Dr Reddy's re-launches Buprenorphine, Naloxone Sublingual Film in US market

The re-launch comes on the heels of a favourable ruling in patent litigation by the United States Court of Appeals for the Federal Circuit.

Hyderabad: In a move to aid people suffering from opioid use disorder, drug major Dr Reddy's Laboratories has recently re-launched its Buprenorphine and Naloxone Sublingual Film in the US market.

Dr Reddy's Laboratories on Wednesday announced the re-launch of its Buprenorphine and Naloxone Sublingual Film in the US market after a favourable court ruling.

Buprenorphine and Naloxone Sublingual Film, 2 mg/0.5 mg, 4 mg/1 mg, 8 mg/2 mg, and 12 mg/3 mg, is a therapeutic equivalent generic version of Suboxone (buprenorphine and naloxone) sublingual film, Dr Reddy's said in a BSE filing.

Buprenorphine/naloxone, sold under the brand name Suboxone among others, is a combination medication that includes buprenorphine and naloxone. In combination with counselling, it is used to treat opioid use disorder. It decreases withdrawal symptoms for about 24 hours. Buprenorphine/naloxone is available for use in two different forms, under the tongue or in the cheek.

The re-launch comes on the heels of a favourable ruling in patent litigation by the United States Court of Appeals for the Federal Circuit.

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"We are pleased with the decision of the appellate court in Dr Reddy's favour, vacating the preliminary injunction that had prevented Dr Reddy's from continuing to market this important drug to the public," said Marc Kikuchi, Chief Executive Officer, North America Generics.

"Dr Reddy's is committed to providing affordable treatment options for opioid use disorder and addiction. We look forward to helping patients and our communities in the United States who are impacted by the opioid epidemic."

Dr Reddy's Laboratories is a multinational pharmaceutical company based in Hyderabad. The company was founded by Anji Reddy, who previously worked in the mentor institute Indian Drugs and Pharmaceuticals Limited, of Hyderabad.

The company manufactures and markets a wide range of pharmaceuticals in India and overseas. The company has over 190 medications, 60 active pharmaceutical ingredients (APIs) for drug manufacture, diagnostic kits, critical care, and biotechnology products.

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