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:	142
Patent Applications:	1,249
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
Novartis	JADENU SPRINKLE	deferasirox	GRANULE;ORAL	207968-003	May 18, 2017
Novartis	JADENU SPRINKLE	deferasirox	GRANULE;ORAL	207968-002	May 18, 2017

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/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 SPRINKLE

See the table below for patents covering JADENU SPRINKLE 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 JADENU SPRINKLE

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

JADENU SPRINKLE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for JADENU SPRINKLE

Introduction to JADENU SPRINKLE

JADENU SPRINKLE, a formulation of the iron chelator deferasirox, is used to treat chronic iron overload in patients undergoing regular blood transfusions and those with non-transfusion-dependent thalassemia (NTDT) syndromes. Here, we delve into the market dynamics and financial trajectory of this crucial medication.

Regulatory Milestones

JADENU SPRINKLE has undergone several key regulatory milestones. It was granted accelerated approval for marketing on May 18, 2017, under the New Drug Application (NDA) 207968 by the FDA. This approval was part of a broader regulatory framework that includes other formulations of deferasirox, such as Exjade and Jadenu tablets[1].

Indications and Usage

JADENU SPRINKLE is indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older, as well as for patients 10 years and older with NTDT syndromes who have a liver iron concentration of at least 5 mg Fe per gram of dry weight and a serum ferritin greater than 300 mcg/L[4].

Dosage and Administration

The dosage of JADENU SPRINKLE is calculated based on the patient's weight and renal function. For patients with an estimated glomerular filtration rate (eGFR) greater than 60 mL/min/1.73 m^2, the initial dose is 14 mg per kg once daily. The dose must be adjusted based on serum ferritin levels and renal function[4].

Side Effects and Safety Considerations

JADENU SPRINKLE, like other deferasirox formulations, comes with several potentially serious side effects, including acute kidney injury, hepatic toxicity, gastrointestinal hemorrhage, severe skin reactions, and low blood cell counts due to bone marrow suppression. These side effects necessitate careful monitoring and dose adjustments[2][4].

Market Competition

The launch of generic versions of JADENU SPRINKLE has significantly impacted the market dynamics. Aucta Pharmaceuticals and Oakrum Pharma announced the launch of a generic version of JADENU SPRINKLE in 2021, which is expected to increase competition and potentially reduce prices. Generic drug prices generally decline with the number of competitors, especially when there are eight or more competitors in the market[3][5].

Impact of Generic Competition

Generic competition can lead to a reduction in prices, as seen in other pharmaceutical markets. When multiple generic firms enter the market, prices tend to fall closer to long-run marginal costs. For instance, studies have shown that generic drug prices can be 35% to 50% above long-run marginal costs for the initial generic monopolist but decline as more competitors enter the market[3].

Financial Trajectory

Revenue and Sales

JADENU SPRINKLE has generated significant revenue. For the 12-month period ending January 2021, deferasirox granules had annual sales in the U.S. exceeding $31 million. The introduction of generic versions is likely to affect these revenues, as generic alternatives often capture a substantial market share due to their lower prices[5].

Cost to Patients

The cost of JADENU SPRINKLE can be substantial for patients. For example, the price for a 30-tablet supply of JADENU oral tablets can range from approximately $1,595 for the 90 mg strength to $6,351.42 for the 360 mg strength. Generic versions may offer more affordable options, reducing the financial burden on patients[2].

Assistance Programs and Affordability

To mitigate the high cost, various assistance programs are available. Pharmaceutical companies and partner organizations often provide financial assistance to help patients cover the out-of-pocket expenses associated with these medications. The launch of generic versions further enhances affordability by introducing more cost-effective alternatives[2][5].

Future Outlook

Market Expansion and Competition

The partnership between Aucta Pharmaceuticals and Oakrum Pharma to launch generic deferasirox granules is part of a broader strategy to expand their product portfolios in niche generics and branded specialty products. This move is expected to contribute significantly to the growth of these companies over the next couple of years. Additional approvals and launches of other products are anticipated, further shaping the market dynamics[5].

Regulatory and Policy Impacts

Regulatory policies, such as those related to generic drug approvals and competition, play a crucial role in shaping the market. The FDA's scrutiny of generic drug applications and policies on simultaneous approvals can influence the timing and cost of market entry for generic competitors. These factors can impact the financial trajectory of branded drugs like JADENU SPRINKLE by affecting the competitive landscape[3].

Key Takeaways

• Regulatory Approvals: JADENU SPRINKLE was granted accelerated approval in 2017, with other formulations of deferasirox also approved under different NDAs.
• Indications and Usage: It treats chronic iron overload in transfusion-dependent and non-transfusion-dependent thalassemia patients.
• Dosage and Administration: Dosing is based on weight and renal function, with adjustments necessary based on serum ferritin levels.
• Side Effects: Potentially serious side effects include acute kidney injury, hepatic toxicity, and severe skin reactions.
• Market Competition: The introduction of generic versions increases competition, potentially reducing prices.
• Financial Trajectory: Significant revenue generation, with generic competition likely to impact future revenues.
• Affordability: Assistance programs and generic versions help reduce the financial burden on patients.

FAQs

What are the indications for JADENU SPRINKLE?

JADENU SPRINKLE is indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older, and for patients 10 years and older with non-transfusion-dependent thalassemia (NTDT) syndromes[4].

How is JADENU SPRINKLE administered?

JADENU SPRINKLE is administered orally, preferably on an empty stomach or with a light meal, by sprinkling the full dose on soft food like yogurt or applesauce[4].

What are the potential serious side effects of JADENU SPRINKLE?

Potential serious side effects include acute kidney injury, hepatic toxicity, gastrointestinal hemorrhage, severe skin reactions, and low blood cell counts due to bone marrow suppression[2][4].

How does the introduction of generic versions affect the market?

The introduction of generic versions increases competition, leading to a potential reduction in prices as more competitors enter the market[3][5].

What assistance programs are available to help with the cost of JADENU SPRINKLE?

Various assistance programs are available to help patients cover the out-of-pocket expenses associated with JADENU SPRINKLE, and the launch of generic versions further enhances affordability[2][5].

What is the expected impact of generic competition on the revenue of JADENU SPRINKLE?

Generic competition is expected to reduce the revenue of JADENU SPRINKLE as prices decline with the entry of more competitors, making the medication more affordable but reducing the market share and revenue of the branded version[3][5].

Sources

1. FDA Clinical Review: Jadenu® (deferasirox) Clinical Review PREA - FDA.
2. AmeriPharma Specialty: Jadenu: A Treatment for Chronic Iron Overload and Thalassemia.
3. Federal Trade Commission: Generic Drug Industry Dynamics.
4. Novartis: JADENU® | Novartis.
5. PR Newswire: Aucta Pharma and Oakrum Pharma Announce Launch of Generic Version of JADENU® Sprinkle (Deferasirox Granules).