RIVASTIGMINE - PharmaCompass

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RIVASTIGMINEPHARMACOMPASS MARKET OVERVIEWPharmaCompass.comNew Delhi: support@pharmacompass.comParis: gj@pharmacompass.com

OverviewRivastigmine (sold under the trade name Exelon) is a parasympathomimetic or cholinergicAgent.Synonyms: Exelon , Rivastigmine tartrate , Rivastach Patch, Prometax , SDZ ENA 713PATENTOVERVIEW& NEWSPRODUCTANDPATENT INTHE U.S.Chemical Name: (S)-3-[1-(dimethylamino)ethyl]phenyl N-ethyl-N-methylcarbamateTherapeutic Indication: It is used for the treatment of mild to moderate dementia of theAlzheimer's type and dementia due to Parkinson's disease.Originator: NovartisOriginator Market: The United StatesDeveloper: Novartis; Ono PharmaceuticalPatent in the USNovartis’ Exelon has 6 patents for Transdermal Patch (Extended Release) which are set to expirein Jan 2019

Related news and articles The Hague District Court rejected Novartis’ claim based on infringement of its patent for patchescontaining rivastigmine against Alvogen and Focus Farma because the patent was invalid- July 7, 2016Novartis 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 & NEWSGLOBAL NEWS Novartis has been battling generic-drug makers over the Exelon patch patents in multiple suits overthe past few years:- November 6, 2015(i) Novartis and LTS Lohmann Therapie-Systeme AG claim Dr. Reddy’s and Amneal and its New Yorkand India subsidiaries infringed two patents associated with Exelon(ii) The brand name drugmaker sued Par Pharmaceuticals and Watson Lab. over the Exelon patchpatents in 2013(iii) A judge ruled that Watson infringed the patents in its ANDA in June 2014 and Par settled, only togo 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 ofjurisdiction in August

Patch Alvogen Launches the FirstGeneric Exelon Patch in theUnited States market September 04, 2015GENERICLANDSCAPEU.S. MARKET Sandoz launches authorizedgeneric version of Exelon Patchin the United States market September 2, 2015Capsules Sun Pharma introduces genericrivastigmine capsules in the UnitedStates market- July 2, 2010 Dr. Reddy’s announces the launchof Rivastigmine Tartrate Capsulesin the United States market September 22, 2011Generic overview: detailed description here

PRODUCT SALESINFORMATIONU.S. MARKETExelon Patch is the first and only patch to treat all stages of Alzheimer's diseaseSales 2011 from IMS dataEXELON * brand and generic Rivastigmine tartrate had U.S. sales of approximately 92.6 million forthe most recent twelve months ending June 2011.Sales Data from U.S. Medicare Prescription Payment in 2013Capsules generics areon the riseDRUG NAMEGENERIC NAMEBENEFICIARIESPRESCRIPTIONSCLAIMSTOTAL DRUG COSTExelonExelonRivastigmine PatchRivastigmine Tartrate Capsules235,0601,09278,0981,1291,381,7683,704 465,772,265.79 1,395,838.32RivastigmineRivastigmine Tartrate Capsules51,76236,189333,686 54,729,264.75Sales 2014 from IMS dataMarket Size : 26.7 million globalsales of Rivastigmine in 2015 (as per IMS Data)Market share: 9 %As per U.S. Medicare Prescription (2013):Capsules sales : 11 %Patch Sales: 89 %Novartis’s Exelon patch, delivered sales of approximately 400 million USD in the United Statesduring 2014.Sales Data from Annual Reports 2015COMPANYNAMEPRODUCTNAMEACTIVEINGREDIENTMAIN THERAPEUTICINDICATION2014 REVENUEIN MILLIONS(USD)NovartisExelon Caps/Exelon PatchRivastigmineNeuroscience andMental Health1,0092015 REVENUE IN SALES DIFFERENCE INGROWTHMILLIONSMILLIONS(%)(USD)(USD)728-281-28%

GLOBALAPI SUPPLIERLANDSCAPES.NO.COMPANY NAMECOUNTRY1Aarti Drugs LtdIndia2Actavis Group Ptc Ehf3AlembicPharmaceuticals Ltd45Regulatory Filings(US DMF, CEP/COS,EU Written Confirmation)[1/3]Apotex Pharmachem IncAurobindo Pharma LtdUS tigmine Hydrogen TartrateFiled ( 2009)-Issued (2013)Import Alert(23-3-2015)IrelandRivastigmine Hydrogen TartrateFiled ( 2009)---IndiaRivastigmineFiled ( 2015)Issued (2015)Issued (2013)-Rivastigmine TartrateFiled ( 2008)---Rivastigmine Hydrogen Tartrate-Issued (2014)--RivastigmineFiled ( 2015)--Rivastigmine TartrateFiled ( 2008)WarningLetter(30/01/15)RivastigmineFiled ( 2015)Rivastigmine TartrateFiled ( 2010)---Rivastigmine Hydrogen Tartrate-Issued ( 2015)--CanadaIndiaACTIVE INGREDIENTSALL COMBINED--6Cadila Healthcare LtdIndiaRivastigmineFiled ( 2013)-Issued (2013)-7Cambrex Karlskoga AbUnitedStatesRivastigmineFiled ( 2015)Issued (2016)--Rivastigmine Hydrogen Tartrate-Issued (2016)--8CentaurPharmaceuticalsIndiaRivastigmine Hydrogen Tartrate--Issued (2016)-9Cipla LtdIndiaRivastigmine Hydrogen TartrateFiled ( 2003)Issued (2015)Issued (2013)-10Dr Reddys LaboratoriesLtdIndiaRivastigmineFiled ( 2012)-Issued (2013)WarningLetter(11/05/15)Rivastigmine Tartrate--Issued (2016)-Rivastigmine Hydrogen TartrateFiled( 2004) (2008)Issued (2015)Issued (2016-

S.NO.COMPANY NAMECOUNTRYACTIVE INGREDIENTSALL COMBINEDUS LAPI SUPPLIERGLOBALLANDSCAPEAPI SupplierLandscape11Erregierre SpaItalyRivastigmineFiled ( 2011)---Rivastigmine TartrateFiled ( 2007)---15MacleodsPharmaceuticals LtdRegulatory Filings(US DMF, CEP/COS,withDMF & COSEU Written Confirmation)16MSN Organics PrivateLtd[2/3]12Excella Gmbh De 90537FeuchtGermanyRivastigmine-Issued (2015)--13Interquim SaSpainRivastigmineFiled ( 2009)Issued (2015)--Rivastigmine HydrogenTartrate-Issued (2015)--RivastigmineFiled ( 2011)---Rivastigmine TartrateFiled ( 2011)---IndiaRivastigmine TartrateFiled ( 2010)---IndiaRivastigmineFiled ( 2015)---Rivastigmine TartrateFiled ( 2014)---Rivastigmine HydrogenTartrate-Issued (2016)--RivastigmineFiled( 2010) (2012)Issued (2015)Issued (2013)-Rivastigmine TartrateFiled ( 2010)--Rivastigmine HydrogenTartrate-Issued (2014)Issued (2013)Rivastigmine HydrogenTartrate--Issued (2014)1417Jubilant Generics LtdMylan Laboratories LtdIndiaUnitedStates[2/3]18Nuray Chemicals Pvt.Ltd.,India-

peRegulatory FilingswithDMF& COS(USDMF,CEP/COSandEU WrittenConfirmation)[3/3][3/3]S.NO.COMPANY NAMECOUNTRYACTIVE INGREDIENTSALL COMBINEDUS DMFCEP/COSEU WRITTENCONFIRMATIONCOMPLIANCEISSUES19Orchid Chemicals AndPharmaceuticals LtdIndiaRivastigmine--Issued (2013)-Rivastigmine TartrateFiled ( 2007)-Issued (2013)-Shodhana LaboratoriesLtd.IndiaRivastigmine--Issued (2013)-Rivastigmine HydrogenTartrate--Issued (2013)-21Sun PharmaceuticalIndustries LtdIndiaRivastigmine TartrateFiled ( 2004)-Issued (2013)-22Zhejiang JiuzhouPharmaceutical Co., Ltd.CN 318 000 Taizhou CityChinaRivastigmine-Issued(2015)--20Conclusion: Total API Suppliers 22API Suppliers for :India # 14 (i.e. more than 50%)United States # 2Canada # 1China # 1Germany # 1Italy # 1Ireland # 1Spain # 1

Other Suppliers in various databasesRivastigmineGLOBALAPI SUPPLIERLANDSCAPEOthers Bioiberica S.AHangzhou Read Chemical Co.,Ltd.Hubei Lansun Biochemistry Pharmaceutical Co., Ltd.Interquim, S.A.Mylan Laboratories LimitedNovartis Pharma AGNovartis Ringaskiddy LtdShenzhen Oriental Pharmaceutical Co., Ltd.(CPHI China Exhibitor Product List)(CPHI China Exhibitor Product List)(CPHI China Exhibitor Product List)*(New Zealand Database)*(New Zealand Database)*(New Zealand Database)*(New Zealand Database)(CPHI China Exhibitor Product List)Rivastigmine Tartrate Alembic Pharmaceuticals Limited, Unit IBharat PharmaBOC SciencesCipla LtdDalian Wondersun Biochemical Technology Co,.LtdGlobe Quimica LtdaHangzhou Neway Chemicals Co.,LtdLangfang Gaobo Jingband Pharmaceutical Co.,Ltd.(Mexico COFEPRIS Database )(Product List)(Product List)(New Zealand Database)(CPHI China Exhibitor Product List)(Product List)(CPHI China Exhibitor Product List)(CPHI China Exhibitor Product List)Rivastigmine Hydrogen Tartrate Aarti Drugs LimitedCipla LtdInterquimSun Pharmaceutical(Iran API Registration )(Iran API Registration )(Iran API Registration )* Manufacturer for both Rivastigmine and Rivastigmine Tartrate

COMPANY NAME (SUPPLIERS)EGYPT MARKETCUSTOMERS SUPPLIERSLANDSCAPECommercial opportunityfor RS IN EGYPTAarti Drugs LimitedIndiaAl Esraa Pharmaceutical Optima-egyptDr Reddy's Laboratories LtdIndiaGlobal NAPI Pharmaceuticals (GNP), Hikma pharmaEmcure Pharmaceutical LimitedIndiaGlobal NAPI Pharmaceuticals (GNP)Interquim S.A-spainSpainEva pharma for Pharmaceuticals and Medical AppliancesMahavir Laboratories Private LtdIndiaArab Company for Pharmaceuticals & Medicinal Plants(Mepaco- Medi Food)MSN Organics P LtdIndiauniversal pharmceutical industries (unipharma)Shodhana Laboratories LtdIndiaMash Company For Pharmaceutical Industries(Mash Premiere)Sun Pharmaceutical Industries-indiaIndiaEva pharma for Pharmaceuticals and Medical AppliancesShanghai Daishang Chemical Co.,Ltd-chinaChinaZhengzhou Sigma Chemical Co.Ltd-chinaChinaZhiyu Biotechnology Co,ltd-chinaChinaMash Company For Pharmaceutical Industries(Mash Premiere)Mash Company For Pharmaceutical Industries(Mash Premiere)Mash Company For Pharmaceutical Industries(Mash Premiere)Conclusion: Egypt' s pharmaceutical and healthcare sector presents a high-risk investment opportunityfor international drug makers Egypt finished dosage formulators import API majorly from India and China

COMPETITORANALYSISAPI TradeStatistics[1/2]API Imports to India from Jan 2015- Mid 2016Major destinations from where API has been Imported are :IMPORTING PORTQUANTITY(KGS)CIF ( )AVG. PRICE( /KGS)Spain5.544,455.08,082.7AhmedabadSlovak RepublicMumbai 349.0Imported by Zydus Cadila from Spain(Highly possibility that the supplier is Interquim)Imported by Rusan Pharma fromSlovak Republic(Highly possibility that the supplier is Saneca)The United States16.2gms of API was imported for USD 132,475. Possible suppliers can be Mylan US or CambrexKarlskogaFrom Jan 2015- Mid 2016,Less than 10 Kg API has beenimported into IndiaFrance11gms of API was imported for USD 9,844

API Exports of India from Jan 2015- Mid 2016Major destinations where API has been exported are :EXPORTING PORTDESTINATION IN INDIACOMPETITORANALYSISAPI TradeStatistics[2/2]Seoul - Incheon Int'Mumbai AirHyderabad AirAhmedabadBoston - Logan, MaMumbai AirPhiladelphiaMumbai AirGuarulhosAhmedabadMumbai AirReykjavikMumbai AirAhmedabadTehranMumbai AirQUANTITY(KGS)CIF ( )AVG. PRICE( 99.83,386.53,640.03,594.13,594.1Exported by Emcure to Marham Daru, IranFrom Jan 2015-Mid 2016;Total Export Of API - 2,653 Kg/ USD 9,650,590Export of different salts of API mentioned belowRivastigmine: 2,090 Kg/ USD 7,261,356Rivastigmine Tartrate: 368 Kg/ USD 1,320,979Rivastigmine Hydrogen Tartrate: 198 Kg/ USD 1,068,947API exported by Mumbai - 2,375 Kg/ USD 8,648,618 Mylan (Mumbai) exported 814 Kg/ USD 2,625,032 Other exports are of Oceanic Pharmachem[104 Kg/ 400891] and Cipla based on transaction data Centaur Pharma, Macleods , Sun Pharmaceuticalscan be other possible suppliers from Mumbai Alembic Pharmaceuticals exported 197 Kg/ USD 660,215 API from Ahmedabad as per the transactiondata Hyderabad exported 67 Kg/ USD 309,044 API ; possible supplier can be Aurobindo Pharma, MSNorganic, Hetero Drugs, Shodhana Laboratories as per the transaction data Bangalore exported 14 Kg/ USD 32,713 APIConclusion: API export of India (2,552Kgs) has been almost 365 times compare to the APIimport (7Kgs) to India

FDF Imports to India from Jan 2015- Mid 2016Major destinations from where FDF has been imported are:IMPORTING PORTDESTINATION IN INDIACOMPETITORANALYSISSpain1,162,336Bombay Air Cargo881,879Mumbai Air280,457GermanyMumbai AirIceland600,371198,781187,578Chennai Air11,20321,256Bombay Air Cargo16,912Ahmedabad4,344United States20,329Mumbai Air20,329France230Bangalore Air[1/2]600,371Chennai Air CargoJapanFDF TradeStatisticsCIF ( )GRAND TOTAL230From Jan 2015-Mid 2016; USD 2,003,303 FDF has been importedTransdermal PatchUSD1,804,522CapsulesUSD198,781Rivastigmine Transdermal patch was imported by Novartis India,Possible supplier from Spain can be Novartis Farmaceutica as per thelist of Imported finished formulation (registered) (June 2014- Dec. 2014which is valid till 2017) issued by CDSCO (India)Rivastigmine capsules was imported by Novartis India,Possible supplier from Germany can be M/S Lts Lohmanni as per the listof Imported finished formulation (registered) (June 2014- Dec. 2014which is valid till 2017) issued by CDSCO (India)Actavis Pharma Development Centre (Chennai) imported Capsules fromIceland2,003,303Mumbai imported USD 1,799,948 Exelon Patch Lupin and Cliantha Research, India are among the few importers who imported Rivastigmine TransdermalPatch from Japan Sidmak Laboratories, India imported USD 4,170 Exelon patch from the United States

FDF Exports of India from Jan 2015- Mid 2016Major destinations from where FDF has been exported:EXPORTING PORTCOMPETITORANALYSISFDF TradeStatistics[2/2]Chicago, IlDetroit MiMiami, FlPrague - RuzyneWixomKuala LumpurHelsinkiBrownsburgChicagoLondon MetropolitanStuttgartCIF ( ,798168,451146,005111,544106,071From Jan 2015-Mid 2016; USD 8,112,264 FDF has been exportedCapsulesUSD 8,112,109PatchUSD 155Mumbai exported USD 6,155,118 capsulesHyderabad exported USD 1,937,414 capsulesAhmedabad exported USD 7,400 capsulesSummary of FDF exports of India: Mylan Laboratories, India exported USD 437,033 Rivastigmine Capsules to Medis International A S, Serbia Mind (Torrent Pharmaceuticals), India exported USD 429,979 capsules (Brand Name: Rivadem) Macleods Pharmaceuticals, India exported USD 343,710 capsules to Macleods Pharmaceuticals USA as per thetransaction data Sun Pharmaceuticals, India exported USD 266,480 capsules (Brand Name: Rivamer and Rivastigmine Tartrate) Torrent Pharmaceuticals, India exported USD 230,798 capsules (Brand Name: Rivastigmin Orion) to OrionCorp, Finland Dr. Reddy, India exported USD 1,612,049 capsules to Dr. Reddy’s, United States Pharmascience exported USD 19,194 capsules (Brand Name: PMS- rivastigmine) Zydus exported USD 18,274 capsules out of IndiaConclusion: India exported USD 8,112,264 FDF which is almost 4 times compare to theFDF import (USD 2,003,303)

COMPANY NAMEGLOBALFINISHED DOSAGEFORMULATORS[1/5]Genericon Pharma Gesellschaft M.B.HSTADA Arzneimittel GmbhEnestia Belgium N.V / S.A.Eurogenerics N.VNovartis (Bangladesh) Ltd.Sun Pharmaceutical (Bangladesh) Ltd.Apotex IncGeneric Medical Partners IncMint Pharmaceuticals IncNovopharm LtdPharmascience IncPro Doc LimiteeS & D Pharma CZ , Spol . S.R.OOrifarm Generics A / S, DenmarkPharmacodane ApsAl Esraa Pharmaceutical OptimaEva Pharma For Pharmaceuticals And Medical AppliancesMash Company For Pharmaceutical IndustriesMepaco-medifoodUnipharma Co.Western Pharmaceuticals IndustriesDelpharm Huningue SASLaboratoires Plasto SanteTEVA SantéZydus FranceACC Gmbh Analytical Clinical ConceptsAliud Pharma Gmbh & Co. KgAMW GmbhBetapharm Arzneimittel GmbhGenus Pharmaceuticals LtdHexal AGLek Pharmaceuticals D.DLts Lohmann Therapie Systeme AgMerckle GMBHNeuraxpharm Arzneimittel angladeshCanadaCanadaCanadaCanadaCanadaCanadaCzech xpharm.de/html-de/start.php

COMPANY NAMEGLOBALFINISHED DOSAGEFORMULATORS[2/5]Novartis Pharma GmbhPHAST Society For Pharmaceutical Quality Standards MbhSalutas Pharma GmbhStada Arzneimittel AgTorrent Pharma GmbhWelding Gmbh & Co. KgWinthrop Arzneimittel GmbhGenepharm SaGlobal Napi PharmaceuticalsHeumann Pharma Gmbh & Co. Generica KGKleva Pharmaceuticals SALavipharm SAPharmanel Pharmaceuticals SA,PharmathenSpecifar S.AVianex S.AMylan Hungary Kft.Actavis Group PTC EhfAurochem Pharmaceuticals (India) Pvt. LtdAlembic Pharmaceuticals LimitedCipla LtdMylan Laboratories LimitedOrchid Healthcare (Una División De Orchid Chemicals &Pharmaceuticals Ltda.) De IndiaVeros Healthcare Pvt . Ltd . De IndiaMcdermott Laboratories LimitedSuir Pharma (Formerly A Stada AG Manufacturing Site)Jeil Pharmaceutical Co., Ltd.Myungmoon Pharm. Co., LtdAPL Swift Services (Malta) LimitedMilpharm LimitedCentrafarm Services B.V.Focus FarmaTeva Pharma p://www.torrentpharma.com/int com/home/home-27.htm?lang l/http://www.tevapharm.com/teva worldwide/europe/teva in netherlands/

GLOBALFINISHED DOSAGEFORMULATORS[3/5]COMPANY NAMECOUNTRYWEBSITETjoapack Netherlands BVDouglas Pharmaceuticals (Fiji) LimitedDouglas Manufacturing LtdICN Polfa Rzeszów S.A.Jelfa SAPabianice Polfa SATeva Operations Poland Sp . Z O.O.Valeant Sp. Z O.O. Sp. J.NetherlandsNew ZealandNew ZealandPolandPolandPolandPolandPolandFarma-aps Pharmaceuticals, SAS.C. Rompharm Company S.R.L.HBM Pharma S.R.O.Krka, D. D., Novo MestoCinfa Laboratories, SaKern PharmaLaboratorios Medicamentos Internacionales S.ALaboratorios Vir S.A.LabosuanLacer S.ANovartis Farmacéutica, S.AAcino AgNovartis Pharma-switzerlandNovartis (Thailand) LtdWorld Medicine Ilac San Ve Tic LTD StlBristol Laboratories LimitedGenerics [UK] LtdHikma PharmaNicobrand LimitedRosemont Pharmaceuticals LtdPortugalRomaniaSlovak nSwitzerlandSwitzerlandThailandTurkeyUnited KingdomUnited KingdomUnited KingdomUnited KingdomUnited /http://www.acino-pharma.com/html/index.php?id 1&L ww.rosemontpharma.com/

Watson Labs [NDC No. 0591-3208-60] is gettingthe USFDA approved product manufactured inIndia by Cipla based on the LabelGLOBALFINISHED DOSAGEFORMULATORS[4/5]Alvogen is getting the USFDA approved productmanufactured in Germany by Acino AG on the basis ofNDC No. 47781-304-03 (mentioned on Medlibrary)

GLOBALFINISHED DOSAGEFORMULATORS[5/5]Breckenridge Pharmaceutical [NDC No. 51991-793-33] isgetting the USFDA approved product manufactured in Indiaby Alembic Pharmaceuticals based on the LabelSun Pharmaceuticals Industries, US[NDC 62756-145-86] is getting the USFDAapproved product manufactured in Indiaby Sun Pharmaceuticals India based onthe label

NO GENERICS PRESENT IN BELOW MENTIONED COUNTRIESArab Emirates, Bahrain, China, Costa Rica, Colombia, Lebanon, Mexico, SaudiArabia, Singapore, Sudan, TaiwanNOT LAUNCHED IN BELOW MENTIONED COUNTRIESOPPORTUNITIESTOCONSIDERGuatemala, VietnamOPPORTUNITY FOR API MANUFACTURER IN MENTIONED COUNTRIESMEXICOAlembic Pharmaceuticals Limited, Unit I is the only API manufacturerIRANCipla, Interquim and Sun Pharmaceutical are the API manufacturerJAPANNo JPDMF fillings

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) . Mid 2016. From Jan 2015- Mid 2016, Less than 10 Kg API has been imported into India . API Expo

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