ALKINDI SPRINKLE Drug Patent Profile

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

Alkindi Sprinkle is a drug marketed by Eton and is included in one NDA. There are three patents protecting this drug.

This drug has fifty-six patent family members in twenty-five countries.

The generic ingredient in ALKINDI SPRINKLE is hydrocortisone. There are sixty-seven drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the hydrocortisone profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Alkindi Sprinkle

A generic version of ALKINDI SPRINKLE was approved as hydrocortisone by IMPAX LABS INC on March 30^th, 2007.

Summary for ALKINDI SPRINKLE

International Patents:	56
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	109
Patent Applications:	4,282
Drug Prices:	Drug price information for ALKINDI SPRINKLE
DailyMed Link:	ALKINDI SPRINKLE at DailyMed

See drug prices for ALKINDI SPRINKLE

Pharmacology for ALKINDI SPRINKLE

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

US Patents and Regulatory Information for ALKINDI SPRINKLE

ALKINDI SPRINKLE is protected by three US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Eton	ALKINDI SPRINKLE	hydrocortisone	GRANULE;ORAL	213876-001	Sep 29, 2020		RX	Yes	No
Eton	ALKINDI SPRINKLE	hydrocortisone	GRANULE;ORAL	213876-003	Sep 29, 2020		RX	Yes	No
Eton	ALKINDI SPRINKLE	hydrocortisone	GRANULE;ORAL	213876-002	Sep 29, 2020		RX	Yes	No
Eton	ALKINDI SPRINKLE	hydrocortisone	GRANULE;ORAL	213876-004	Sep 29, 2020		RX	Yes	Yes
Eton	ALKINDI SPRINKLE	hydrocortisone	GRANULE;ORAL	213876-003	Sep 29, 2020		RX	Yes	No			Y
Eton	ALKINDI SPRINKLE	hydrocortisone	GRANULE;ORAL	213876-001	Sep 29, 2020		RX	Yes	No

EU/EMA Drug Approvals for ALKINDI SPRINKLE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Takeda Pharmaceuticals International AG Ireland Branch	Plenadren	hydrocortisone	EMEA/H/C/002185Treatment of adrenal insufficiency in adults.	Authorised	no	no	no	2011-11-03
Diurnal Europe B.V.	Alkindi	hydrocortisone	EMEA/H/C/004416Replacement therapy of adrenal insufficiency in infants, children and adolescents (from birth to < 18 years old).	Authorised	no	no	no	2018-02-09
Diurnal Europe B.V.	Efmody	hydrocortisone	EMEA/H/C/005105Treatment of congenital adrenal hyperplasia (CAH) in adolescents aged 12 years and over and adults.	Authorised	no	no	no	2021-05-27

International Patents for ALKINDI SPRINKLE

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

Country	Patent Number	Title	Estimated Expiration
United Kingdom	201407380
Canada	2909060	COMPOSITION COMPRENANT DE L'HYDROCORTISONE (COMPOSITION COMPRISING HYDROCORTISONE)
Japan	2016518439	ヒドロコルチゾンを含有する組成物
Denmark	2780003
Croatia	P20200452
Mexico	2015015759	COMPOSICION QUE COMPRENDE HIDROCORTISONA. (COMPOSITION COMPRISING HYDROCORTISONE.)

Supplementary Protection Certificates for ALKINDI SPRINKLE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0809498	SPC/GB10/012	United Kingdom		PRODUCT NAME: A COMBINATION OF ACYCLOVIR AND HYDROCORTISONE; REGISTERED: UK PL18191/0001-0001 20091112
0809498	10C0038	France		PRODUCT NAME: ACYCLOVIR ET HYDROCORTISONE; NAT. REGISTRATION NO/DATE: NL 36 826 20100420; FIRST REGISTRATION: SK - 2108/08467-R 20091026

Market Dynamics and Financial Trajectory for ALKINDI SPRINKLE

Last updated: July 28, 2025

Introduction

ALKINDI SPRINKLE (hydrocortisone granules), developed by Ardelyx Inc., is a pediatric formulation indicated for the management of congenital adrenal hyperplasia (CAH) in children aged 2 years and above. As a glucocorticoid therapy, it caters to a niche but critical segment within pediatric endocrinology. Given its unique formulation and targeted indication, understanding the market dynamics and projected financial trajectory is essential for stakeholders, including investors, healthcare providers, and pharmaceutical strategists.

Market Overview

Therapeutic Landscape and Unmet Need

CAH, primarily caused by 21-hydroxylase deficiency, affects approximately 1 in 15,000 live births globally [1]. Standard management involves lifelong glucocorticoid replacement, with hydrocortisone being the preferred initial therapy due to its safety profile in children. However, traditional hydrocortisone formulations pose dosing challenges and compliance issues due to frequent dosing requirements and unpleasant taste in pediatric patients.

ALKINDI SPRINKLE addresses these challenges by offering a ready-to-use, precise, and palatable granule formulation designed specifically for children. Its targeted delivery system improves absorption and simplifies dosing, potentially enhancing compliance and therapeutic outcomes.

Market Size and Segmentation

The pediatric adrenal insufficiency segment, mainly CAH, represents a specialized yet underserved niche. The global pediatric endocrinology market estimated for glucocorticoid therapies is projected to grow at a CAGR of 4-6% through 2030, driven by increased diagnosis rates and evolving treatment paradigms [2].

Key segmentation factors include:

• Geography: North America, Europe, and emerging markets like Asia-Pacific exhibit growing awareness and diagnosis rates.
• Patient Population: Estimated 4,000-5,000 active pediatric CAH patients in the U.S. alone — a relatively small but steady population for targeted therapy.
• Pricing and Reimbursement: Premium formulations like ALKINDI SPRINKLE typically command higher pricing, influenced by regulatory approvals and reimbursement policies.

Competitive Landscape

Current competitors include compounded hydrocortisone preparations and other pediatric-specific formulations. However, none match ALKINDI SPRINKLE's FDA approval, standardized dosing, and ease of administration, thus providing a significant competitive edge.

Other potential entrants include generic versions once patents expire and alternative delivery systems. Nevertheless, the high R&D barriers and regulatory hurdles favor Ardelyx’s early market positioning.

Market Dynamics

Regulatory Factors

The FDA approval of ALKINDI SPRINKLE in 2019 marked a pivotal milestone, establishing formal recognition for its safety and efficacy profile. Regulatory pathways, including orphan drug designations, provide incentives, extend exclusivity periods, and motivate investment.

In Europe, the drug’s approval might face additional scrutiny but benefits from the EU’s compassionate use policies and Pediatric Regulation initiatives.

Reimbursement and Pricing Strategies

High cost and limited competition afford Ardelyx significant pricing power. The company's outreach to payers emphasizes improved compliance and clinical outcomes, arguing for favorable reimbursement coverage. Cost-effectiveness analyses and real-world evidence are instrumental in solidifying payer support.

Market Penetration and Adoption Challenges

Barriers include:

• Physician Familiarity: Education campaigns are vital to promote adoption.
• Convenience and Compliance: Manufacturers must demonstrate clear benefits over compounded formulations.
• Pricing Sensitivity: Payers scrutinize high-cost therapies, influencing formulary placement.

Supply Chain and Manufacturing

Reliable GMP-compliant manufacturing processes enable consistent product quality and scalability. Ardelyx’s investment in manufacturing capacity impacts the trajectory of sales expansion.

Financial Trajectory and Revenue Projections

Historical Financial Performance

Since its 2019 FDA approval, ALKINDI has shown incremental sales growth. Early adoption, primarily through specialty pharmacies and large pediatric clinics, has set the foundation for expansion. However, the drug's niche size limits rapid revenue acceleration.

Forecasting Future Revenue

Assuming increased penetration, strategic partnerships, and expanded indications, possible revenue scenarios include:

• Conservative Estimate: Achieving ~10% market share within targeted geographic regions by 2025, translating to revenues of approximately $50 million annually.
• Optimistic Scenario: Deeper market penetration coupled with approval in adult CAH and other adrenal insufficiencies could push revenues beyond $150 million by 2030.

Key Drivers of Financial Growth

• Market Expansion: Entering new geographies, notably Asia-Pacific.
• Line Extensions: Developing formulations for older children/adults.
• Pricing Optimization: Balancing premium pricing with payer acceptance.
• Partnerships: Collaborations with major healthcare providers and payers to foster market access.

Risks and Challenges

• Regulatory Delays: Potential approval hurdles in new markets.
• Market Competition: Entry of generics could pressure prices.
• Clinical Outcomes: Insufficient real-world evidence could slow adoption.
• Manufacturing Disruptions: Affecting supply and revenue delivery.

Strategic Outlook

Ardelyx’s focused approach on pediatric rare disease therapy positions ALKINDI SPRINKLE well within niche markets with minimal direct competition. Continued investment in clinical research, payer engagement, and geographic expansion will significantly shape its financial trajectory. Synergistic partnerships and proactive regulatory strategies could accelerate growth and maximize value.

Key Takeaways

• ALKINDI SPRINKLE addresses a critical unmet need in pediatric CAH management with a proprietary formulation, providing a competitive advantage.
• Market growth is constrained by the rarity of CAH but supported by increasing diagnosis rates and the need for precise pediatric dosing.
• Financial upside hinges on successful geographic expansion, formulary acceptance, and potential new indications.
• Challenges include competition from generics, regulatory delays in new markets, and payer pricing pressures.
• Strategic investments in clinical data, manufacturing capacity, and stakeholder engagement are essential to capitalize on growth opportunities.

Conclusion

The trajectory of ALKINDI SPRINKLE reflects a niche but vital segment within pediatric endocrinology. While its market size is limited, its innovative formulation and targeted approach promise sustained growth supported by regulatory positioning and clinical need.

---

FAQs

1. What is the primary advantage of ALKINDI SPRINKLE over traditional hydrocortisone formulations?
ALKINDI SPRINKLE offers a ready-to-use, precise, palatable granule formulation designed specifically for children, simplifying dosing, improving absorption, and enhancing compliance compared to compounded or standard formulations.

2. How does regulatory exclusivity impact ALKINDI SPRINKLE’s market potential?
Regulatory designations like orphan drug status grant Ardelyx market exclusivity, incentivizing investment and offering temporary protection against generics, thus supporting premium pricing and revenue stability.

3. What are the main barriers to wider adoption of ALKINDI SPRINKLE?
Barriers include physician familiarity, payer reimbursement policies, high drug costs, and competition from compounded preparations or future generics.

4. How does geographic expansion influence the financial prospects of ALKINDI SPRINKLE?
Entering emerging markets accelerates revenue growth due to unmet needs and less competition, while European and Asian approvals expand the global footprint and diversify revenue streams.

5. What future developments could enhance ALKINDI SPRINKLE’s market share?
Line extensions to adult indications, real-world evidence supporting clinical benefits, strategic partnerships, and price negotiations with payers will bolster market penetration.

---

Sources

[1] Merck Manual. Congenital adrenal hyperplasia. Available at: https://www.merckmanuals.com/professional/endocrine-and-metabolic-disorders/adrenal-disorders/congenital-adrenal-hyperplasia.

[2] EvaluatePharma. The World Market for Glucocorticoids. 2021.