Company Overview of Sandoz Inc.
Sandoz Inc. develops, manufactures, markets, and distributes generic pharmaceutical products. Its therapeutic drug categories include anti-infectives, central nervous system disorder treatments, cardiovascular medicines, gastrointestinal agents, oncology therapies, respiratory therapies, alimentary tract and metabolism, blood and blood-forming organs, and antineoplastic and immunomodulating agents. The company provides oral solid generics to advanced application forms, such as transdermal patches and implants; and complex products, such as follow-on biologics (biosimilars), injectables, and inhalables. It sells its products to small and large retailers, wholesalers, hospitals, prescription b...
100 College Road West
Princeton, NJ 08540
Founded in 1946
Key Executives for Sandoz Inc.
President and Head of North America
President of Oriel Therapeutics
Vice President of Legal, IP & Compliance and General Counsel of NA
Head of Global Development Biopharmaceuticals & Oncology Injectables
Head of Biopharmaceuticals and Oncology Injectables
Compensation as of Fiscal Year 2016.
Sandoz Inc. Key Developments
AstraZeneca PLC Enters into Agreement with Sandoz, Inc. to Resolve Faslodex Patent Litigation in the US
Jul 13 16
AstraZeneca PLC announced that it has entered into an agreement with Sandoz Inc. and affiliates to resolve Faslodex (fulvestrant) patent litigation in the US relating to Sandoz's generic fulvestrant product, for which it is seeking FDA approval. The US Faslodex patents in question are due to expire in January 2021, with paediatric exclusivity continuing until July 2021. On July 12, 2016, the United States District Court for the District of New Jersey entered a consent judgment filed by AstraZeneca and Sandoz, which includes an injunction preventing Sandoz from launching a generic fulvestrant product until 25 March 2019, or earlier in some circumstances.
United Therapeutics Corporation Announces Settlement of Patent Litigation with Sandoz Inc
Sep 30 15
United Therapeutics Corporation announced that it has entered into a settlement agreement with Sandoz Inc.relating to ongoing litigation concerning certain patents relating to United Therapeutics' product, Remodulin(R) (treprostinil) Injection, and Sandoz's Abbreviated New Drug Application ("ANDA") seeking approval by the U.S. Food and Drug Administration to market a generic version of Remodulin. Under the Settlement Agreement, United Therapeutics granted to Sandoz a non-exclusive license to manufacture and commercialize the generic version of Remodulin described in its ANDA filing in the United States beginning on June 26, 2018, although Sandoz may be permitted to enter the market earlier under certain circumstances. The license included in the Settlement Agreement does not permit Sandoz the right to manufacture a generic version of any other United Therapeutics product, such as Tyvaso(R) (treprostinil) Inhalation Solution or Orenitram(R) (treprostinil) Extended-Release Tablets, nor does it grant any rights with respect to any technology associated with the Remodulin Implantable System being developed by the Company and Medtronic Inc., or the pre-filled semi-disposable pump system being developed by the Company and DEKA Research & Development Corp. The Settlement Agreement does not grant Sandoz any rights other than those required to launch Sandoz's generic version of Remodulin. In accordance with the Settlement Agreement, the parties will submit the Settlement Agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review. The pending litigation with Sandoz consists of a pending appeal by Sandoz of the August 2014 ruling by the U.S. District Court for the District of New Jersey finding that U.S. Patent No. 6,765,117 is valid and enforceable against Sandoz, and an appeal by United Therapeutics with respect to the District Court's finding that U.S. Patent No. 7,999,007 would not be infringed upon by Sandoz's generic product. Pending litigation between the parties also includes a separate lawsuit filed in September 2014 by United Therapeutics against Sandoz in the same U.S. District Court, alleging infringement of U.S. Patent No. 8,497,393. Pursuant to the Settlement Agreement, the parties will terminate all currently pending litigation.
Appeals Court Affirms Shire plc’s Vyvanse (Lisdexamfetamine Dimesylate) Patents Valid Until 2023
Sep 25 15
Shire plc announced that the Court of Appeals of the Federal Circuit has upheld the summary judgment ruling of the U.S. District Court for the District of New Jersey that certain claims of the patents protecting Vyvanse (lisdexamfetamine dimesylate) are valid. Shire’s lawsuit included all of the known pharmaceutical manufacturers that filed Abbreviated New Drug Applications with the U.S. Food and Drug Administration seeking to market generic versions of Vyvanse, along with their Active Pharmaceutical Ingredient manufacturer of lisdexamfetamine dimesylate API. The ANDA-defendants are Actavis LLC/Actavis Elizabeth LLC; Amneal Pharmaceuticals, LLC; Mylan Pharmaceuticals Inc./Mylan Inc.; Roxane Laboratories Inc.; and Sandoz Inc. The API manufacturer and supplier to each of the ANDA-defendants is Johnson Matthey Inc./Johnson Matthey Pharmaceutical Materials. The ruling prevents the ANDA defendants from launching generic versions of Vyvanse until the expiration of these patents in 2023. The defendants may move for rehearing at the Federal Circuit, or may file a petition at the U.S. Supreme Court. The Court of Appeals of the Federal Circuit affirmed the District Court’s summary judgment ruling that 18 patent claims from four of the FDA Orange Book-listed patents for Vyvanse are valid. The ANDA defendants’ infringement of these claims was not contested on appeal. These patent claims cover Vyvanse’s active ingredient, the lisdexamfetamine dimesylate compound, and a method of using lisdexamfetamine dimesylate for the treatment of ADHD. As to the API-manufacturer, the court of appeals of the Federal Circuit found that Johnson Matthey was not liable for the API it sold the ANDA defendants up to this point because it did not submit an ANDA.
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