Glenmark Pharmaceuticals’ Abbreviated New Drug Application (ANDA) for Dimethyl Fumarate Delayed-Release Capsules, 120 mg and 240 mg has received approval from FDA officials. The new drug product is the generic version of Biogen’s Tecfidera Delayed-Release Capsules, 120 mg and 240 mg.1

Dimethyl fumarate is indicated to treat relapsing forms of multiple sclerosis in adult patients.2

Common adverse effects of dimethyl fumarate include flushing, redness, itching, or rash; and nausea, vomiting, diarrhea, stomach pain, or indigestion. Serious adverse effects include allergic reaction, decreases in white blood cell count, liver problems, herpes zoster infections, and progressive multifocal leukoencephalopathy, a rare brain infection that usually leads to death.2

In addition to Glenmark’s product, Camber Pharmaceuticals and Dr. Reddy’s Laboratories have also received ANDA approvals from the FDA for generic versions of Tecfidera. Camber and Dr. Reddy’s each launched their respective products within the last few weeks.3,4

According to IQVIA, sales data for the 12 month period ending August, the market for Biogen’s delayed-release dimethyl fumarate capsules, 120 mg and 240 mg achieved annual sales of approximately $3.8 billion.1,4


REFERENCES
 
  1. Glenmark Pharmaceuticals receives ANDA approval for Dimethyl Fumarate Delayed-Release Capsules, 120 mg and 240 mg [news release]. Mumbai, India; October 7, 2020: Glenmark. Accessed October 7, 2020. [email]
  2. Biogen. Indication and Important Safety Information. Tecfidera.com. Accessed October 7, 2020. https://www.tecfidera.com/
  3. Camber Pharma Launches Generic Tecfidera® Capsules. Pharmacy Times. Published September 25, 2020. Accessed October 7, 2020. https://www.pharmacytimes.com/news/camber-pharma-launches-generic-tecfidera-capsules
  4. Dr. Reddy’s Laboratories Announce Launch of Dimethyl Fumarate Delayed-Release Capsules in the US Market. Pharmacy Times. Published October 1, 2020. Accessed October 7, 2020. https://www.pharmacytimes.com/news/dr-reddys-laboratories-announces-launch-of-dimethyl-fumarate-delayed-release-capsules-in-the-us-market