List of Tables - Shodhgangashodhganga.inflibnet.ac.in/bitstream/10603/8538/7/07_list of...
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16 List of Tables Table No Title Page No. Table 1.1 Pharmaceutical Sales of Top 10 Markets (2009). 3 Table 1.2 Top 20 Pharmaceutical Markets Rankings up to 2015. 4 Table 1.3 Top 20 Innovator companies share in Worldwide Prescription sales. 7 Table 1.4 Top 20 leading World Generic Companies in 2010 & their Worldwide Market share. 9 Table 1.5 Top 20 Global Therapeutic Classes up to 2010 (Total audited markets). 12 Table 1.6 Worldwide R&D spending by Pharmaceutical & Biotech Companies for 2002 to 2016(fig. in US$ bn.). 14 Table. 1.7 Major Trading partners of in Bulk Drugs (SITC 541 medicinal products except medicaments) (figs. in US$ mn.). 21 Table 1.8 Major Trading partners of U.S.A in Formulations (SITC 542 medicaments) (figs. in US$ mn.). 24 Table 1.9 Sales of Leading Therapy Classes for 2010. 28 Table 1.10 Country wise Exports of India’s Bulk drugs, Pharmaceuticals and Fine chemicals (figs. in US$mn.). 35 Table 1.11 Top Listed Indian Pharmaceutical companies Acquisition and Mergers. 40 Table 1.12 Designation for Therapeutic Equivalence Code. 66 Table 1.13 Market Exclusivities granted by U.S.FDA through 505(b)(2) Process. 73
Transcript of List of Tables - Shodhgangashodhganga.inflibnet.ac.in/bitstream/10603/8538/7/07_list of...
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List of TablesTable
NoTitle Page
No.
Table1.1
Pharmaceutical Sales of Top 10 Markets (2009). 3
Table1.2
Top 20 Pharmaceutical Markets Rankings up to 2015. 4
Table1.3
Top 20 Innovator companies share in WorldwidePrescription sales.
7
Table1.4
Top 20 leading World Generic Companies in 2010 & theirWorldwide Market share.
9
Table1.5
Top 20 Global Therapeutic Classes up to 2010 (Totalaudited markets).
12
Table1.6
Worldwide R&D spending by Pharmaceutical & BiotechCompanies for 2002 to 2016(fig. in US$ bn.).
14
Table.1.7
Major Trading partners of in Bulk Drugs (SITC 541medicinal products except medicaments) (figs. in US$ mn.).
21
Table1.8
Major Trading partners of U.S.A in Formulations (SITC 542medicaments) (figs. in US$ mn.).
24
Table1.9
Sales of Leading Therapy Classes for 2010. 28
Table1.10
Country wise Exports of India’s Bulk drugs,Pharmaceuticals and Fine chemicals (figs. in US$mn.).
35
Table1.11
Top Listed Indian Pharmaceutical companies Acquisitionand Mergers.
40
Table1.12
Designation for Therapeutic Equivalence Code. 66
Table1.13
Market Exclusivities granted by U.S.FDA through 505(b)(2)Process.
73
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Table2.1
Sample list of HS codes & their descriptions which are notincluded in India’s Official basket of HS codes for Drugs,Pharmaceuticals & fine chemicals.
95
Table2.2
Comparison of Identified HS Codes with existing OfficialBasket of India.
99
Table3.1
Total Number of Type II Active DMFs filed with U.S.FDA ason 24 Oct 2011.
105
Table3.2
Year wise cumulative Number of DMFs filings of India withU.S.FDA from 1972 to 2010.
108
Table3.3
Yearly Number of Type II active DMFs filed by top Countrieswith U.S.FDA as on 24 Oct 2011.
110
TableNo
Title PageNo.
Table3.4
Top Companies having Type II Active DMFs with U.S.FDA. 112
Table3.5
List of Molecules having 15 or more than 15 type II activeDMFs active from India.
113
Table3.6
Total Number of Product approvals granted by U.S.FDA to37 Countries(as on 28 December 2011).
118
Table3.7
Number of Product approvals granted by U.S.FDA prior to1982.
121
Table3.8
Regulatory Compliance status of India with variousRegulatory Authorities of the world
124
Table3.9
Year wise % share of India, U.S.A, Israel and Switzerland inPrescription Generics approvals granted by U.S.FDA.
128
Table3.10
% Share of All Countries in all Pharmaceutical ProductApprovals [Biological Licensing Applications (BLA), Genericdrug, New Drug Application (NDA), New Molecular Entity(NME)] in Prescription, OTC, Tentative and DiscontinuedProducts.
133
Table3.11
Number of Active Companies from different countries &their Product basket with U.S.FDA.
137
Table3.12
Top 25 Companies with Generic drug Product approvalswith U.S.FDA.
139
Table3.13
Number of Indian Companies & their Product approvalBasket with U.S.FDA as on 11 May 2010.
141
Table3.14
% Share in Prescription, OTC, Tentative, DiscontinuedProduct approvals.
146
Table3.15
% Share in Prescription, OTC, Tentative and DiscontinuedProduct approvals of U.S.A.
148
18
Table3.16
% Share in Prescription, OTC, Tentative and DiscontinuedProduct approvals of India.
151
Table3.17
India’s status in approval wise Prescription GenericMolecules.
154
Table3.18
Approvals wise Top Generic Prescription products in whereIndia is absent.
156
Table3.19
Dosage form wise approvals in Prescription, OTC,Tentative & Discontinued Products.
160
Table3.20
Selected block buster Drugs going Off Patent in differentTherapeutic Category.
161
TableNo
Title PageNo.
Table3.21
Therapeutic category wise Molecule Opportunity withU.S.FDA.
169
Table.3.22
Year wise number of Warning letters issued to threecountries.
172
Table3.23
Total number of Warning Letters Issued to IndianCompanies with the Reasons.
173
Table3.24
Region wise Share of India’s Import of Drugs,Pharmaceuticals & Fine Chemicals (2006-07 to 2010-11)(figs. in US $ mn., %).
181
Table3.25
Region wise Share of India’s Exports Drugs,Pharmaceuticals & Fine Chemicals (2006-07 to 2010-11)(figs. in US $ mn., %).
184
Table3.26
India’s Rank in Bulk drugs and Formulations Exports 1989to 2010) (figs. in US $ mn., %).
188
Table4.1
Year wise cumulative Number of DMFs filings of India withU.S.FDA from 1972 to 2010.
194
Table4.2
Year wise cumulative Number of ANDA approvals of Indiawith U.S.FDA from 1982 to 2010.
196
Table4.3
Yearly Exports of Bulk drugs and Formulations(1989 to 2010) (figs. in US $ mn., %).
198
Table4.4
Year wise India’s DMF filings and Formulation approvalswith U.S.FDA and Pharmaceutical Imports of USA fromIndia.
200
19
Table4.5
Year wise growth rates of DMF’s and ANDA’s Registrationswith U.S.FDA from 1989 to 2010.
205
Table4.6
Trends in growth rates of DMFs & ANDA Registrations withU.S.FDA observed from 2001 to 2010.
206
Table4.7
Scenario Analysis of India’s Exports of PharmaceuticalProducts to U.S.A based on Multiple Linear RegressionModel (figs.US$ mn.).
208
List of FiguresFigure No Title
Figure1.1
Global Pharmaceutical Sales (1999-2011) (figs. in US$ bn.)
Figure 1.2 Worldwide Total Prescription drug sales from 2002 to 2016(figs. in US$ bn.).
Figure 1.3 Worldwide Total Pharmaceutical R & D Spend in2002 to 2016.
Figure 1.4 % Share of Generics in U.S. Prescription Drug Market.
Figure1.5 Composition of Trade of Pharmaceuticals of U.S.A(figs. inUS$ mn.).
Figure 1.6 Savings to U.S. Health care system from 2000 to 2010 (figs.in US$ bn.).
Figure 1.7 Generic cost savings by Therapeutic category(figs. in US$bn.).
Figure 1.8India’s Exports of Bulk drugs, Pharmaceuticals & Finechemicals (figs. in US$ mn.).
Figure 1.9Country wise Approvals of ARVs by WHO as on Jan 2009.
Figure1.10
Indexed Manufacturing Cost.
Figure1.11 Number of unique Establishments Inspected by U.S.FDA2001 to sep 2010.
Figure1.12 Relative Indexed Cost of Skilled Chemist.
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Figure1.13 Comparison of R & D cost in India and U.S.A..Figure 1.14 Flow chart for Pharmaceutical Product Registration.Figure 1.15 Product Registration Applications in U.S.FDA.Figure 1.16 Generic Drug Review Process.Figure 1.17 Flow Chart for Marketing Protection for New Drug after
U.S.FDA approval.Figure 1.18 Prozac erosion and Generic Fluoxetine appraisal.Figure 1.19 Comparison of data trend by Top three generic companies on
Paragraph IV Challenge.Figure 1.20 Paragraph IV Patent Challenges – Impax Labs (selected
products).Figure 1.21 Indicative list of Pharmaceutical Product Patents expiry IMS
Patent Focus-Dialog Pro (as on June 2011).Figure 1.22 Pharmaceutical Product Patents granted in India.
Figure No Title
2.1 Study Plan.Figure 3.1 Total Number of Type II Active DMFs filed with U.S.FDA
along with number of holder companies for top 10 countries(as on 24 Oct 2011).
Figure 3.2 Yearly number of Type II active DMFs filed by top Countrieswith U.S.FDA as on 24 Oct 2011.
Figure 3.3 % Share of Generic Product Approvals with U.S.FDA.Figure3.4 % Share of Active ANDAs with U.S.FDA.Figure3.5 Changing scenario of prescription generic product
approvals(1991-2010).Figure 3.6 % Share of all countries in Prescription product approvals.Figure 3.7 % SHARE OF ALL COUNTRIES IN OTC PRODUCT
APPROVALS.Figure 3.8 % Share of all countries in Tentative product approvals.Figure 3.9 % Share of all countries in Discontinued product approvals.Figure 3.10 Therapeutic category wise share of all generic approvals
granted by U.S.FDA.Figure 3.11 Therapeutic category wise share of all generic approvals
(Prescription, OTC, Tentative and Discontinued) granted byU.S.FDA.
Figure3.12 Top Countries Prescription drug approvals share in CNS,CVS, Anti Infective, Anti Cancer, GI Tract, Analgesic and AntiInflammatory category.
Figure 3.13 % Share of Therapeutic category wise Generic drug approvalsof U.S.A.
Figure 3.14 % Share of Therapeutic category wise Generic drugapprovals of India.
Figure 3.15 Top Therapy category’s of U.S.A by Value (2009) and their
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CAGR (2005-09) (figs.US$mn.& %).Figure 3.16 Issue of U.S.FDA Warning Letters to different Countries
(1996 to Oct 2011).Figure 3.17 Year wise total number of Warning Letters issued by U.S.FDAFigure 3.18 Companies with the Patent Challenges on record as on June
2011.Figure 3.19 % Share of India’s Pharmaceutical Sector Exports(figs. in %).
Figure 3.20 % Share of India’s Pharmaceutical Sector Imports(figs. in %).Figure 3.21 Region wise share of India’s Imports of Drugs,
Pharmaceuticals & Fine chemicals, 2010-11(figs. in US $mn., %).
Figure 3.22 Region wise share of India’s Exports of Drugs,Pharmaceuticals & Fine Chemicals 2010-11 (figs. in US $mn., %).
Figure No Title
Figure 3.23 % Share of India’s Exports of Bulk drugs and Pharmaceuticalproducts to U.S.A (SITC 541&542)(figs. in US$ mn.).
Figure 3.24 India’s Bulk Drug and Formulation Exports to U.S.A (figs. inUS $ mn.).
