Sandoz introduces authorized generic version of LESCOL® XL in the US
Princeton, New Jersey, October 16, 2015 – Sandoz today announced the US introduction of fluvastatin sodium extended-release tablets, USP, an authorized generic version (AGx) of LESCOL® XL, which is marketed by Novartis Pharmaceuticals Corporation. This is another great example of cross-divisional collaboration in the context of the ongoing Novartis Group Rx-Gx program.
Fluvastatin sodium extended-release tablets, USP are indicated as an adjunctive therapy with changes to diet to lower cholesterol, slow the progression of heart disease and reduce the risk of needing procedures to improve blood flow to the heart. Approximately 71 million American adults (33.5%) have high LDL, or “bad” cholesterol. 
Sandoz launches our AGx to optimize performance across the full product lifecycle and to maximize overall Group market share. Under the US system, there is six month exclusivity for the first generic company to successfully challenge a patent (a so called Paragraph IV), so this is all about managing a three-player market for six months before everyone else enters the market.
As timing the market entry of an AGx typically depends on the timing of the first generic competitor, we are never sure of the exact launch date. This means successfully managing shelf life, and being constantly ready to launch at a moment’s notice, sometimes over a long time period.
“Sandoz is committed to expanding our portfolio of affordable, high-quality treatment options for US patients,” said Peter Goldschmidt, President of Sandoz Inc. “We are pleased to work with our Novartis Pharmaceuticals Corporation colleagues to offer an authorized generic version of LESCOL® XL to the tens of millions of Americans trying to control their cholesterol.”
According to IMS Health, US sales for fluvastatin sodium extended-release tablets, USP were approximately USD 45 million for the 12 months ending in May 2014. Sandoz is marketing fluvastatin sodium in 80 mg strength extended release tablets.
The foregoing release contains forward-looking statements that can be identified by words such as “launches,” “introduction,” “launch,” “will,” or similar terms, or by express or implied discussions regarding potential future product approvals, or regarding potential revenues from fluvastatin sodium extended-release tablets, USP or any potential future products. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that any potential new products will receive regulatory approval in the future, or that fluvastatin sodium extended-release tablets, USP or any such potential new products will be commercially successful in the future. In particular, management’s expectations could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; competition in general, including potential approval of additional versions of fluvastatin sodium extended-release tablets, USP; government, industry and general public pricing pressures; unexpected patent litigation outcomes; unexpected manufacturing issues; general economic and industry conditions, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis 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 across 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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1. Center for Disease and Control and Prevention: “Cholesterol”. Accessed July 8, 2014.
Available from: http://www.cdc.gov/cholesterol/facts.htm
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For further information:
Sandoz US Communications
Sandoz Global Communications
+49 8024 476 1906
1 For full safety information, please see the fluvastatin sodium extended-release tablets, USP prescribing information, available in the Product Catalog at www.us.sandoz.com.
2 LESCOL® XL is a registered trademark of Novartis AG.