Dr. Reddy's Laboratories Re-Launches Buprenorphine and Naloxone Sublingual Film after Favourable Ruling in Patent Litigation
22 February 2019 - - Indian pharmaceutical company Dr. Reddy's Laboratories Ltd. ((BSE: 500124) (NSE: DRREDDY) (NYSE: RDY) has re-launched 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 company said.

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 US 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.

The Federal Circuit's decision went into effect yesterday. As a result of the Federal Circuit's ruling, Dr. Reddy's has resumed shipping of the product.

In June 2018, the US 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 and preliminary injunction against Dr. Reddy's.

The TRO and preliminary injunction did not prohibit commercial manufacturing of the product.

Dr. Reddy's Laboratories offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. its major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology.

The company operates in markets across the globe. its major markets include USA, India, Russia and CIS countries, and Europe.