Transcript THOMSON REUTERS PRESENTATION TEMPLATE

PERCEPTIONS vs. REALITY
Facts and Figures on the Generic Industry
DAVID HARDING
MARCH 12, 2008
DCAT WEEK
Agenda
• History of Thomson Scientific, API Intelligence
• ANDA Trends
• Trends in Paragraph IV filings
• Availability of High-Quality API
• Trends in Regulatory Filings and FDA Inspections
2
TS API Intelligence is the leading supplier of
strategic competitive intelligence and product
targeting systems to the generic industry
• Newport Strategies was founded in 1990 and acquired by
Thomson Scientific in 2004
• Industry pioneer in research and analysis of how global API
development drives competition in launched pharmaceutical
products
• Horizon Global and Vision CI are used by professionals in
–
–
–
–
–
–
Product Targeting and Evaluation
Business Development & Licensing
Corporate Development and M&A
R&D, Market Research
Competitive and Business Intelligence
API Sourcing
• In use at more than 150 companies including 8 of the world’s
Top 10 innovators and 38 of the Top 50 generic companies
What are the Combined US Sales of Products
Losing Patent Protection in 2008?
1.
2.
3.
4.
5.
43%
$0 - $5 Billion
$5 - $10 Billion
$10 - $15 Billion
$15 - $20 Billion
>$20 Billion
21%
21%
7%
$0 - $5
Billion
7%
$5 - $10
Billion
$10 - $15
Billion
$15 - $20
Billion
>$20
Billion
Generic Opportunities in the U.S.
• Over 150 products, including 20 blockbusters, with $77 Billion in total
branded drug sales in the US are coming off patent in the next 5
years
25000
40
35
20000
25
15000
20
10000
15
# Drugs Losing Exclusivity
Sales Billions USD
30
Non-Blockbuster
Blockbuster
Drugs losing Exclusivity
10
5000
5
0
0
2008
2009
2010
2011
2012
Source: Newport Horizon Global™
What Country had the Most ANDA Approvals
in 2007?
25% 25%
GERMANY
INDIA
USA
CHINA
ISRAEL
EL
IS
RA
A
C
H
IN
SA
U
IA
IN
D
ER
M
A
N
Y
17% 17% 17%
G
1.
2.
3.
4.
5.
2007 Final ANDA Approvals by Country
Other; 25; 5%
Jordan; 11; 2%
Iceland; 14; 3%
Switzerland; 19;
4%
USA; 169; 38%
Canada; 24; 5%
Germany; 25; 5%
Israel; 40; 9%
Source: FDA, Newport Horizon Global™
India; 132; 29%
200
20
180
18
160
16
140
14
120
12
100
10
80
8
60
6
40
4
20
2
0
0
1998
1999
2000
2001
2002
2003
2004
2005
2006
# Holders
# ANDAs
Total ANDA Approvals by Indian Generics
2007
Source: Newport Horizon Global™
Tentative
Final
Holders
Top 10 Companies by Number of Final ANDA
Approvals: 1998 – 2007
Group
Teva Pharmaceutical Industries Ltd
Novartis AG
Apotex Inc
Ranbaxy Laboratories Ltd
Mylan Laboratories
Barr Laboratories Inc
Watson Pharmaceuticals Inc
Vintage Pharmaceuticals Inc
Taro Pharmaceutical USA Inc
Boehringer Ingelheim KG
Country
Israel
Switzerland
Canada
India
USA
USA
USA
USA
Israel
Germany
Number
427
280
219
180
168
121
120
116
115
113
Source: Newport Horizon Global ™
Major New Generic Launches - 2007
• Of the 29 products that witnessed first ANDA approval in
2007, 15 of them were considered blockbusters
• Some major new generic launches of 2007 include:
– Ceterizine HCl
– Carvedilol
– Pantoprazole Sodium
– Zolpidem Tartrate
– Risedronate Sodium
– Valacyclovir HCl
Source: FDA, Newport Horizon Global™
Anticipated 2008 Generic Launches
• 25 products will lose patent protection in 2008 in the US
and see generic competition
• Some anticipated generic launches of 2008 include:
– Memantine HCl
– Topiramate
– Risperidone
– Levetiracetam
– Ropinirole HCl
– Alfuzolin HCl
– Eplerenone
– Rocuronium Bromide
Source: FDA, Newport Horizon Global™
How Many Unique Molecules/Combinations
Received First ANDA filings with Paragraph IV
Certification in 2007?
25%
0
>4
30
-4
0
17%
-3
0
-2
0
17%
10
10
17%
20
0-10
10-20
20-30
30-40
>40
0-
1.
2.
3.
4.
5.
25%
Paragraph IV Patent Challenges - 2007
• 27 unique molecules or molecule combinations saw first
Paragraph IV Patent challenge in 2007
• Some Examples (RLD):
– Abilify
– Boniva
– Crestor
– Opana
– Strattera
– Zanaflex
Source: Newport Horizon Global™
Patent Challenges by Country
Other; 32; 6%
Germany; 10; 2%
Iceland; 17; 3%
Switzerland; 34; 6%
USA; 200; 37%
Canada; 43; 8%
Israel; 89; 17%
Source: Newport Horizon Global™
India; 113; 21%
Top 10 Companies by Number of Patent
Challenges
Group
Teva Pharmaceutical Industries Ltd
Apotex Inc
Mylan Laboratories Inc
Barr Laboratories Inc
Novartis AG
Dr Reddy’s Group
Ranbaxy Laboratories Ltd
Sun Pharmaceutical Industries Ltd
Watson Pharmaceuticals Inc
Par Pharmaceutical Companies Inc
Country
Number
Israel
78
Canada
36
USA
35
USA
34
Switzerland
31
India
29
India
26
India
24
USA
20
USA
19
Source: Newport Horizon Global™
Paragraph IV Patent Challenges - 2008
• There are 29 molecules with New Chemical Entity
exclusivity expiring in 2009, so therefore are exposed to
Paragraph IV Patent Challenge in 2008
• So far in 2008, 5 molecules (or combinations) have seen
their first patent challenges
• Some major products that will likely see a Patent
Challenge include:
– Duloxetine HCl
– Pregabalin
– Tiotropium Bromide
Source: FDA, Newport Horizon Global™, data as of
2/29/2008
Number of Corporate Groups
Availability of High-Quality API for India, China
and Rest of World
160
140
120
100
India
China
ROW
80
60
40
20
0
Established
Less Established Potential Future
Source: Newport Horizon Global™
US DMF Filings by Indian, Chinese and Rest of
World API Manufacturers: 1998 - 2007
Number of Type II DMFs
350
312
300
250
257
200
167 159
150
185 189
292
267 274
250
226
282
233
India
China
ROW
160
115
100
50
0
32
27
26
6
33
9
47
55
70
78
90
20
19
25
6
1998 1999 2000 2001 2002 2003 2004 2005 2006 2007
Source: Newport Horizon Global™
Number of Plants Inspected by US FDA: 2001 –
2007
Ireland; 16; 3%
Spain; 19; 4%
England; 22; 4%
USA; 173; 32%
Switzerland; 20; 4%
Japan; 30; 6%
Germany; 30; 6%
France; 26; 5%
China; 57; 11%
India; 71; 13%
Source: Newport Horizon Global™
Italy; 65; 12%
Thank you!
David Harding
Sales Support Specialist, API Intelligence
Pharmaceutical and Chemical Markets
Thomson Reuters
215 Commercial Street
Portland, Maine 04101
USA
+ 1 (207) 871-9700 x27
[email protected]