EXJADE Drug Patent Profile

Which patents cover Exjade, and what generic alternatives are available?

Exjade is a drug marketed by Novartis and is included in one NDA.

The generic ingredient in EXJADE is deferasirox. There are twenty drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the deferasirox profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Exjade

A generic version of EXJADE was approved as deferasirox by ACTAVIS ELIZABETH on January 26^th, 2016.

Summary for EXJADE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	142
Clinical Trials:	36
Patent Applications:	1,351
Drug Prices:	Drug price information for EXJADE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EXJADE
What excipients (inactive ingredients) are in EXJADE?	EXJADE excipients list
DailyMed Link:	EXJADE at DailyMed

See drug prices for EXJADE

Recent Clinical Trials for EXJADE

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

Sponsor	Phase
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Phase 2
DisperSol Technologies, LLC	Phase 2
Fondazione Italiana Sindromi Mielodisplastiche-ETS	Phase 2

See all EXJADE clinical trials

Pharmacology for EXJADE

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

Paragraph IV (Patent) Challenges for EXJADE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EXJADE	Tablets for Suspension	deferasirox	125 mg, 250 mg, and 500 mg	021882	1	2011-10-28

US Patents and Regulatory Information for EXJADE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	EXJADE	deferasirox	TABLET, FOR SUSPENSION;ORAL	021882-001	Nov 2, 2005	AB	RX	Yes	No
Novartis	EXJADE	deferasirox	TABLET, FOR SUSPENSION;ORAL	021882-002	Nov 2, 2005	AB	RX	Yes	No
Novartis	EXJADE	deferasirox	TABLET, FOR SUSPENSION;ORAL	021882-003	Nov 2, 2005	AB	RX	Yes	Yes

Expired US Patents for EXJADE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	EXJADE	deferasirox	TABLET, FOR SUSPENSION;ORAL	021882-003	Nov 2, 2005	6,465,504
Novartis	EXJADE	deferasirox	TABLET, FOR SUSPENSION;ORAL	021882-001	Nov 2, 2005	6,465,504
Novartis	EXJADE	deferasirox	TABLET, FOR SUSPENSION;ORAL	021882-003	Nov 2, 2005	6,596,750

EU/EMA Drug Approvals for EXJADE

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 EXJADE

See the table below for patents covering EXJADE around the world.

Country	Patent Number	Title	Estimated Expiration
Czech Republic	291470	Substituované 3,5-difenyl-1,2,4-triazoly, jejich použití jako léčiv chelatujících kovy a způsob jejich přípravy (Substituted 3,5-diphenyl-1,2,4-triazoles, their use as iron chelating medicaments and process of their preparation)
Cyprus	2429	Substituted 3,5-diphenyl-1,2,4-triazoles and theiruse as pharmaceutical metal chelators.
Austria	226435

Supplementary Protection Certificates for EXJADE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0914118	SPC 035/2006	Ireland		SPC 035/2006: 20070528, EXPIRES: 20210827
0914118	300248	Netherlands		300248, 20170624, EXPIRES: 20210827

EXJADE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for EXJADE (Deferasirox)

Introduction to EXJADE (Deferasirox)

EXJADE, also known as deferasirox, is an oral iron chelation therapy used to treat chronic iron overload resulting from blood transfusions in patients with conditions such as thalassemia and sickle cell anemia. Here, we delve into the market dynamics and financial trajectory of this crucial medication.

Market Size and Growth

The global deferasirox market, which includes EXJADE, 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[1].

Key Drivers of Market Growth

Several factors are driving the growth of the EXJADE market:

Increasing Prevalence of Iron Overload Disorders

The rising prevalence of conditions such as thalassemia and sickle cell anemia, which necessitate frequent blood transfusions and subsequent iron chelation therapy, is a significant driver. These conditions are more common in certain regions, particularly in Asia-Pacific countries like China, India, and Japan[1].

Improved Diagnosis and Awareness

Enhanced diagnostic techniques and increasing awareness about the risks associated with iron overload are leading to higher treatment rates. Patient awareness campaigns and education initiatives are crucial in this regard[1].

Advancements in Pharmaceutical Formulations

Pharmaceutical companies are investing in research and development to improve the efficacy and safety profile of deferasirox. New formulations, such as dispersible tablets, are being introduced to enhance patient compliance, especially among pediatric patients[3].

Expanded Patient Access Programs

Government policies, expanded health insurance coverage, and patient access programs are reducing the financial burden on patients, making advanced treatments more accessible. This is particularly significant in developing countries where rising disposable incomes are enabling more patients to afford these treatments[1].

Market Segmentation

The EXJADE market is segmented based on product type, application, distribution channel, and region.

Product Type

The market is segmented into various dosages such as 90mg, 125mg, 250mg, 360mg, and others. The availability of different dosages caters to the diverse needs of patients[1].

Application

The primary applications are transfusional iron overload and non-transfusion-dependent thalassemia (NTDT) caused iron overload. These segments are driven by the specific needs of patients with different types of iron overload conditions[1].

Distribution Channel

The market is divided into hospital pharmacies, retail pharmacies, and online providers. The expansion of online pharmacies and patient access programs has increased the reach of EXJADE[1].

Regional Analysis

North America and Europe currently dominate the market due to their well-established healthcare infrastructure and high awareness levels. However, the Asia-Pacific region is emerging as a lucrative market driven by rapid urbanization, expansion of healthcare access, and increasing awareness of genetic blood disorders[1][3].

Financial Trajectory

Revenue and Sales

EXJADE had significant sales in the past, with annual sales of $134 million in the U.S. as of December 2018[4]. The global market is expected to grow substantially, reaching $4.6 billion by 2033[1].

Competitive Landscape

The market is competitive, with key players such as Novartis AG, Teva Pharmaceutical Industries Ltd., Dr. Reddy’s Laboratories, Inc., and others. These companies are investing in marketing strategies, research and development, and expanding their distribution networks to increase market share[1].

Generic Versions

The launch of generic versions of EXJADE, such as the one by Teva Pharmaceutical Industries Ltd., has introduced more affordable treatment options. This has expanded access to the medication, particularly in regions with limited financial resources[4].

Challenges and Limitations

High Cost of Treatment

The high cost of EXJADE treatment can be a significant barrier, especially in regions with limited access to healthcare services and financial resources. This restricts the adoption of the drug in some areas[3].

Adverse Effects and Safety Concerns

EXJADE is associated with adverse effects such as gastrointestinal disturbances, skin rashes, and renal impairment. These safety concerns can limit its widespread adoption and pose challenges in terms of patient compliance[3].

Limited Access to Healthcare Services

In some regions, particularly low-income countries, limited access to healthcare services and specialized treatment options can hinder the growth of the EXJADE market[3].

Opportunities for Growth

Untapped Emerging Markets

Emerging markets, particularly in Asia-Pacific, Latin America, and the Middle East and Africa, present significant growth opportunities. Rapidly developing healthcare infrastructure, increasing disposable income, and improving awareness contribute to the market’s potential[3].

Collaborations and Partnerships

Collaborations with healthcare organizations, research institutes, and other stakeholders can lead to the development of innovative treatment approaches and expand market reach. Focusing on the pediatric population and introducing new formulations are also key opportunities[3].

Key Takeaways

• The global deferasirox market, including EXJADE, is projected to grow from $2.9 billion in 2023 to $4.6 billion by 2033.
• Key drivers include the increasing prevalence of iron overload disorders, improved diagnosis and awareness, advancements in pharmaceutical formulations, and expanded patient access programs.
• The market is segmented by product type, application, distribution channel, and region, with North America and Europe currently dominating but Asia-Pacific emerging as a significant growth area.
• Challenges include the high cost of treatment, adverse effects, and limited access to healthcare services.
• Opportunities for growth lie in untapped emerging markets, collaborations, and focusing on the pediatric population.

FAQs

What is EXJADE used for?

EXJADE (deferasirox) is used to treat chronic iron overload due to blood transfusions in patients with conditions such as thalassemia and sickle cell anemia[4].

What is the projected market size of deferasirox by 2033?

The global deferasirox market is projected to reach $4.6 billion by 2033[1].

What are the key drivers of the EXJADE market growth?

Key drivers include the increasing prevalence of iron overload disorders, improved diagnosis and awareness, advancements in pharmaceutical formulations, and expanded patient access programs[1].

Which regions are expected to see significant growth in the EXJADE market?

The Asia-Pacific region, along with Latin America and the Middle East and Africa, are expected to witness significant growth due to the increasing prevalence of conditions requiring blood transfusions and improving healthcare access[1][3].

What are the main challenges facing the EXJADE market?

Challenges include the high cost of treatment, adverse effects, and limited access to healthcare services in some regions[3].

Sources

1. Allied Market Research, "Deferasirox Market Statistics, Trends | Forecast - 2033"
2. Pacira BioSciences, "Pacira BioSciences Reports Fourth Quarter and Full-Year 2023"
3. MarkWide Research, "Exjade market 2024-2032 | Size, Share, Growth"
4. Teva Pharmaceutical Industries Ltd., "Teva Announces Launch of a Generic Version of EXJADE (deferasirox) Tablets For Oral Suspension in the United States"
5. Novartis, "Novartis Financial Results Q4 2022 – English"