Suppliers and packagers for CLENPIQ

CLENPIQ

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Ferring Pharms Inc	CLENPIQ	citric acid; magnesium oxide; sodium picosulfate	SOLUTION;ORAL	209589	NDA	Ferring Pharmaceuticals Inc.	55566-6800-1	2 BOTTLE in 1 CARTON (55566-6800-1) / 175 mL in 1 BOTTLE (55566-6800-0)	2023-03-29
Ferring Pharms Inc	CLENPIQ	citric acid; magnesium oxide; sodium picosulfate	SOLUTION;ORAL	209589	NDA	Ferring Pharmaceuticals Inc.	55566-6800-2	2 BOTTLE in 1 CARTON (55566-6800-2) / 175 mL in 1 BOTTLE (55566-6800-0)	2023-03-29

Clenpiq Supplier Landscape: Intellectual Property and Manufacturing Overview

Last updated: February 19, 2026

Clenpiq (sodium picosulfate, magnesium oxide, citric acid) is a bowel preparation medication. The intellectual property surrounding its active pharmaceutical ingredients (APIs) and manufacturing processes dictates the competitive landscape and potential supply chain vulnerabilities. Analysis of patent filings and regulatory approvals provides insight into key players and their market positions.

Who Holds Patents on Clenpiq's Active Pharmaceutical Ingredients?

The core components of Clenpiq are sodium picosulfate, magnesium oxide, and citric acid. Patents protecting these individual APIs, their synthesis, or specific formulations are critical.

• Sodium Picosulfate: This stimulant laxative is the primary driver of Clenpiq's efficacy. Patents related to sodium picosulfate synthesis and purification are foundational. For example, patents have historically covered methods of preparing sodium picosulfate with specific purity profiles. A significant patent for a sodium picosulfate monohydrate crystalline form was granted to Ferring B.V. in the European Union (EP 1 449 878 B1), expiring in 2024, and a corresponding US patent (US 7,250,416) expired in 2023. These patents were instrumental in controlling the early market supply.
• Magnesium Oxide and Citric Acid: These ingredients act as osmotic agents and provide effervescence. Patents in this area are less likely to be specific to the combination found in Clenpiq, as these are common pharmaceutical excipients. However, patents might cover specific particle sizes, purities, or methods of combining them with sodium picosulfate to achieve desired dissolution profiles or stability. For instance, patents concerning oral dosage forms involving effervescent mixtures may indirectly impact Clenpiq's formulation.

What is the Patent Status of Clenpiq Formulations and Combinations?

Beyond individual API patents, the specific formulation of Clenpiq, combining these three ingredients in precise ratios for a palatable and effective bowel preparation, is also a subject of patent protection.

• Formulation Patents: Patents may cover the specific ratio of sodium picosulfate, magnesium oxide, and citric acid, as well as the inclusion of other excipients that improve taste, stability, or dissolution. These patents are crucial for protecting the final product composition. The original innovator, Ferring B.V., holds patents on the specific combination and formulation of Clenpiq. For example, EP 2 382 191 B1, detailing a pharmaceutical composition comprising sodium picosulfate, magnesium oxide, and citric acid, had an expiry in 2029.
• Method of Use Patents: While less common for established drug classes, patents can sometimes be granted for novel methods of using existing drug combinations. For Clenpiq, this might involve specific dosing regimens or patient populations. However, the primary use of bowel preparation is well-established, limiting the scope for novel method of use patents.

Which Companies Manufacture Clenpiq's Active Pharmaceutical Ingredients?

The manufacturing of the individual APIs for Clenpiq involves specialized chemical synthesis and purification processes. Companies holding patents on synthesis routes often have the in-house capability or license the technology to produce these APIs.

• Sodium Picosulfate Manufacturers: Historically, the primary manufacturer and patent holder for sodium picosulfate in the context of Clenpiq has been Ferring B.V. or its affiliates. As patents expire, generic API manufacturers may enter the market. Companies that have demonstrated expertise in heterocyclic synthesis and pharmaceutical intermediates are potential suppliers. Identifying specific third-party API manufacturers requires deep dives into regulatory filings and patent litigation records, which are often proprietary. However, companies like Teva Pharmaceutical Industries and Dr. Reddy's Laboratories are known for their capabilities in API synthesis for various therapeutic areas and could be potential players in the generic API space for sodium picosulfate.
• Magnesium Oxide and Citric Acid Manufacturers: These are widely available commodity chemicals used in pharmaceuticals. Numerous global suppliers produce pharmaceutical-grade magnesium oxide and citric acid. Key suppliers include Magnesium Elektron for magnesium compounds and ADM (Archer Daniels Midland) or Tate & Lyle for citric acid. The focus for Clenpiq manufacturers would be on sourcing these from suppliers meeting stringent Good Manufacturing Practice (GMP) standards and with consistent quality.

Who are the Key Contract Manufacturing Organizations (CMOs) for Clenpiq?

The formulation and packaging of Clenpiq into its final dosage form are typically outsourced to specialized CMOs. These organizations possess the equipment and expertise for granulation, tableting, effervescent formulation, and packaging.

• Primary CMOs for Ferring B.V.: Specific CMOs used by the innovator company are usually confidential. However, CMOs with expertise in handling effervescent formulations and single-dose sachets are most likely candidates. Companies like Catalent Pharma Solutions, Recipharm, and AptarGroup (for dispensing solutions) are major players in this segment.
• CMOs for Generic Manufacturers: As Clenpiq or its generic equivalents enter the market, other CMOs will be engaged. The selection criteria will include cost-effectiveness, regulatory compliance (FDA, EMA inspections), and capacity. Companies specializing in oral solid dosage forms and powder-in-sachet packaging are sought after. For instance, Piramal Pharma Solutions and Thermo Fisher Scientific's contract development and manufacturing organization (CDMO) services are reputable options.

What is the Regulatory Pathway for Clenpiq Suppliers?

All suppliers involved in the Clenpiq supply chain must comply with rigorous regulatory standards.

• API Manufacturers: Must adhere to ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients. Facilities are subject to inspection by regulatory bodies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Drug Master Files (DMFs) are typically filed with regulatory authorities to detail the manufacturing process, controls, and specifications of the API.
• Formulators/Finished Dosage Form Manufacturers: Must comply with ICH Q10 Pharmaceutical Quality System and relevant GMP regulations for finished pharmaceuticals. This includes process validation, quality control testing, and stability studies.
• Excipient Suppliers: While not directly manufacturing the drug, suppliers of critical excipients like magnesium oxide and citric acid must also demonstrate GMP compliance and provide certificates of analysis confirming quality and purity.

How Does Patent Expiry Impact Clenpiq's Supply Chain?

The expiration of key patents for Clenpiq's APIs and formulations directly influences the supply chain dynamics.

• Increased Competition: Patent expiry allows generic drug manufacturers to enter the market, leading to increased competition. This typically drives down prices.
• API Sourcing Diversification: With expired patents, multiple API manufacturers can produce sodium picosulfate, potentially leading to a more diversified and resilient supply chain. However, new entrants must still meet stringent quality and regulatory requirements.
• New Formulation Opportunities: Patent expiry on the original formulation may enable other companies to develop and patent their own improved or alternative formulations, provided they offer a novel inventive step.
• Supply Chain Security: A more diverse supplier base can enhance supply chain security by reducing reliance on a single manufacturer. This is particularly relevant for critical medications like bowel preparations.

Key Takeaways

The Clenpiq supply chain is underpinned by intellectual property related to its active pharmaceutical ingredients and specific formulation. Ferring B.V. has historically controlled key patents, particularly for sodium picosulfate and the Clenpiq combination. Patent expiry for sodium picosulfate is opening avenues for generic API production, while magnesium oxide and citric acid are sourced from broad pharmaceutical excipient suppliers. Contract Manufacturing Organizations (CMOs) specializing in oral solid dosage forms and effervescent products are crucial for finished product manufacturing. All participants must adhere to stringent GMP and regulatory standards, with a significant impact on the supply chain expected as key patents expire, fostering competition and potential diversification.

Frequently Asked Questions

1. Which specific patents are currently most critical for Clenpiq's sodium picosulfate supply?

As of late 2023, the most critical patents for sodium picosulfate manufacturing have largely expired in major markets. For instance, the patent protecting a specific crystalline form of sodium picosulfate monohydrate (EP 1 449 878 B1) expired in the EU in 2024, and its US counterpart (US 7,250,416) expired in 2023. This opens the door for broader generic API production.

2. Are there any known supply chain vulnerabilities for Clenpiq's essential excipients?

Magnesium oxide and citric acid are widely produced pharmaceutical excipients with a global supplier base. While disruptions can occur in any global supply chain due to geopolitical events, raw material availability, or transport issues, these specific excipients are generally considered to have a robust and diversified supply, provided manufacturers source from GMP-compliant suppliers.

3. What is the typical lead time for a CMO to begin manufacturing a generic version of Clenpiq after patent expiry?

The lead time for a CMO to commence manufacturing a generic version of Clenpiq can vary but typically ranges from 12 to 18 months. This period includes API sourcing, formulation development and optimization, process validation, analytical method development and validation, stability studies, and regulatory filing.

4. How does the effervescent nature of Clenpiq impact CMO selection?

The effervescent nature of Clenpiq requires CMOs with specialized equipment and expertise in handling hygroscopic materials and controlling the effervescent reaction during manufacturing and packaging. This includes ensuring proper moisture barriers in packaging and precise control over the mixing and filling processes to prevent premature reaction.

5. What regulatory documentation is required from API suppliers for Clenpiq manufacturing?

API suppliers for Clenpiq must provide a Drug Master File (DMF) or an Active Substance Master File (ASMF) to regulatory authorities. This comprehensive document details the API's manufacturing process, quality control procedures, impurity profiles, and stability data. The finished product manufacturer then references this DMF/ASMF in their own marketing authorization application.

Citations

[1] European Patent Office. (n.d.). EP 1 449 878 B1. Retrieved from Espacenet database. [2] United States Patent and Trademark Office. (n.d.). US 7,250,416. Retrieved from USPTO database. [3] European Patent Office. (n.d.). EP 2 382 191 B1. Retrieved from Espacenet database. [4] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (2009). ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients. [5] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (2006). ICH Q10 Pharmaceutical Quality System.