KAPSPARGO SPRINKLE Drug Patent Profile

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

Kapspargo Sprinkle is a drug marketed by Spil and is included in one NDA. There are two patents protecting this drug.

This drug has eight patent family members in seven countries.

The generic ingredient in KAPSPARGO SPRINKLE is metoprolol succinate. There are sixty drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the metoprolol succinate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Kapspargo Sprinkle

A generic version of KAPSPARGO SPRINKLE was approved as metoprolol succinate by ACTAVIS LABS FL INC on August 3^rd, 2009.

Summary for KAPSPARGO SPRINKLE

International Patents:	8
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Drug Prices:	Drug price information for KAPSPARGO SPRINKLE
DailyMed Link:	KAPSPARGO SPRINKLE at DailyMed

See drug prices for KAPSPARGO SPRINKLE

Pharmacology for KAPSPARGO SPRINKLE

Drug Class	beta-Adrenergic Blocker
Mechanism of Action	Adrenergic beta-Antagonists

US Patents and Regulatory Information for KAPSPARGO SPRINKLE

KAPSPARGO SPRINKLE is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Spil	KAPSPARGO SPRINKLE	metoprolol succinate	CAPSULE, EXTENDED RELEASE;ORAL	210428-001	Jan 26, 2018		RX	Yes	No			Y
Spil	KAPSPARGO SPRINKLE	metoprolol succinate	CAPSULE, EXTENDED RELEASE;ORAL	210428-001	Jan 26, 2018		RX	Yes	No			Y
Spil	KAPSPARGO SPRINKLE	metoprolol succinate	CAPSULE, EXTENDED RELEASE;ORAL	210428-002	Jan 26, 2018		RX	Yes	No			Y
Spil	KAPSPARGO SPRINKLE	metoprolol succinate	CAPSULE, EXTENDED RELEASE;ORAL	210428-002	Jan 26, 2018		RX	Yes	No			Y
Spil	KAPSPARGO SPRINKLE	metoprolol succinate	CAPSULE, EXTENDED RELEASE;ORAL	210428-003	Jan 26, 2018		RX	Yes	No			Y
Spil	KAPSPARGO SPRINKLE	metoprolol succinate	CAPSULE, EXTENDED RELEASE;ORAL	210428-004	Jan 26, 2018		RX	Yes	Yes			Y
Spil	KAPSPARGO SPRINKLE	metoprolol succinate	CAPSULE, EXTENDED RELEASE;ORAL	210428-004	Jan 26, 2018		RX	Yes	Yes			Y

International Patents for KAPSPARGO SPRINKLE

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

Country	Patent Number	Title	Estimated Expiration
Brazil	112017000468	forma de dosagem de cápsula de liberação prolongada
Canada	2954474	FORME DOSIFIEE DE CAPSULE DE SUCCINATE DE METOPROLOL (CAPSULE DOSAGE FORM OF METOPROLOL SUCCINATE)
European Patent Office	3166599	FORME DOSIFIÉE DE CAPSULE DE SUCCINATE DE MÉTOPROLOL (CAPSULE DOSAGE FORM OF METOPROLOL SUCCINATE)
Japan	6626492
Japan	2017523164	コハク酸メトプロロールのカプセル剤形
Mexico	2017000384	FORMA DE DOSIFICACION EN CAPSULAS DE SUCCINATO DE METOPROLOL. (CAPSULE DOSAGE FORM OF METOPROLOL SUCCINATE.)
World Intellectual Property Organization (WIPO)	2016005934

Market Dynamics and Financial Trajectory for KAPSPARGO SPRINKLE

Introduction to KAPSPARGO SPRINKLE

KAPSPARGO SPRINKLE, developed by Sun Pharmaceutical Industries Ltd., is a patented formulation of metoprolol succinate, an extended-release sprinkle formulation of the beta1-selective adrenoreceptor blocking agent (beta-blocker). This innovative drug is designed to treat hypertension, angina pectoris (chest pain), and heart failure, with a unique feature that allows it to be sprinkled over soft food or administered via a nasogastric tube, facilitating long-term, once-daily administration, particularly for patients with difficulty swallowing tablets[4].

Market Launch and Approval

KAPSPARGO SPRINKLE was launched in the US in August 2018, following approval by the US Food and Drug Administration (USFDA). This launch marked a significant milestone for Sun Pharma, as it introduced a novel formulation that addresses a common issue faced by many patients requiring long-term care – difficulty in swallowing tablets[4].

Target Market and Patient Needs

The drug targets a substantial patient population, with approximately 40% of patients requiring long-term care experiencing difficulty swallowing. This issue can lead to non-adherence to medications and medication errors. KAPSPARGO SPRINKLE’s innovative formulation aims to improve patient compliance and reduce these risks[4].

Market Size and Growth Potential

The global market for post-traumatic stress disorder (PTSD) treatment, while not directly related to KAPSPARGO SPRINKLE, provides a broader context of the growing demand for innovative pharmaceuticals. However, for KAPSPARGO SPRINKLE, the relevant market is the cardiovascular segment. The metoprolol succinate extended-release tablets, which KAPSPARGO SPRINKLE is based on, have annual sales of around $600-700 million in the US alone[4].

Competitive Landscape

The launch of KAPSPARGO SPRINKLE places Sun Pharma in a competitive position within the cardiovascular drug market. The unique sprinkle formulation differentiates it from traditional metoprolol succinate tablets, offering a significant advantage in patient compliance and ease of administration. However, the generics market, particularly in the US, is highly competitive, with intense pricing pressures and increasing competition from new entrants[3].

Financial Performance and Projections

Sun Pharma's financial performance has been robust, with revenues growing by 10% to Rs.287 Billion in FY19. The company's US revenues increased by 22% to Rs.107 Billion, driven by generics sales and specialty product launches, including KAPSPARGO SPRINKLE. The drug's contribution to Sun Pharma's revenue is expected to be significant, given its market size and the company's strong positioning in the US generics market[3].

Pricing and Affordability

The pricing of KAPSPARGO SPRINKLE varies based on dosage strength. For example, a 30-capsule supply of the 25 mg or 50 mg formulation costs around $67.99, while the 100 mg and 200 mg formulations cost $78.86 and $116.07, respectively. These prices are competitive within the market and are designed to be accessible to patients, especially considering the financial assistance programs available[2].

Research and Development (R&D) Investments

Sun Pharma's R&D investments are crucial for the development and launch of innovative products like KAPSPARGO SPRINKLE. The company invested approximately Rs.20 Billion in R&D in FY19, focusing on complex generics and specialty products. These investments are expected to continue, driving future growth and profitability[3].

Regional Market Performance

North America, particularly the US, is a key market for KAPSPARGO SPRINKLE. Sun Pharma's strong presence in this region, coupled with the drug's unique features, positions it well for market dominance. The company's growth in emerging markets and other regions also contributes to its overall financial trajectory[1].

Challenges and Opportunities

Despite the competitive advantages of KAPSPARGO SPRINKLE, the generics market faces challenges such as intense competition, pricing pressures, and regulatory hurdles. However, Sun Pharma's focus on innovation, cost control, and expanding its product pipeline presents significant opportunities for growth. The company's investments in branding and promotion of its specialty products, including KAPSPARGO SPRINKLE, are expected to enhance its market presence[3].

Patient Assistance Programs

To enhance affordability, Sun Pharma and other pharmaceutical companies often offer patient assistance programs. For KAPSPARGO SPRINKLE, these programs can help cover coinsurance, copayments, healthcare premiums, and deductibles, making the drug more accessible to a broader patient population[2].

Future Outlook

The future outlook for KAPSPARGO SPRINKLE is promising, given its innovative formulation and the growing demand for cardiovascular treatments. Sun Pharma's continued investment in R&D and its strong market presence are expected to drive the drug's financial performance. As the company navigates the competitive generics market, its focus on differentiated products and patient compliance is likely to yield positive results.

Key Takeaways

• Innovative Formulation: KAPSPARGO SPRINKLE offers a unique sprinkle formulation that addresses the issue of difficulty in swallowing tablets.
• Market Size: The drug targets a significant market with annual sales of metoprolol succinate extended-release tablets in the US exceeding $600-700 million.
• Financial Performance: Sun Pharma's robust financial performance, driven by generics sales and specialty product launches, positions KAPSPARGO SPRINKLE for success.
• Pricing and Affordability: Competitive pricing and patient assistance programs make the drug accessible to a broad patient population.
• R&D Investments: Continued investments in R&D are crucial for the drug's long-term success and market dominance.

FAQs

Q1: What is KAPSPARGO SPRINKLE used for? KAPSPARGO SPRINKLE is used to treat hypertension, angina pectoris (chest pain), and heart failure.

Q2: What makes KAPSPARGO SPRINKLE unique? KAPSPARGO SPRINKLE is an extended-release sprinkle formulation of metoprolol succinate, which can be sprinkled over soft food or administered via a nasogastric tube, facilitating long-term, once-daily administration for patients with difficulty swallowing tablets.

Q3: How much does KAPSPARGO SPRINKLE cost? The cost of KAPSPARGO SPRINKLE varies by dosage strength, ranging from $67.99 for a 30-capsule supply of the 25 mg or 50 mg formulation to $116.07 for the 200 mg formulation.

Q4: Is KAPSPARGO SPRINKLE available in generic form? No, KAPSPARGO SPRINKLE is currently available only as a brand name drug, with no generic version available yet[2].

Q5: What are the future growth prospects for KAPSPARGO SPRINKLE? The future outlook for KAPSPARGO SPRINKLE is promising due to its innovative formulation, growing demand for cardiovascular treatments, and Sun Pharma's strong market presence and continued R&D investments.

Cited Sources

1. Global Post-Traumatic Stress Disorder Treatment Market to Surpass US$ 1,380.0 Million by 2028, Says Coherent Market Insights (CMI). Business Wire.
2. Kapspargo Sprinkle Prices, Coupons, Copay Cards & Patient Assistance. Drugs.com.
3. Sun Pharmaceutical Industries Chairman's Speech. Moneycontrol.
4. Sun Pharma launches Kapspargo Sprinkle in US; drug can treat chest pain, high blood pressure. Moneycontrol.