Sandoz launches authorized generic version of EXELON® PATCH
Sep 02, 2015
Princeton, New Jersey, September 2, 2015 – Sandoz today announced the US market introduction of rivastigmine transdermal system, an authorized generic version of EXELON® PATCH1, marketed by Novartis Pharmaceuticals Corporation.
Rivastigmine patch is indicated for the treatment of mild, moderate and severe memory problems (dementia) associated with Alzheimer’s disease. Rivastigmine is also used to treat people with mild to moderate memory problems (dementia) associated with Parkinson’s disease."Sandoz is pleased to make rivastigmine patch available as a generic option for patients with memory problems associated with Alzheimer’s disease,” said Peter Goldschmidt, President of Sandoz Inc. “Rivastigmine has been studied for more than a decade in clinical trials and is the only Alzheimer's disease treatment that comes in the form of a patch with the medication absorbed through the skin.” According to IMS Health, US sales for rivastigmine patch were approximately USD 646 million for the 12 months ending in June 2015. Sandoz is marketing rivastigmine in 13.3mg strength, the same strength as the brand.
Important Safety Information2
Rivastigmine patch should not be used if the patient is allergic to any component in the patch, including the active ingredient rivastigmine. Rivastigmine patch should also not be used if the patient has had a skin reaction that spread beyond the patch size, had blisters, increased skin redness, or swelling, or did not get better within 48 hours after removal of the patch. Mistakes in using the rivastigmine patch have resulted in serious side effects; some cases have required hospitalization, and rarely, have led to death. Most mistakes have involved not removing the old patch when putting on a new one and the use of multiple patches at one time. Only one rivastigmine patch should be worn at a time. If you accidentally apply more than one rivastigmine patch, remove all of them and inform the doctor immediately. Rivastigmine patch can also cause serious stomach side effects, including nausea, vomiting, diarrhea, dehydration, decreased appetite, weight loss, and bleeding in your stomach (ulcers). Dehydration may result from prolonged vomiting or diarrhea and can be associated with serious outcomes. The incidence and severity of these reactions are dose related. For this reason, treatment should be initiated with rivastigmine at a dose of 4.6 mg/24 hours and titrated to a dose of 9.5 mg/24 hours, and then 13.3 mg/24 hours, if appropriate. If you have not taken the rivastigmine patch for more than 3 days, do not start taking it again until you have talked with a doctor. Some people have had a skin reaction called allergic contact dermatitis (ACD) when using rivastigmine patch. Stop using rivastigmine patch and call your health provider right away if you experience reactions that spread beyond the patch size, are intense in nature, and do not improve within 48 hours after the patch is removed. Syptoms of ACD may be intense and including itching, redness, swelling, warmth or tenderness of the skin, or peeling or blistering of the skin, which may ooze, drain or crust over. The most common side effects of rivastigmine patch include depression, headache, anxiety, dizziness, stomach pain, urinary tract infections, muscle weakness, tiredness and trouble sleeping. Weight should be checked while the person is using rivastigmine patch. Weight loss/loss of appetite may occur. People below 50 kg (110 lbs.) may experience more side effects and may have to stop using rivastigmine patch due to these side effects. People at risk for stomach ulcers or who take certain medicines should tell their doctor before starting rivastigmine patch, because serious stomach problems, such as bleeding, may occur. Rivastigmine patch may cause fainting or slow heart rate; people with certain heart conditions should tell their doctor before starting therapy. People with serious lung conditions and difficulty breathing, bladder problems, or seizures should consult their doctor before using rivastigmine patch. Extrapyramidal symptoms (e.g. uncontrollable facial or body movements, including tremor and restlessness) could occur or get worse.Parkinsonian symptoms, particularly tremor, have worsened in Parkinson’s disease dementia patients treated with rivastigmine tartrate capsules. Before using rivastigmine patch, people should also tell their doctor about any medical conditions they have, including if they have had a loss of appetite or are losing weight, or if they have had a skin reaction to rivastigmine (the medicine in rivastigmine patch) in the past. People on rivastigmine patch who feel dizzy or drowsy should not drive or use machines. Tell the doctor about all other prescription or nonprescription medicines the patient is taking. Rivastigmine patch should not be taken at the same time as metoclopramide (use to treat heartburn, nausea and vomiting) and with medicines that have a similar effect on the body and the brain (cholinomimetic agents) or with anticholinergic medicines.Rivastigmine patch should not be taken at the same times as medicines that reduce your blood pressure (beta-blockers). Inform the doctor if the patient needs surgery requiring anesthesia while using rivastigmine patch.
The foregoing release contains forward-looking statements that can be identified by words such as “launches,” “introduction,” or similar terms, or by express or implied discussions regarding potential revenues from rivastigmine patch. 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 rivastigmine patch 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 generic versions of rivastigmine patch; national trends toward health care cost containment, including ongoing pricing pressures; unexpected litigation outcomes; unexpected safety issues; unexpected manufacturing or quality 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, a division of Novartis, is a global leader in generic pharmaceuticals, driving sustainable access to high-quality healthcare. Sandoz employs more than 26,000 people worldwide and supplies a broad range of affordable, primarily off-patent products to patients and customers around the globe. The Sandoz global portfolio comprises approximately 1,100 molecules, which accounted for 2014 sales of USD 9.6 billion. Sandoz holds the global #1 position in biosimilars as well as in generic anti-infectives, ophthalmics and transplantation medicines. Nearly half of Sandoz's portfolio is in differentiated products – products that are scientifically more difficult to 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 consistently driven growth in selected geographies and differentiated product areas through a series of targeted acquisitions.