Dr Reddy's Labs gains after re-launch of generic Suboxone film in US

Dr Reddy's Laboratories rose 0.54% to Rs 2,537.25 at 09:19 IST on BSE after the company announced the re-launch of a therapeutic equivalent generic version of Suboxone sublingual film, in the United States market.

The announcement was made after market hours yesterday, 20 February 2019.

Meanwhile, the S&P BSE Sensex was up 26.62 points, or 0.07% to 35,782.88

On the BSE, 3,639 shares were traded in the counter so far compared with average daily volumes of 1.05 lakh shares in the past two weeks. The stock had hit a high of Rs 2,554.90 and a low of Rs 2,526.35 so far during the day. The stock hit a 52-week high of Rs 2,875 on 4 February 2019. The stock hit a 52-week low of Rs 1,888 on 21 May 2018.

Dr Reddy's Laboratories announced the re-launch of its Buprenorphine and Naloxone Sublingual Film, 2 mg/0.5 mg, 4 mg/1 mg, 8 mg/2 mg, and 12 mg/3 mg, a therapeutic equivalent generic version of Suboxone (buprenorphine and naloxone) sublingual film, in the United States market.

The re-launch comes on the heels of a favorable decision issued by the United States Court of Appeals for the Federal Circuit concluding that Indivior had not shown that it is likely to succeed on its claim that Dr Reddy's product infringes U.S. Patent No. 9,931,305. The Federal Circuit's decision vacates the District Court's preliminary injunction that had prohibited Dr Reddy's from selling its generic version of Suboxone (buprenorphine and naloxone) sublingual film. As a result of the Federal Circuit's ruling, Dr Reddy's has resumed shipping of the product.

In June 2018, the U.S. Food and Drug Administration (USFDA) approved Dr Reddy's Buprenorphine and Naloxone Sublingual Film, in four strengths including 2 mg/0.5 mg, 4 mg/1 mg, 8 mg/2 mg, and 12 mg/3 mg, for sale in the US market. The product was launched immediately after approval, with sales and commercialization activities halted as a result of a court-imposed temporary restraining order (TRO) and preliminary injunction against Dr Reddy's. The TRO and preliminary injunction did not prohibit commercial manufacturing of the product.

On a consolidated basis, net profit of Dr Reddy's Laboratories rose 65.28% to Rs 500.30 crore on 1.16% rise in net sales to Rs 3850 crore in Q3 December 2018 over Q3 December 2017.

Dr Reddy's Laboratories is an integrated pharmaceutical company. Through its three businesses - Pharmaceutical Services & Active Ingredients, Global Generics and Proprietary Products - Dr Reddy's offers a portfolio of products and services including APls, custom pharmaceutical services, generics, biosimilars and differentiated formulations.

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