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-five 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-four 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:	25
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	175
Patent Applications:	4,614
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

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/000466 Onsenal 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reduction of polyp burden on the risk of intestinal cancer has not been demonstrated (see sections 4.4 and 5.1)	Withdrawn	no	no	no	2003-10-17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
Russian Federation	2017144574
New Zealand	737561	Oral composition of celecoxib for treatment of pain
Canada	2987272	COMPOSITION ORALE DE CELECOXIB POUR LE TRAITEMENT DE LA DOULEUR (ORAL COMPOSITION OF CELECOXIB FOR TREATMENT OF PAIN)
Brazil	112018074486	composição oral de celecoxib para tratamento da dor

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

ELYXYB Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ELYXYB

Introduction to ELYXYB

ELYXYB, an oral solution of celecoxib, is a significant player in the migraine treatment market. Formulated using a self-micro emulsifying drug delivery system, it enhances the solubility and bioavailability of celecoxib, leading to better absorption and faster onset of action[1].

Market Size and Potential

The U.S. oral migraine drug market is substantial, estimated to be around $1.8 billion in 2022 and projected to grow to $2.3 billion by 2025. This market presents a lucrative opportunity for ELYXYB, especially given its unique formulation and clinical efficacy[3][5].

Canadian Market

In addition to the U.S. market, ELYXYB is also being positioned for approval in Canada, where the migraine therapeutic market is estimated to reach approximately $400 million by 2025. The filing of a New Drug Submission (NDS) with Health Canada marks a critical step in expanding ELYXYB's reach[5].

Clinical Efficacy and Differentiation

ELYXYB's clinical data show compelling results, including a meaningful speed of onset with maximum plasma concentration (Tmax) achieved in approximately 60 minutes. In pivotal studies, ELYXYB demonstrated significant pain relief compared to placebo, with a higher percentage of patients achieving Most Bothersome Symptom (MBS) freedom and headache pain freedom within two hours post-dose[1].

Fast-Acting and Safe Alternative

ELYXYB is positioned as a fast-acting NSAID with potentially lower gastrointestinal side effects, which is a common concern with long-term NSAID use. This profile makes it an attractive option for patients who do not respond well to triptans or have contraindications to triptan use[5].

Commercial Strategy and Launch

U.S. Launch

Scilex Holding Company announced the commercial launch of ELYXYB in the U.S. in April 2023, marking a significant milestone in its strategy to build a robust offering of non-opioid pain treatments. The launch is expected to diversify Scilex's revenue stream and drive substantial near- and long-term accretion to its cash flows and earnings[4].

Sales Force and Market Coverage

The Scilex sales force, comprising approximately 65 pain specialists, covers more than 80% of the targeted physicians, ensuring strong market penetration and coverage for ELYXYB[4].

Financial Trajectory

Revenue Projections

ELYXYB is expected to contribute significantly to Scilex's revenue growth. The drug targets a large and growing market, and its unique formulation and clinical efficacy position it for strong market acceptance. The estimated peak sales potential for ELYXYB, while not explicitly stated, is part of a broader strategy that includes other products like ZTlido® and Gloperba®, which are projected to reach substantial sales figures[3][4].

Synergies and Cost Structure

The acquisition and integration of ELYXYB into Scilex's portfolio are expected to leverage existing commercial expertise and infrastructure, thereby maintaining a strong balance sheet and positioning the company for additional business development opportunities. The deal structure allows for the realization of significant synergies, such as the annual run-rate synergies achieved by Collegium Pharmaceutical after acquiring BioDelivery Sciences International (BDSI), which included ELYXYB in its portfolio[1][2].

Competitive Landscape

Market Competition

The migraine treatment market is competitive, with various treatments available, including triptans and other NSAIDs. However, ELYXYB's fast-acting nature and potential for fewer gastrointestinal side effects differentiate it from other options. Clinicians have expressed a desire for fast and safe alternatives, which ELYXYB is well-positioned to address[5].

Regulatory Hurdles

While ELYXYB has received FDA approval in the U.S., its approval in Canada is pending. Regulatory hurdles and market penetration challenges are potential risks, but the clinical data and market need for alternative migraine treatments support its potential for success[5].

Long-Term Implications

Shifts in Prescribing Habits

If ELYXYB proves to be a superior option, it could drive shifts in prescribing habits, with clinicians opting for this fast-acting and safer alternative. This could also prompt competitors to accelerate the development of their own alternative migraine treatments, further intensifying market competition[5].

Expansion and Growth

The success of ELYXYB is part of Scilex's broader strategy to expand its non-opioid pain management portfolio. The company is exploring ways to maximize the value of its subsidiary, Scilex Pharmaceuticals, including potential spin-offs or public listings, which could unlock substantial shareholder value[3].

Key Takeaways

• Market Size: ELYXYB targets the $1.8 billion U.S. oral migraine drug market and the $400 million Canadian market.
• Clinical Efficacy: ELYXYB shows significant pain relief within 45 minutes and has a faster onset of action compared to other NSAIDs.
• Commercial Strategy: The drug is part of Scilex's strategy to build a robust non-opioid pain treatment portfolio.
• Financial Trajectory: Expected to contribute significantly to Scilex's revenue growth and leverage existing commercial expertise.
• Competitive Landscape: Differentiates itself with fast-acting nature and fewer gastrointestinal side effects.

FAQs

What is ELYXYB and how does it work?

ELYXYB is an oral solution of celecoxib, formulated using a self-micro emulsifying drug delivery system that improves solubility and bioavailability, leading to better absorption and faster onset of action.

What is the market size for ELYXYB in the U.S. and Canada?

The U.S. oral migraine drug market is estimated to be $1.8 billion in 2022 and projected to grow to $2.3 billion by 2025. The Canadian market is estimated to reach approximately $400 million by 2025.

How does ELYXYB differentiate itself in the migraine treatment market?

ELYXYB is a fast-acting NSAID with potentially lower gastrointestinal side effects, making it an attractive option for patients who do not respond well to triptans or have contraindications to triptan use.

What are the financial projections for ELYXYB?

ELYXYB is expected to contribute significantly to Scilex's revenue growth, leveraging existing commercial expertise and infrastructure to maintain a strong balance sheet.

What are the potential risks and challenges for ELYXYB?

Regulatory hurdles, market penetration challenges, and competition from existing and new migraine treatments are potential risks, but the clinical data and market need support its potential for success.

How does the approval process in Canada impact ELYXYB's market potential?

The filing of a New Drug Submission (NDS) with Health Canada is a critical step in expanding ELYXYB's reach into the Canadian market, which is estimated to be worth $400 million by 2025. Approval would further enhance the drug's market potential and revenue projections.