Deferasirox - Generic Drug Details

What are the generic sources for deferasirox and what is the scope of freedom to operate?

Deferasirox is the generic ingredient in four branded drugs marketed by Alkem Labs Ltd, Amneal, Annora Pharma, Aucta, Cipla, MSN, Norvium Bioscience, Teva Pharms Usa, Novartis, Actavis Elizabeth, Alembic, Bionpharma, Glenmark Speclt, Sun Pharm, Torrent, Zydus Pharms, Aurobindo Pharma Ltd, Chartwell Rx, Piramal, Stevens J, and Novartis Pharms Corp, and is included in thirty-six NDAs. There is one patent protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Deferasirox has sixty-seven patent family members in forty-two countries.

There are twenty drug master file entries for deferasirox. Twenty-one suppliers are listed for this compound.

Summary for deferasirox

International Patents:	67
US Patents:	1
Tradenames:	4
Applicants:	21
NDAs:	36
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	21
Raw Ingredient (Bulk) Api Vendors:	143
Clinical Trials:	96
Patent Applications:	2,192
Drug Prices:	Drug price trends for deferasirox
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for deferasirox
What excipients (inactive ingredients) are in deferasirox?	deferasirox excipients list
DailyMed Link:	deferasirox at DailyMed

See drug prices for deferasirox

Recent Clinical Trials for deferasirox

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Phase 2
Children's Hospital Karachi	Phase 2/Phase 3
EmeraMed	Phase 2

See all deferasirox clinical trials

Pharmacology for deferasirox

Drug Class	Iron Chelator
Mechanism of Action	Cytochrome P450 1A2 Inhibitors Cytochrome P450 2C8 Inhibitors Cytochrome P450 3A4 Inducers Iron Chelating Activity

Anatomical Therapeutic Chemical (ATC) Classes for deferasirox

V03AC	Iron chelating agents
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

Paragraph IV (Patent) Challenges for DEFERASIROX

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
JADENU	Tablets	deferasirox	180 mg	206910	1	2016-04-21
JADENU	Tablets	deferasirox	90 mg and 360 mg	206910	1	2015-10-19
EXJADE	Tablets for Suspension	deferasirox	125 mg, 250 mg, and 500 mg	021882	1	2011-10-28

US Patents and Regulatory Information for deferasirox

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cipla	DEFERASIROX	deferasirox	GRANULE;ORAL	215026-003	Feb 23, 2022	AB	RX	No	No
Teva Pharms Usa	DEFERASIROX	deferasirox	TABLET;ORAL	209223-002	Nov 25, 2019		DISCN	No	No
Piramal	DEFERASIROX	deferasirox	TABLET;ORAL	212995-001	Dec 30, 2019	AB	RX	No	No
Alkem Labs Ltd	DEFERASIROX	deferasirox	TABLET;ORAL	210555-003	Jul 2, 2020	AB	RX	No	No
Actavis Elizabeth	DEFERASIROX	deferasirox	TABLET;ORAL	208697-002	Dec 13, 2019	AB	RX	No	No

Expired US Patents for deferasirox

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis Pharms Corp	JADENU	deferasirox	TABLET;ORAL	206910-001	Mar 30, 2015	6,465,504
Novartis Pharms Corp	JADENU	deferasirox	TABLET;ORAL	206910-003	Mar 30, 2015	6,465,504
Novartis	EXJADE	deferasirox	TABLET, FOR SUSPENSION;ORAL	021882-001	Nov 2, 2005	6,596,750
Novartis	EXJADE	deferasirox	TABLET, FOR SUSPENSION;ORAL	021882-003	Nov 2, 2005	6,596,750
Novartis	JADENU SPRINKLE	deferasirox	GRANULE;ORAL	207968-001	May 18, 2017	6,465,504

EU/EMA Drug Approvals for deferasirox

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Mylan Pharmaceuticals Limited	Deferasirox Mylan	deferasirox	EMEA/H/C/005014 Deferasirox Mylan is indicated forthe treatment of chronic iron overload due to frequent blood transfusions (≥7 ml/kg/month of packed red blood cells) in patients with beta thalassaemia major aged 6 years and olderthe treatment of chronic iron overload due to blood transfusions when deferoxamine therapy is contraindicated or inadequate in the following patient groups:in paediatric patients with beta thalassaemia major with iron overload due to frequent blood transfusions (≥7 ml/kg/month of packed red blood cells) aged 2 to 5 years,in adult and paediatric patients with beta thalassaemia major with iron overload due to infrequent blood transfusions (	Authorised	yes	no	no	2019-09-26
Novartis Europharm Limited	Exjade	deferasirox	EMEA/H/C/000670 Exjade is indicated for the treatment of chronic iron overload due to frequent blood transfusions (≥ 7 ml/kg/month of packed red blood cells) in patients with beta thalassaemia major aged six years and older.Exjade is also indicated for the treatment of chronic iron overload due to blood transfusions when deferoxamine therapy is contraindicated or inadequate in the following patient groups:in patients with beta thalassaemia major with iron overload due to frequent blood transfusions (≥ 7 ml/kg/month of packed red blood cells) aged two to five years;in patients with beta thalassaemia major with iron overload due to infrequent blood transfusions (< 7 ml/kg/month of packed red blood cells) aged two years and older;in patients with other anaemias aged two years and older.Exjade is also indicated for the treatment of chronic iron overload requiring chelation therapy when deferoxamine therapy is contraindicated or inadequate in patients with non-transfusion-dependent thalassaemia syndromes aged 10 years and older.	Authorised	no	no	no	2006-08-28
Accord Healthcare S.L.U.	Deferasirox Accord	deferasirox	EMEA/H/C/005156 Deferasirox Accord is indicated for the treatment of chronic iron overload due to frequent blood transfusions (≥7 ml/kg/month of packed red blood cells) in patients with beta thalassaemia major aged 6 years and older.Deferasirox Accord is also indicated for the treatment of chronic iron overload due to blood transfusions when deferoxamine therapy is contraindicated or inadequate in the following patient groups:in paediatric patients with beta thalassaemia major with iron overload due to frequent blood transfusions (≥7 ml/kg/month of packed red blood cells) aged 2 to 5 years,in adult and paediatric patients with beta thalassaemia major with iron overload due to infrequent blood transfusions (	Authorised	yes	no	no	2020-01-09

International Patents for deferasirox

Country	Patent Number	Title	Estimated Expiration
Cyprus	1121315
Taiwan	201442742	Oral formulations of deferasirox
Saudi Arabia	515360425	صيغ للإعطاء بالفم من ديفيرازيروكس (Oral formulations of deferasirox)
Slovenia	3124018
Cyprus	1120021

Supplementary Protection Certificates for deferasirox

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0914118	PA2007001,C0914118	Lithuania		PRODUCT NAME: DEFERASIROXUM; REGISTRATION NO/DATE: EU/1/06/356/001 2006-08-28, EU/1/06/356/002 2006-08-28, EU/1/06/356/003 2006-08-28, EU/1/06/356/004 2006-08-28, EU/1/06/356/005 2006-08-28, EU/1/06/356/00 20060828
0914118	SPC/GB07/002	United Kingdom		SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB07/002 GRANTED TO NOVARTIS AG IN RESPECT OF THE PRODUCT DEFERASIROX AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, ESPECIALLY 4-(3,5-BIS(2-HYDROXYPHENYL)-(1,2,4) TRIAZOL-L-YL) BENZOIC ACID, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6179 DATED 24 OCTOBER 2007 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 30 AUGUST 2021.
0914118	PA2007001	Lithuania		PRODUCT NAME: DEFERASIROXUM; REGISTRATION NO/DATE: EU/1/06/356/001 2006 08 28, EU/1/06/356/002 2006 08 28, EU/1/06/356/003 2006 08 28, EU/1/06/356/004 2006 08 28, EU/1/06/356/005 2006 08 28, EU/1/06/356/00 20060828
0914118	C00914118/01	Switzerland		PRODUCT NAME: DEFERASIROX; REGISTRATION NUMBER/DATE: SWISSMEDIC 57466 03.11.2005
0914118	06C0049	France		PRODUCT NAME: DEFERASIROX OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE IN FRANCE: EU/1/06/356/001 DU 20060828; REGISTRATION NO/DATE AT EEC: EU/1/06/356/001 DU 20060828

Deferasirox Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Deferasirox

Market Introduction and Definition

Deferasirox, an oral iron chelation therapy, is used to treat chronic iron overload resulting from blood transfusions in conditions such as thalassemia, sickle cell anemia, and other transfusion-dependent anemias. The global deferasirox market is poised for significant growth, driven by several key factors.

Market Size and Growth Rate

The global deferasirox market was valued at $2.9 billion in 2023 and is projected to reach $4.6 billion by 2033, growing at a compound annual growth rate (CAGR) of 4.7% from 2024 to 2033[4].

Key Drivers of Market Growth

Several factors are driving the growth of the deferasirox market:

• Increasing Prevalence of Iron Overload Disorders: The rising incidence of conditions such as thalassemia and sickle cell anemia, which necessitate effective iron chelation therapies, is a significant driver[4].
• Improved Diagnosis and Awareness: Enhanced diagnostic techniques and increased awareness campaigns are leading to higher treatment rates[4].
• Advancements in Pharmaceutical Formulations: Pharmaceutical companies are investing in research and development to enhance the efficacy and safety profile of deferasirox, leading to new formulations and combination therapies[4].
• Expanding Healthcare Infrastructure: Improved healthcare infrastructure, especially in developing countries, and expanding health insurance coverage are facilitating greater access to advanced treatments[4].

Geographical Market Analysis

The deferasirox market is geographically segmented, with different regions contributing significantly to its growth:

• North America: This region holds a significant market share due to its advanced healthcare infrastructure, high prevalence of congenital hemolytic anemias, and substantial patient awareness. The U.S. and Canada are key markets in this region[4].
• Europe: Europe is the second-largest market, driven by the increased use of deferasirox by healthcare professionals and a diverse distribution network[1].
• Asia-Pacific: This region is emerging as a lucrative market, driven by rapid urbanization, expansion of healthcare access, and increasing awareness of genetic blood disorders. Countries like China, India, and Japan are at the forefront of this growth[4].

Product Type and Application Segmentation

The deferasirox market is segmented based on product type and application:

• Product Type: The market is segmented into 500mg, 250mg, 215mg, and other formulations[1].
• Application: Deferasirox is used in treating conditions such as β-thalassemia, myelodysplastic syndromes (MDS), sickle cell disease (SCD), aplastic anemia (AA), and Diamond-Blackfan anemia (DBA)[1].

End-Users and Distribution Channels

The market is also segmented based on end-users and distribution channels:

• End-Users: Specialty clinics, hospitals, home care, and other healthcare settings are the primary end-users[1].
• Distribution Channels: The drug is distributed through direct tender, hospital pharmacy, retail pharmacy, online pharmacy, and other channels[1].

Cost Effectiveness and Economic Analysis

Studies have shown that deferasirox is cost-effective compared to other iron chelation therapies:

• A UK-based study indicated that deferasirox is cost-effective in lower-risk, transfusion-dependent MDS patients, with a cost per quality-adjusted life year (QALY) gained of £20,822[2].
• Another analysis suggested that deferasirox offers additional quality of life benefits due to its simpler mode of administration compared to desferrioxamine (DFO)[2].

Challenges and Limitations

Despite the growth potential, the deferasirox market faces some challenges:

• Adverse Effects: Adverse effects related to the drug, such as gastrointestinal issues and renal impairment, can hamper market growth[1].
• Product Recalls: Occasional product recalls due to safety concerns can impact market dynamics[1].
• Competition: The presence of other iron chelation therapies, such as deferiprone and desferrioxamine, poses competitive challenges[5].

Competitive Landscape

The deferasirox market is competitive, with several key players:

• Novartis AG: The original developer of deferasirox, which is marketed under the brand name Exjade.
• Taj Pharmaceuticals Limited: Known for its generic formulations.
• Dr. Reddy’s Laboratories, Inc.: Another major player in the generic market.
• Teva Pharmaceutical Industries Ltd.: Offers a range of generic and branded formulations.
• Other Key Players: Include Glenmark Pharmaceuticals Inc., Viatris Inc., Sun Pharmaceutical Industries Ltd., Zydus Group, and NATCO Pharma Limited[4].

Government Policies and Funding

Government policies and funding play a crucial role in the growth of the deferasirox market:

• Healthcare Policies: Policies that facilitate access to advanced treatments and supportive government initiatives contribute significantly to market growth[4].
• Research Funding: Funding for research and development helps in enhancing the efficacy and safety profile of deferasirox, leading to new formulations and combination therapies[4].

Patient Epidemiology Analysis

The patient epidemiology analysis highlights the increasing incidence of conditions requiring iron chelation therapy:

• Global Incidence: The rising incidence of anaemia worldwide and the increasing inheritance of genetic disorders are driving the demand for deferasirox[1].
• Demographic Impact: The growing geriatric population, which is more susceptible to chronic conditions requiring transfusions, also contributes to market growth[4].

Key Takeaways

• The global deferasirox market is expected to grow significantly, driven by the increasing prevalence of iron overload disorders and advancements in pharmaceutical formulations.
• North America and Europe are currently the largest markets, but the Asia-Pacific region is emerging as a key growth area.
• The market faces challenges such as adverse effects and competition from other iron chelation therapies.
• Government policies and funding are crucial for market growth.

Frequently Asked Questions (FAQs)

What is the current market size of the global deferasirox market?

The global deferasirox market was valued at $2.9 billion in 2023[4].

What is the projected growth rate of the deferasirox market from 2024 to 2033?

The market is projected to grow at a CAGR of 4.7% from 2024 to 2033[4].

Which regions are the largest markets for deferasirox?

North America and Europe are currently the largest markets, with the Asia-Pacific region emerging as a significant growth area[1][4].

What are the key drivers of the deferasirox market growth?

Key drivers include the increasing prevalence of iron overload disorders, improved diagnosis and awareness, advancements in pharmaceutical formulations, and supportive government initiatives[4].

What are the common applications of deferasirox?

Deferasirox is used in treating conditions such as β-thalassemia, myelodysplastic syndromes (MDS), sickle cell disease (SCD), aplastic anemia (AA), and Diamond-Blackfan anemia (DBA)[1].

Cited Sources:

1. Global Deferasirox Market - Industry Trends and Forecast to 2028 - Data Bridge Market Research
2. Cost effectiveness of deferasirox compared to desferrioxamine in the ... - PubMed
3. Deferasirox Tablet Market Size Insights Report 2024-2032 - Southeast News Channel Nebraska
4. Deferasirox Market Statistics, Trends | Forecast - 2033 - Allied Market Research
5. Pharmacoeconomic Review - Deferiprone (Ferriprox) - NCBI - NCBI Books