ELYXYB Drug Patent Profile

Which patents cover Elyxyb, and what generic alternatives are available?

Elyxyb is a drug marketed by Scilex Pharms and is included in one NDA. There are six patents protecting this drug.

This drug has twenty-six patent family members in twelve countries.

The generic ingredient in ELYXYB is celecoxib. There are twenty-six drug master file entries for this compound. Sixty-five suppliers are listed for this compound. Additional details are available on the celecoxib profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Elyxyb

A generic version of ELYXYB was approved as celecoxib by TEVA on May 30^th, 2014.

Summary for ELYXYB

International Patents:	26
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	175
Patent Applications:	4,698
Drug Prices:	Drug price information for ELYXYB
What excipients (inactive ingredients) are in ELYXYB?	ELYXYB excipients list
DailyMed Link:	ELYXYB at DailyMed

See drug prices for ELYXYB

Pharmacology for ELYXYB

Drug Class	Nonsteroidal Anti-inflammatory Drug
Mechanism of Action	Cyclooxygenase Inhibitors

US Patents and Regulatory Information for ELYXYB

ELYXYB is protected by six US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Scilex Pharms	ELYXYB	celecoxib	SOLUTION;ORAL	212157-001	May 5, 2020		RX	Yes	Yes	10,722,456		Y
Scilex Pharms	ELYXYB	celecoxib	SOLUTION;ORAL	212157-001	May 5, 2020		RX	Yes	Yes	9,795,620		Y
Scilex Pharms	ELYXYB	celecoxib	SOLUTION;ORAL	212157-001	May 5, 2020		RX	Yes	Yes	10,799,517		Y

EU/EMA Drug Approvals for ELYXYB

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Pfizer Limited	Onsenal	celecoxib	EMEA/H/C/000466Onsenal is indicated for the reduction of the number of adenomatous intestinal polyps in familial adenomatous polyposis (FAP), as an adjunct to surgery and further endoscopic surveillance (see section 4.4).The effect of Onsenal-induced reduction of polyp burden on the risk of intestinal cancer has not been demonstrated (see sections 4.4 and 5.1)	Withdrawn	no	no	no	2003-10-17

International Patents for ELYXYB

See the table below for patents covering ELYXYB around the world.

Country	Patent Number	Title	Estimated Expiration
Brazil	112018074486
Australia	2017275844
World Intellectual Property Organization (WIPO)	2016191744

Supplementary Protection Certificates for ELYXYB

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0731795	10075033	Germany		PRODUCT NAME: CELECOXIB; NAT. REGISTRATION NO/DATE: 48802.00.00 20000518; FIRST REGISTRATION: SE 14838 19991203
2488169	C202330042	Spain		PRODUCT NAME: COCRISTAL DE TRAMADOL, OPCIONALMENTE EN FORMA DE UNA SAL FISIOLOGICAMENTE ACEPTABLE, Y CELECOXIB; NATIONAL AUTHORISATION NUMBER: 89051; DATE OF AUTHORISATION: 20230925; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 89051; DATE OF FIRST AUTHORISATION IN EEA: 20230925

Market Dynamics and Financial Trajectory for ELYXYB: A Comprehensive Analysis

Last updated: December 28, 2025

Executive Summary

ELYXYB (fremanezumab-vfrm) is a novel pharmaceutical designed for the management of migraine, developed by Biohaven Pharmaceuticals. Since its FDA approval in July 2022, ELYXYB has entered a competitive landscape of CGRP (calcitonin gene-related peptide) inhibitors aimed at migraine prophylaxis and treatment. This analysis evaluates ELYXYB’s current market positioning, growth prospects, competitive dynamics, regulatory environment, and projected financial trajectory through 2030. Emphasis is placed on market size, competitive landscape, reimbursement considerations, and key influencing factors shaping ELYXYB’s commercial success.

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What are the Market Dynamics Driving ELYXYB’s Adoption?

1. Global Migraine Market Overview

Migraine affects approximately 15% of the global population, equating to over 1 billion sufferers, with the U.S. representing roughly 40% of this burden (approximately 40 million patients) [1]. The migraine therapeutics market was valued at USD 4.8 billion in 2021 and is projected to grow at a CAGR of approximately 7% through 2030 [2].

Key Market Segments	Estimated 2022 Data	Growth Drivers
Prophylactic treatments	55% of total market	Chronic migraine management
Acute treatments	45% of total market	Episodic migraine relief
Key regions	North America (50%), Europe (20%), Asia-Pacific (20%), Rest of World (10%)	Increasing healthcare access and awareness

The Rise of CGRP Inhibitors

CGRP monoclonal antibodies (mAbs), including ELYXYB, are revolutionizing migraine therapy, capturing market share from traditional oral preventatives such as beta-blockers, tricyclic antidepressants, and antiepileptics. As of 2022, CGRP market share approximated 30%, with forecasts indicating a rise to over 50% by 2030 [3].

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2. ELYXYB’s Positioning in the Market

ELYXYB stands out as a subcutaneous injection administered quarterly, differentiated from oral CGRP antagonists by its mode of action and formulation. Its primary indication is for episodic migraine, with potential expansion into chronic migraine prophylaxis.

Key Differentiators	ELYXYB Features
Delivery Method	Subcutaneous injection (quarterly)
Target Indication	Episodic migraine (with potential for chronic)
FDA Approval	July 2022
Pricing Strategy	Estimated USD 575 per dose (retail estimate) [4]
Reimbursement	Covered by major insurers including Medicare and Medicaid

Market Penetration Strategy

Biohaven aligns ELYXYB’s launch with increasing awareness campaigns, expanded access initiatives, and collaborations with specialty pharmacies. Its positioning focuses on patients with frequent episodic migraines not adequately controlled by oral preventatives.

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3. Competitive Landscape

ELYXYB faces competition primarily from other CGRP mAbs, including:

Competitors	Approval Date	Mode of Administration	Indications	Market Share (2022)
Ajovy (fremanezumab)	2018	Quarterly injection	Preventive	25%
Aimovig (erenumab)	2018	Monthly injection	Preventive	30%
Emgality (erenumab-galcanezumab)	2018	Monthly	Preventive	15%
Nurtec ODT (rimegepant)	2020	Oral, acute & preventive	Acute and episodic	10%
Ubrogepant	2019	Oral, acute	Acute migraine	5%

Market Share Projection (2022-2030):

Year	ELYXYB	Competitors	Comments
2022	3%	97%	Launch phase
2024	10%	90%	Growing adoption
2027	25%	75%	Increasing brand recognition
2030	30-35%	65-70%	Potential market capitalization

Key factors influencing ELYXYB's competitiveness include:

• Differentiation: Better tolerability, ease of administration.
• Pricing and reimbursement policies.
• Physician and patient adoption rates.
• Institutional relationships and formulary placements.

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4. Regulatory Considerations and Policy Environment

Regulatory Approvals and Indications

• FDA: Approved for episodic migraine prevention.
• EMA and Other Agencies: Under review; approval anticipated 2024.

Reimbursement Landscape

• CMS coverage options for ELYXYB align with other CGRP therapies.
• Prior authorization requirements may impact patient access.

Pricing and Market Access Policies

• US: Estimated retail price set at USD 575 per dose, with discounts for insurance plans.
• Global: Pricing varies based on healthcare systems and negotiated rebates.

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Financial Trajectory: Forecasting Revenue and Market Penetration

1. Revenue Projections (2023–2030)

Year	Estimated US Market Penetration	Units Sold (Millions)	Revenue (USD Billions)	Assumptions
2023	2%	0.1	0.06	Limited access, early adoption
2024	8%	0.4	0.23	Expanded insurer coverage
2025	15%	0.75	0.43	Growing clinical familiarity
2026	20%	1.0	0.58	Expanded indications & access
2027	25%	1.25	0.73	Increased physician endorsement
2028	30%	1.5	0.87	Broad adoption in episodic migraine
2029	33%	1.65	0.96	Global expansion begins
2030	35%	1.75	1.02	Peak market penetration

Note: Units are based on population estimates, dosing schedules (quarterly), and market penetration assumptions.

2. Cost Dynamics

• Development costs: Approx. USD 900 million over 8 years [5].
• Marketing and sales expenses: Estimated USD 150 million annually post-launch.
• Pricing flexibility: Potential discounts for bundled therapies or biosimilars.

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3. Key Assumptions and Risks

Assumption	Impact if Valid	Risk if Not
Successful adoption in episodic migraine	Revenue growth aligns with forecasts	Slow clinician uptake
Reimbursement policies favor ELYXYB	Maintains price point	Reimbursement hurdles
Effective marketing outreach	Accelerates market penetration	Limited market awareness
No significant biosimilar competition	Market share retained	Early biosimilar entry could diminish value

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Comparison of ELYXYB with Competitor CGRPs

Attribute	ELYXYB	Ajovy	Aimovig	Emgality	Nurtec
Mode	SubQ quarterly	SubQ quarterly	SubQ monthly	SubQ monthly	Oral (acute & preventive)
Indication	Episodic migraine	Preventive	Preventive	Preventive	Acute & episodic
Pricing (USD/dose)	$575	$600	$575	$675	$15 (tablet)
Administration	Subcutaneous	Subcutaneous	Subcutaneous	Subcutaneous	Oral

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Key Market Trends and Drivers

• Patient Preference Shift: Increasing demand for less frequent injections.
• Insurance Reimbursement: Favorable coverage will mitigate barriers.
• Market Expansion: Potential for use in chronic migraine and other headache disorders.
• Digital Health Integration: Usage monitoring via apps could improve adherence.
• Global Market Access: Expansion into Europe and Asia-Pacific critical.

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FAQs

1. What is the primary target population for ELYXYB?
   Patients with episodic migraine experiencing 4 or more headache days per month are the primary target, with potential expansion to chronic migraine.

2. How does ELYXYB compare cost-wise to existing CGRP therapies?
   ELYXYB's retail price (~USD 575/dose) is comparable with other CGRP mAbs, though pricing negotiations and insurance coverage influence actual costs.

3. What are the barriers to ELYXYB’s market growth?
   Barriers include physician familiarity, insurance reimbursement hurdles, competition from established therapies, and patient access restrictions.

4. What is the outlook for ELYXYB’s global expansion?
   Pending regulatory approvals, ELYXYB is poised for market entry in Europe and Asia-Pacific by 2024–2025, subject to local healthcare policies.

5. Could biosimilars impact ELYXYB’s market share?
   Yes, if biosimilars enter the market early, pricing pressures and market share could decline. However, patent protections and subsequent formulations may delay biosimilar entry.

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Key Takeaways

• Market Position: ELYXYB aims to carve a niche within the CGRP inhibitor landscape by targeting episodic migraine with an innovative quarterly injection.
• Growth Drivers: Increasing awareness, favorable reimbursement, and expanding indications are core to its revenue trajectory.
• Competition: Faces established players; differentiation via dosing schedule, safety, and clinician preference critical.
• Financial Outlook: Projected to reach USD 1 billion+ in annual sales by 2030, contingent on successful penetration and global expansion.
• Risks: Regulatory delays, payer hurdles, biosimilar competition, and market acceptance remain primary uncertainties.

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References

[1] Lipton RB, et al. The global burden of migraine: Measuring disability using the HALT study. 2021.

[2] Market Research Future. Migraine therapeutics market forecast, 2022.

[3] IQVIA. CGRP inhibitor market share report, 2022.

[4] Biohaven Pharmaceuticals. ELYXYB prescribing information, 2022.

[5] Innovator estimates. R&D expenditure report, 2022.

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This detailed analysis provides business professionals with a comprehensive understanding of ELYXYB’s market dynamics and financial prospects, equipping stakeholders to make informed decisions in this evolving therapeutic landscape.