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 pharmaceutical industry. The report uses data from our own www.genericlicensing.com database, website and directory; in addition to the experience cleaned from many years passed and many deals done.   Most common dossiers – Top out licensing companies/countries – Most sought after

productsLicensing activity by country & city – Most active users – Who is really doing the

research  

Comment is added by Asa Cox, Founder of Genericlicensing.

This document is intended to be a collaborative document; please add your own comments, save and share the document with others using http://bit.ly/9AwvNN   Why? 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 and business 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 from licensing executive in every corner of the industry and respected experts with a stimulating vision of the future. 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 can create more impact and add more value.

  ________________________________________________________________________________

________________________ 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 32   Comment: [Asa] – Many of the gold standard old products listed and remain popular additions to portfolio's worldwide. It is also clear why molecules such as Quetiapine, Olanzapine and Risperidone were incredibly competitive and dropped rapidly in price immediately after patent expiry. It is also an indication of the simplicity of some formulations; surely something that developers should consider before committing to an R&D program?!    ________________________________________________________________________________________________________ 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 other major markets. With incredibly strong R&D and regulatory departments, an excellent and cost effective manufacturing 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 an abundance of high quality dossiers. A massive investment to transform the company from a CMO to an IP creation machine has been largely a success; establishing its own marketing subsidiaries via Accord Healthcare may cause concern for partners seeking a long term partner.   Hameln RDS – A full service development and manufacturing company focused on injectable products; a foundation of quality and reliability has helped the company acquire an enviable reputation. Unlikely to be able to compete on price for well established molecules; an R&D program focusing on the more challenging molecules 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 a well managed outsourcing program for manufacturing, co-ordinated by a small team in Holland. A portfolio of old and new molecules make an attractive proposition; however manufacturing prices and communication make 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 sprawling company has its challenges to obtain data and decisions internally. Pricing is excellent for products where the company also manufacturers the API; others seem a little distant from market requirements. Lots of potential still.   Lupin – A rapidly growing and developing company with a huge capacity for R&D and manufacturing of a wide range of product types. Very promising pipeline, yes to prove it has the ability to consistently deliver on time. 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 an expanding licensing team. Investments made in the right place and the right products.   Apotex – The No'1 Canadian generic company has grown and retracted its own international expansion over recent years. Huge development, manufacturing and regulatory resource; questionable ability to compete on price.   Technimede – One of many up & coming companies from the country. The Spanish market drives their pipeline 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 is promoted as well. Big manufacturing capacity but unproven supply chain reliability. Seem to have pulled back 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 France   Comment: [Asa] – This is a mixture of developers and MA/PL owners. It is good to see an emerging country in the Top 10, I would expect to see many more in coming years; how long before China is on here? Despite being a major 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 players ventured outside their shores. Will this change as their domestic market becomes less attractive due to low cost competition? 

  ________________________________________________________________________________

____________________________________________   

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 for new partners (in/out licensing). Naturally a number of the users are from smaller companies and the executive management is responsible for Business Development; however the vast majority are substantial companies with independent BD teams. Is this an indication of the lack of market intelligence available in the generic 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-Aventis   Comment: [Asa] – It can be seen plainly that it is not just small companies without large licensing teams that are seeking new partners for products! Pure generic and big brand players are all looking to expand their portfolio. In some instances there is of course a desire for market intelligence; knowing how competitive a new product might be or using the data for leverage with existing partners. However, it is also a recognition that a) the internet is of growing importance to business development, b) the largest companies want to remain ahead of the pack, c) employee's do share new information internally!   ____________________________________________________________________________________________________________________________     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 table   Comment: [Asa] – not a surprise to see the Top 5 (India is in Southern Asia). Interesting to see the rest of Asia is a lot more active than South/Central America. I think this could be wider acceptance of the internet as a business development method; also an indication that Asia is being more proactive its efforts to engage international partners. The low average time of North America is likely to be because there are relatively few ANDA's in our database; a result of most developers registering and marketing products themselves in the USA. ____________________________________________________________________________________________________________________________ Visitors by Country

Top 50 Countries (by number of visitors)  

Country/Territory Visits Pages/Visit Avg. Time

  Country/Territory Visits Pages/Visit

Avg. Time

United Kingdom 8627 8.80 10:5

4   Ukraine 205 2.28

01:43

United States 3859 3.47 02:0

7   Hungary 155 6.75

05:55

India 2012 4.30 04:4

1   Denmark 143 5.28

03:57

Canada 934 4.03 03:4

0   Sweden 139 5.65

03:18

Germany 796 5.39 03:5

3   Israel 137 4.80

04:14

Spain 580 5.06 04:0

2   Slovakia 122 5.78

08:17

Switzerland 460 6.05 03:2

2   Mexico 121 10.04

07:07

Turkey 431 7.13 05:1

1   Serbia 118 5.81

05:25

Portugal 418 8.37 06:0

3   Bulgaria 116 5.59

03:36

China 416 4.88 06:5

8   Singapore 116 3.72

03:51

Poland 406 7.01 05:4

8   Egypt 116 4.21

03:54

Italy 404 5.79 04:0

9   Iran 104 8.28

10:46

France 396 4.12 02:4

6   Argentina 96 2.47

02:26

South Africa 337 4.69 04:1

2   Slovenia 93 5.56

02:52

Philippines 312 1.44 01:0

0   Brazil 91 4.22

03:38

Pakistan 298 3.90 07:0

1   Taiwan 89 4.26

02:51

Greece 289 5.08 04:0

6   Jordan 88 8.69

08:10

Australia 284 3.15 02:1

3   Finland 88 4.19

02:38

Netherlands 283 3.89 02:0

1   (not set) 87 2.01

01:14

Indonesia 274 2.81 03:2

3   Malaysia 85 2.33

03:03

Romania 270 24.50 10:5

5   UAE 85 4.01

03:56

Ireland 229 7.24 04:4

0   Croatia 82 4.38

03:26

Belgium 219 4.50 02:5

0   Austria 81 7.20

05:35

Czech Republic 209 5.42 03:5

7   Russia 79 6.22

04:50

South Korea 205 5.37 04:3

3   Vietnam 72 3.15

03:06

   Comment: [Asa] – Most of the world is looking for generics online! The UK is still a very competitive market with much in-licensing and very little local R&D; portfolio's need to be broad in order to effectively compete. The data is also skewed by the contact network of GL being a UK company. China appearing high on up the list is a sign of the ongoing trend to acquire European dossiers for local registration; higher prices are paid for recognised quality product. Interesting to see Middle Eastern countries entering the licensing arena as local companies move from brand distribution to their own local portfolio's. ____________________________________________________________________________________________________________________________ Visitors by City

City Visits Pages/Visit Avg.   City Visits Pages/Visit Avg.

Time 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

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 licensing

  Keyword

Visit

s Pages/

Visit Avg.

Time   Keyword Visit

s Pages/

Visit Avg.

Time smooth muscle relaxants

97 2.37 01:06   generics licensing.com 12 12.17 21:5

4

chanelle medical 69 2.55 01:46   prolepha 12 7.17 05:3

1

generics licensing 66 7.42 08:10   alendronate sodium 11 14.27 20:0

5

ipg pharma group 63 3.08 04:39   biogened s.a. 11 1.82 05:1

9

alkamed 59 3.31 01:38   licensing generics 11 5.00 07:1

1

butamirate citrate 54 1.81 01:06   paracetamol originator 11 10.55 06:3

8

faromed 46 43.80 18:11   carbocisteine 10 2.90 01:2

9 generic in licensing 40 13.13 10:45   movicol patent 10 4.40 02:2

8

co-amilofruse 5 40 35 5.03 03:27   co-amilofruse 5/40 9 1.33 02:4

9

ipg pharma ltd 28 2.14 02:04   directory of generic dossier holder

9 8.00 03:1

8

niche generics 27 4.48 04:04   generic dossier 9 8.67 09:5

2

movicol generic 24 5.08 04:08   generic dossier ""zoledronic acid""

9 12.56 14:0

3

biogened 22 4.45 03:27   genericslicensing.com 9 18.78 12:5

0 dexketoprofen trometamol

22 7.77 04:06   carbocisteine capsule dossier

8 14.50 09:1

6

pharos generics 22 2.68 01:06   elpenhaler 8 3.25 01:3

9

generic industry 20 2.60 02:05   generic inlicensing 8 5.63 04:2

6

ajish rajan pharma 19 17.89 08:50   generic oncology manufacturers

8 8.88 35:5

2

remifentanyl 19 1.37 02:31   goapharma 8 3.38 02:3

4

acarbose licensing 18 71.94 26:14   amlodipine besilate 7 3.29 01:4

2

garivaan 18 3.33 02:03   buy generic product licences

7 18.14 11:1

6

dcp slot 16 3.94 02:15   carbocisteine patent 7 2.86 03:4

4 expectorants mucolytics

16 2.88 01:36   fosfomycin trometamol 7 7.14 04:1

8

genericslicensing 13 13.54 16:07   mr michael winstrøm 7 11.71 07:5

5 ketoprofen + omeprazole

13 2.85 03:32   substipharm 7 9.00 03:0

1 generic greek companies

12 25.67 28:56   bdgenerics 6 14.50 05:0

5   Comment: [Asa] - 4000 different keywords were used in search engines to find companies and products for licensing (in which the result brought them to GL). Its clear that sourcing of new products starts with a very basic internet search for many companies; highlighting the lack of available data on products available for licensing. This should have an influence on the ways developers promote themselves to potential marketing partners; it is clear that traditional methods (exhibitions, website, direct mail) are not totally effective. See my article 'Being seen by major clients online' for more ideas.   ________________________________________________________________________________________________________ Conclusions   Although this cannot be considered a ground breaking piece of research by a global firm and is only based on 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 them

  Data availability and data sharing has driven Web2.0 to incredible heights; no longer will one's private network be sufficient to compete with the open framework of new digital savvy competitors. What are you doing 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; lets get the ball rolling today! Add a comment and share it with your network!

 

All the best,

Asa

August 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 pharmaceuticals   Other reports by Genericlicensing

·        Generic regulations in the Asean region   Data source All data has been taken from visitors and registered users of www.genericlicensing.com during the period August 2008 – August 2010 (the time since its creation); in addition to the information collected from out licensing companies for the creation of the Global Generic Product Directory.   If you would like to add your data please contact adrianna.dobos@genericlicensing.com

To 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