RIVASTIGMINE PHARMACOMPASS MARKET OVERVIEW PharmaCompass.com New Delhi: [email protected] Paris: [email protected] Overview Rivastigmine (sold under the trade name Exelon) is a parasympathomimetic or cholinergic Agent. Synonyms: Exelon™, Rivastigmine tartrate , Rivastach® Patch, Prometax®, SDZ ENA 713 Chemical Name: (S)-3-[1-(dimethylamino)ethyl]phenyl N-ethyl-N-methylcarbamate PRODUCTPATENT OVERVIEW& NEWS Therapeutic Indication: It is used for the treatment of mild to moderate dementia of the AND Alzheimer's type and dementia due to Parkinson's disease. Originator: Novartis PATENT IN Originator Market: The United States THE U.S. Developer: Novartis; Ono Pharmaceutical Patent in the US Novartis’ Exelon has 6 patents for Transdermal Patch (Extended Release) which are set to expire in Jan 2019 Related news and articles • The Hague District Court rejected Novartis’ claim based on infringement of its patent for patches containing rivastigmine against Alvogen and Focus Farma because the patent was invalid- July 7, 2016 Novartis AG is co-owner of EP 2 292 219 B1 (EP 219), granted on 12 June 2013. EP 219 relates to a “Transdermal therapeutic system for the administration of rivastigmine” PATENT & NEWS • Novartis has been battling generic-drug makers over the Exelon patch patents in multiple suits over GLOBAL NEWS the past few years:- November 6, 2015 (i) Novartis and LTS Lohmann Therapie-Systeme AG claim Dr. Reddy’s and Amneal and its New York and India subsidiaries infringed two patents associated with Exelon (ii) The brand name drugmaker sued Par Pharmaceuticals and Watson Lab. over the Exelon patch patents in 2013 (iii) A judge ruled that Watson infringed the patents in its ANDA in June 2014 and Par settled, only to go to trial later (iv) After beating Watson, Novartis took on Mylan Pharmaceuticals in June 2014 as well (v) Zydus Pharma (USA) also got slapped with an Exelon suit in 2014, but it was thrown out for lack of jurisdiction in August Patch Alvogen Launches the First Generic Exelon® Patch in the United States market - September 04, 2015 Sandoz launches authorized generic version of Exelon® Patch GENERIC in the United States market - September 2, 2015 LANDSCAPE U.S. MARKET Capsules Sun Pharma introduces generic rivastigmine capsules in the United States market- July 2, 2010 Dr. Reddy’s announces the launch of Rivastigmine Tartrate Capsules in the United States market - September 22, 2011 Generic overview: detailed description here PRODUCT SALES INFORMATION Exelon® Patch is the first and only patch to treat all stages of Alzheimer's disease U.S. MARKET Sales 2011 from IMS data EXELON®* brand and generic Rivastigmine tartrate had U.S. sales of approximately $92.6 million for the most recent twelve months ending June 2011. Sales Data from U.S. Medicare Prescription Payment in 2013 DRUG NAME GENERIC NAME BENEFICIARIES PRESCRIPTIONS CLAIMS TOTAL DRUG COST Capsules generics are Exelon Rivastigmine Patch 235,060 78,098 1,381,768 $465,772,265.79 Exelon Rivastigmine Tartrate Capsules 1,092 1,129 3,704 $1,395,838.32 on the rise Rivastigmine Rivastigmine Tartrate Capsules 51,762 36,189 333,686 $54,729,264.75 Sales 2014 from IMS data Novartis’s Exelon® patch, delivered sales of approximately $400 million USD in the United States during 2014. Market Size : $ 26.7 million global sales of Rivastigmine in 2015 (as per IMS Data) Sales Data from Annual Reports 2015 Market share: 9 % 2014 REVENUE 2015 REVENUE IN SALES DIFFERENCE IN COMPANY PRODUCT ACTIVE MAIN THERAPEUTIC GROWTH IN MILLIONS MILLIONS MILLIONS NAME NAME INGREDIENT INDICATION (%) As per U.S. Medicare Prescription (2013): (USD) (USD) (USD) Exelon Caps/ Neuroscience and Capsules sales : 11 % Novartis Rivastigmine 1,009 728 -281 -28% Patch Sales: 89 % Exelon Patch Mental Health S. COMPANY NAME COUNTRY ACTIVE INGREDIENTS US DMF CEP/ WRITTEN COMPLIANCE NO. ALL COMBINED COS CONFIRMATION ISSUES 1 Aarti Drugs Ltd India Rivastigmine Hydrogen Tartrate Filed ( 2009) - Issued (2013) Import Alert (23-3-2015) GLOBAL 2 Actavis Group Ptc Ehf Ireland Rivastigmine Hydrogen Tartrate Filed ( 2009) - - - 3 Alembic India Rivastigmine Filed ( 2015) Issued (2015) Issued (2013) - Pharmaceuticals Ltd API SUPPLIER Rivastigmine Tartrate Filed ( 2008) - - - Rivastigmine Hydrogen Tartrate - Issued (2014) - - LANDSCAPE 4 Apotex Pharmachem Inc Canada Rivastigmine Filed ( 2015) -- Warning Letter Rivastigmine Tartrate Filed ( 2008) - (30/01/15) 5 Aurobindo Pharma Ltd India Rivastigmine Filed ( 2015) - Rivastigmine Tartrate Filed ( 2010) - - - Rivastigmine Hydrogen Tartrate - Issued ( 2015) - - Regulatory Filings 6 Cadila Healthcare Ltd India Rivastigmine Filed ( 2013) - Issued (2013) - (US DMF, CEP/COS, 7 Cambrex Karlskoga Ab United Rivastigmine Filed ( 2015) Issued (2016) - - States EU Written Confirmation) Rivastigmine Hydrogen Tartrate - Issued (2016) - - 8 Centaur India Rivastigmine Hydrogen Tartrate - - Issued (2016) - Pharmaceuticals Rivastigmine Hydrogen Tartrate [1/3] 9 Cipla Ltd India Filed ( 2003) Issued (2015) Issued (2013) - 10 Dr Reddys Laboratories India Rivastigmine Filed ( 2012) - Issued (2013) Warning Ltd Letter (11/05/15) Rivastigmine Tartrate - - Issued (2016) - Rivastigmine Hydrogen Tartrate Filed Issued (2015) Issued (2016 - ( 2004) (2008) S. COMPANY NAME COUNTRY ACTIVE INGREDIENTS US DMF CEP/ WRITTEN COMPLIANCE NO. ALL COMBINED COS CONFIRMATION ISSUES 11 Erregierre Spa Italy Rivastigmine Filed ( 2011) - - - GLOBAL Rivastigmine Tartrate Filed ( 2007) - - - 12 Excella Gmbh De 90537 Germany Rivastigmine - Issued (2015) - - Feucht API SUPPLIER 13 Interquim Sa Spain Rivastigmine Filed ( 2009) Issued (2015) - - Rivastigmine Hydrogen - Issued (2015) - - LANDSCAPEGLOBAL Tartrate 14 Jubilant Generics Ltd India Rivastigmine Filed ( 2011) - - - API Supplier Rivastigmine Tartrate Filed ( 2011) - - - 15 Macleods India Rivastigmine Tartrate Filed ( 2010) - - - Landscape Pharmaceuticals Ltd 16 MSN Organics Private India Rivastigmine Filed ( 2015) - - - Regulatory Filings Ltd Rivastigmine Tartrate Filed ( 2014) - - - (US DMF, CEP/COS, Rivastigmine Hydrogen - Issued (2016) - - with DMF & COS Tartrate EU Written Confirmation) 17 Mylan Laboratories Ltd United Rivastigmine Filed Issued (2015) Issued (2013) - [2/3] States ( 2010) (2012) Rivastigmine Tartrate Filed ( 2010) - - [2/3] Rivastigmine Hydrogen - Issued (2014) Issued (2013) Tartrate 18 Nuray Chemicals Pvt. India Rivastigmine Hydrogen - - Issued (2014) - Ltd., Tartrate S. COMPANY NAME COUNTRY ACTIVE INGREDIENTS US DMF CEP/ EU WRITTEN COMPLIANCE NO. ALL COMBINED COS CONFIRMATION ISSUES GLOBAL 19 Orchid Chemicals And India Rivastigmine - - Issued (2013) - Pharmaceuticals Ltd API SUPPLIER Rivastigmine Tartrate Filed ( 2007) - Issued (2013) - GLOBAL 20 Shodhana Laboratories India Rivastigmine - - Issued (2013) - Ltd. LANDSCAPE Rivastigmine Hydrogen - - Issued (2013) - API Supplier Tartrate 21 Sun Pharmaceutical India Rivastigmine Tartrate Filed ( 2004) - Issued (2013) - Industries Ltd Landscape 22 Zhejiang Jiuzhou China Rivastigmine - Issued - - Pharmaceutical Co., Ltd. (2015) CN 318 000 Taizhou City Regulatory Filings (USwith DMF, DMF CEP/COS & COS and Conclusion: Total API Suppliers= 22 API Suppliers for : EU Written[3/3 Confirmation)] India # 14 (i.e. more than 50%) United States # 2 Canada # 1 [3/3] China # 1 Germany # 1 Italy # 1 Ireland # 1 Spain # 1 Other Suppliers in various databases Rivastigmine Bioiberica S.A (CPHI China Exhibitor Product List) Hangzhou Read Chemical Co.,Ltd. (CPHI China Exhibitor Product List) Hubei Lansun Biochemistry Pharmaceutical Co., Ltd. (CPHI China Exhibitor Product List) Interquim, S.A. *(New Zealand Database) Mylan Laboratories Limited *(New Zealand Database) Novartis Pharma AG *(New Zealand Database) GLOBAL Novartis Ringaskiddy Ltd *(New Zealand Database) API SUPPLIER Shenzhen Oriental Pharmaceutical Co., Ltd. (CPHI China Exhibitor Product List) Rivastigmine Tartrate LANDSCAPE Alembic Pharmaceuticals Limited, Unit I (Mexico COFEPRIS Database ) Bharat Pharma (Product List) BOC Sciences (Product List) Cipla Ltd (New Zealand Database) Dalian Wondersun Biochemical Technology Co,.Ltd (CPHI China Exhibitor Product List) Globe Quimica Ltda (Product List) Hangzhou Neway Chemicals Co.,Ltd (CPHI China Exhibitor Product List) Others Langfang Gaobo Jingband Pharmaceutical Co.,Ltd. (CPHI China Exhibitor Product List) Rivastigmine Hydrogen Tartrate Aarti Drugs Limited Cipla Ltd (Iran API Registration ) Interquim (Iran API Registration ) Sun Pharmaceutical (Iran API Registration ) * Manufacturer for both Rivastigmine and Rivastigmine Tartrate COMPANY NAME (SUPPLIERS) COUNTRY CUSTOMERS IN EGYPT Aarti Drugs Limited India Al Esraa Pharmaceutical Optima-egypt Dr Reddy's Laboratories Ltd India Global NAPI Pharmaceuticals (GNP), Hikma pharma Emcure Pharmaceutical Limited India Global NAPI Pharmaceuticals (GNP) EGYPT MARKET Interquim S.A-spain Spain Eva pharma for Pharmaceuticals and Medical Appliances Arab Company for Pharmaceuticals & Medicinal Plants Mahavir Laboratories Private Ltd India CUSTOMERS SUPPLIERS (Mepaco- Medi Food) LANDSCAPE MSN Organics P Ltd India universal pharmceutical industries (unipharma) Mash Company For Pharmaceutical Industries Shodhana Laboratories Ltd India (Mash Premiere) Sun Pharmaceutical Industries-india India Eva pharma for Pharmaceuticals and Medical Appliances Mash Company For Pharmaceutical Industries Shanghai Daishang Chemical Co.,Ltd-china China (Mash Premiere) Mash Company For Pharmaceutical Industries Zhengzhou Sigma Chemical Co.Ltd-china China (Mash Premiere)