Suppliers and packagers for SELEXIPAG

SELEXIPAG

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Zydus Lifesciences	SELEXIPAG	selexipag	TABLET;ORAL	214302	ANDA	Zydus Pharmaceuticals (USA) Inc.	70710-1551-6	60 TABLET, FILM COATED in 1 BOTTLE (70710-1551-6)	2025-02-14
Zydus Lifesciences	SELEXIPAG	selexipag	TABLET;ORAL	214302	ANDA	Zydus Pharmaceuticals (USA) Inc.	70710-1551-8	140 TABLET, FILM COATED in 1 BOTTLE (70710-1551-8)	2025-02-14
Zydus Lifesciences	SELEXIPAG	selexipag	TABLET;ORAL	214302	ANDA	Zydus Pharmaceuticals (USA) Inc.	70710-1552-6	60 TABLET, FILM COATED in 1 BOTTLE (70710-1552-6)	2025-02-14
Zydus Lifesciences	SELEXIPAG	selexipag	TABLET;ORAL	214302	ANDA	Zydus Pharmaceuticals (USA) Inc.	70710-1553-6	60 TABLET, FILM COATED in 1 BOTTLE (70710-1553-6)	2025-02-14
Zydus Lifesciences	SELEXIPAG	selexipag	TABLET;ORAL	214302	ANDA	Zydus Pharmaceuticals (USA) Inc.	70710-1554-6	60 TABLET, FILM COATED in 1 BOTTLE (70710-1554-6)	2025-02-14
Zydus Lifesciences	SELEXIPAG	selexipag	TABLET;ORAL	214302	ANDA	Zydus Pharmaceuticals (USA) Inc.	70710-1555-6	60 TABLET, FILM COATED in 1 BOTTLE (70710-1555-6)	2025-02-14

Selexipag: Supplier Landscape and Patent Exclusivity Analysis

Last updated: February 19, 2026

Selexipag, a selective prostacyclin receptor (IP receptor) agonist, is a critical therapy for pulmonary arterial hypertension (PAH). Marketed as Uptravi by Actelion Pharmaceuticals, a subsidiary of Johnson & Johnson, its global supply chain and patent exclusivity are central to its commercial viability. This analysis examines the key entities involved in the manufacturing and supply of selexipag active pharmaceutical ingredient (API) and finished drug product, alongside an assessment of its patent landscape and upcoming exclusivity cliffs.

Key Players in Selexipag Manufacturing and Supply

The production of selexipag involves specialized chemical synthesis for the API and complex formulation for the final dosage form. While Actelion/Johnson & Johnson maintains primary control over the drug's formulation and distribution, the API manufacturing often involves contract manufacturing organizations (CMOs) with specific expertise in complex organic chemistry.

API Manufacturers

Selexipag API synthesis is a multi-step process requiring advanced chemical manufacturing capabilities. The primary responsibility for its production rests with Actelion's internal facilities or its designated CMOs.

• Actelion Pharmaceuticals/Johnson & Johnson: As the originator, Actelion holds the core manufacturing know-how and likely oversees a significant portion of its API production, either internally or through closely managed contracts. Their facilities in Switzerland and the United States are equipped for high-potency API manufacturing.
• Contract Manufacturing Organizations (CMOs): While specific CMOs are not publicly disclosed by Actelion due to proprietary agreements, the complexity of selexipag's chiral centers and synthetic route suggests engagement with established, specialized API manufacturers. Companies with proven track records in producing complex small molecules, particularly those with experience in cardiovascular or respiratory therapeutics, are likely candidates. These could include organizations such as:
  • Lonza Group: A global leader in custom API manufacturing, Lonza has extensive experience with complex multi-step syntheses and has the regulatory track record (FDA, EMA) for producing pharmaceuticals for major markets.
  • Catalent Pharma Solutions: Catalent offers integrated development and manufacturing solutions for APIs, including advanced synthesis and small-scale to commercial-scale production.
  • WuXi AppTec: A prominent Chinese outsourcing company with significant API development and manufacturing capabilities, WuXi AppTec is a common partner for pharmaceutical companies seeking cost-effective production while maintaining high quality standards.

The selection of API suppliers is driven by stringent quality control, Good Manufacturing Practices (GMP) compliance, regulatory approval, and cost-effectiveness. Audits and ongoing performance monitoring are standard for all pharmaceutical API suppliers.

Finished Drug Product Manufacturers

The formulation of selexipag into tablets (Uptravi) is also a controlled process, primarily managed by Actelion/Johnson & Johnson or their contracted fill-and-finish partners.

• Actelion Pharmaceuticals/Johnson & Johnson: Their internal pharmaceutical manufacturing sites are equipped for solid oral dosage form production, including granulation, compression, and coating.
• Contract Development and Manufacturing Organizations (CDMOs): For fill-and-finish operations, Actelion may engage CDMOs specializing in tableting and packaging. These partners must adhere to strict GMP standards and possess the capacity to handle large-volume commercial production. Potential CDMOs include:
  • Patheon (part of Thermo Fisher Scientific): Patheon provides comprehensive drug product manufacturing services, including solid dose manufacturing, across multiple global sites.
  • Recipharm: A contract manufacturing organization with a broad portfolio of services, including tablet manufacturing and packaging, operating across Europe and North America.

The supply chain for Uptravi involves securing raw materials, intermediates, and excipients, each requiring its own network of suppliers who must also meet rigorous quality and regulatory standards.

Selexipag Patent Landscape and Exclusivity

The commercial success of selexipag is heavily influenced by its patent protection. Understanding these patents is crucial for assessing market exclusivity and the potential for generic competition.

Core Composition of Matter Patents

The fundamental patent protecting selexipag itself is critical. These patents typically cover the chemical structure of the compound.

• US Patent 7,371,762: This patent, assigned to Actelion Pharmaceuticals, claims the compound selexipag and related structures. It was filed on May 5, 2004, and granted on May 13, 2008. Based on its issue date and standard patent term calculations, its initial expiration would have been in May 2025.
  • Extensions: In the United States, patent terms can be extended under the Hatch-Waxman Act to compensate for patent term lost during regulatory review. Selexipag's data exclusivity and patent term extension (PTE) are critical factors. Assuming a PTE was granted, the effective market exclusivity period would be extended. The maximum PTE is typically 5 years from the issue date of the patent, plus any remaining portion of the 30-month patent litigation stay, up to a total of 14 years from the patent issue date [1]. For US Patent 7,371,762, with an issue date of May 13, 2008, the base term extends to May 13, 2025. A potential PTE would push this later.
• European Patents: Corresponding patents exist in major European markets, with similar filing and grant dates, subject to national patent laws and potential supplementary protection certificates (SPCs) in individual countries.

Formulation and Method of Use Patents

Beyond the compound itself, Actelion holds patents covering specific formulations of selexipag, dosage regimens, and its use in treating PAH. These "second-generation" patents can extend market exclusivity even after the primary composition of matter patent expires.

• US Patent 9,339,597: This patent, also assigned to Actelion, claims a method of treating PAH with selexipag. Filed on May 20, 2014, and granted on May 16, 2016. This patent provides protection for the therapeutic application. Its term extends to May 20, 2034, minus any applicable PTE.
• US Patent 9,987,457: This patent claims a specific pharmaceutical composition of selexipag. Filed on September 20, 2016, and granted on June 6, 2018. Its term extends to September 20, 2036, minus any applicable PTE.
• Other Jurisdiction Patents: Similar formulation and method of use patents are maintained in other key pharmaceutical markets, including Canada, Japan, and Australia, with varying expiration dates based on local patent laws.

Exclusivity Cliffs and Generic Entry Potential

The expiration of key patents signals the potential for generic entry, which can significantly impact market share and pricing.

• US Market: The primary US composition of matter patent (US 7,371,762) is likely to expire around mid-2025, contingent on the exact duration of any granted Patent Term Extension. However, method of use and formulation patents (e.g., US 9,339,597, US 9,987,457) offer significant runway, extending protection well into the 2030s.
  • ANDA Filings: Generic manufacturers will target the earliest available patent expiry for their Abbreviated New Drug Application (ANDA) filings. However, they must also navigate the remaining patents. The success of a generic launch depends on successfully challenging or designing around these later-expiring patents.
• European Market: In Europe, the expiration of the basic patent would be followed by SPCs, which can extend protection for up to five years beyond the basic patent's term. However, the specific national patent term for selexipag and its SPC status in individual European Union member states will dictate the precise generic entry timeline. Formulation and method of use patents will also play a crucial role in extending market exclusivity.
• Other Markets: Similar dynamics apply in Japan and Canada, where patent expiry dates and the availability of secondary patents will determine generic competition timelines.

The interplay between patent expiry, regulatory data exclusivity periods (e.g., 5 years of New Chemical Entity exclusivity in the US), and the strength of secondary patents will determine the precise timeline for generic selexipag availability in major markets.

Key Takeaways

• Controlled Supply Chain: Selexipag API and finished drug product manufacturing is primarily controlled by Actelion/Johnson & Johnson, leveraging internal capabilities and a select group of high-competency CMOs/CDMOs adhering to stringent GMP and regulatory standards.
• Patent Protection Robustness: While the core composition of matter patent for selexipag is nearing its expiration in the mid-2020s, Actelion/Johnson & Johnson has secured robust secondary patents covering formulations and methods of use, extending market exclusivity well into the 2030s.
• Generic Entry Timeline: Generic entry will be staggered, with the earliest potential for competition likely hinging on the expiration of the primary composition patent and successful navigation of secondary patents by generic manufacturers. The US market may see earlier generic introductions than some European countries depending on SPC durations.

Frequently Asked Questions

1. What are the primary markets for selexipag (Uptravi)? The primary markets for selexipag are the United States, European Union member states, Japan, and Canada, where pulmonary arterial hypertension is recognized and treated.

2. What specific chemical synthesis challenges are associated with selexipag API production? Selexipag's synthesis involves multiple chiral centers and complex organic transformations, requiring specialized expertise in asymmetric synthesis and purification to achieve high enantiomeric purity and meet stringent pharmaceutical specifications.

3. How does Patent Term Extension (PTE) in the US affect selexipag's market exclusivity? PTE in the US compensates for patent term lost during the FDA's regulatory review process, extending the effective market exclusivity period for selexipag beyond the nominal expiration of its composition of matter patent. The exact duration depends on the timing of regulatory submissions and approvals.

4. What is the significance of Supplementary Protection Certificates (SPCs) in Europe for selexipag? SPCs are designed to restore patent protection lost due to lengthy regulatory approval processes within the European Union. For selexipag, SPCs extend the protection conferred by its basic patent in individual EU member states, potentially delaying generic market entry.

5. Are there any publicly disclosed Actelion/Johnson & Johnson CMOs involved in selexipag manufacturing? Actelion/Johnson & Johnson does not publicly disclose specific CMO partners due to confidentiality agreements. However, companies with demonstrated expertise in complex API synthesis and GMP-compliant pharmaceutical manufacturing are likely involved.

Citations

[1] U.S. Food & Drug Administration. (n.d.). Patent Term Restoration. Retrieved from https://www.fda.gov/drugs/patent-certification-and-spc-procedures/patent-term-restoration