ACIPHEX SPRINKLE Drug Patent Profile

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

Aciphex Sprinkle is a drug marketed by Aytu and is included in one NDA.

The generic ingredient in ACIPHEX SPRINKLE is rabeprazole sodium. There are thirty drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the rabeprazole sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Aciphex Sprinkle

A generic version of ACIPHEX SPRINKLE was approved as rabeprazole sodium by CHARTWELL RX on November 8^th, 2013.

Summary for ACIPHEX SPRINKLE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	115
Patent Applications:	1,194
Drug Prices:	Drug price information for ACIPHEX SPRINKLE
DailyMed Link:	ACIPHEX SPRINKLE at DailyMed

See drug prices for ACIPHEX SPRINKLE

US Patents and Regulatory Information for ACIPHEX SPRINKLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aytu	ACIPHEX SPRINKLE	rabeprazole sodium	CAPSULE, DELAYED RELEASE;ORAL	204736-001	Mar 26, 2013		DISCN	Yes	No
Aytu	ACIPHEX SPRINKLE	rabeprazole sodium	CAPSULE, DELAYED RELEASE;ORAL	204736-002	Mar 26, 2013		DISCN	Yes	No

Expired US Patents for ACIPHEX SPRINKLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Aytu	ACIPHEX SPRINKLE	rabeprazole sodium	CAPSULE, DELAYED RELEASE;ORAL	204736-001	Mar 26, 2013	5,045,552*PED
Aytu	ACIPHEX SPRINKLE	rabeprazole sodium	CAPSULE, DELAYED RELEASE;ORAL	204736-002	Mar 26, 2013	5,045,552*PED

International Patents for ACIPHEX SPRINKLE

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

Country	Patent Number	Title	Estimated Expiration
Denmark	575887
Denmark	171024
German Democratic Republic	290192	PYRIDINDERIVAT MIT ANTIULZEROESER WIRKUNG
Greece	3026762
Japan	H07291967	PYRIDINE DERIVATIVE AND ULCER THERAPEUTIC AGENT COMPOUND THE SAME
South Korea	910003330

Supplementary Protection Certificates for ACIPHEX SPRINKLE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0268956	1999C0030	Belgium		PRODUCT NAME: RABEPRAZOLE SODIUM; NAT. REGISTRATION NO/DATE: 5532 IE 1 F 3 19990201; FIRST REGISTRATION: GB 10555/0010 19980508
0268956	21/1999	Austria		PRODUCT NAME: RABEPRAZOL UND SEINE PHARMAZEUTISCH GEEIGNETEN SALZE, INSBESONDERE RABEPRAZOL-NATRIUM; NAT. REGISTRATION NO/DATE: 1-22777 UND 1-22778 19981112; FIRST REGISTRATION: GB 10555/0010 UND 10555/0008 19980508
0268956	C990015	Netherlands		PRODUCT NAME: RABEPRAZOLI, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER RABEPRAZOLI NATRICUM; NATL REGISTRATION NO/DATE: RVG 23210-11 19981208; FIRST REGISTRATION: GB 10555/0008 AND 10555/0010 19980508
0268956	SPC/GB98/040	United Kingdom		PRODUCT NAME: RABEPRAZOLE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING THE SODIUM SALT; REGISTERED: UK 10555/0010 19980508; UK 10555/0008 19980508

Market Dynamics and Financial Trajectory for ACIPHEX SPRINKLE

Introduction

ACIPHEX SPRINKLE, a formulation of rabeprazole sodium, is a delayed-release capsule indicated for the treatment of Gastroesophageal Reflux Disease (GERD) in pediatric patients aged 1 to 11 years. This article delves into the market dynamics and financial trajectory of ACIPHEX SPRINKLE, highlighting its usage, prescribing patterns, and the financial implications for the companies involved.

Market Indication and Usage

ACIPHEX SPRINKLE is specifically designed for pediatric patients, addressing a significant need in the treatment of GERD in this age group. The drug is recommended for use in patients weighing less than 15 kg at a dose of 5 mg once daily, with the option to increase to 10 mg if there is an inadequate response. For patients weighing 15 kg or more, the recommended dose is 10 mg once daily[4].

Prescribing Patterns and Patient Demographics

The prescribing patterns for ACIPHEX SPRINKLE show a significant focus on pediatric patients. Between September 2011 and August 2015, the largest proportion of use was among patients aged 1-11 years, accounting for approximately 69% of pediatric patients. Patients younger than 1 year old accounted for 25% of pediatric patients, while those aged 12-16 years made up a smaller but still significant portion[1].

Top Prescribing Specialties

The top prescribing specialties for ACIPHEX SPRINKLE include pediatricians, who accounted for approximately 47% of total prescriptions, followed by gastroenterologists at 14%. This indicates a strong presence in both primary care and specialized gastroenterology settings[1].

Diagnoses Associated with Use

ACIPHEX SPRINKLE is primarily prescribed for the treatment of GERD, which is a common condition in pediatric patients. The drug's efficacy was established in a two-part, randomized, multicenter study involving pediatric patients with endoscopically-proven GERD[4].

Financial Performance and Revenue

The financial performance of ACIPHEX SPRINKLE is tied to its parent company's overall revenue and market strategy. The drug is part of the portfolio of Eisai Inc., although specific financial data for ACIPHEX SPRINKLE alone is not readily available. However, the overall market for proton pump inhibitors (PPIs), which includes ACIPHEX SPRINKLE, is substantial.

Revenue from PPIs

While specific revenue figures for ACIPHEX SPRINKLE are not provided, the broader market for PPIs is significant. For instance, the total number of prescriptions dispensed for rabeprazole tablets (which include ACIPHEX SPRINKLE) was 3.2 million between March 2013 and August 2015, compared to 8,368 prescriptions for ACIPHEX SPRINKLE during the same period[1].

Company Financials

Companies involved in the development and marketing of similar pharmaceutical products provide insight into the financial trajectory. For example, Avadel Pharmaceuticals, which focuses on innovative products including those for unmet medical needs, reported net revenues of $27.8 million in 2017. Although this is not directly related to ACIPHEX SPRINKLE, it illustrates the financial landscape for pharmaceutical companies targeting niche markets[3].

Market Competition and Exclusivity

The market for PPIs is competitive, with several products available. However, ACIPHEX SPRINKLE holds a unique position due to its pediatric indication and formulation. The drug's delayed-release sprinkle capsules make it easier to administer to children, which can be a competitive advantage.

Regulatory Environment

The regulatory environment plays a crucial role in the financial trajectory of pharmaceutical products. ACIPHEX SPRINKLE's approval and continued use are subject to postmarketing surveillance and adverse event reporting. The FDA's evaluation of postmarketing adverse event reports and drug utilization data ensures the drug's safety and efficacy in pediatric patients[1].

Future Outlook

The future outlook for ACIPHEX SPRINKLE is tied to ongoing market demand for effective GERD treatments in pediatric patients. As the population grows and awareness of GERD increases, the demand for specialized treatments like ACIPHEX SPRINKLE is likely to remain steady or increase.

Market Growth Potential

The potential for market growth is significant, given the large number of pediatric patients suffering from GERD. With proper marketing and continued clinical support, ACIPHEX SPRINKLE can maintain its market share and potentially expand its user base.

Challenges and Opportunities

Challenges include competition from other PPIs and the need for ongoing safety monitoring. However, opportunities exist in expanding the drug's indication to other age groups or conditions, as well as in international markets where there may be unmet needs for pediatric GERD treatments.

Key Takeaways

• Pediatric Focus: ACIPHEX SPRINKLE is specifically designed for pediatric patients aged 1-11 years, addressing a significant need in GERD treatment.
• Prescribing Patterns: Pediatricians and gastroenterologists are the primary prescribers, indicating strong support from both primary care and specialized settings.
• Financial Performance: While specific revenue data is limited, the broader PPI market is substantial, and companies like Avadel Pharmaceuticals illustrate the financial potential in niche pharmaceutical markets.
• Regulatory Compliance: Ongoing postmarketing surveillance ensures the drug's safety and efficacy.
• Future Outlook: Steady demand and potential market growth are expected due to the drug's unique formulation and indication.

FAQs

Q: What is ACIPHEX SPRINKLE used for?

A: ACIPHEX SPRINKLE is used for the treatment of Gastroesophageal Reflux Disease (GERD) in pediatric patients aged 1 to 11 years.

Q: How is ACIPHEX SPRINKLE administered?

A: The drug is administered by sprinkling the granule contents of the capsule on a spoonful of soft food or liquid, 30 minutes before a meal. The granules should not be chewed or crushed.

Q: What are the common prescribing specialties for ACIPHEX SPRINKLE?

A: The top prescribing specialties include pediatricians (approximately 47%) and gastroenterologists (approximately 14%).

Q: What are the potential financial implications for companies marketing ACIPHEX SPRINKLE?

A: The financial implications include steady revenue from prescriptions, potential market growth due to unmet needs in pediatric GERD treatment, and the need for ongoing investment in safety monitoring and marketing.

Q: Are there any contraindications for ACIPHEX SPRINKLE?

A: Yes, ACIPHEX SPRINKLE is contraindicated in patients with known hypersensitivity to rabeprazole, substituted benzimidazoles, or any component of the formulation. It is also contraindicated with rilpivirine-containing products[4].

Cited Sources

1. FDA: ACIPHEX SPRINKLE Safety and Drug Utilization Review[1].
2. Cerecor Inc.: Financial Results for the Fourth Quarter and Full Year 2017[2].
3. Avadel Pharmaceuticals: Annual Report 2017[3].
4. Drugs.com: Aciphex Sprinkle: Package Insert / Prescribing Information[4].