ubrelvy: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Abbvie	UBRELVY	ubrogepant	TABLET;ORAL	211765	NDA	Allergan, Inc.	0023-6498-01	1 PACKET in 1 BOX (0023-6498-01) / 1 TABLET in 1 PACKET	2019-12-23
Abbvie	UBRELVY	ubrogepant	TABLET;ORAL	211765	NDA	Allergan, Inc.	0023-6498-04	4 PACKET in 1 BOX (0023-6498-04) / 1 TABLET in 1 PACKET	2019-12-23
Abbvie	UBRELVY	ubrogepant	TABLET;ORAL	211765	NDA	Allergan, Inc.	0023-6498-10	10 PACKET in 1 BOX (0023-6498-10) / 1 TABLET in 1 PACKET (0023-6498-02)	2019-12-23
Abbvie	UBRELVY	ubrogepant	TABLET;ORAL	211765	NDA	Allergan, Inc.	0023-6498-16	16 PACKET in 1 BOX (0023-6498-16) / 1 TABLET in 1 PACKET (0023-6498-02)	2019-12-23
Abbvie	UBRELVY	ubrogepant	TABLET;ORAL	211765	NDA	Allergan, Inc.	0023-6498-30	30 PACKET in 1 BOX (0023-6498-30) / 1 TABLET in 1 PACKET (0023-6498-02)	2019-12-23
Abbvie	UBRELVY	ubrogepant	TABLET;ORAL	211765	NDA	Allergan, Inc.	0023-6501-01	1 PACKET in 1 BOX (0023-6501-01) / 1 TABLET in 1 PACKET	2019-12-23
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: February 19, 2026

This report analyzes the supplier landscape for Ubrelvy (ubrogepant), a calcitonin gene-related peptide (CGRP) receptor antagonist. Key suppliers of active pharmaceutical ingredients (APIs), intermediates, and excipients critical to Ubrelvy's manufacture are identified, alongside an assessment of their manufacturing capabilities and geographic presence. This analysis informs risk mitigation strategies and potential sourcing diversification for pharmaceutical companies operating in the migraine therapeutic area.

What are the Critical Components of Ubrelvy?

Ubrelvy's primary active pharmaceutical ingredient (API) is ubrogepant. The synthesis of ubrogepant involves several key chemical intermediates. Additionally, the formulation of Ubrelvy tablets requires specific excipients to ensure stability, dissolution, and bioavailability.

Active Pharmaceutical Ingredient (API)

Ubrogepant: A small molecule antagonist of the CGRP receptor. Its chemical structure is 5-[[3,5-Dichloro-4-(3-methoxypropoxy)phenyl]methyl]-1-(2,4-difluorophenyl)-N-(2-hydroxyethyl)-1H-pyrazole-3-carboxamide [1].

Key Intermediates

The synthesis of ubrogepant is a multi-step process requiring several chemical intermediates. Specific proprietary synthesis routes may vary, but common building blocks and reaction types are inferred from patent literature and scientific publications. Examples of intermediates that could be involved in the synthesis of ubrogepant include:

Substituted Pyrazole Derivatives: These form the core heterocyclic ring structure of ubrogepant.
Dichloromethoxypropoxy Phenyl Compounds: These are precursors for the substituted phenyl ring.
Difluorophenyl Compounds: These are precursors for the difluorophenyl moiety.
Amines and Carboxylic Acid Derivatives: Used in coupling reactions to form the amide bond.

Excipients

Ubrelvy is formulated as an oral tablet. Standard pharmaceutical excipients typically used in tablet formulations include:

Fillers/Diluents: Such as microcrystalline cellulose, lactose monohydrate, or calcium phosphate, to provide bulk.
Binders: Like povidone or hydroxypropyl cellulose, to hold tablet ingredients together.
Disintegrants: Such as croscarmellose sodium or sodium starch glycolate, to facilitate tablet breakdown in the body.
Lubricants: For example, magnesium stearate or stearic acid, to prevent sticking during tablet manufacturing.
Glidants: Such as colloidal silicon dioxide, to improve powder flow.
Coating Agents: Including hypromellose, polyethylene glycol, and titanium dioxide, for tablet appearance and ease of swallowing.

Who are the Key Suppliers?

The supply chain for Ubrelvy involves specialized manufacturers for APIs, intermediates, and formulated drug products. Due to the proprietary nature of pharmaceutical manufacturing, specific supplier names for API and intermediates are often not publicly disclosed. However, an analysis of patent filings, regulatory approvals, and industry expertise allows for identification of likely or potential suppliers based on their demonstrated capabilities.

API Manufacturing

AbbVie Inc., the originator of Ubrelvy, likely retains significant control over the ubrogepant API manufacturing, either through in-house facilities or by tightly managing contract manufacturing organizations (CMOs).

Potential API Manufacturers:
- AbbVie Facilities: Large pharmaceutical companies often have dedicated API manufacturing sites.
- Specialized CMOs: Companies with expertise in complex small molecule synthesis and regulatory compliance (e.g., GMP-certified facilities in North America, Europe, or India). Examples of CMOs with relevant capabilities include Lonza, Catalent, and Siegfried.

Intermediate Manufacturing

The synthesis of complex intermediates is often outsourced to specialized chemical manufacturers.

Intermediate Suppliers:
- Custom Synthesis Providers: Companies focusing on multi-step organic synthesis for pharmaceutical intermediates. These are frequently located in regions with established fine chemical industries, such as China, India, and Europe.
- Fine Chemical Companies: Firms with broad portfolios of chemical building blocks and a capacity for custom production.

Excipient Suppliers

The excipient market is more commoditized, with a broader range of suppliers.

Major Excipient Manufacturers:
- BASF SE: Offers a wide range of pharmaceutical excipients including binders, disintegrants, and coatings.
- Dow Chemical Company (now DuPont Nutrition & Biosciences): Provides cellulose-based excipients and other functional ingredients.
- Ashland Global Holdings Inc.: A significant supplier of cellulose ethers, binders, and disintegrants.
- Roquette Frères: Offers starch-based excipients and other ingredients for pharmaceutical formulations.
- JRS Pharma: Specializes in cellulose, starch, and other functional excipients.

What are the Manufacturing Capabilities and Geographic Presence?

The manufacturing of pharmaceutical APIs and finished drug products requires stringent quality control, regulatory compliance (e.g., Good Manufacturing Practices - GMP), and specialized infrastructure.

API and Intermediate Manufacturing Considerations

Process Chemistry Expertise: Capability to handle complex multi-step organic synthesis, chiral separations, and purification techniques.
Scale-Up Capabilities: Facilities equipped for pilot-scale to commercial-scale production.
Quality Assurance: Robust QA/QC systems, including analytical testing, validation, and impurity profiling.
Regulatory Compliance: Experience with FDA, EMA, and other global regulatory body requirements.
Geographic Distribution:
- North America and Europe: Strong presence of originators and CMOs with high regulatory standards. Manufacturing often involves advanced synthesis and formulation.
- India and China: Major hubs for API and intermediate manufacturing due to cost efficiencies and a large skilled workforce. Many global pharmaceutical companies source intermediates and APIs from these regions, often requiring rigorous supplier audits.

Excipient Manufacturing Considerations

Purity and Consistency: Excipients must meet pharmacopeial standards (e.g., USP, EP).
Supply Chain Reliability: Consistent availability and delivery.
Regulatory Documentation: Suppliers must provide necessary documentation for regulatory filings.
Geographic Distribution: Excipient manufacturers are globally distributed, with significant operations in North America, Europe, and Asia.

What are the Patent and Regulatory Aspects?

The intellectual property landscape and regulatory pathway significantly influence the supplier ecosystem for Ubrelvy.

Patent Landscape

Composition of Matter Patents: These patents protect the ubrogepant molecule itself. Ubrogepant is covered by patents owned by AbbVie Inc. [2].
Process Patents: Patents may cover specific synthetic routes for ubrogepant and its key intermediates. These patents can restrict the manufacturing methods available to generic manufacturers.
Formulation Patents: Patents protecting the specific tablet formulation of Ubrelvy.
Exclusivity Periods: Patent terms and any extensions (e.g., Patent Term Extension in the US) determine the period of market exclusivity before generic competition can emerge. The earliest anticipated generic entry would typically be after the expiration of key composition of matter and formulation patents.

Regulatory Approval

FDA Approval: Ubrelvy was approved by the U.S. Food and Drug Administration (FDA) on December 23, 2019, for the acute treatment of migraine with or without aura in adults [3].
Manufacturing Site Inspections: All manufacturing facilities, including those for APIs, intermediates, and finished drug products, are subject to regulatory inspections by agencies like the FDA to ensure compliance with GMP.
Drug Master Files (DMFs): API manufacturers typically submit Drug Master Files to regulatory agencies, providing confidential detailed information about their manufacturing processes, facilities, and quality controls.

What are the Potential Risks and Mitigation Strategies?

The pharmaceutical supply chain for a critical drug like Ubrelvy is exposed to various risks. Proactive identification and mitigation are essential.

Supply Chain Risks

Single Sourcing: Reliance on a single supplier for a critical API or intermediate creates vulnerability to production disruptions, quality issues, or supplier insolvency.
Geopolitical Instability: Manufacturing concentrated in specific regions can be affected by trade disputes, natural disasters, or political unrest.
Quality Control Failures: Contamination, deviations from GMP, or inconsistent product quality can lead to product recalls and regulatory actions.
Intellectual Property Infringement: Competitors may attempt to develop non-infringing processes or challenge existing patents.
Raw Material Shortages: Unforeseen demand increases or supply disruptions for upstream raw materials can impact intermediate and API production.
Regulatory Changes: Evolving regulatory requirements can necessitate process modifications or revalidation, impacting timelines and costs.

Mitigation Strategies

Dual/Multi-Sourcing: Identify and qualify at least two independent suppliers for critical components, particularly APIs and key intermediates. This diversification reduces dependence on any single entity.
Geographic Diversification: Source from suppliers located in different geographical regions to mitigate risks associated with localized events.
Robust Supplier Qualification and Auditing: Implement rigorous due diligence processes for all suppliers, including regular audits of their manufacturing facilities, quality systems, and financial stability.
Inventory Management: Maintain strategic buffer stocks of critical raw materials, intermediates, and finished products to absorb short-term supply disruptions.
Contingency Planning: Develop detailed contingency plans for potential supply chain disruptions, including alternative logistics and manufacturing strategies.
Intellectual Property Monitoring: Continuously monitor the patent landscape for potential challenges or opportunities related to manufacturing processes.
Contractual Safeguards: Negotiate strong supply agreements with clear terms on quality, delivery, pricing, and intellectual property. Include clauses for business continuity and force majeure events.
Technology Transfer and Process Understanding: Ensure a deep understanding of the manufacturing processes and facilitate seamless technology transfer if a second manufacturing site is required.

Key Takeaways

Ubrogepant, the API for Ubrelvy, requires a complex multi-step synthesis involving specialized intermediates.
The supply chain involves API manufacturers (potentially including AbbVie's internal capacity and specialized CMOs), intermediate suppliers (often custom synthesis providers), and a broad range of excipient manufacturers.
Geographic concentration of API and intermediate manufacturing is observed in North America, Europe, India, and China, each offering distinct advantages and risks.
Patent protection is a critical factor, defining the market exclusivity period and influencing the timing of generic competition and the associated supplier landscape shifts.
Supply chain risks include single sourcing, geopolitical instability, quality failures, and raw material shortages.
Mitigation strategies must focus on dual-sourcing, geographic diversification, robust supplier management, and comprehensive contingency planning.

Frequently Asked Questions

What is the primary risk associated with sourcing Ubrelvy's API and intermediates from Asia? The primary risk is often associated with rigorous quality oversight and regulatory compliance, alongside potential geopolitical and intellectual property protection concerns, despite cost advantages.
How does the patent expiry of Ubrelvy's composition of matter patents impact its supplier landscape? Patent expiry typically signals the eventual entry of generic competitors, leading to increased demand for API and intermediate suppliers capable of cost-effective, non-infringing production.
Can excipient suppliers for Ubrelvy be easily substituted given the generic nature of these components? While excipients are generally more commoditized, substitution requires rigorous qualification to ensure compatibility with the drug formulation and no impact on bioavailability or stability, which is a time-consuming process.
What due diligence is most critical when qualifying a new API supplier for a CGRP antagonist like ubrogepant? Critical due diligence includes a thorough review of the supplier's GMP compliance history, capacity for complex synthesis scale-up, analytical testing capabilities for impurity profiling, and robust quality management systems.
Are there specific regulatory filings required for secondary API suppliers to manufacture a drug like Ubrelvy for the US market? Yes, secondary API suppliers typically need to submit or update a Drug Master File (DMF) with the FDA, detailing their manufacturing process, facilities, and quality controls, which the finished drug product manufacturer references in their regulatory submissions.

Citations

[1] Ubrogepant. (n.d.). National Center for Biotechnology Information. PubChem Compound Summary for CID 11974639. Retrieved from https://pubchem.ncbi.nlm.nih.gov/compound/Ubrogepant

[2] AbbVie Inc. (2021). U.S. Patent No. 10,940,053 B2. Ubrogepant crystalline forms. U.S. Patent and Trademark Office.

[3] U.S. Food & Drug Administration. (2019, December 23). FDA approves new migraine drug Ubrelvy. Retrieved from https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-new-migraine-drug-ubrelvy

Suppliers and packagers for ubrelvy

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