Académique Documents
Professionnel Documents
Culture Documents
Todays Discussion
Marketing Issues
Information Sources
2 CDER
Center for Drug Evaluation and Research
What is a Generic Drug?
3 CDER
Center for Drug Evaluation and Research
Brand vs. Generic
Feel Get
Better Better
4 CDER
Center for Drug Evaluation and Research
What is the Main Consumer
5 CDER
Center for Drug Evaluation and Research
Legislative History
7 CDER
Center for Drug Evaluation and Research
When can a Generic Drug
be Marketed?
8 CDER
Center for Drug Evaluation and Research
Patent Protection
Exclusivity
Award/reward of marketing protection of 3 to
5 years for innovative development to an
existing product (i.e. new uses, strengths)
6 months for pediatrics
9 CDER
Center for Drug Evaluation and Research
What are the Basic
10 CDER
Center for Drug Evaluation and Research
Brand Name Drug vs. Generic Drug
5. Controls 5. Controls
6. Microbiology 6. Microbiology
7. Inspection 7. Inspection
8. Testing 8. Testing
9. Animal Studies
10. Clinical Studies 9. Bioequivalence
11 CDER
11. Bioavailability Center for Drug Evaluation and Research
What is Bioequivalence?
12 CDER
Center for Drug Evaluation and Research
Bioequivalent Inequivalent
Drug Concentration
8 8
7 7
6 6
5 5
4 4
3 3
2 2
1 1
0 0
6 12 18 24 30 36 6 12 18 24 30 36
Time Hours Time Hours
- Test/Generic
- Reference/Brand
Generic Drug
Review Process
14 CDER
Center for Drug Evaluation and Research
Statistics
1000 19
880
900
Months to Approve
18.4 793
18.5
18.3 766 18
800
18
Applications
682
700
600 563 17.5
17.3 510
500 467
449
413
17
361364 373
400 16.6
16.5
307310
16.3 16.3
300
16
200
100 15.5
0 15
2001 2002 2003 2004 2005 2006 2007
15
Receipts Approvals AP Times
CDER
Center for Drug Evaluation and Research
Post-Marketing
16 CDER
Center for Drug Evaluation and Research
How is Quality Assured?
for Generics
19 CDER
Center for Drug Evaluation and Research
Why Should You be
Interested?
20 CDER
Center for Drug Evaluation and Research
Economics
Prescription Drugs
1984 2006
Generics
14.0%
Brand
Brand 34.0% Generics
86.0% 66.0%
22 CDER
Center for Drug Evaluation and Research
Market Share vs. Dollar Volume?
$250 billion
Prescription Sales
Volume 2006 Generics
16.0%
Brand Generics
Brand
34.0% 66.0%
84%
200
55.9 Government 74
150 Programs
CMS
25 CDER
Center for Drug Evaluation and Research
Future
26 CDER
Center for Drug Evaluation and Research
Top Selling Drugs U.S.
27 CDER
Center for Drug Evaluation and Research
Marketing Issues
28 CDER
Center for Drug Evaluation and Research
Applicant Issues
- Quality by Design
31 CDER
Center for Drug Evaluation and Research
Quality by Design
Harmonization (ICH)
Review Process
35 CDER
Center for Drug Evaluation and Research
Information Sources
36 CDER
Center for Drug Evaluation and Research
APPROVED
DRUG PRODUCTS
WITH
28 TH EDITION
THE PRODUCTS IN THIS LIST HAVE BEEN APPROVED UNDER
COSMETIC ACT.
OFFICE OF MANAGEMENT
DIVISION OF DATABASE MANAGEMENT
2008
37
http://www.accessdata.fda.gov/ob/
CDER
Center for Drug Evaluation and Research
Orange Book
http://www.fda.gov/cder/ogd/index.htm
http://www.fda.gov/cder/regulatory/applications/anda.htm
http://www.accessdata.fda.gov/scripts/cder/iig/index.cfm
Ted Sherwood
FDA/CDER/OPS
White Oak, Bldg 21, Room 3528 Phone: 301-796-1605
10903 New Hampshire Ave. Fax:
Silver Spring, MD 20903-0002 301-847-8721
40 edward.sherwood@fda.hhs.gov CDER