrated for the therapies, one can very well invest in creating a pipeline for these segments."
At present, Lupin is the fifth largest generic entity by prescriptions in America. The company is seeing its US sales and profitability driven by a strong pipeline of niche products. The March 2014 quarter revenues are likely to be driven by generic launches of Trizivir (HIV treatment drug), Triplix (cholesterol lowering), Cymbalta (anti-depressant drug) and Zymaxid (antibacterial eye drops).
Zymaxid and Triplix generics are likely to see limited competition even after the 180-day exclusivity ends. Cymbalta has seen its market share increase by 30 basis points, to 11.5%, show recent data.
The company is expected to launch the Niaspan generic, a cholesterol lowering drug, in the near term. This will strengthen its lipid control drug portfolio. Lupin has brand Antara for the same indication; it had also launched authorised generics to counter the competition. In the same segment, its generic launches of Tricor and Triplix continue to provide momentum.
The company is building up its oral contraceptive portfolio, which will get a boost from interesting launches such as those of Yaz and Loestrin.
Hitesh Mahida at KR Chowksey Shares and Securities says Lupin's three products in the pipeline (two in respiratory and one in dermatology) could get launched by 2016-17, strengthening its niche dermatology and respiratory range. The company is expected to maintain its run rate of close to 20 ANDA (Abbreviated New Drug Approvals) launches in the US every year.
Lupin's scrip had hit an all-time high of Rs 1,003 on March 3. Compared to the BSE healthcare index that lost almost five% over its closing price on February 28, Lupin was trading marginally up at Rs 962 during the same period.
