Lupin launches HIV drug in US
The generic version of Trizivir tablets is launched with 180 days of marketing exclusivity.
New Delhi, December 24, 2013: Indian drug firm Lupin has launched the generic version of ViiV Healthcare's Trizivir tablets in the US market with 180 days of marketing exclusivity. Lupin said in a statement that its US subsidiary Lupin Pharmaceuticals Inc has launched Abacavir Sulfate, Lamivudine and Zidovudine tablets in the US after the US District Court for the District of Delaware ruled that Lupin's generic version of Trizivir did not infringe on patents.
It may be noted here that the Indian drug firm had already received approval from the US Food and Drug Administration (USFDA) for the same. Since Lupin was the first applicant to file an abbreviated new drug application (ANDA) for Trizivir tablets and hence is entitled for 180 days of marketing exclusivity.
The sales of Trizivir tablets stood at US$ 111.6 million, according to the IMS MAT September 2013 data.
Lupin’s cumulative ANDA filings with the USFDA stood at 183, as on October 30, 2013 and the company has received 93 approvals to date.