Suppliers and packagers for OGSIVEO

OGSIVEO

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Springworks	OGSIVEO	nirogacestat hydrobromide	TABLET;ORAL	217677	NDA	SpringWorks Therapeutics, Inc.	82448-100-14	14 TABLET, FILM COATED in 1 BLISTER PACK (82448-100-14)	2023-11-27
Springworks	OGSIVEO	nirogacestat hydrobromide	TABLET;ORAL	217677	NDA	SpringWorks Therapeutics, Inc.	82448-150-14	14 TABLET, FILM COATED in 1 BLISTER PACK (82448-150-14)	2023-11-27

OGSIVEO (Nirogacestat) Supplier Landscape

Last updated: February 19, 2026

This report analyzes the supplier landscape for OGSIVEO (nirogacestat), a novel drug for desmoid tumors. The analysis focuses on the primary manufacturers, excipient providers, and packaging suppliers critical to OGSIVEO's production. Key patent data and regulatory filings are examined to identify potential supply chain risks and opportunities.

What is OGSIVEO (Nirogacestat)?

OGSIVEO (nirogacestat) is an oral, twice-daily, selective gamma-secretase inhibitor. Gamma-secretase is an enzyme complex involved in the Notch signaling pathway. Aberrant activation of the Notch pathway is implicated in the pathogenesis of desmoid tumors, a group of rare, aggressive fibrotic neoplasms [1]. By inhibiting gamma-secretase, nirogacestat disrupts this signaling pathway, thereby aiming to reduce tumor growth and progression.

On November 22, 2023, OGSIVEO received FDA approval for the treatment of adult and pediatric patients 12 years of age and older with progressing desmoid tumors who require systemic treatment [1]. This approval marks the first FDA-approved therapy specifically for desmoid tumors, a condition with historically limited treatment options.

Who Manufactures OGSIVEO?

The active pharmaceutical ingredient (API) for OGSIVEO is nirogacestat. The drug is developed and commercialized by SpringWorks Therapeutics, Inc. [1]. SpringWorks Therapeutics is responsible for the overall manufacturing and supply chain management of OGSIVEO.

While SpringWorks Therapeutics holds the marketing authorization, the actual manufacturing of the API and the finished drug product is typically outsourced to Contract Development and Manufacturing Organizations (CDMOs). Identifying specific CDMOs involved in nirogacestat production requires access to detailed supply chain agreements, which are generally proprietary. However, major pharmaceutical CDMOs with expertise in small molecule API synthesis and finished dosage form manufacturing are likely partners.

Likely CDMO Capabilities:

• API Synthesis: Facilities capable of multi-step organic synthesis under current Good Manufacturing Practices (cGMP).
• Formulation Development: Expertise in developing stable oral solid dosage forms (tablets or capsules).
• Commercial Scale Manufacturing: Large-scale production capacity for API and finished product.
• Analytical Testing and Quality Control: Robust systems for ensuring product purity, potency, and stability.

SpringWorks Therapeutics manages the selection, auditing, and oversight of these CDMO partners to ensure compliance with regulatory standards and maintain supply chain integrity.

What Excipients are Used in OGSIVEO?

The precise list of excipients used in OGSIVEO's formulation is detailed in its regulatory filings, specifically the New Drug Application (NDA) submitted to the FDA. While not publicly disclosed in exhaustive detail, typical excipients in oral solid dosage forms include:

• Fillers/Diluents: To provide bulk to the tablet or capsule, such as microcrystalline cellulose, lactose, or dicalcium phosphate.
• Binders: To hold the tablet ingredients together, like povidone or hydroxypropyl methylcellulose (HPMC).
• Disintegrants: To help the tablet break apart in the digestive tract, such as croscarmellose sodium or sodium starch glycolate.
• Lubricants: To prevent ingredients from sticking to manufacturing equipment, commonly magnesium stearate or stearic acid.
• Glidants: To improve powder flow, such as colloidal silicon dioxide.
• Coating Agents: For tablet film coating, which can include polymers (e.g., HPMC, polyethylene glycol), plasticizers, and colorants.

Key Excipient Suppliers:

The pharmaceutical industry relies on a global network of excipient manufacturers. Major suppliers for these common excipients include:

• DuPont (now IFF): A significant supplier of microcrystalline cellulose (MCC) and other cellulosic derivatives.
• Ashland: Provides binders, disintegrants, and coating polymers.
• BASF: A large producer of excipients, including povidones and crospovidones.
• JRS Pharma: Offers a range of cellulose-based excipients.
• Colorcon: Specializes in pharmaceutical film coatings and excipients.

SpringWorks Therapeutics, through its manufacturing partners, will source these excipients from qualified suppliers who meet stringent cGMP standards and have a proven track record of quality and reliability. The selection of excipients also considers their compatibility with nirogacestat, the desired release profile, and manufacturing feasibility.

What are the Packaging Requirements for OGSIVEO?

OGSIVEO is supplied as an oral solid dosage form, likely in bottles or blister packs. Packaging plays a critical role in protecting the drug from environmental factors such as moisture, light, and oxygen, thereby ensuring its stability and shelf life.

Primary Packaging Components:

• Bottles: High-density polyethylene (HDPE) or glass bottles, typically with child-resistant closures.
• Caps/Closures: Including liners to ensure a tight seal.
• Blister Packs: Often made from polyvinyl chloride (PVC) or thermoformable plastics, with backing foils (e.g., aluminum).
• Desiccants: Silica gel packets may be included in bottles to absorb moisture.

Secondary Packaging Components:

• Cartons: Printed cardboard boxes containing the primary packaging.
• Labels: Providing essential information for identification, dosage, and warnings.
• Patient Information Leaflets: Detailing usage instructions, side effects, and other important information.

Key Packaging Suppliers:

The pharmaceutical packaging sector is diverse, with specialized suppliers for each component.

• Berry Global: A large manufacturer of plastic packaging solutions, including bottles and closures for pharmaceuticals.
• Amcor: Offers a wide range of rigid and flexible packaging, including pharmaceutical bottles and blister pack films.
• Schott AG: A leading supplier of pharmaceutical glass tubing and packaging, including vials and bottles.
• Multi-Pack: Specializes in blister packaging solutions.
• Cylindrella: Provides specialized closures and dispensing systems.

The choice of packaging materials is critical for maintaining OGSIVEO's stability. Stability studies, conducted during drug development, will determine the most suitable primary packaging to ensure the drug remains within its quality specifications throughout its intended shelf life.

Intellectual Property and Patent Landscape

The patent landscape surrounding nirogacestat is a key determinant of its market exclusivity and the long-term supply chain strategy. SpringWorks Therapeutics holds patents protecting the composition of matter, methods of use, and potentially manufacturing processes for nirogacestat.

Key Patent Considerations:

• Composition of Matter Patents: These patents protect the nirogacestat molecule itself and typically provide the longest period of exclusivity.
• Method of Use Patents: These patents cover the use of nirogacestat for treating specific conditions, such as desmoid tumors.
• Formulation Patents: Patents that claim specific pharmaceutical compositions or dosage forms of nirogacestat.
• Process Patents: Patents that protect specific methods of manufacturing nirogacestat or its intermediates.

As of OGSIVEO's approval in November 2023, SpringWorks Therapeutics possesses patents that provide market exclusivity. The primary composition of matter patent for nirogacestat, if still in force, would be a significant asset. The expiration of these key patents will pave the way for generic competition.

Patent Expiration and Generic Entry:

The earliest possible date for generic entry is typically 7 years after the approval of a new molecular entity (NME) in the US, under the Hatch-Waxman Act, in certain circumstances, or the expiration of the primary patent. However, patent term extensions and other regulatory exclusivities can extend market protection.

• US Patent Protection: SpringWorks Therapeutics benefits from regulatory exclusivities and patent protection for OGSIVEO. The exact duration of these protections is crucial for strategic planning.
• Global Patent Strategy: SpringWorks Therapeutics will have secured patent protection in key global markets.
• Potential for Litigation: The patent landscape for NMEs is often subject to challenges by potential generic manufacturers, which can lead to complex litigation.

Companies considering OGSIVEO's long-term supply chain or investment need to thoroughly analyze the patent portfolio, including granted patents, pending applications, and potential expiration dates for the core molecule and key therapeutic uses.

Regulatory Landscape and Supply Chain Compliance

The manufacturing and distribution of OGSIVEO are subject to stringent regulatory oversight by health authorities worldwide, primarily the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Compliance with current Good Manufacturing Practices (cGMP) is mandatory at all stages of the supply chain.

Key Regulatory Requirements:

• cGMP Compliance: All manufacturing facilities, including those for API and finished drug product, must adhere to cGMP guidelines. This covers aspects like quality management systems, personnel training, facility maintenance, process validation, and record-keeping.
• Drug Master Files (DMFs): API manufacturers typically file DMFs with regulatory agencies. These confidential documents contain detailed information about the manufacturing process, facilities, and quality controls for the API.
• Site Inspections: Regulatory agencies conduct routine inspections of manufacturing sites to ensure ongoing cGMP compliance.
• Quality Agreements: Formal Quality Agreements between SpringWorks Therapeutics and its CDMOs are essential. These agreements define the responsibilities of each party regarding manufacturing, quality control, change management, and issue resolution.
• Supply Chain Security: Measures to prevent counterfeiting, diversion, and adulteration of the drug product throughout the supply chain are critical. This includes serialization and track-and-trace requirements.
• Post-Approval Changes: Any changes to the manufacturing process, suppliers, or specifications must be reported to and, in many cases, approved by regulatory authorities.

Impact on Suppliers:

Suppliers of raw materials, excipients, and packaging must also demonstrate cGMP compliance or adherence to equivalent quality standards. They are subject to audits by both SpringWorks Therapeutics and its CDMO partners to ensure the quality and consistency of their products. Failure by any supplier to meet these standards can disrupt the entire OGSIVEO supply chain and lead to regulatory action.

Supply Chain Risks and Mitigation Strategies

The supply chain for a novel pharmaceutical like OGSIVEO is complex and inherently carries risks. Identifying and mitigating these risks is paramount for ensuring uninterrupted patient access to the medication.

Potential Supply Chain Risks:

1. API Manufacturing Dependence: Reliance on a limited number of CDMOs for nirogacestat API production. A disruption at a single site due to quality issues, regulatory non-compliance, or geopolitical events could have severe consequences.
2. Excipient Sourcing: Dependence on a few key suppliers for critical excipients. Shortages or quality issues with a single excipient can halt production.
3. Packaging Material Availability: Limited availability or quality issues with specialized pharmaceutical packaging components.
4. Geopolitical Instability and Trade Restrictions: Disruptions to international shipping routes, trade wars, or political unrest in regions where key suppliers are located.
5. Natural Disasters and Pandemics: Events like earthquakes, floods, or widespread health crises can impact manufacturing capacity and logistics.
6. Intellectual Property Challenges: Litigation over patents can lead to uncertainty and potential market disruption if generic competitors emerge prematurely.
7. Regulatory Changes: Evolving regulatory requirements for manufacturing and supply chain integrity.

Mitigation Strategies:

• Dual Sourcing: Establishing relationships with at least two qualified suppliers for critical raw materials, excipients, and packaging components where feasible.
• Supplier Audits and Qualification: Rigorous and regular auditing of all critical suppliers to ensure cGMP compliance and robust quality systems.
• Inventory Management: Maintaining strategic safety stock of key raw materials, intermediates, and finished product to buffer against short-term supply disruptions.
• Geographic Diversification: Sourcing from suppliers located in different geographic regions to reduce exposure to localized risks.
• Contingency Planning: Developing detailed business continuity plans for all critical supply chain nodes.
• Close Regulatory Engagement: Proactive communication with regulatory agencies regarding any potential supply chain issues.
• Contractual Safeguards: Robust contracts with suppliers that include clear quality standards, supply commitments, and penalties for non-compliance.
• Technological Advancement: Investing in supply chain visibility tools and advanced analytics to monitor potential risks in real-time.

SpringWorks Therapeutics and its manufacturing partners must continuously monitor the global supply chain for OGSIVEO, adapt to emerging risks, and ensure the robust qualification and oversight of all suppliers to maintain a reliable and compliant supply.

Key Takeaways

• OGSIVEO (nirogacestat) is a first-in-class treatment for desmoid tumors, approved by the FDA in November 2023.
• SpringWorks Therapeutics, Inc. is the commercializing entity, responsible for the OGSIVEO supply chain.
• API and finished drug product manufacturing are typically outsourced to specialized CDMOs under strict cGMP controls.
• The formulation of OGSIVEO requires standard pharmaceutical excipients, sourced from global suppliers with proven quality and compliance.
• Primary and secondary packaging are critical for product stability and regulatory compliance, involving specialized packaging manufacturers.
• SpringWorks Therapeutics holds key patents protecting nirogacestat, providing market exclusivity that will eventually expire, opening the door for generic competition.
• Supply chain integrity is maintained through rigorous cGMP compliance, supplier qualification, and adherence to evolving regulatory requirements.
• Potential risks include API manufacturing dependence, excipient shortages, geopolitical instability, and IP challenges, necessitating strategies like dual sourcing and robust contingency planning.

Frequently Asked Questions

What is the primary active pharmaceutical ingredient (API) in OGSIVEO?

The primary API in OGSIVEO is nirogacestat.

Which company is responsible for the commercialization and supply of OGSIVEO?

SpringWorks Therapeutics, Inc. is responsible for the commercialization and supply of OGSIVEO.

Does SpringWorks Therapeutics manufacture OGSIVEO in-house, or is it outsourced?

The manufacturing of OGSIVEO's API and finished drug product is typically outsourced to Contract Development and Manufacturing Organizations (CDMOs).

What are the main categories of excipients used in oral solid dosage forms like OGSIVEO?

Excipients commonly used include fillers/diluents, binders, disintegrants, lubricants, glidants, and coating agents.

What is the typical timeline for generic competition following the approval of a new molecular entity like OGSIVEO?

Generic competition typically becomes possible after the expiration of primary patents and any applicable regulatory exclusivities, which can vary but often commence around 7 years post-approval in the US under specific provisions of the Hatch-Waxman Act.

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Cited Sources

[1] U.S. Food and Drug Administration. (2023). FDA approves first treatment for desmoid tumors. Retrieved from FDA Press Release (Note: A direct, stable URL to a specific press release is ideal if available. If not, a general link to the FDA's press release archive or relevant drug approval page may be used, but specificity is preferred).