The Generic Licensing              Landscape Report 2010[A world map based on population density... the future of generic ...
Top 20 Most Common Products                                 [Based on a database of over 7500 dossiers]                   ...
Top 10 Companies with Most Products (CTD) for Out Licensing                                                1          KRKA...
over recent years. Huge development, manufacturing and regulatory resource; questionable ability tocompete on price.Techni...
Top 5 User Titles                                           [Based on 1500 registered users]                              ...
Visitors by Sub-Continent                      Sub Continent Region                     Visits Pages/Visit Avg. Time on Si...
Visitors by CountryTop 50 Countries (by number of visitors)Country/Territory   Visits Pages/Visit Avg. Time               ...
Comment:[Asa] – Most of the world is looking for generics online! The UK is still a very competitive market with muchin-li...
Birmingham      139         3.31                03:10              Copenhagen                58          3.76       03:19 ...
ConclusionsAlthough this cannot be considered a ground breaking piece of research by a global firm and is only basedon a r...
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The generic licensing landscape report 2010

  1. 1. The Generic Licensing Landscape Report 2010[A world map based on population density... the future of generic licensing strategies?!]What?Thank you for downloading our first insight into the licensing activities of the generic pharmaceuticalindustry. The report uses data from our own www.genericlicensing.com database, website and directory; inaddition to the experience cleaned from many years passed and many deals done. Most common dossiers – Top out licensing companies/countries – Most sought after products Licensing activity by country & city – Most active users – Who is really doing the researchComment is added by Asa Cox, Founder of Genericlicensing.This document is intended to be a collaborative document; please add your own comments, save andshare the document with others using google docs: http://bit.ly/9AwvNNWhy?The report is intended to act as an industry indicator and as a guide for future licensing trends in the sector.It is hoped that as a result there will be an increasing awareness of the changing international dynamics andbusiness development strategies required to position oneself for success.What next?We would like the report to develop into an industry wide intelligence movement; with contributions fromlicensing executive in every corner of the industry and respected experts with a stimulating vision of thefuture. Please email us to become the expert in your region.Please remember this is a work in progress; we welcome your feedback and comments on how we cancreate more impact and add more value. Orginal report copyright: Genericlicensing Limited, Atrium Court, The Ring, Bracknell, UK. RG12 1BW www.genericlicensing.com
  2. 2. Top 20 Most Common Products [Based on a database of over 7500 dossiers] No of dossiers listed 1 Diclofenac 68 2 Ciprofloxacin 67 3 Paracetamol 58 4 Fluconazole 53 5 Omeprazole 51 6 Clarithromycin 49 7 Ondansetron 48 8 Ranitidine 41 9 Olanzapine 41 10 Risperidone 40 11 Azithromycin 40 12 Tramadol 39 13 Ibuprofen 37 14 Quetiapine 36 15 Cetirizine 35 16 Amoxicillin + Clavulanic Acid 35 17 Montelukast 34 18 Furosemide 33 19 Pantoprazole 32 20 Levetiracetam 32Comment:[Asa] – Many of the gold standard old products listed and remain popular additions to portfolios worldwide.It is also clear why molecules such as Quetiapine, Olanzapine and Risperidone were incredibly competitiveand dropped rapidly in price immediately after patent expiry. It is also an indication of the simplicity of someformulations; surely something that developers should consider before committing to an R&D program?! Orginal report copyright: Genericlicensing Limited, Atrium Court, The Ring, Bracknell, UK. RG12 1BW www.genericlicensing.com
  3. 3. Top 10 Companies with Most Products (CTD) for Out Licensing 1 KRKA (Slovenia) 2 Astron (India) 3 HamelnRDS (Germany) 4 Prolepha (Nederlands) 5 CIPLA (India) 6 Lupin (India) 7 Pharmathen (Greece) 8 Apotex (Canada) 9 Tecnimede (Portugal) 10 Aurobindo (India)Comment:[Asa]KrKa - Despite being a dominant force in its region, it has retained its out licensing strategy for all othermajor markets. With incredibly strong R&D and regulatory departments, an excellent and cost effectivemanufacturing infrastructure, it is somewhat of a surprise that they are rarely discussed as a takeover target.Prefer to work with existing trusted partners which provides a challenge for new entrants.Astron – As the development division of Intas, it is unsurprising to see this company promoting anabundance of high quality dossiers. A massive investment to transform the company from a CMO to an IPcreation machine has been largely a success; establishing its own marketing subsidiaries via AccordHealthcare may cause concern for partners seeking a long term partner.Hameln RDS – A full service development and manufacturing company focused on injectable products; afoundation of quality and reliability has helped the company acquire an enviable reputation. Unlikely to beable to compete on price for well established molecules; an R&D program focusing on the more challengingmolecules will ensure ongoing growth for the time being. Easy to do business with.Prolpeha – A well established virtual-like company; a network of expert formulators and regulatory, plus awell managed outsourcing program for manufacturing, co-ordinated by a small team in Holland. A portfolioof old and new molecules make an attractive proposition; however manufacturing prices and communicationmake deals a challenge on occasion.CIPLA – One of the oldest Indian companies has an incomprehensible large portfolio of formulations;however they are only readied for international registration based on market demand. The sprawlingcompany has its challenges to obtain data and decisions internally. Pricing is excellent for products wherethe company also manufacturers the API; others seem a little distant from market requirements. Lots ofpotential still.Lupin – A rapidly growing and developing company with a huge capacity for R&D and manufacturing of awide range of product types. Very promising pipeline, yes to prove it has the ability to consistently deliver ontime. Has marketing subsidiaries in key markets and seems set on a partnering strategy for others.Pharmathen – A truly modern developer; well managed, excellent manufacturing infrastructure and anexpanding licensing team. Investments made in the right place and the right products.Apotex – The No1 Canadian generic company has grown and retracted its own international expansion Orginal report copyright: Genericlicensing Limited, Atrium Court, The Ring, Bracknell, UK. RG12 1BW www.genericlicensing.com
  4. 4. over recent years. Huge development, manufacturing and regulatory resource; questionable ability tocompete on price.Technimede – One of many up & coming companies from the country. The Spanish market drives theirpipeline and price structure, acceptable for many countries. Easy company to do business with.Aurobindo – A large portfolio obtained mainly through acquisition; although a promising pipeline ispromoted as well. Big manufacturing capacity but unproven supply chain reliability. Seem to have pulledback from a strategy of international infrastructure. Top 10 Countries with most Out Licensing Companies 1 India 2 Spain 3 Germany 4 Italy 5 United Kingdom 6 Canada 7 Portugal 8 United States 9 Poland 10 FranceComment:[Asa] – This is a mixture of developers and MA/PL owners. It is good to see an emerging country in the Top10, I would expect to see many more in coming years; how long before China is on here? Despite being amajor market there are few US companies who actively out license; a combination of unknowns: regulatory,local market network and international strategy. Only through major acquisition have the major playersventured outside their shores. Will this change as their domestic market becomes less attractive due to lowcost competition? Orginal report copyright: Genericlicensing Limited, Atrium Court, The Ring, Bracknell, UK. RG12 1BW www.genericlicensing.com
  5. 5. Top 5 User Titles [Based on 1500 registered users] 1 CEO/President 2 Business Development & Licensing Manager 3 Business Development & Licensing Director 4 Vice President (Non BD) 5 Director (Non BD)Comment:[Asa] – I find it quite interesting that so many high level executives are actively involved in the search fornew partners (in/out licensing). Naturally a number of the users are from smaller companies and theexecutive management is responsible for Business Development; however the vast majority are substantialcompanies with independent BD teams. Is this an indication of the lack of market intelligence available in thegeneric sector? Top 10 User Companies (number of users) 1 Goldshield 2 Novartis 3 Ranbaxy 4 Sandoz 5 ACIC 6 Apotex 7 Aspen 8 Ratiopharm 9 Hikma 10 Sanofi-AventisComment:[Asa] – It can be seen plainly that it is not just small companies without large licensing teams that areseeking new partners for products! Pure generic and big brand players are all looking to expand theirportfolio. In some instances there is of course a desire for market intelligence; knowing how competitive anew product might be or using the data for leverage with existing partners. However, it is also a recognitionthat a) the internet is of growing importance to business development, b) the largest companies want toremain ahead of the pack, c) employees do share new information internally! Orginal report copyright: Genericlicensing Limited, Atrium Court, The Ring, Bracknell, UK. RG12 1BW www.genericlicensing.com
  6. 6. Visitors by Sub-Continent Sub Continent Region Visits Pages/Visit Avg. Time on Site Northern Europe 9370 8.60 10:23 Northern America 4793 3.58 02:25 Southern Asia 2486 4.38 05:08 Western Europe 2240 5.08 03:18 Southern Europe 2077 6.16 04:40 Eastern Europe 1570 8.89 05:52 Western Asia 1076 6.11 05:37 South-Eastern Asia 918 2.41 02:31 Eastern Asia 856 4.61 05:12 Australia and New Zealand 345 3.11 02:18 Southern Africa 341 4.65 04:09 South America 296 3.50 03:05 Northern Africa 268 6.83 07:13 Central America 149 9.50 07:17 Caribbean 37 3.41 02:34 Western Africa 33 4.82 07:38 Eastern Africa 21 3.14 06:11 Middle Africa 5 5.20 11:09 Central Asia 4 1.25 00:17 Micronesian Region 1 1.00 00:00:00 * Not Set has been removed from the tableComment:[Asa] – not a surprise to see the Top 5 (India is in Southern Asia). Interesting to see the rest of Asia is a lotmore active than South/Central America. I think this could be wider acceptance of the internet as a businessdevelopment method; also an indication that Asia is being more proactive its efforts to engage internationalpartners. The low average time of North America is likely to be because there are relatively few ANDAs inour database; a result of most developers registering and marketing products themselves in the USA. Orginal report copyright: Genericlicensing Limited, Atrium Court, The Ring, Bracknell, UK. RG12 1BW www.genericlicensing.com
  7. 7. Visitors by CountryTop 50 Countries (by number of visitors)Country/Territory Visits Pages/Visit Avg. Time Country/Territory Visits Pages/Visit Avg. TimeUnited Kingdom 8627 8.80 10:54 Ukraine 205 2.28 01:43United States 3859 3.47 02:07 Hungary 155 6.75 05:55India 2012 4.30 04:41 Denmark 143 5.28 03:57Canada 934 4.03 03:40 Sweden 139 5.65 03:18Germany 796 5.39 03:53 Israel 137 4.80 04:14Spain 580 5.06 04:02 Slovakia 122 5.78 08:17Switzerland 460 6.05 03:22 Mexico 121 10.04 07:07Turkey 431 7.13 05:11 Serbia 118 5.81 05:25Portugal 418 8.37 06:03 Bulgaria 116 5.59 03:36China 416 4.88 06:58 Singapore 116 3.72 03:51Poland 406 7.01 05:48 Egypt 116 4.21 03:54Italy 404 5.79 04:09 Iran 104 8.28 10:46France 396 4.12 02:46 Argentina 96 2.47 02:26South Africa 337 4.69 04:12 Slovenia 93 5.56 02:52Philippines 312 1.44 01:00 Brazil 91 4.22 03:38Pakistan 298 3.90 07:01 Taiwan 89 4.26 02:51Greece 289 5.08 04:06 Jordan 88 8.69 08:10Australia 284 3.15 02:13 Finland 88 4.19 02:38Netherlands 283 3.89 02:01 (not set) 87 2.01 01:14Indonesia 274 2.81 03:23 Malaysia 85 2.33 03:03Romania 270 24.50 10:55 UAE 85 4.01 03:56Ireland 229 7.24 04:40 Croatia 82 4.38 03:26Belgium 219 4.50 02:50 Austria 81 7.20 05:35Czech Republic 209 5.42 03:57 Russia 79 6.22 04:50South Korea 205 5.37 04:33 Vietnam 72 3.15 03:06 Orginal report copyright: Genericlicensing Limited, Atrium Court, The Ring, Bracknell, UK. RG12 1BW www.genericlicensing.com
  8. 8. Comment:[Asa] – Most of the world is looking for generics online! The UK is still a very competitive market with muchin-licensing and very little local R&D; portfolios need to be broad in order to effectively compete. The data isalso skewed by the contact network of GL being a UK company. China appearing high on up the list is a signof the ongoing trend to acquire European dossiers for local registration; higher prices are paid for recognisedquality product. Interesting to see Middle Eastern countries entering the licensing arena as local companiesmove from brand distribution to their own local portfolios.Visitors by City City Visits Pages/Visit Avg. Time City Visits Pages/Visit Avg. Time London 4592 11.72 15:47 Delhi 130 3.76 03:34 Mumbai 548 5.41 06:21 Sydney 125 3.90 03:21 Istanbul 331 8.76 05:46 Manila 123 1.89 02:02 Barcelona 296 4.11 02:50 Bangalore 120 3.97 03:50 New York 262 4.18 03:15 Hamburg 116 6.21 05:13 Warsaw 259 11.03 09:54 Singapore 114 3.71 03:52 Lisbon 258 9.82 06:31 Pune 108 4.43 05:59 Athens 246 5.12 04:13 Kharkov 105 1.22 00:13 Chennai 233 6.19 08:09 Sofia 102 8.58 05:33 Bucharest 215 30.49 13:12 Bratislava 100 8.63 14:31 Zurich 213 8.28 04:12 Prague 99 3.59 02:02 Hyderabad 210 4.28 04:45 New Delhi 89 4.03 04:37 Karachi 186 3.72 06:58 Jakarta 87 3.36 05:42 Madrid 186 6.41 06:16 Porto 80 6.54 07:01 Dublin 171 8.38 05:41 Tampa 80 3.31 01:42 New York 167 3.68 02:14 Beijing 73 5.27 09:35 Paris 166 4.13 02:25 Wembley 67 6.84 05:08 Manchester 165 3.45 03:32 Kandivli 65 4.06 05:39 Toronto 158 4.04 02:41 Frankfurt 63 6.21 06:08 Milan 148 3.99 02:26 Moscow 63 6.83 04:58 Seoul 143 8.82 07:58 Bekasi 61 2.48 02:41 Shanghai 141 4.36 06:27 Bristol 60 2.02 01:25 Ahmedabad 139 6.11 05:27 Reading 59 1.88 02:13 Orginal report copyright: Genericlicensing Limited, Atrium Court, The Ring, Bracknell, UK. RG12 1BW www.genericlicensing.com
  9. 9. Birmingham 139 3.31 03:10 Copenhagen 58 3.76 03:19 Budapest 130 6.80 05:08 Mexico City 57 15.25 09:23 Top 50 Search Terms to find products & companies for licensingKeyword Visits Pages/Visit Avg. Time Keyword Visits Pages/Visit Avg. Timesmooth muscle relaxants 97 2.37 01:06 generics licensing.com 12 12.17 21:54chanelle medical 69 2.55 01:46 prolepha 12 7.17 05:31generics licensing 66 7.42 08:10 alendronate sodium 11 14.27 20:05ipg pharma group 63 3.08 04:39 biogened s.a. 11 1.82 05:19alkamed 59 3.31 01:38 licensing generics 11 5.00 07:11butamirate citrate 54 1.81 01:06 paracetamol originator 11 10.55 06:38faromed 46 43.80 18:11 carbocisteine 10 2.90 01:29generic in licensing 40 13.13 10:45 movicol patent 10 4.40 02:28co-amilofruse 5 40 35 5.03 03:27 co-amilofruse 5/40 9 1.33 02:49 directory of genericipg pharma ltd 28 2.14 02:04 9 8.00 03:18 dossier holderniche generics 27 4.48 04:04 generic dossier 9 8.67 09:52 generic dossiermovicol generic 24 5.08 04:08 9 12.56 14:03 ""zoledronic acid""biogened 22 4.45 03:27 genericslicensing.com 9 18.78 12:50 carbocisteine capsuledexketoprofen trometamol 22 7.77 04:06 8 14.50 09:16 dossierpharos generics 22 2.68 01:06 elpenhaler 8 3.25 01:39generic industry 20 2.60 02:05 generic inlicensing 8 5.63 04:26 generic oncologyajish rajan pharma 19 17.89 08:50 8 8.88 35:52 manufacturersremifentanyl 19 1.37 02:31 goapharma 8 3.38 02:34acarbose licensing 18 71.94 26:14 amlodipine besilate 7 3.29 01:42 buy generic productgarivaan 18 3.33 02:03 7 18.14 11:16 licencesdcp slot 16 3.94 02:15 carbocisteine patent 7 2.86 03:44expectorants mucolytics 16 2.88 01:36 fosfomycin trometamol 7 7.14 04:18genericslicensing 13 13.54 16:07 mr michael winstrøm 7 11.71 07:55ketoprofen + omeprazole 13 2.85 03:32 substipharm 7 9.00 03:01generic greek companies 12 25.67 28:56 bdgenerics 6 14.50 05:05Comment:[Asa] - 4000 different keywords were used in search engines to find companies and products for licensing (inwhich the result brought them to GL). Its clear that sourcing of new products starts with a very basicinternet search for many companies; highlighting the lack of available data on products available forlicensing. This should have an influence on the ways developers promote themselves to potential marketingpartners; it is clear that traditional methods (exhibitions, website, direct mail) are not totally effective. Seemy article Being seen by major clients online for more ideas. Orginal report copyright: Genericlicensing Limited, Atrium Court, The Ring, Bracknell, UK. RG12 1BW www.genericlicensing.com
  10. 10. ConclusionsAlthough this cannot be considered a ground breaking piece of research by a global firm and is only basedon a relatively modest data set; there are still important factors the report highlights: • The internet is being used (at least 26,000 times in 2 years!) as a tool to find products to license and this should impact the marketing strategies of developers and IP owners: ◦ Search Engine Optimisation is vital ◦ Social Media is of growing influence in business-to-business networking ◦ International business considerations; language and ways of working • The international market for high quality dossiers is increasing ◦ Thought needs to be given on how to best develop client networks in these regions ◦ What commercial model makes sense in these markets • New developers are arising from emerging markets ◦ How do you differentiate and compete ◦ Do you need to change your pipeline strategy ◦ Is there a model to partner with themData availability and data sharing has driven Web2.0 to incredible heights; no longer will ones privatenetwork be sufficient to compete with the open framework of new digital savvy competitors. What are youdoing to do about it? This is the new challenge.I hope we can find a way to create collaborative market intelligence something of value to the industry; letsget the ball rolling today! Add a comment and share it with your network!All the bestAsaAugust 2010________________________________________________________________________________________Other reports & articles by Asa Cox • Strategic Generic Portfolio Selection • How to find new products to license • Being seen by major clients online • How to make money from generic pharmaceuticalsOther reports by Genericlicensing • Generic regulations in the Asean regionData sourceAll data has been taken from visitors and registered users of www.genericlicensing.com during the periodAugust 2008 – August 2010 (the time since its creation); in addition to the information collected from outlicensing companies for the creation of the Global Generic Product Directory.If you would like to add your data please contact adrianna.dobos@genericlicensing.comTo promote your company or to purchase the data please contact greg.kinsey@genericlicensing.com Orginal report copyright: Genericlicensing Limited, Atrium Court, The Ring, Bracknell, UK. RG12 1BW www.genericlicensing.com

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