Synopsis
Indoco Remedies Ltd was granted approval from the USFDA to sell its generic Lofexidine tablets, used for opioid withdrawal. This approval includes 180 days of market exclusivity. The company plans an immediate US launch, manufacturing the product in Goa. Expected sales are estimated at USD 15.59 million, with signicant growth anticipated.

Drugmaker Indoco Remedies Ltd on Wednesday said it has received nal approval from the US health regulator to market its generic Lofexidine tablets, used in opioid discontinuation treatment, with 180 days of competitive generic therapy exclusivity. The approval by the US Food and Drug Administration (USFDA) is for Lofeidine tablets 0.18 mg, a generic equivalent of Lucemyra tablets, 0.18 mg of USWM, LLC, Indoco Remedies said in a regulatory ling.

"Indoco has been granted a Competitive Generic Therapy (CGT) designation by the USFDA and being the rst approved generic, is eligible for 180 days of CGT exclusivity for Lofexidine tablets, 0.18 mg in the USA," it added.

This exclusivity will begin to run from the date of the rst commercial marketing of the product. Indoco intends to launch the product immediately in the US, the company said.

The USFDA designates a drug with inadequate generic competition as a CGT.

"This strengthens our position in the US market, driving us closer to expanding our reach in the US," Indoco Remedies Managing Director Aditi Panandikar said on the development.

The product will be manufactured by Indoco at its manufacturing facility in Verna, Goa, the company said.

This product is indicated for mitigation of symptoms associated with acute withdrawal from opioids and for facilitation of the completion of opioid discontinuation treatment.

Citing IQVIA Health data, the company said sales of the product are around USD 15.59 million with an expected growth of 38 per cent.