Lupin Announces Launch Of Pregnancy Prevention Tablets In US, Details Here!
Latest updates have revealed that major Pharmaceutical, Lupin have launched one of its produced named Mibelas 24 Fe - used for actively preventing pregnancy - in the United States market. Mumbai Pharmaceuticals, Lupin Ltd, which is India's second-largest pharmaceutical company based on revenue generation, revealed on Thursday that it has launched a generic version of Allergan Pharmaceuticals International Minastrin 24 Fe tablets in the United States' market.
"The company today announced the launch of Mibelas 24 Fe (Norethindrone Acetate and Ethinyl Estradiol chewable tablets, 1 mg/0.02 mg and Ferrous Fumarate tablets, 75 mg) having received an approval from the USFDA earlier," the pharmaceutical company said in a BSE filing.
According to DNAIndia, Lupin revealed that the recently launched tablet is the AB-rated generic equivalent of Allergan Plc's Minastrin 24 Fe tablets also used for pregnancy prevention. It is also reported that Minastrin 24 Fe chewable tablets had the United States sales of USD 360.5 million in 2016.
Allergan Pharmaceuticals International Minastrin 24 Fe tablet is primarily used by females to prevent pregnancy. Lupin stated in a press release, that the new product is expected to add $49 million to sales figure and $22 million to profit in FY18, according to Livemint.
However, amid the challenges in the United States environment and a high base, the Pharmaceutical Company is expected to perform well. According to an analyst at Phillip Capital India, Surya Patra, this is because of the steady flow of Lupin's product approvals and a good pipeline.
Lupin is expected to sell the chewable tablets, which contains 0.02 mg Ethinyl Estradiol, 1 mg norethindrone acetate, and 75 mg ferrous fumarate, under the name of Mibelas 24 Fe. A spokesperson for the Pharmaceutical Company revealed that Lupin has altogether launched 28 of its products in the oral contraceptives segment in the United States.
It is reported that shares of the company closed 0.41 percent up at Rs 1,456.40 on BSE. Lupin has an 180-day marketing exclusivity for the product, which invariably means no other generic versions of Minastrin 24 Fe tablets, can be launched during this period.
The company is also reported to have received approval from the United States Food and Drug Administration for its generic version of Braintree Laboratories' Suprep bowel prep kit, earlier this month. The prep kit is used in cleansing the colon before colonoscopy in adults, which is also eligible for an 180-day marketing exclusivity. However, Lupin has not launched the product in the United States.
Lupin has launched seven products in the United States since January 2017 and has got approval for eight generic drugs. Currently, the Pharmaceutical Company is reported to have 134 abbreviated new drug applications awaiting approval from the United States Food and Drug Administration (FDA).
The consolidated sales of the company rose to 31.5 percent last year, with a Rs4,404.94 crore in the December quarter. While sales in the United States, which accounts for nearly 50 percent of the company's revenue, rose 53.4 percent to $316 million.