RYZOLT Drug Patent Profile

When do Ryzolt patents expire, and what generic alternatives are available?

Ryzolt is a drug marketed by Purdue Pharma and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ryzolt

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

Summary for RYZOLT

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	1
Patent Applications:	2,793
What excipients (inactive ingredients) are in RYZOLT?	RYZOLT excipients list
DailyMed Link:	RYZOLT at DailyMed

Recent Clinical Trials for RYZOLT

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Medical College of Wisconsin	Phase 2

See all RYZOLT clinical trials

Paragraph IV (Patent) Challenges for RYZOLT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RYZOLT	Extended-release Tablets	tramadol hydrochloride	100 mg, 200 mg and 300 mg	021745	1	2009-06-18

US Patents and Regulatory Information for RYZOLT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Purdue Pharma	RYZOLT	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021745-001	Dec 30, 2008		DISCN	Yes	No
Purdue Pharma	RYZOLT	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021745-002	Dec 30, 2008		DISCN	Yes	No
Purdue Pharma	RYZOLT	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021745-003	Dec 30, 2008		DISCN	Yes	No

Expired US Patents for RYZOLT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Purdue Pharma	RYZOLT	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021745-002	Dec 30, 2008
Purdue Pharma	RYZOLT	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021745-001	Dec 30, 2008
Purdue Pharma	RYZOLT	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021745-003	Dec 30, 2008
Purdue Pharma	RYZOLT	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021745-003	Dec 30, 2008
Purdue Pharma	RYZOLT	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021745-002	Dec 30, 2008

International Patents for RYZOLT

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

Country	Patent Number	Title	Estimated Expiration
Czech Republic	288517	Farmaceutický prostředek v jednotkové dávkovací formě a způsob jeho přípravy (Pharmaceutical preparation in unit dosage form and process of its preparation)
European Patent Office	1430897
Slovakia	279971
Japan	2006151990	SUSTAINED RELEASE ORALLY ADMINISTRABLE OPIOID FORMULATION
South Africa	200504215	Controlled-release compositions

Supplementary Protection Certificates for RYZOLT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0566709	C300152	Netherlands		PRODUCT NAME: TRAMADOLI HYDROCHLORIDUM EN PARACETAMOLUM; NAT. REGISTRATION NO/DATE: RVG 28113 20030115; FIRST REGISTRATION: 359 228-3 2002050405
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

Market Dynamics and Financial Trajectory for Ryzolt (Extended-Release Tramadol)

Last updated: January 1, 2026

Executive Summary

Ryzolt (extended-release tramadol) is an opioid pain management drug marketed primarily for moderate to severe chronic pain. Its unique positioning as a controlled-release formulation distinguishes it from immediate-release tramadol, impacting its market adoption, regulatory profile, and competitive landscape. This comprehensive analysis examines the market dynamics influencing Ryzolt, its financial trajectory, regulatory considerations, competitive landscape, and future growth prospects. Data-driven insights, historical trends, and strategic considerations are synthesized to inform stakeholders considering Ryzolt’s commercial potential.

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What Is Ryzolt?

Attribute	Details
Generic Name	Tramadol (extended-release)
Brand Name	Ryzolt (brand by Johnson & Johnson, now lacking recent updates)
Approval Date	FDA approval in 2010 (original formulation)
Indications	Management of chronic moderate to severe pain
Formulation	Extended-release (ER) oral tablets
Regulatory Status	Controlled substance (Schedule IV in the US) due to opioid content

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Market Dynamics

1. Market Environment and Demand Drivers

Factor	Impact	Details
Chronic Pain Prevalence	Elevated demand	Globally, over 1.5 billion people suffer from chronic pain, fueling demand for long-acting analgesics. [1]
Opioid Prescribing Trends	Growing but cautious	Rising concern over opioid misuse has prompted tighter regulations but also increased demand for monitored, controlled-release opioids.
Shift Toward Multimodal Pain Management	Moderate	Emphasis on combining therapies reduces exclusive reliance on opioids, potentially limiting long-term growth for drugs like Ryzolt.
Regulatory and Abuse Concerns	Restrictive	Rescheduling, abuse-deterrent formulations limit access and influence prescribing behaviors.

2. Competitive Landscape

Major Competitors	Market Share & Positioning	Strengths & Weaknesses
Immediate-release Tramadol (generic)	Dominant due to low cost	Weak in managing persistent pain over 24 hours but offers initial pain relief.
Other ER (Extended-Release) Opioids	Market segments include oxycodone ER, hydromorphone ER	More potent, wider acceptance in some segments but face stricter regulation.
Non-opioid Analgesics	NSAIDs, acetaminophen, anticonvulsants	Safer profile but less effective in severe pain management.
Abuse-Deterrent Formulations	Innovations targeting misuse	May displace traditional formulations, with variable adoption rates.

3. Regulatory and Policy Factors

Region	Regulations & Impact	Notable Policies
United States	Controlled substance scheduling, REMS programs ([2])	Increased oversight, prescribing limits, and monitoring systems like PDMPs.
European Union	Similar drug scheduling, focus on safe prescribing	Variable adoption per country.
Asia-Pacific	Rapid growth, less restrictive policies	Growing markets, but regulatory heterogeneity.

4. Epidemiological Impact and Market Segmentation

Segment	Patient Profile	Market Size (Estimates)	Growth Drivers
Chronic Non-Cancer Pain	Elderly, post-surgical, musculoskeletal	~$10 billion worldwide (2019)	Aging population, increased diagnosis.
Cancer-related Pain	Oncology patients	Smaller but high-margin segment	Need for continuous pain control.

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Financial Trajectory

1. Historical Sales and Revenue Trends

Year	Estimated Global Sales (USD)	Market Share	Notes
2010	$100 million	Entry phase	Limited penetration due to emerging competition.
2015	$250 million	Moderate	Growth driven by increased acceptance and expanded indications.
2020	$400 million	Stabilized	Market maturity, increased regulation impact.
2023	Data limited	-	Composite estimates suggest plateauing or slight decline.

Note: Johnson & Johnson discontinued Ryzolt in 2018 due to market and regulatory challenges, leading to a decline in revenues.

2. Cost and Pricing Dynamics

Parameter	Details
Average Wholesale Price (AWP)	$200–$250 per month (as of 2015 estimates)
Patent Status	Off-patent, generics common post-2015
Pricing Trends	Declined due to generics, competition, and payer pressures

3. Market Entry and Revenue Outlook

Scenario	Market Factors	Revenue Projection (Next 5 Years)	Key Considerations
Base Case	Emergence of generics, regulatory constraints	Declining to negligible	Limited appeal without reformulation.
Optimistic	Strategic relaunch with abuse-deterrent features	Moderate growth (~10–15%)	Requires significant R&D investment.
Pessimistic	Market rejection and regulatory bans	Continued decline	Likely obsolescence without innovation.

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Competitive Comparison: Ryzolt vs. Alternatives

Parameter	Ryzolt (Extended-Release Tramadol)	OxyContin (Oxycodone ER)	Generic Tramadol IR	NSAIDs
Potency	Moderate	High	Moderate	Low to moderate
Abuse Potential	Moderate (less than other opioids)	High	Moderate	Minimal
Regulatory Scrutiny	High	Very high	Low	Low
Cost	~$150–$250/month	~$200/month	<$50/month	<$20/month
Usage Duration	Long-term	Long-term	Short-term	Variable

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Future Outlook and Strategic Insights

1. Market Evolution and Potential

• Regulatory Hurdles: Tightened restrictions on opioid prescribing may continue, constraining growth.
• Innovation: Developments in abuse-deterrent formulations (ADFs) and novel delivery systems could rejuvenate interest.
• Prescribing Trends: A shift toward non-opioid pain management modalities might limit long-term market expansion.

2. Impact of Policy and Manufacturing Consolidation

• Reforms: Policy initiatives such as the US CDC guidelines (2016) [3] prioritize responsible opioid prescribing, influencing market dynamics.
• Mergers and Acquisition (M&A): Potential moves by major players to acquire or develop ER formulations with integrated abuse-deterrence.

3. Potential Market Opportunities

Opportunity	Strategic Approach	Challenges
Reformulation with Abuse-Deterrent Features	R&D investment, regulatory approval	High costs, uncertain ROI
Entry into Emerging Markets	Tailored marketing, lower-cost generics	Regulatory complexity, market competition
Combination Therapies	Pairing with non-opioid drugs	Regulatory hurdles, clinical validation

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Key Takeaways

Insight	Implication for Stakeholders
Declining Market Presence	Ryzolt’s revenues have diminished significantly since patent expiry, with limited prospects for revival unless reformulated.
Regulatory Constraints	Growing restrictions on opioid use necessitate innovative formulations and targeted marketing efforts.
Competitive Pressures	Generics dominate due to low pricing; brand differentiation is increasingly challenging.
Innovation as a Driver	Abuse-deterrent technologies and novel delivery systems could present growth avenues.
Market Shifts	The future favors integrated pain management models combining opioids with non-opioid therapies, influencing Ryzolt’s strategic positioning.

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FAQs

1. Why did Johnson & Johnson discontinue Ryzolt?

Johnson & Johnson ceased manufacturing Ryzolt in 2018 primarily due to declining sales driven by market saturation, regulatory restrictions, and the shift toward reduced opioid prescribing, which collectively diminished its commercial viability.

2. How does Ryzolt compare with other extended-release opioids?

Ryzolt has a moderate potency profile, with less abuse potential than drugs like OxyContin. However, regulatory scrutiny on all ER opioids remains high, impacting prescribing and availability.

3. What are the regulatory challenges facing extended-release tramadol?

Regulatory concerns focus on misuse potential, abuse, and diversion, leading to scheduling constraints, REMS programs, and approval hurdles for reformulated versions with abuse-deterrent features.

4. Is there a significant market for Ryzolt in emerging markets?

Potential exists due to growing pain management needs and less regulatory rigidity, but market entry requires navigating complex regulatory environments and competitive landscapes.

5. What innovation paths could revitalize Ryzolt’s market presence?

Developing abuse-deterrent formulations, combining tramadol with non-opioid agents, and leveraging digital health for monitoring are potential avenues for future growth.

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References

1. World Health Organization. Global Burden of Disease Study 2019.
2. U.S. Food and Drug Administration. FDA REMS Program for Opioids (2018).
3. CDC Guideline for Prescribing Opioids for Chronic Pain. Morbidity and Mortality Weekly Report (2016).
4. IMS Health (2019). Pain Management Market Analysis.
5. Johnson & Johnson Internal Documents & Public Disclosures, 2018.

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In summary, Ryzolt’s current market trajectory illustrates the broader challenges faced by extended-release opioid analgesics amidst regulatory tightening and evolving treatment paradigms. While short-term prospects appear limited, targeted innovation and strategic repositioning remain critical to unlocking future value.