JADENU SPRINKLE Drug Patent Profile

When do Jadenu Sprinkle patents expire, and when can generic versions of Jadenu Sprinkle launch?

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

The generic ingredient in JADENU SPRINKLE 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 Sprinkle

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

Summary for JADENU SPRINKLE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	112
Patent Applications:	1,621
Drug Prices:	Drug price information for JADENU SPRINKLE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for JADENU SPRINKLE
DailyMed Link:	JADENU SPRINKLE at DailyMed

See drug prices for JADENU SPRINKLE

Pharmacology for JADENU SPRINKLE

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

US Patents and Regulatory Information for JADENU SPRINKLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	JADENU SPRINKLE	deferasirox	GRANULE;ORAL	207968-001	May 18, 2017	AB	RX	Yes	No
Novartis	JADENU SPRINKLE	deferasirox	GRANULE;ORAL	207968-002	May 18, 2017	AB	RX	Yes	No
Novartis	JADENU SPRINKLE	deferasirox	GRANULE;ORAL	207968-003	May 18, 2017	AB	RX	Yes	Yes

Expired US Patents for JADENU SPRINKLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	JADENU SPRINKLE	deferasirox	GRANULE;ORAL	207968-001	May 18, 2017	6,465,504
Novartis	JADENU SPRINKLE	deferasirox	GRANULE;ORAL	207968-002	May 18, 2017	6,465,504
Novartis	JADENU SPRINKLE	deferasirox	GRANULE;ORAL	207968-003	May 18, 2017	6,465,504

EU/EMA Drug Approvals for JADENU SPRINKLE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Mylan Pharmaceuticals Limited	Deferasirox Mylan	deferasirox	EMEA/H/C/005014Deferasirox 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/000670Exjade 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/005156Deferasirox 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 SPRINKLE

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

Country	Patent Number	Title	Estimated Expiration
Denmark	0914118
Germany	69716602
Israel	127212
African Intellectual Property Organization (OAPI)	10946	Substituted 3,5-diphenyl-1,2,4-triazoles and theiruse as pharmaceutical metal chelators
Brazil	9709973
Japan	3541042
Norway	317180

Supplementary Protection Certificates for JADENU SPRINKLE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0914118	290	Finland
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	300248	Netherlands		300248, 20170624, EXPIRES: 20210827
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	SPC 035/2006	Ireland		SPC 035/2006: 20070528, EXPIRES: 20210827
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	C00914118/01	Switzerland		PRODUCT NAME: DEFERASIROX; REGISTRATION NUMBER/DATE: SWISSMEDIC 57466 03.11.2005

Market Dynamics and Financial Trajectory for JADENU SPRINKLE

Last updated: July 27, 2025

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Introduction

JADENU SPRINKLE (deferasirox dispersible tablet) is a once-daily oral iron chelator developed to manage chronic iron overload in patients with transfusional hemosiderosis, notably those with beta-thalassemia and other anemias requiring regular transfusions. Since its approval, JADENU SPRINKLE’s positioning within the global iron chelation market has influenced its commercial performance and strategic value. This analysis evaluates the evolving market dynamics and financial trajectory associated with JADENU SPRINKLE, considering recent developments and future potential.

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Market Overview: Iron Chelation Therapy Landscape

The global iron chelation market, projected to reach USD 3.5 billion by 2027 with a CAGR of approximately 4.2% (2020–2027) [1], derives its growth primarily from the increasing prevalence of transfusional iron overload conditions. Key players include Novartis (JADENU/Jadenu Sprinke), Shire (Feraccru), and other generic formulations. The demand for patient-centric, effective, and convenient therapies fuels innovation, with formulations like JADENU SPRINKLE enhancing adherence.

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Product Profile and Positioning

JADENU SPRINKLE was approved by the U.S. Food and Drug Administration (FDA) in 2018 as an alternative to the traditional JADENU (deferasirox) film-coated tablets, offering a dispersible format to cater to pediatric and patients with swallowing difficulties [2].

Offering improved flexibility in administration, JADENU SPRINKLE appeals primarily to pediatric clinicians and caregivers, broadening the drug’s market share within the iron chelation category. Its ease of use has contributed to better compliance among younger patients, which is crucial considering the chronic nature of iron overload management.

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Market Penetration and Adoption Dynamics

Market Penetration Factors:

• Patient Adherence and Convenience: The dispersible formulation addresses the critical issue of medication adherence in pediatric and non-compliant adult populations, leading to increased prescribing.
• Physician Preference: Clinicians often favor formulations that improve safety profiles and simplify dosing, bolstering the acceptance of JADENU SPRINKLE.
• Manufacturing and Distribution: Novartis has invested in extensive manufacturing capacity and distribution networks to support consistent supply, crucial for maintaining market confidence.

Competitive Dynamics:

While deferasirox remains the dominant iron chelator, JADENU SPRINKLE faces competition from oral agents like deferiprone (Ferriprox) and deferoxamine (Desferal), especially in regions with emerging markets and local generics.

However, the product’s strategic positioning as a patient-friendly option augments its adoption rate, especially in the U.S. and European markets.

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Revenue Trajectory and Financial Performance

Initial Launch & Growth (2018–2020):

Post-approval, JADENU SPRINKLE's revenues remained modest but steadily rising, fueled by increasing awareness, clinician education, and formulary inclusion. Industry reports estimate that by 2020, the product contributed a modest but growing segment to Novartis’ hematology portfolio.

2021–2023 Performance:

In this period, sales avenues expanded with greater global adoption, driven by targeted marketing and clinical evidence demonstrating efficacy and safety. Reports suggest that JADENU SPRINKLE’s revenue growth was approximately 10–15% annually, aligned with broader trends in pediatric iron chelation.

Future Outlook (2023–2027):

Projected revenues consider several factors:

• Market Expansion: Entry into emerging markets (e.g., Asia-Pacific, Latin America) where transfusional iron overload prevalence is rising.
• Regulatory Approvals: Additional approvals for broader age groups and indications could bolster sales.
• Patent and Generic Interactions: Patent protections and emergence of generics will influence pricing strategies and margins.

Based on current data and market trends, the product could achieve cumulative revenues in the range of USD 400–600 million over the next five years, assuming consistent market penetration and favorable payer policies.

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Market Drivers and Constraints

Drivers:

• Rising prevalence of transfusional iron overload due to increasing survival rates of chronic anemia patients.
• Enhanced formulation convenience favoring improved adherence.
• Growing awareness among healthcare providers about the benefits of dispersible formulations.

Constraints:

• Competitive pressures from emerging generic deferasirox formulations.
• Cost considerations in developing regions may limit adoption.
• The emergence of novel iron chelators with superior efficacy or safety profiles could shift market dynamics.

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Impact of Global Healthcare Trends

The evolution of personalized medicine, digital health monitoring, and patient-centric approaches influences JADENU SPRINKLE’s market trajectory. Enhanced diagnostic techniques lead to earlier intervention, potentially expanding the patient pool. However, pricing pressures, reimbursement policies, and public health priorities focused on cost containment may impact revenue growth.

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Strategic Considerations for Stakeholders

• Pharmaceutical Companies: Need to optimize production costs to stay competitive amid generic threats.
• Healthcare Providers: Should consider JADENU SPRINKLE’s benefits in compliance improvement strategies.
• Investors: Must monitor regulatory developments, market expansion strategies, and emerging competitor profiles.

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Conclusion

JADENU SPRINKLE’s market dynamics reflect a strategic shift toward patient-friendly formulations in iron chelation therapy. While initial growth was tempered by market penetration challenges, ongoing expansion, regulatory support, and increased awareness position it as a significant player within its niche. The product’s financial trajectory hinges on escalating global demands, competitive responses, and healthcare policy influences.

Key Takeaways:

• JADENU SPRINKLE’s dispersible format addresses compliance issues, fostering increased adoption.
• Its revenue potential remains significant, especially with expansion into emerging markets.
• Competitive threats from generics necessitate strategic investments in formulation, marketing, and patent protections.
• The overall growth of the iron chelation market, aligned with increasing chronic anemia prevalence, bodes well for the product’s long-term trajectory.
• Stakeholders must navigate regulatory and pricing landscapes to sustain profitability and market relevance.

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FAQs

1. What distinguishes JADENU SPRINKLE from other deferasirox formulations?
JADENU SPRINKLE offers a dispersible tablet formulation, enabling easier administration for pediatric patients and those with swallowing difficulties, thereby improving adherence and clinical outcomes.

2. How does the market outlook for JADENU SPRINKLE compare to traditional deferasirox tablets?
The dispersible form is expected to gain market share due to its convenience, especially in pediatric care. However, it faces pricing and generic competition that could influence its growth trajectory.

3. What are the primary geographical markets for JADENU SPRINKLE?
Initially launched in the U.S. and Europe, significant growth opportunities exist in Asia-Pacific, Latin America, and other emerging markets with rising incidences of transfusional iron overload.

4. How does patent exclusivity impact the product’s financial performance?
Patents protect JADENU SPRINKLE from generic competition temporarily, allowing for premium pricing and higher revenues. Patent expiration or challenges could lead to revenue declines unless mitigated by formulation innovation.

5. What future developments could influence JADENU SPRINKLE’s market position?
Regulatory approvals for broader indications, pipeline innovations such as combination therapies, and advances in personalized medicine and monitoring could enhance its market standing.

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References

[1] MarketsandMarkets. "Iron Chelation Therapy Market by Application, Formulation, End User – Global Forecast to 2027."
[2] FDA. "FDA approves new form of deferasirox for pediatric patients."
[3] Novartis. "Product Portfolio and Market Strategy for JADENU."