JADENU Drug Patent Profile

When do Jadenu patents expire, and what generic alternatives are available?

Jadenu is a drug marketed by Novartis Pharms Corp and Novartis and is included in two NDAs. There is one patent protecting this drug and two Paragraph IV challenges.

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

The generic ingredient in JADENU 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 Jadenu

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

Summary for JADENU

International Patents:	67
US Patents:	1
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	143
Clinical Trials:	2
Patent Applications:	1,351
Drug Prices:	Drug price information for JADENU
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for JADENU
What excipients (inactive ingredients) are in JADENU?	JADENU excipients list
DailyMed Link:	JADENU at DailyMed

See drug prices for JADENU

Recent Clinical Trials for JADENU

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

Sponsor	Phase
DisperSol Technologies, LLC	Phase 2
Novartis Pharmaceuticals	Phase 2

See all JADENU clinical trials

Pharmacology for JADENU

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 JADENU

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

US Patents and Regulatory Information for JADENU

JADENU is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis Pharms Corp	JADENU	deferasirox	TABLET;ORAL	206910-001	Mar 30, 2015	AB	RX	Yes	No	9,283,209		Y	Y
Novartis	JADENU SPRINKLE	deferasirox	GRANULE;ORAL	207968-001	May 18, 2017	AB	RX	Yes	No
Novartis Pharms Corp	JADENU	deferasirox	TABLET;ORAL	206910-002	Mar 30, 2015	AB	RX	Yes	No	9,283,209		Y	Y
Novartis Pharms Corp	JADENU	deferasirox	TABLET;ORAL	206910-003	Mar 30, 2015	AB	RX	Yes	Yes	9,283,209		Y	Y

Expired US Patents for JADENU

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis Pharms Corp	JADENU	deferasirox	TABLET;ORAL	206910-002	Mar 30, 2015	6,465,504
Novartis Pharms Corp	JADENU	deferasirox	TABLET;ORAL	206910-002	Mar 30, 2015	6,596,750
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	6,596,750

EU/EMA Drug Approvals for JADENU

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 JADENU

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

Country	Patent Number	Title	Estimated Expiration
Slovenia	914118
Eurasian Patent Organization	201591665	ОРАЛЬНЫЕ СОСТАВЫ ДЕФЕРАЗИРОКСА
Jordan	3570	صيغ للإعطاء بالفم من ديفيرازيروكس (ORAL FORMULATIONS OF DEFERASIROX)
Montenegro	03297	ORALNE FORMULACIJE DEFERASIROKSA (ORAL FORMULATIONS OF DEFERASIROX)

Supplementary Protection Certificates for JADENU

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	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	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	290	Finland

Market Dynamics and Financial Trajectory for the Drug: Jadenu

Introduction to Jadenu

Jadenu, also known as deferasirox, is an oral iron chelation therapy used to treat chronic iron overload, a condition often associated with blood transfusions in patients with thalassemia and sickle cell anemia. Here, we will delve into the market dynamics and financial trajectory of Jadenu.

Market Size and Growth

The global deferasirox market, which includes Jadenu, 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][4].

Key Drivers of Market Growth

Several factors are driving the growth of the deferasirox market:

Increasing Prevalence of Iron Overload Disorders

The rising prevalence of conditions such as thalassemia and sickle cell anemia, which necessitate effective iron chelation therapies, is a significant driver. These conditions require frequent blood transfusions, leading to chronic iron overload, and thus, an increased demand for treatments like Jadenu[1].

Improved Diagnosis and Awareness

Enhanced diagnosis rates and increased awareness among patients and healthcare providers about the risks associated with iron overload and the benefits of chelation therapy are also contributing to market growth. Patient awareness campaigns and education initiatives play a crucial role in this aspect[1].

Advancements in Pharmaceutical Formulations

Pharmaceutical companies are investing in research and development to enhance the efficacy and safety profile of deferasirox. This includes the development of new formulations and combination therapies, which broaden the application of Jadenu and reduce side effects, thereby driving market growth[1].

Expanded Patient Access Programs

Government policies and funding aimed at improving healthcare outcomes, along with expanding health insurance coverage globally, reduce the financial burden on patients. This facilitates greater adoption of deferasirox, especially in regions with growing healthcare infrastructure[1].

Regional Market Dynamics

North America

North America represents a significant portion of the deferasirox market share due to its advanced healthcare infrastructure, high prevalence of congenital hemolytic anemias, and substantial patient awareness. Extensive research and development activities, along with strong support from healthcare policies, contribute to the market growth in this region[1].

Asia-Pacific

The Asia-Pacific region is emerging as a lucrative market for deferasirox. Rapid urbanization, expansion of healthcare access, and increased awareness of genetic blood disorders in countries like China, India, and Japan are driving this growth. The large populations in China and India, with a high incidence of congenital hemolytic anemias, necessitate effective iron chelation therapies, further boosting the market[1].

Financial Performance of Jadenu

Revenue Trends

Jadenu, marketed by Novartis, has seen fluctuations in its revenue due to various market factors. For instance, in the fourth quarter of 2022, the sales of Exjade/Jadenu declined by 53% (48% in constant currencies) due to pressure from generic competition[2].

Impact of Generic Competition

The introduction of generic versions of deferasirox has significantly impacted the sales of branded products like Jadenu. This competition has led to a decline in revenue for Novartis, as seen in their financial reports[2][5].

Cost and Pricing

The cost of Jadenu tablets can be notably high for some patients, varying based on the strength of the tablets and insurance coverage. For example, a supply of 30 Jadenu oral tablets (90 mg) can cost around $1,595, while the cost for 180 mg and 360 mg tablets can be $3,180.51 and $6,351.42, respectively[3].

Competitive Landscape

The deferasirox market is competitive, with several key players including Novartis AG, Zydus Group, Dr. Reddy’s Laboratories, Inc., NATCO Pharma Limited, Viatris Inc., Sun Pharmaceutical Industries Ltd., and others. These companies are investing in marketing strategies to increase product visibility and market share[1][4].

Government Policies and Funding

Government initiatives to improve healthcare outcomes and increase access to advanced treatments significantly contribute to the deferasirox market. Policies aimed at expanding health insurance coverage, especially for chronic diseases, reduce the financial burden on patients and facilitate greater adoption of deferasirox[1].

Future Outlook

The future outlook for the deferasirox market, including Jadenu, is positive due to the increasing demand for effective iron chelation therapies. The market is expected to continue growing, driven by advancements in pharmaceutical formulations, expanded patient access programs, and supportive government initiatives.

Key Takeaways

• The global deferasirox market is projected to reach $4.6 billion by 2033, growing at a CAGR of 4.7%.
• Increasing prevalence of iron overload disorders and improved diagnosis and awareness are key drivers.
• Advancements in pharmaceutical formulations and expanded patient access programs contribute to market growth.
• North America and the Asia-Pacific region are significant markets due to their healthcare infrastructure and growing awareness.
• Generic competition has impacted the revenue of branded products like Jadenu.
• High costs and varying insurance coverage affect patient affordability.

FAQs

What is the projected market size of the deferasirox market by 2033?

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

What is the CAGR of the deferasirox market from 2024 to 2033?

The deferasirox market is expected to exhibit a CAGR of 4.7% from 2024 to 2033[1][4].

Which regions are significant for the deferasirox market?

North America and the Asia-Pacific region are significant markets due to their advanced healthcare infrastructure and growing awareness of genetic blood disorders[1].

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 expanded patient access programs[1].

How does generic competition affect the sales of Jadenu?

Generic competition has significantly impacted the sales of branded products like Jadenu, leading to a decline in revenue for Novartis[2][5].

Sources

1. Allied Market Research, "Deferasirox Market Statistics, Trends | Forecast - 2033"
2. Novartis, "Novartis Q4 2022 Condensed Financial Report – Supplementary Data"
3. AmeriPharma Specialty, "Jadenu: A Treatment for Chronic Iron Overload and Thalassemia"
4. Business Research Insights, "Deferasirox Market Size, Growth, Trends & Analysis [2032]"
5. Novartis, "Novartis First Quarter 2022 Condensed Interim Financial Report"