Generic Exelon Patch Launched
September 10, 2015 – Alvogen announced the launch of the first generic equivalent the Exelon patch (rivastigmine transdermal system). Exelon, manufactured by Novartis, was first approved by the FDA on July 7, 2005 as a transdermal delivery system of rivastigmine, a reversible acetylcholinesterase inhibitor indicated for the treatment of mild, moderate, and severe memory problems associated with Alzheimer’s disease, and mild to moderate dementia associated with Parkinson’s disease. The generic version of the Excelon Patch will be available in three strengths (4.6mg/24 hours, 9.5mg/24 hours, and 13.3mg/24 hours) even though 13.3mg/24 hours strength has received full FDA approval. Alvogen has 180 days of marketing exclusivity for the 13.3mg/24 hours strength. It is recommended that the rivastigimine transdermal system be initiated at a dose of 4.6mg/24 hours, titrated to a dose of 9.5mg/24 hours, and could be increased to 13.3mg/24 hours due to the incidence and severity of serious stomach side effects like nausea, vomiting, and ulcers being dose related. Based on IMS data, there was approximately $400 million in U.S. sales of Norvatis’ Exelon patch in 2014.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability. All trademarks are the property of their respective owners.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.