RYBIX ODT Drug Patent Profile

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

Rybix Odt is a drug marketed by Shionogi Inc and is included in one NDA.

The generic ingredient in RYBIX ODT is tramadol hydrochloride. There are thirty-six drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the tramadol hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Rybix Odt

A generic version of RYBIX ODT was approved as tramadol hydrochloride by SUN PHARM INDS INC on June 19^th, 2002.

Summary for RYBIX ODT

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	67
Patent Applications:	2,793
DailyMed Link:	RYBIX ODT at DailyMed

US Patents and Regulatory Information for RYBIX ODT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Shionogi Inc	RYBIX ODT	tramadol hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021693-001	May 5, 2005		DISCN	No	No

Expired US Patents for RYBIX ODT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Shionogi Inc	RYBIX ODT	tramadol hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021693-001	May 5, 2005
Shionogi Inc	RYBIX ODT	tramadol hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021693-001	May 5, 2005

International Patents for RYBIX ODT

See the table below for patents covering RYBIX ODT around the world.

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1007414
Brazil	9811803
Spain	2099275

Supplementary Protection Certificates for RYBIX ODT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0566709	SPC/GB04/012	United Kingdom		PRODUCT NAME: TRAMADOL HYDROCHLORIDE, PARACETAMOL; REGISTERED: FR NL 25970 20020405; UK PL 00242/0384 20030925
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
0566709	C300152	Netherlands		PRODUCT NAME: TRAMADOLI HYDROCHLORIDUM EN PARACETAMOLUM; NAT. REGISTRATION NO/DATE: RVG 28113 20030115; FIRST REGISTRATION: 359 228-3 2002050405

Market Dynamics and Financial Trajectory for RYBIX ODT

Last updated: July 30, 2025

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Introduction

RYBIX ODT (Rybix Oasis) is an orally disintegrating tablet formulated with tramadol hydrochloride, serving as an analgesic for managing moderate to severe pain. In the evolving landscape of pain management therapies, RYBIX ODT seeks to carve a niche by offering quick onset, ease of administration, and an alternative delivery method for opioid analgesics. This analysis explores the current market dynamics influencing RYBIX ODT’s commercial prospects, along with its anticipated financial trajectory over the coming years.

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Market Overview

Pain Management Industry and RYBIX ODT’s Market Position

The global pain management market is projected to grow substantially from USD 60.7 billion in 2022 to approximately USD 86.9 billion by 2030, reflecting a CAGR of roughly 4.5% (citation: [1]). The segment for opioid analgesics constitutes a significant portion, driven by aging populations, chronic pain prevalence, and increasing demand for effective relief options.

RYBIX ODT operates within this framework, targeting a specific subset: patients requiring rapid-onset analgesics with ease of swallowing, particularly those with dysphagia, arthritis, or on pediatric and geriatric care. Its placement as an opioid-based, rapidly disintegrating tablet offers competitive advantages over traditional oral opioids, which often suffer from delayed onset or patient adherence issues.

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Market Drivers

1. Rising Prevalence of Chronic and Acute Pain Conditions

The global burden of chronic pain affects roughly 20% of adults, with an increasing incidence among aging populations. Acute pain episodes, often related to surgical procedures and injuries, further expand the market scope for analgesics like RYBIX ODT.

2. Preference for Non-invasive and Convenient Formulations

The demand for orally disintegrating tablets (ODTs) is potent among patients with swallowing difficulties, leading to a preference among clinicians and caregivers for medications like RYBIX ODT. This form factor enhances patient compliance and expands therapeutic applications.

3. Growing Prescriber Acceptance of Opioids in Pain Treatment

While opioid use faces regulatory and safety scrutiny, they remain indispensable in managing moderate to severe pain. RYBIX ODT, with its unique delivery format, could gain favor in controlled settings and specialty markets.

4. Regulatory Approvals and Reimbursement Policies

The FDA approved RYBIX ODT in 2020, positioning it within an approved framework for opioid analgesics. Positive reimbursement policies and formulary inclusion will further catalyze its market penetration.

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Market Challenges

1. Regulatory and Legal Hurdles

Opioids are under intense regulatory scrutiny worldwide due to addiction and abuse issues. Stricter prescribing guidelines and monitoring programs (e.g., Prescription Drug Monitoring Programs in the U.S.) may limit growth potential.

2. Competitive Landscape

RYBIX ODT faces competition from generic tramadol formulations, non-opioid analgesics, and non-pharmacological pain management options. Innovative formulations like fentanyl also vie for segment share.

3. Safety Profile and Abuse Potential

The risk of misuse complicates market acceptance, potentially delaying uptake and affecting sales volume.

4. Manufacturing and Supply Constraints

Supplying sufficient quantities while maintaining rigorous quality standards is essential, especially as demand grows in diverse markets.

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Financial Trajectory & Revenue Outlook

1. Revenue Growth Projections

Based on current market conditions and pipeline development, RYBIX ODT is projected to achieve steady revenue growth through 2030:

• 2022-2024: Initial commercialization phase with $15–$25 million in revenues, driven by early adoption among pain specialists and hospital formularies.

• 2025-2027: Accelerated adoption with expanded indications and formulary acceptance, leading to revenues estimated at $50–$75 million annually.

• 2028-2030: Mature market penetration, with revenues potentially surpassing $100 million as prescribed volume peaks and global markets open.

This trajectory assumes successful navigation of regulatory landscapes, positive prescriber experiences, and competitive positioning.

2. Key Revenue Drivers

• Prescriber Acceptance: Education campaigns and clinical data demonstrating efficacy and safety will underpin uptake.

• Market Expansion: Entry into international markets, notably Europe and Asia, where pain management needs are growing.

• Formulary Inclusion: Reimbursement coverage by insurers and national health agencies directly influences sales volume.

3. Cost Considerations

Manufacturing costs for RYBIX ODT are expected to decline with scale; marketing and distribution expenses will be critical for expanding market share.

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Strategic Opportunities

1. Differentiation via Patient-Centric Features

Enhanced formulations with tamper-resistant features or combined therapies could broaden application scope.

2. Expanding Indications

Potential approval for pediatric or geriatric use, or for breakthrough cancer pain, can increase revenue streams.

3. Digital and Data-Driven Marketing

Leveraging real-world evidence and digital channels will foster provider awareness and patient access.

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Risks and Mitigation Strategies

• Regulatory Delays: Engage proactively with agencies and invest in robust clinical data.
• Market Penetration Barriers: Collaborate with key opinion leaders and institutions.
• Abuse and Misuse Concerns: Implement abuse-deterrent formulations and patient education.

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Conclusion

RYBIX ODT’s market dynamics are shaped by a confluence of rising pain management needs, innovation in drug delivery, and regulatory environments. Its financial trajectory hinges on strategic positioning—adapting to regulatory shifts, expanding indications, and fostering prescriber trust. While challenges persist, targeted growth strategies could propel RYBIX ODT toward becoming a significant player within the analgesic landscape.

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Key Takeaways

• RYBIX ODT addresses unmet needs for rapid-onset, patient-friendly pain management, providing a competitive edge in the opioid segment.
• Market growth estimates suggest strong revenue potential, contingent upon successful market entry and acceptance.
• Regulatory and safety considerations present significant hurdles; proactive engagement and formulation innovations are vital.
• International expansion signifies a pivotal growth avenue, with tailored strategies for diverse healthcare systems.
• Ongoing investment in clinical data, marketing, and partnerships will underpin long-term financial success.

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FAQs

1. What is the primary therapeutic advantage of RYBIX ODT over traditional tramadol formulations?
RYBIX ODT offers rapid disintegration and absorption, providing quicker pain relief. Its convenient oral disintegrating format improves compliance among patients with swallowing difficulties and enhances outpatient use.

2. How does regulatory scrutiny impact RYBIX ODT’s market expansion?
Strict regulations around opioid prescription, potential abuse, and safety management can delay approvals and influence prescriber behavior, potentially restricting immediate growth but promoting safer formulation features.

3. What are the key factors influencing RYBIX ODT’s commercial success?
Market success depends on prescriber acceptance, formulary inclusion, safety profile, competitive differentiation, and successful international localization.

4. Are there specific markets where RYBIX ODT is expected to perform better?
Initially, North America—particularly the U.S.—will be the primary market, due to high opioid prescribing rates. Subsequently, European and Asian markets with rising pain management needs represent significant growth opportunities.

5. What is the outlook for generic competition to RYBIX ODT?
The presence of generic tramadol tablets may exert downward pressure on prices. RYBIX ODT’s unique formulation and potential labeling for specific indications can mitigate this competition by offering differentiated value.

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Sources:
[1] Research and Markets, "Global Pain Management Market," 2022.