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Drugmaker Lupin is among the three generic drug companies benefiting from a favourable US court ruling on Bayer’s oral contraceptive product, Yaz.
The Mumbai-based drug company Lupin said it was seeking approval from the US regulatory authority, the Food and Drug Administration, to sell its generic or chemically similar version of Yaz in the US.
The other two global generic majors that contested Bayer’s patent on the drug, and are selling their generic versions in the US market, are Actavis and Novartis’ generics-arm Sandoz.
Patent ‘invalid’
The development follows the ruling of the US Court of Appeals for the Federal Circuit that said the Bayer patent for the US was invalid, thereby reversing an earlier judgment by a lower district court. In its statement, Lupin said that its generic version of Yaz (Drospirenone and Ethinyl Estradiol tablets) were for the prevention of pregnancy.
The total sales for the branded and generic versions of the product stood at $361 million, according to industry estimates.
Foreign media reports quote a Bayer spokesperson saying that the company would evaluate its options, following the Court’s ruling.
The patent on the drug involved in the challenge expires on June 30, 2014, the report said, citing the ruling.
Side-effects
In the past, Bayer has been in a spot with the US regulatory authority on its birth control drugs Yasmin and Yaz.
Last year, the regulatory agency required both products to sport labels that cautioned patients on blood clots.
After reviewing the issue, the US FDA had concluded “that drospirenone-containing birth control pills may be associated with a higher risk for blood clots than other progestin-containing pills.”
According to global reports, Bayer would fork out about $400 million to settle about 1,900 of 6,000 claims in the US over blood clots caused by Yasmin.
Lupin shares closed up two per cent on the BSE, at Rs 673 on Wednesday.
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