Pharma major, Lupin has declared that the US Court of Appeals for the Federal Circuit has ruled in its favor regarding its appeal of a previous judgment by a lower court for Bayer AG’s Yaz oral contraceptive product.
On April 16, 2013 the United States Court of Appeals for the Federal Circuit has ruled that United States Patent No RE 37,564 (the RE '564 Patent) is invalid thereby reversing the district court’s decision of validity.
Lupin’s Generic Drospirenone and Ethinyl Estradiol Tablets (3 mg + 0.02 mg) of Bayer AG’s Yaz tablets are indicated for prevention of pregnancy, to treat the symptoms of premenstrual dysphoric disorder (PMDD) for women and to treat moderate acne for women at least 14 years old only if the patient desires an oral contraceptive for birth control. The total sales for Branded and generic sales for the product stood at $361 million (IMS MAT Dec 2012).
Lupin is the 5th largest and fastest growing generics player in the US (5.1% market share by prescriptions, IMS Health) and the 3rd largest Indian pharmaceutical company by sales. The company is also the fastest growing top 10 generic pharmaceutical players in Japan and South Africa (IMS).
