Instant Report

Date: 07-Oct-2020

Lupin Receives US FDA Approval To Market Generic Tecfidera DR Capsules

Pharma major Lupin Limited has received approval for its dimethyl fumarate delayed-release capsules, 120 mg and 240 mg, from the United States Food and Drug Administration (FDA), to market a generic equivalent of Tecfidera delayed-release capsules, 120 mg and 240 mg, of Biogen, Inc.

The product is expected to be launched shortly.

Dimethyl fumarate delayed-release capsules, 120 mg and 240 mg, are indicated for the treatment of patients with relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

Dimethyl fumarate delayed-release capsules had an annual sales of approximately US$ 3788 million in the US, according to IQVIA MAT June 2020.

Date: 02-Dec-2020

Lupin Receives US FDA Approval To Market For Penicillamine Tablets

Pharma major Lupin Limited has received approval from the United States Food and Drug Administration (FDA) to market for penicillamine tablets USP, 250 mg, a generic equivalent of Depen tablets, 250 mg, of Mylan Specialty, L.P.

The product would be manufactured at Lupin’s Nagpur facility and is expected to be launched shortly.

Penicillamine tablets USP, 250 mg, are indicated in the treatment of Wilson’s disease, Cystinuria, and in patients with severe, active rheumatoid arthritis who have failed to respond to an adequate trial of conventional therapy.

Penicillamine tablets USP had an annual sales of approximately US$4 million in the US, according to IQVIA MAT September 2020.

Date: 08-Jan-2021

Lupin Receives US FDA Approval To Market Generic Synjardy XR Tablets

Lupin Limited, global pharmaceutical company, has received tentative approval for its empagliflozin and metformin hydrochloride extended release (ER) tablets, 5 mg/1000 mg, 10 mg/1000 mg, 12.5 mg/1000 mg, and 25 mg/1000 mg, from the United States Food and Drug Administration (FDA), to market a generic equivalent of Synjardy XR tablets, 5 mg/1000 mg, 10 mg/1000 mg, 12.5 mg/1000 mg, and 25 mg/1000 mg, of Boehringer Ingelheim Pharmaceuticals, Inc.

The product will be manufactured at Lupin's Nagpur facility in India.

Empagliflozin and metformin hydrochloride extended-release (ER) tablets, 5 mg/1000 mg, 10 mg/1000 mg, 12.5 mg/1000 mg, and 25 mg/1000 mg, are indicated as an adjunct to diet and exercise, to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and metformin hydrochloride is appropriate.

Empagliflozin and metformin hydrochloride extended-release tablets had estimated annual sales of US$ 357 million in the US, according to IQVIA MAT November 2020.

Date: 10-Feb-2021

Lupin Receives US FDA Approval To Market Generic Kerydin Topical Solution

Global pharma major Lupin Limited has received approval for its tavaborole topical solution, 5%, from the United States Food and Drug Administration (FDA), to market a generic equivalent of Kerydin topical solution, 5%, of Anacor Pharmaceuticals, Inc.

The product will be manufactured at Lupin's facility in Pithampur, India.

Tavaborole topical solution, 5%, is an oxaborole antifungal indicated for the topical treatment of onychomycosis of the toenails due to trichophyton rubrum or trichophyton mentagrophytes.

Tavaborole topical solution had estimated annual sales of US$ 76 million in the US, according to IQVIA MAT December 2020.