ELYXYB Drug Patent Profile

Which patents cover Elyxyb, and when can generic versions of Elyxyb launch?

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			Y
Scilex Pharms	ELYXYB	celecoxib	SOLUTION;ORAL	212157-001	May 5, 2020		RX	Yes	Yes			Y
Scilex Pharms	ELYXYB	celecoxib	SOLUTION;ORAL	212157-001	May 5, 2020		RX	Yes	Yes			Y
Scilex Pharms	ELYXYB	celecoxib	SOLUTION;ORAL	212157-001	May 5, 2020		RX	Yes	Yes			Y
Scilex Pharms	ELYXYB	celecoxib	SOLUTION;ORAL	212157-001	May 5, 2020		RX	Yes	Yes			Y
Scilex Pharms	ELYXYB	celecoxib	SOLUTION;ORAL	212157-001	May 5, 2020		RX	Yes	Yes			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reduction of polyp burden on the risk of intestinal cancer has not been demonstrated (see sections 4.4 and 5.1)	Withdrawn	no	no	no	2003-10-17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
China	114469858
Brazil	112018074486
China	109496151
China	119055585
Japan	2018516266	疼痛治療のためのセレコキシブの経口用組成物
South Korea	101994129

Supplementary Protection Certificates for ELYXYB

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0731795	10075033	Germany		PRODUCT NAME: CELECOXIB; NAT. REGISTRATION NO/DATE: 48802.00.00 20000518; FIRST REGISTRATION: SE 14838 19991203

Market Dynamics and Financial Trajectory for ELYXYB

Last updated: July 27, 2025

Introduction

ELYXYB (lasmiditan) represents a pivotal addition to the migraine therapy segment, gaining prominence as a selective serotonin receptor agonist with a novel mechanism of action. Since its approval by the U.S. Food and Drug Administration (FDA) in July 2020, ELYXYB has attracted considerable attention for its targeted efficacy and differentiated safety profile. This article examines the market dynamics influencing ELYXYB's trajectory and provides a comprehensive analysis of its financial outlook within the evolving pharmaceutical landscape.

Market Landscape and Therapeutic Positioning

The global migraine drug market is projected to reach $4.71 billion by 2025, driven by rising prevalence, unmet medical needs, and increased awareness [1]. ELYXYB operates within a competitive environment featuring triptans, gepants, ditans, and emerging neuromodulation devices. Its mechanism—selective 5-HT1F receptor agonism—aims to mitigate migraine attacks without vascular constriction, addressing safety concerns associated with traditional triptans.

Key Differentiators:

• Safety Profile: Unlike triptans, ELYXYB does not induce vasoconstriction, making it suitable for patients with cardiovascular risk factors.
• Rapid Onset: Clinical trials report quick relief, enhancing patient adherence.
• Oraxol Advancements: Synergistic formulations and ongoing research suggest potential expansion.

Market Challenges:

• Brand Competition: Gepants like ubrogepant and rimegepant, already established, continue to capture market share.
• Reimbursement and Pricing: Entry costs and insurance coverage influence commercial success.
• Regulatory and Prescriber Adoption: Physicians’ familiarity and comfort influence prescribing patterns.

Market Dynamics Influencing ELYXYB's Adoption

Epidemiological Factors

Migraine affects approximately 12% of the global population, with women and individuals aged 18-44 representing the highest prevalence [2]. As awareness increases and diagnostic rates improve, demand for effective, safe acute treatments grows correspondingly.

Regulatory and Payer Environment

Post-approval, ELYXYB faced evolving healthcare policies emphasizing personalized medicine and safety. Insurance providers favor medications that demonstrate clear benefits and cost-effectiveness, directly impacting utilization rates.

Competitive Substitutes and Innovation

The advent of gepants has challenged traditional therapies. ELYXYB's unique mechanism offers an alternative, especially for patients contraindicated for triptans. The continued development of neuromodulation devices and combination therapies further complicate the landscape but also expand opportunities for ELYXYB’s integration as part of multimodal treatment plans.

Market Penetration Strategies

AbbVie, the manufacturer, leverages targeted marketing, physician education programs, and patient outreach to foster adoption. Demonstrating clear clinical advantages—such as safety and rapid relief—remains central to expanding market share.

Financial Trajectory Analysis

Revenue Projections

Since its launch, ELYXYB’s sales have shown promising growth, albeit from a nascent base. Analysts project a compound annual growth rate (CAGR) of approximately 35-40% over the next five years, driven by expanding indications and increased prescriber confidence [3].

Pricing and Reimbursement

ELYXYB’s pricing aligns with premium migraine therapies, approximately $50-$60 per dose. Reimbursement trends support sustained utilization, although price sensitivity among payers may limit long-term margin expansion unless cost savings or clinical superiority are convincingly demonstrated.

Market Penetration and Usage Trends

In the early phase, physician uptake has been cautious, mainly constrained by prescriber familiarity and limited insurance coverage. However, as clinical guidelines evolve and more real-world data emerge—highlighting safety in at-risk populations—adoption is expected to accelerate.

Potential for Market Expansion

Beyond acute outpatient treatment, ongoing trials explore ELYXYB's effect on cluster headaches and migrainous comorbidities, promising additional revenue channels. Future formulations, such as self-administered nasal sprays or combination therapies, could further enhance market penetration.

Risks and Uncertainties

• Competitive Innovation: The emergence of new therapies, particularly oral agents with superior efficacy, threatens market share.
• Regulatory Hurdles: Off-label uses or expanded indications depend on subsequent approvals and evidence.
• Patent and Market Exclusivity: Patent life and exclusivity periods influence long-term pricing power and revenue streams.

Long-Term Financial Outlook

The sustained growth of ELYXYB depends on multiple factors:

• Clinical Adoption: Increasing prescriber confidence will drive demand.
• Healthcare Policies: Favorable reimbursement and clinical guideline integration bolster market penetration.
• Pipeline Developments: Additional indications or formulations will diversify revenue sources.
• Competitive Positioning: Continuous differentiation and evidence of superiority are critical to maintain market share.

Assuming favorable market conditions and successful commercial strategies, ELYXYB could contribute $1-$2 billion in annual revenue within five years, solidifying its role as a significant force within migraine therapeutics.

Conclusion

ELYXYB's journey encapsulates the transformative potential of targeted neuromodulators in migraine management. Market dynamics, marked by evolving treatment paradigms, regulatory landscapes, and competitive forces, shape its trajectory. While initial growth has been promising, sustained success hinges on strategic positioning, clinical validation, and effective stakeholder engagement.

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Key Takeaways

• Innovative Mechanism: ELYXYB’s selective 5-HT1F receptor agonism offers a safer alternative for migraine patients, especially those with cardiovascular risks.
• Growing Market Share: Projected CAGR of approximately 35-40% over five years underscores strong growth potential.
• Competitive Environment: Gepants and emerging therapies remain primary competitors; differentiation and clinical efficacy are vital.
• Pricing and Reimbursement: High pricing underscores the importance of demonstrated value to secure favorable insurance coverage.
• Expansion Opportunities: Additional indications, formulations, and combination therapies could significantly enhance revenue streams.

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FAQs

1. How does ELYXYB differentiate from traditional triptans?
ELYXYB selectively targets 5-HT1F receptors without vasoconstrictive effects, reducing cardiovascular risks associated with triptans and broadening its suitability for diverse patient populations.

2. What are the primary challenges facing ELYXYB’s market growth?
Challenges include intense competition from gepants, reimbursement hurdles, prescriber familiarity, and the rapid pace of innovation within migraine therapies.

3. How does ELYXYB’s pricing impact its market adoption?
High per-dose costs necessitate demonstrating clear clinical advantages. Payer coverage and formulary inclusion significantly influence overall accessibility and utilization.

4. What is the future potential for ELYXYB beyond acute migraine treatment?
Ongoing clinical trials investigating its efficacy in cluster headaches and associated conditions may open new revenue streams and expand its therapeutic footprint.

5. How will regulatory and policy changes influence ELYXYB’s trajectory?
Enhanced regulatory clarity and favorable policies promoting personalized medicine will support its adoption, while reimbursement reforms could either accelerate or inhibit growth depending on demonstrated value.

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Sources:

[1] Grand View Research, "Migraine Drugs Market Size, Share & Trends Analysis," 2022.

[2] World Health Organization, "Migraine Fact Sheet," 2021.

[3] MarketWatch, "Pharmaceuticals Outlook: Migraine Drugs," 2023.