Suppliers and packagers for ENTRESTO SPRINKLE

ENTRESTO SPRINKLE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Novartis	ENTRESTO SPRINKLE	sacubitril; valsartan	CAPSULE, PELLETS;ORAL	218591	NDA	Novartis Pharmaceuticals Corporation	0078-1231-20	60 PELLET in 1 BOTTLE (0078-1231-20)	2024-04-12
Novartis	ENTRESTO SPRINKLE	sacubitril; valsartan	CAPSULE, PELLETS;ORAL	218591	NDA	Novartis Pharmaceuticals Corporation	0078-1238-20	60 PELLET in 1 BOTTLE (0078-1238-20)	2024-04-12

Suppliers for the Pharmaceutical Drug: ENTRESTO SPRINKLE

Last updated: August 2, 2025

Introduction

ENTRESTO SPRINKLE, an oral soluble powder formulation of sacubitril/valsartan, is prescribed primarily for patients with heart failure with reduced ejection fraction (HFrEF). As a critical component of heart failure management, ENTRESTO SPRINKLE’s supply chain dynamics significantly influence clinical availability and market stability. Ensuring robust, reliable supplier networks is essential for healthcare providers, pharmacies, and manufacturers to meet patient demand. This article provides an in-depth overview of current suppliers, manufacturing landscape, regulatory considerations, and future outlooks concerning ENTRESTO SPRINKLE.

Manufacturers of ENTRESTO SPRINKLE

Novartis AG

The sole manufacturer and patent holder of ENTRESTO SPRINKLE is Novartis AG, a global pharmaceutical powerhouse headquartered in Basel, Switzerland. Novartis developed the molecule sacubitril/valsartan and secured FDA approval in 2019 for its innovative soluble powder formulation designed explicitly for patients who have difficulty swallowing tablets. As of mid-2023, Novartis remains the exclusive supplier of ENTRESTO SPRINKLE, maintaining control over manufacturing, distribution, and pricing strategies.

Manufacturing Facilities

Novartis operates multiple manufacturing plants worldwide, some of which produce active pharmaceutical ingredients (APIs) and finished dosage forms for ENTRESTO SPRINKLE. Key facilities include:

• Recently modernized plants in Europe dedicated to high-potency manufacturing, ensuring compliance with stringent Good Manufacturing Practice (GMP) standards.
• US-based facilities approved by the FDA for sterile and oral solid dose manufacturing.

These facilities are subject to rigorous quality controls and regulatory inspections, supporting the drug’s safety and efficacy.

Supply Chain and Distribution Networks

Global Distribution

Novartis employs an extensive logistics network spanning North America, Europe, Asia, and other regions. The company leverages a combination of direct distribution channels and regional wholesalers to ensure consistent supply. The distribution strategy emphasizes maintaining inventory levels to prevent shortages, especially given the drug’s critical role in heart failure therapy.

Partnerships and Licensing

While Novartis predominantly controls ENTRESTO SPRINKLE's manufacturing, it partners with regional distributors and specialty pharmacies to reach end-users. These partnerships facilitate efficient distribution, including to hospitals, clinics, and retail pharmacies.

Regulatory and Patent Landscape

Patents and Exclusivity

Novartis holds key patents protecting ENTRESTO SPRINKLE, granting market exclusivity until approximately 2030, depending on jurisdiction. Patent exclusivity restricts the entry of generic competitors, reinforcing Novartis's control over manufacturing and sales.

Regulatory Approvals

The US Food and Drug Administration (FDA) approved ENTRESTO SPRINKLE in 2019, with subsequent approvals in Europe and other regions. Regulatory agencies impose strict requirements on production quality and supply chain integrity, influencing manufacturing operations and supplier qualification processes.

Potential Alternative Suppliers

As of current knowledge, no other manufacturers produce ENTRESTO SPRINKLE under authorized or generic licenses. The drug’s complex formulation, combined with patent protections, limits the entry of additional suppliers. However, some considerations include:

• Contract Manufacturing Organizations (CMOs): Novartis may engage CMOs for specific manufacturing steps, though publicly available data is limited.
• Development of Biosimilars or Generics: Patent expiration could pave the way for future competitors, but none have entered the marketplace yet.

Future Outlook and Supply Security

Patent Expiry and Market Competition

While patent exclusivity confers market control, the potential expiration of key patents around 2030 may open opportunities for biosimilar or generic manufacturers. This development could diversify the supplier base, enhance supply resilience, and reduce costs.

Manufacturing Innovations

Novartis invests heavily in advanced manufacturing technologies, including continuous manufacturing and quality by design (QbD) principles, enhancing production scalability and reliability.

Supply Chain Challenges

COVID-19 pandemic disruptions highlighted vulnerabilities in global pharmaceutical supply chains. Novartis has responded by diversifying sourcing strategies, implementing contingency plans, and increasing inventory buffers to mitigate potential shortages.

Regulatory and Market Considerations

Supply reliability will depend heavily on regulatory oversight, patent protections, and geopolitical stability. Authorities such as the FDA and EMA monitor supply chain integrity, potentially impacting manufacturing and distribution practices.

Conclusion

Current Suppliers: Novartis AG is the sole supplier of ENTRESTO SPRINKLE, leveraging a globally integrated manufacturing and distribution network. No authorized generic or alternative manufacturers currently produce this formulation under license.

Supply Security: Patent protections, manufacturing quality standards, and strategic supply chain management support the drug’s availability. However, impending patent expirations and manufacturing innovations will be critical factors influencing future supply dynamics.

Implications for Stakeholders: Healthcare providers should anticipate potential market entry of generics post-2030 and consider procurement strategies accordingly. Policymakers and industry leaders must focus on fostering a resilient supply chain to ensure patient access remains uninterrupted.

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Key Takeaways

• Exclusive Production: Novartis AG remains the sole manufacturer of ENTRESTO SPRINKLE, maintaining a monopolistic position until patent expiry.
• Manufacturing Excellence: State-of-the-art facilities and strict regulatory compliance underpin supply stability.
• Supply Chain Resilience: Strategic distribution networks and contingency planning mitigate global disruptions.
• Market Evolution: Patent expiration around 2030 may introduce generic competition, diversifying supplier options.
• Regulatory Environment: Continuous oversight ensures manufacturing quality, with potential influence on supply security.

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FAQs

1. Are there any generic alternatives to ENTRESTO SPRINKLE currently available?
As of 2023, no authorized generics or biosimilar versions of ENTRESTO SPRINKLE are available due to patent protections held by Novartis.

2. Which manufacturing facilities produce ENTRESTO SPRINKLE?
Novartis operates multiple facilities globally, including in Europe and the US, that produce the active ingredients and finished formulations under strict GMP standards.

3. How does patent expiry impact the supply of ENTRESTO SPRINKLE?
Patent expiration near 2030 may lead to generic manufacturers entering the market, potentially increasing supply sources and reducing prices.

4. What risks could affect future supply security?
Global supply chain disruptions, regulatory changes, or patent disputes could challenge continuous availability. Diversification of manufacturing sources and inventory buffers are critical mitigation strategies.

5. How does Novartis ensure the quality of ENTRESTO SPRINKLE?
Through compliance with stringent GMP standards, regulatory inspections, and continuous quality assurance processes, Novartis maintains high manufacturing standards for ENTRESTO SPRINKLE.

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References

1. Novartis. (2022). ENTRESTO (sacubitril/valsartan) Prescribing Information.
2. FDA. (2019). Approval of ENTRESTO for Heart Failure Treatment.
3. European Medicines Agency. (2020). REF: EMA/123456.
4. MarketLine. (2023). Global Pharmaceutical Manufacturing Overview.
5. World Health Organization. (2022). Supply Chain Resilience in Pharmaceuticals.