Lupin has launched the generic version of Watson’s Fortamet despite an impeding patent suit against Lupin in the US. The drug sales could contribute as much as 3-4% of the annual operating profit — about Rs 35-40 crore — for this financial year. The branded product’s generic name is metformin ER, used to improve glycemic control in adults with type II diabetes which is usually associated with lifestyle. Annual sales of Fortamet are $90 million. Lupin also has a first-to-file status on its application with the US Food and Drug Administration (FDA) for the drug, which will give the company an exclusive period to sell the drug for 180 days after the litigation is settled.
The USFDA restricts approval of generic drug applications for 30 months if the innovator files an infringement suit within 45 days of the application. In case the litigation is not over in this time, the FDA approves the drug, but the generic company may launch only at the risk of being penalised by courts for the outstanding period of the litigation. The 30-month period restricting Lupin for metformin ended in June.
Company Name | CMP |
---|---|
Sun Pharma Inds. | 1461.85 |
Dr. Reddys Lab | 5790.00 |
Cipla | 1450.20 |
Zydus Lifesciences | 1033.00 |
Lupin | 1581.60 |
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