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Sandoz controversies

Controversies tied to this brand in public sources. A listing is not a finding of fault.

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  1. 2020

    Astellas files patent-infringement complaint against pharmaceutical companies

    Lawsuit filed

    Astellas Pharma Inc. and affiliated plaintiffs filed a complaint in Delaware against 21 pharmaceutical companies, alleging that their proposed generic versions of Myrbetriq would infringe the '780 patent. The plaintiffs sought court relief; the allegations are claims in the complaint.

    Source excerpt

    • At the District Court of Delaware on Tuesday, Astellas Pharma Inc. (API), Astellas Ireland Co. Ltd. (AICL), and Astellas Pharma Global Development (APGD) filed a complaint against 21 pharmaceutical companies alleging patent infringement.
    • The defendants are as follows: Sandoz Inc., Actavis Elizabeth LLC, Actavis LLC, Teva Pharmaceuticals USA Inc., Apotex Inc., Apotex Corp., Aurobindo Pharma Ltd., Aurobindo Pharma USA Inc., Aurolife Pharma LLC, Sawai Pharmaceutical Co. Ltd., Sawai USA Inc., Prinston Pharmaceutical Inc., Zhejiang Huahai Pharmaceutical Co. Ltd., Huahai US Inc., Solco Healthcare US LLC, Windlas Healthcare Pvt. Ltd., Windlas Biotech Ltd., Zydus Pharmaceuticals (USA) Inc., Cadila Healthcare Ltd. (doing business as Zydus Cadila), Lupin Ltd., and Lupin Pharmaceuticals, Inc.
    • The patent in question, deemed the ’780 patent, corresponds to APGD’s Myrbetriq extended-release tablets, containing active ingredient mirabegron, which is used to treat overactive bladder.
    Source

  2. 2019

    Sandoz recalls ranitidine capsules over NDMA contamination

    Recall announced

    Sandoz Inc. voluntarily recalled all quantities and lots within expiry of its Ranitidine Hydrochloride Capsules in the United States to the consumer level. The recall followed confirmation that batches of the product were contaminated with NDMA above levels established by the FDA. The company stated that it had received no reports of related adverse events to date.

    Company response

    • Recall — Sandoz Inc.

      Sandoz Inc. is voluntarily recalling all quantities and lots within expiry of Ranitidine Hydrochloride Capsules in the US to the consumer level because of confirmed contamination with N-Nitrosodimethylamine (NDMA) above levels established by the FDA in batches of Sandoz Ranitidine Hydrochloride Capsules.

    Source excerpt

    • Sandoz Inc. is voluntarily recalling all quantities and lots within expiry of Ranitidine Hydrochloride Capsules in the US to the consumer level because of confirmed contamination with N-Nitrosodimethylamine (NDMA) above levels established by the FDA in batches of Sandoz Ranitidine Hydrochloride Capsules.
    Source