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:	2,977
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

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/002185 Treatment of adrenal insufficiency in adults.	Authorised	no	no	no	2011-11-03
Diurnal Europe B.V.	Alkindi	hydrocortisone	EMEA/H/C/004416 Replacement 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/005105 Treatment 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
Canada	2909060	COMPOSITION COMPRENANT DE L'HYDROCORTISONE (COMPOSITION COMPRISING HYDROCORTISONE)
Hong Kong	1214131	包含氫化可的松的組合物 (COMPOSITION COMPRISING HYDROCORTISONE)
Russian Federation	2015150303	Композиция, содержащая гидрокортизон

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

ALKINDI SPRINKLE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ALKINDI SPRINKLE

Introduction to ALKINDI SPRINKLE

ALKINDI SPRINKLE, developed and marketed by Eton Pharmaceuticals, is a treatment for adrenal insufficiency, specifically designed for pediatric patients. It is a granule formulation of hydrocortisone that can be sprinkled on food, making it easier for children to take their medication.

Market Opportunity

The market for ALKINDI SPRINKLE is significant, particularly in the niche of rare diseases. Diurnal Group plc, the original developer of Alkindi (the European counterpart of ALKINDI SPRINKLE), has identified a substantial market opportunity for this product. For instance, in countries like Australia, Japan, and the Netherlands, there is a considerable potential for Alkindi and similar products, with market opportunities ranging from $7 million to $397 million depending on the region[3].

Revenue Growth

ALKINDI SPRINKLE has demonstrated robust revenue growth over the past few years. In the third quarter of 2024, it achieved a 55% year-over-year revenue growth, marking a significant milestone for Eton Pharmaceuticals. This growth is part of a larger trend, as the product has consistently shown strong performance, contributing to Eton's sequential growth in product sales for 15 consecutive quarters[2].

Financial Performance

The financial performance of ALKINDI SPRINKLE is closely tied to Eton Pharmaceuticals' overall product sales. Here are some key financial highlights:

• Product Sales: In Q3 2024, Eton reported product sales of $9.8 million, with ALKINDI SPRINKLE being a major contributor to this figure. This represents a 40% increase over the prior year period and an 8% increase over the second quarter of 2024[1][2].
• Gross Profit: The gross profit from product sales, including ALKINDI SPRINKLE, was $6.3 million in Q3 2024, up from $4.4 million in the same period of the previous year[1][2].
• Operating Cash Flow: The strong performance of ALKINDI SPRINKLE has also contributed to Eton's positive operating cash flow. In Q3 2024, the company generated $2.9 million in operating cash flow, a significant improvement from previous periods[2].

Market Expansion and Distribution

Eton Pharmaceuticals has been expanding the market reach of ALKINDI SPRINKLE through various distribution agreements and regulatory approvals. For example, Diurnal Group plc, which originally developed Alkindi, has secured approvals and distribution agreements in several countries, including Australia, Israel, and the Netherlands. These efforts are likely to enhance the global availability and adoption of ALKINDI SPRINKLE[3].

Competitive Landscape

In the rare disease market, particularly for adrenal insufficiency treatments, ALKINDI SPRINKLE faces competition from other hydrocortisone formulations. However, its unique granule formulation and ease of administration make it a preferred choice for pediatric patients. Eton Pharmaceuticals' strategic focus on rare diseases and its expanding product portfolio, including the upcoming ET-400, further strengthen its competitive position[2][4].

Regulatory Milestones

Regulatory approvals and milestones are crucial for the continued success of ALKINDI SPRINKLE. The FDA acceptance of Eton's New Drug Application (NDA) for ET-400, another hydrocortisone formulation, sets a positive precedent for the company's regulatory strategy. This approval process and the anticipated launch of ET-400 in 2025 are expected to complement ALKINDI SPRINKLE and enhance patient treatment options[1][2].

Patient Adoption and Support Programs

Eton Pharmaceuticals has implemented patient support programs to enhance the adoption and adherence to ALKINDI SPRINKLE. The Eton Cares program, for instance, has received favorable reviews from both patients and prescribers, indicating a strong commitment to patient care and support. This approach not only improves patient outcomes but also contributes to the product's market success[4].

Future Outlook

The future outlook for ALKINDI SPRINKLE is promising, driven by several factors:

• Continued Revenue Growth: With its strong performance in recent quarters, ALKINDI SPRINKLE is expected to continue contributing significantly to Eton Pharmaceuticals' revenue.
• Market Expansion: Ongoing efforts to expand distribution and secure regulatory approvals in new markets will further increase the product's reach.
• Complementary Products: The anticipated launch of ET-400 and other products in Eton's pipeline is expected to enhance the company's position in the rare disease market and provide additional treatment options for patients[2][4].

Key Takeaways

• Robust Revenue Growth: ALKINDI SPRINKLE has shown consistent and significant revenue growth.
• Strong Financial Performance: The product has contributed to Eton Pharmaceuticals' positive financial metrics, including gross profit and operating cash flow.
• Market Expansion: Efforts to secure distribution agreements and regulatory approvals are expanding the product's global reach.
• Competitive Advantage: The unique formulation and patient support programs give ALKINDI SPRINKLE a competitive edge.
• Future Prospects: The product is expected to continue driving revenue growth and market expansion for Eton Pharmaceuticals.

FAQs

Q: What is ALKINDI SPRINKLE used for? A: ALKINDI SPRINKLE is used to treat adrenal insufficiency in pediatric patients.

Q: How has ALKINDI SPRINKLE performed financially? A: ALKINDI SPRINKLE has shown a 55% year-over-year revenue growth in Q3 2024 and has been a key contributor to Eton Pharmaceuticals' sequential product sales growth.

Q: What are the competitive advantages of ALKINDI SPRINKLE? A: Its unique granule formulation and ease of administration, along with patient support programs like Eton Cares, give ALKINDI SPRINKLE a competitive edge.

Q: What are the future prospects for ALKINDI SPRINKLE? A: The product is expected to continue driving revenue growth and market expansion, especially with the anticipated launch of complementary products like ET-400.

Q: How does ALKINDI SPRINKLE fit into Eton Pharmaceuticals' overall strategy? A: ALKINDI SPRINKLE is part of Eton Pharmaceuticals' focus on rare diseases and its goal to have 10 commercial rare disease products on the market by the end of 2025.

Citations

1. Eton Pharmaceuticals Reports Third Quarter 2024 Financial Results - Eton Pharmaceuticals[1]
2. Eton Pharmaceuticals Reports Third Quarter 2024 Financial Results - StockTitan[2]
3. Diurnal Group plc Annual Report 2021 - AnnualReports.com[3]
4. Eton Pharmaceuticals Reports Second Quarter 2023 Financial Results - BioSpace[4]