Sandoz launches generic version of PREVPAC® in the US
Princeton, New Jersey, March 27, 2014
Sandoz today announced the US launch of lansoprazole capsules, amoxicillin capsules, USP, and clarithromycin tablets, USP, a generic version of PREVPAC®1.
This product is indicated for the eradication of H. pylori infection in patients with duodenal ulcer disease. It comprises amoxicillin and clarithromycin, which are antibiotic medicines, as well as lansoprazole, a proton pump inhibitor that helps decrease production of excess stomach acid2.
“Sandoz is proud to provide a generic version of this important gastro-intestinal therapy,” said Peter Goldschmidt, President of Sandoz Inc. “This launch further expands the Sandoz offering of affordable, high-quality medicines.”
Sandoz is marketing lansoprazole capsules, amoxicillin capsules, USP, and clarithromycin tablets in the same strengths as are marketed for PREVPAC®.
According to IMS Health, US sales for branded lansoprazole capsules, amoxicillin capsules, USP, and clarithromycin tablets, USP were approximately USD 69.7 million for the twelve months ending January 2014.
1PREVPAC® is a registered trademark of Takeda Pharmaceuticals U.S.A. Inc
2For full safety information, please see the lansoprazole capsules, amoxicillin capsules, USP, and clarithromycin tablets prescribing information, available in the Product Catalog at www.us.sandoz.com.
The foregoing release contains forward-looking statements that can be identified by terminology such as "launches," “launch,” or similar expressions, or by express or implied discussions regarding potential new indications or labeling for lansoprazole capsules, amoxicillin capsules, USP, and clarithromycin tablets, USP or regarding potential future revenues from lansoprazole capsules, amoxicillin capsules, USP, and clarithromycin tablets, USP. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with lansoprazole capsules, amoxicillin capsules, USP, and clarithromycin tablets, USP to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that lansoprazole capsules, amoxicillin capsules, USP, and clarithromycin tablets, USP will achieve any particular levels of revenue in the future. In particular, management’s expectations regarding lansoprazole capsules, amoxicillin capsules, USP, and clarithromycin tablets, USP could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; uncertainties regarding actual or potential legal proceedings, including, among others, intellectual property disputes or other legal efforts to prevent or limit Sandoz from selling lansoprazole capsules, amoxicillin capsules, USP, and clarithromycin tablets, USP, and the uncertain outcome of any such litigation; the particular prescribing preferences of physicians and patients; competition in general; government, industry and general public pricing pressures; unexpected manufacturing difficulties or delays; the impact that the foregoing factors could have on the values attributed to the Novartis Group's assets and liabilities as recorded in the Group's consolidated balance sheet, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Sandoz is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
Sandoz, the generic pharmaceuticals division of Novartis, is a global leader in the generic pharmaceutical sector. Sandoz employs over 26,500 employees and its products are sold in more than 160 countries, offering a broad range of high-quality, affordable products that are no longer protected by patents. With USD 9.2 billion in sales in 2013, Sandoz has a portfolio of approximately 1,100 molecules, and holds the #1 position globally in biosimilars as well as in generic injectables, ophthalmics, dermatology and antibiotics, complemented by leading positions in the cardiovascular, metabolism, central nervous system, pain, gastrointestinal, respiratory, and hormonal therapeutic areas. Sandoz develops, produces, and markets these medicines, as well as active pharmaceutical and biotechnological substances. Nearly half of Sandoz's portfolio is in differentiated products, which are defined as products that are more difficult to scientifically develop and manufacture than standard generics.
In addition to strong organic growth since consolidating its generics businesses under the Sandoz brand name in 2003, Sandoz has benefitted from strong growth of its acquisitions, which include Lek (Slovenia), Sabex (Canada), Hexal (Germany), Eon Labs (US), EBEWE Pharma (Austria), Oriel Therapeutics (US), and Fougera Pharmaceuticals (US).
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