Market News
Recent Developments
New product launches
- In December 2021, Camurus AB, a pharmaceutical company, announced that its U.S. licensee Braeburn had received a complete response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for its updated new drug application (NDA) for Brixadi (buprenorphine) extended-release injections for the treatment of opioid use disorder. CRL is a result of continued quality related deficiencies at Braeburn’s U.S. based third party manufacturer, which is identified by the U.S. FDA during a pre-approval inspection.
- In November 2021, Sandoz International GmbH, a global leader in generic and biosimilar medicines, announced the U.S. launch of its authorized generic of Narcan (naloxone hydrochloride) Nasal Spray 4mg that is used to reverse opioid overdose. It is available to people in the U.S. via retail pharmacies and institutions including hospitals•In May 2020, Hikma Pharmaceuticals PLC., a multinational generic pharmaceutical company, launched Buprenorphine Hydrochloride Injection, 0.3mg/mL, the generic version of Buprenex [1] in the U.S. through its U.S. affiliate named Hikma Pharmaceuticals U.S.A Inc.
Acquisition and partnerships
- In April 2021, ABneal Pharmaceuticals, Inc., a pharmaceutical company, and Kashiv Specialty Pharmaceuticals, LLC., a fully-integrated biopharmaceutical company, announced that ABneal Pharmaceuticals LLC., a subsidiary of the ABneal Pharmaceuticals LLC, had completed the acquisition of Kashiv Specialty Pharmaceuticals, LLC., a company that focuses on the development of complex generics, innovative drug delivery platforms and novel 505(b)(2) drugs
- In October 2020, Hikma Pharmaceuticals PLC., a multinational pharmaceutical company, and Arecor Limited, a biopharmaceutical company, announced that both the companies had entered into a new agreement to co-develop a ready-to-administer injectable medicine in the U.S., through Hikma’s affiliate Hikma Pharmaceuticals USA Inc.
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