Indoco Remedies gets USFDA nod to market Lofexidine tablets with 180 days exclusivity

Drugmaker Indoco Remedies Ltd on Wednesday said it has received final 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 Lofexidine tablets 0.18 mg, a generic equivalent of Lucemyra tablets, 0.18 mg of USWM, LLC, Indoco Remedies said in a regulatory filing.

"Indoco has been granted a Competitive Generic Therapy (CGT) designation by the USFDA and being the first 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 first 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.