Lupin launches generic contraceptive pill in US with 180-day exclusivity

Lupin will sell the generic s of Allergan Plc’s Minastrin 24 Fe tablets under the name Mibelas 24 Fe


Lupin has launched 28 products in the oral contraceptives segment in the US. Photo: Bloomberg
Lupin has launched 28 products in the oral contraceptives segment in the US. Photo: Bloomberg

Mumbai: Lupin Ltd, India’s second-largest pharmaceutical company by revenue, said on Thursday that it has launched a generic version of Allergan Plc’s Minastrin 24 Fe tablets in the US.

The company has a 180-day marketing exclusivity for the product, which means no other generic versions of Minastrin 24 Fe tablets, can be launched during this period.

Lupin will sell the chewable tablets, containing 1 mg norethindrone acetate, 0.02 mg ethinyl estradiol and 75 mg ferrous fumarate, under the name of Mibelas 24 Fe.

Allergan’s Minastrin 24 Fe tablets, used by females to prevent pregnancy, had sales of $360.5 million in the US in calendar year 2016, Lupin said in a press release citing data from global healthcare information and service provider IMS Health.

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“This product is likely to add $49 million to sales and $22 million to profit in FY18. Despite the challenging environment in the US and a high base, Lupin is expected to perform well due to steady flow of product approvals and a good pipeline,” said Surya Patra, an analyst at PhillipCapital India.

The company has in all launched 28 products in the oral contraceptives segment in the US, a Lupin spokesperson said.

Earlier this month, Lupin received approval from the US Food and Drug Administration (FDA) for its generic version of Braintree Laboratories’ Suprep bowel prep kit, used for cleansing the colon before colonoscopy in adults, for which it is eligible for a 180-day marketing exclusivity. The product is yet to be launched in the US.

Since January, the Indian drug maker has launched seven products in the US and got approval for eight generic drugs. The company currently has 134 abbreviated new drug applications (ANDAs) awaiting approval of the US FDA.

In the December quarter, the company’s consolidated sales rose 31.5% on year at Rs4,404.94 crore. Sales in the US, which accounts for nearly 50% of revenue, rose 53.4% to $316 million.

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