Dapagliflozin is an AstraZeneca patented medication. In India, Sun Pharma and Abbott serve as licensed partners for dapagliflozin's distribution. While the primary patent for dapagliflozin expired in October 2020, a specific (species) patent safeguards AstraZeneca's dapagliflozin in India until May 15, 2023. Under the brand name "Oxra®," Sun Pharma will undertake the promotion and distribution of dapagliflozin. This medication is approved for use in the United States as a monotherapy and in combination therapy to enhance glycemic control in patients with type 2 diabetes. In China, the National Medical Products Administration (NMPA) approved dapagliflozin, both in combination with metformin and as a standalone treatment, for inadequately-controlled type-2 diabetes mellitus. It was introduced for the treatment of type 2 diabetes in China in 2018. Japan has authorized Forxiga (dapagliflozin) as an oral adjunct treatment to insulin for adults with type-1 diabetes (T1D). The Shanghai Shenkang Hospital Development Center has outlined a three-year plan to promote clinical skills and innovations in municipal hospitals, reflecting a commitment to healthcare advancements. Efforts are being made to expand distribution channels across diverse geographical regions. AstraZeneca is closely monitoring the Indian market to secure a significant share and prevent the infringement of dapagliflozin by generic manufacturers. Regulatory bodies are actively assessing dapagliflozin's drug and approval processes, ensuring compliance with appropriate dose and indication guidelines. For further inquiries, please contact pranayraju66@gmail.com.

1. PRODUCT PROFILE FOR
DAPAGLIFLOZIN
By Pranay Kumar

2. ❑ Executive Summary
❑ Overview
❑ Commercial Scenario
❑ Regulatory Scenario
❑ Partnership Aspects
❑ Clinical Trails Insight
▪ U.S.
▪ Europe
▪ Japan
▪ China
▪ India
❑ Insights 2
TableOfContent

3. 3
Executive Summary
Product Profile For
Dapagliflozin
Key Players
Market Insight
Generic Market Focus
• AstraZeneca
o Sun Pharmaceutical
o Abbott
• Other player’s in the generic market.
• Dapagliflozin is a patented drug of
AstraZeneca.
• Sun Pharma and Abbott are the
licensed partners for the distribution
of dapagliflozin in India.
• The patent of dapagliflozin is
expired in October 2020, But
AstraZeneca dapagliflozin is still
protected by a specific (species)
patent till May 15, 2023, in India.
• Expansion in the emerging market.
• Generics market.
• Pricing strategy for the new product.

4. Introduction
4
Overview
Source: https://www.nhs.uk/medicines/dapagliflozin/#:~:text=Dapagliflozin%20is%20a%20type%20of,your%20body%20through%20your%20pee, https://www.farxiga.com/savings-
support.html#costandafford
❖ Dapagliflozin is a sodium-glucose cotransporter 2 inhibitor indicated for managing diabetes mellitus type 2.
❖ Dapagliflozin used for treat patient suffering from:
▪ Type 2 diabetes.
▪ Patients with heart failure with reduced ejection fraction (HFrEF).
❖ Molecule Type:
▪ Small Molecule
❖ Mechanism of action:
▪ Inhibits the sodium-glucose contransporter 2(SGLT2) which is primarily located in the proximal tubule of the nephron.
❖ Actions Type:
▪ Antagonist inhibitor
❖ Route of Administration:
▪ Oral
❖ Cost & Affordability for Farxiga (dapagliflozin):
▪ FARXIGA is $507.18 for a 30-day supply.

5. 5
CommercialScenario
Source: https://www.medplusmart.com/compositionProducts/Dapagliflozin-10-MG/29059, https://www.drugs.com/ingredient/dapagliflozin.html,
https://www.businesstoday.in/sectors/pharma/astrazeneca-in-legal-fight-with-12-indian-drug-makers-over-rights-to-diabetic-drug-dapagliflozin/story/418704.html
Product Name Type Player Form
Farxiga/Forxiga Patent Rights AstraZeneca Tablets
Oxra Licensing Agreements - AstraZeneca Sun Pharmaceutical Industries Ltd Tablets
Gledepa Licensing Agreements - AstraZeneca Abbott Tablets
Gluxit Branded Generic Eris Lifesciences Ltd Tablets
Dapaglyn Branded Generic Zydus Healthcare Ltd Tablets
Dapaone Branded Generic Msn Laboratories Pvt Ltd Tablets
Dapnat Branded Generic Natco Pharma Ltd Tablets
Udapa Branded Generic USV Pvt Ltd Tablets

6. 6
Regulatory Scenario
Source: https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-type-heart
failure#:~:text=Today%2C%20the%20U.S.%20Food%20and,and%20hospitalization%20for%20heart%20failure., https://www.ema.europa.eu/en/documents/leaflet/european-regulatory-system-
medicines-european-medicines-agency-consistent-approach-medicines_en.pdf,
Region Organization Dosage form Details
U.S. FDA (Food and Drug Administration) Tablet
• Dapagliflozin is approved in the U.S. as monotherapy and as part of combination therapy to
improve glycemic control for patients with type 2 diabetes.
• Farxiga (dapagliflozin) oral tablets for adults with heart failure with reduced ejection fraction
to reduce the risk of cardiovascular death and hospitalization for heart failure.
E.U European Medicines Agency Tablet
• Agency product number (EMEA/H/C/002322), The European medicines regulatory system is
based on a network of around 50 regulatory authorities from the 31 EEA countries (28 EU
Member States plus Iceland, Liechtenstein and Norway), the European Commission and
EMA.
China
National Medical Products
Administration (NMPA) | State Food and
Drug Administration (SFDA)
Tablet
• The China NMPA approved dapagliflozin in combination metformin and with insulin,
separately for the treatment of inadequately-controlled type-2 diabetes mellitus in China.
The drug was launched for the treatment of type 2 diabetes mellitus in China in 2018.
Japan
Japanese Ministry of Health, Labor and
Welfare (MHLW)
Tablet
• Approved Forxiga (dapagliflozin) as an oral adjunct treatment to insulin for adults with type-
1 diabetes (T1D).
India Drugs Controller General of India (DCGI) Tablet
• Marketing Authorization for Dapagliflozin (Forxiga), for the treatment of patients with heart
failure with reduced ejection fraction (HFrEF).

7. 7
Partnership Aspects
Source: http://www.sunpharma.com/Media/Press-Releases/Press%20Release_dapa_versionMarch23.pdf, https://www.astrazeneca.in/content/dam/az-
in/pdf/2019/Intimation%20under%20Reg.30%20of%20SEBI%20Listing%20Regulatoins_Dist%20Agreement.pdf
Company 1 Type Company2 Year Details Insight
Sun Pharma
Distribution
agreement
AstraZeneca March, 2019
Sun Pharma and AstraZeneca announced a partnership for the
distribution of dapagliflozin, distribution of dapagliflozin, an innovative
Type 2 diabetes medicine, in India
Sun Pharma will promote and
distribute dapagliflozin under the
brand name “Oxra®”
Abbott
Distribution
agreement
AstraZeneca December, 2018
Abbott and AstraZeneca announced a partnership for the distribution of
dapagliflozin in India
Abbott will promote and distribute
Dapagliflozin under the brand name
GLEDEPA.

8. 8
Clinical Studies Insight: U.S.
Source: https://clinicaltrials.gov/ct2/results?cond=Dapagliflozin&term=&cntry=&state=&city=&dist=, Refer to secondary research excel.
Clinical Trails Insight
❑ Sample size: 4 studies have been taken into consideration to show how insight is derived.
1
3
Phase Analysis
Not Applicable Phase 1 Phase 1|Phase 2
Phase 2 Phase 2|Phase 3 Phase 3
Phase 4 Blanks
4 studies
1
3
Status Analysis
Completed Active, not recruiting Not yet recruiting
Recruiting Terminated Unknown status
Withdrawn
4 studies
Key Takeaways
• Phase 2| Phase3 and phase 4 are the prominent stages which assist in deriving the potential of the market.
• Major companies and academics institutes have completed status for phase 2, phase 3, and phase 4 to promote the drugs.
1/2

9. 9
Clinical Studies Insight: U.S.
Source: https://clinicaltrials.gov/ct2/results?cond=Dapagliflozin&term=&cntry=&state=&city=&dist=, Refer to secondary research excel.
Clinical Trails Insight
❑ Sample size: 4 studies have been taken into consideration to show how insight is derived.
Key Takeaways
• AstraZeneca is the leading player with the maximum number of
clinical studies.
• Most of the clinical studies are in phase 4 targeting the potential
market.
1 1 1
0
0.2
0.4
0.6
0.8
1
1.2
AstraZeneca Hospital Other Academic Institutes
Top Players Analysis
1 1
1
1
0
1
2
3
AstraZeneca Hospital Other Academic Institutes
Players Vs Status Analysis
Completed Active, not recruiting Not yet recruiting Recruiting
Terminated Unknown status Withdrawn
1 1
2
0
0.5
1
1.5
2
2.5
AstraZeneca Hospital Other Academic Institutes
Players Vs Phase Analysis
Not Applicable Phase 1 Phase 1|Phase 2 Phase 2
Phase 2|Phase 3 Phase 3 Phase 4 Blanks
2/2

10. 10
Clinical TrailsInsight: U.S.
Source: https://clinicaltrials.gov/ct2/results?cond=Dapagliflozin&term=&cntry=&state=&city=&dist=, Refer to secondary research excel.
Identifier
Estimated
Patients
Study Design Intervention Phase Conditions Status
Sponsor/Collabora
tors
NCT03887416 225
Effect of Dapagliflozin
on Nighttime Blood
Pressure in Type 2
Diabetes
Drug: Dapagliflozin 10
MG Oral Tablet
[Farxiga]|Drug:
Placebo Oral Tablet
Phase 4 Type2 Diabetes Recruiting
LM Diagnósticos
S.L.|AstraZeneca
NCT04400760 25
The Effect of
Dapagliflozin on
Platelet Function
testing Profiles in
Diabetic Patients.
Drug: DAPA Tx Phase 2|Phase 3 Platelet Dysfunction Recruiting
The University of The
West Indies
NCT03660683 45
Effect of Saxagliptin
and Dapagliflozin on
Endothelial Progenitor
Cell in Patients With
Type 2 Diabetes
Mellitus
Drug: Dapagliflozin
10mg|Drug:
Saxagliptin 5mg|Drug:
Placebo Oral Tablet
Phase 4
Diabetes Mellitus,
Type 2|Cardiovascular
Diseases
Recruiting
Sabyasachi
Sen|George
Washington
University
NCT02459353 86
Effect of Dapagliflozin
on Glycemic
Variability
Drug:
Dapagliflozin|Drug:
Placebo
Phase 4
Type 2 Diabetes
Mellitus
Completed
The Catholic
University of
Korea|AstraZeneca|S
everance
Hospital|Eulji General
Hospital|Kyung Hee
University Hospital at
Gangdong
1/5

11. 11
Clinical TrailsInsight: Europe
Source: https://www.clinicaltrialsregister.eu/ctr-search/search?query=Dapagliflozin
EudraCT
Number
Sponsor
Protocol
Number
Sponsor
Name
Title
Medical
condition
Enrolled Population Age Phase
2015-005406-11 D1683C00005 AstraZeneca AB
A Multi-Center, Randomised, Double-Blind,
Active-Controlled, Parallel Group, Phase III
Trial to Evaluate the Safety and Efficacy of
Saxagliptin 5 mg Co-administered with
Dapagliflozin 5 mg compared to Saxagliptin
5 mg or Dapagliflozin 5 mg all given as Add-
on therapy to Metformin in Patients with
Type 2 Diabetes who have Inadequate
Glycaemic Control on Metformin Alone
Type 2 diabetes
mellitus,
inadequate
glycaemic control
870 Adults, Elderly Phase 3
2014-001441-24 CUI_001
Medical
University
Innsbruck
Short-term effect of SGLT 2-inhibitor
dapagliflozin on postprandial glucose
excursion and insulin sensitivity in type 1
diabetic patients.
effects of
Dapagliflozin on
postprandial
glucose excursion
and fasting
glucose
homeostasis
- Adults -
2016-000715-33 2015DM07
University of
Dundee & NHS
Tayside
Does Dapaglifozin Regress Left Ventricular
Hypertrophy In Patients With Type 2
Diabetes?
Type 2 diabetes
and left
ventricular
hypertrophy
66 Adults, Elderly -
2/5

12. 12
Clinical TrailsInsight: Japan
Source: https://upload.umin.ac.jp/cgi-open-bin/ctr_e/index.cgi
Unique ID issued by
UMIN
Date of disclosure of
the study information
Title Condition Recruitment status Enrolled
UMIN000038380 2019/10/25 D-HFPEF
Acute heart failure with
preserved ejection fraction
complicated with type 2
diabetes mellitus
Open public recruiting 40
UMIN000035660 2019/01/24
Effects of Dapagliflozin on
Body Composition
Type 2 Diabetes Completed 40
UMIN000030446 2019/01/01
Effect of SGLT2 inhibitor
combined with metformin on
body composition
Type 2 diabetes mellitus Preinitiation 54
UMIN000030514 2018/01/01
The Japanese T2D study for
evaluating Benefits Of a New
first-line therapy with
Dapagliflozin in consideration
of improving QOL (J-BOND
study)
Type 2 diabetes mellitus Enrolling by invitation 252
3/5

13. 13
Clinical TrailsInsight: China
Source:http://www.chictr.org.cn/searchprojen.aspx?title=Dapagliflozin&officialname=&subjectid=&secondaryid=&applier=&studyleader=&ethicalcommitteesanction=&sponsor=&studyailment=&studyailmentcode=&studytype=0&studystag
e=0&studydesign=0&minstudyexecutetime=&maxstudyexecutetime=&recruitmentstatus=0&gender=0&agreetosign=&secsponsor=&regno=&regstatus=0&country=&province=&city=&institution=&institutionlevel=&measure=&intercode=&s
ourceofspends=&createyear=0&isuploadrf=&whetherpublic=&btngo=btn&verifycode=&page=1
Registration
number
Title Type Phase Enrolled Target disease Sources of funding
ChiCTR2000037196
Effect of Dapagliflozin in Type 2
Diabetic Patients with
Hyperfiltration: a Randomized
Controlled Study
Interventional 4 300
Type 2 Diabetic Patients
With Hyperfiltration
Shanghai Shenkang
Hospital Development
Center: Three-year Plan
for Promoting Clinical
Skills and Innovations in
Municipal Hospitals
ChiCTR2000036159
Impact of early using of Dapagliflozin
on left ventricular mass and infarct
size in patients with STEMI
Interventional 0 55
ST-segment elevation
myocardial infarction
Self-finance
ChiCTR2000036076
Comparison of the efficacy and
safety of pioglitazone/metformin
(FDC) in combination with
dapagliflozin therapy versus basal
insulin in combination with
metformin therapy in patients with
inadequately controlled type 2
diabetes mellitus
Interventional 4 75 type 2 diabetes
Hangzhou Sino-US East
China Pharmaceutical
Co., Ltd
4/5

14. 14
Clinical TrailsInsight: India
Source: http://ctri.nic.in/Clinicaltrials/advsearch.php
CTRI No. Title Type of Trial Status
Health
Condition
Intervention
Name
Phase Enrolled
CTRI/2019/05/019286
Dapagliflozin is a
licensed medicine
used for reducing
blood sugar in people
with diabetes and this
study will test
whether it can also
reduce the stiffness in
the liver which
commonly occurs in
diabetes.
Interventional
Total: Not Applicable
Indian: Not Yet
Recruiting
Type 2 diabetes
mellitus with other
specified
complications
Capsule Dapagliflozin - 160
CTRI/2014/08/004872
Multicenter Trial to
Evaluate the Effect of
Dapagliflozin on the
Incidence of
Cardiovascular Events
(DECLARE-TIMI 58) in
Type II diabetes
patients.
Interventional
Total: Closed to
Recruitment of
Participants
Indian: Closed to
Recruitment of
Participants
Diabetes Mellitus,
Non-Insulin-
Dependent High Risk
for Cardiovascular
Event
Type 2 diabetes
mellitus with
circulatory
complications
Dapagliflozin Phase 3
Total- 17150
India - 200
5/5

15. 15
Insights
Strategic Initiatives
• Expansion of distribution channel in the
different geographical regions.
• Pricing strategy to capture major market
share.
• Strategic partnerships to increase revenue
generation.
• Increasing brand awareness among
healthcare professionals.
Market Insights
• Most of the dapagliflozin drug
used for the treatment of acute
heart failure with preserved
ejection fraction complicated with
type 2 diabetes mellitus and
directly used for type 2 diabetes
are in phase 3.
• AstraZeneca is monitoring the
Indian market to hold major share
and stop the infringement of
dapagliflozin drugs by generic
players.
• Regulatory bodies are analyzing
the dapagliflozin drug and process
for approval with the region with
proper guidelines of dose and
indication.

16. THANK YOU