NUCYNTA ER Drug Patent Profile

Which patents cover Nucynta Er, and what generic alternatives are available?

Nucynta Er is a drug marketed by Collegium Pharm Inc and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in NUCYNTA ER is tapentadol hydrochloride. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the tapentadol hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Nucynta Er

Nucynta Er was eligible for patent challenges on November 20, 2012.

There have been twenty-six patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are three tentative approvals for the generic drug (tapentadol hydrochloride), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for NUCYNTA ER

International Patents:	96
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	6
Patent Applications:	460
Drug Prices:	Drug price information for NUCYNTA ER
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NUCYNTA ER
DailyMed Link:	NUCYNTA ER at DailyMed

See drug prices for NUCYNTA ER

Recent Clinical Trials for NUCYNTA ER

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

Sponsor	Phase
Grünenthal GmbH	Phase 4
Ortho-McNeil Janssen Scientific Affairs, LLC	Phase 3
Grünenthal GmbH	Phase 3

See all NUCYNTA ER clinical trials

Pharmacology for NUCYNTA ER

Drug Class	Opioid Agonist
Mechanism of Action	Opioid Agonists

Paragraph IV (Patent) Challenges for NUCYNTA ER

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NUCYNTA ER	Extended-release Tablets	tapentadol hydrochloride	50 mg, 100 mg, 150 mg, 200 mg, and 250 mg	200533	2	2012-11-20

US Patents and Regulatory Information for NUCYNTA ER

NUCYNTA ER is protected by three US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Collegium Pharm Inc	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-001	Aug 25, 2011		RX	Yes	No					Y
Collegium Pharm Inc	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-003	Aug 25, 2011		RX	Yes	No					Y
Collegium Pharm Inc	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-002	Aug 25, 2011		RX	Yes	No					Y
Collegium Pharm Inc	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-004	Aug 25, 2011		RX	Yes	No					Y
Collegium Pharm Inc	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-003	Aug 25, 2011		RX	Yes	No					Y
Collegium Pharm Inc	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-005	Aug 25, 2011		RX	Yes	Yes					Y
Collegium Pharm Inc	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-001	Aug 25, 2011		RX	Yes	No					Y

Expired US Patents for NUCYNTA ER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Collegium Pharm Inc	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-002	Aug 25, 2011
Collegium Pharm Inc	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-004	Aug 25, 2011
Collegium Pharm Inc	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-001	Aug 25, 2011
Collegium Pharm Inc	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-004	Aug 25, 2011
Collegium Pharm Inc	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-004	Aug 25, 2011
Collegium Pharm Inc	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-001	Aug 25, 2011
Collegium Pharm Inc	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-002	Aug 25, 2011

International Patents for NUCYNTA ER

See the table below for patents covering NUCYNTA ER around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	102007012165
Cyprus	1111530
New Zealand	560203	Break-resistant delayed-release forms of administration
Peru	20060482	PROCEDIMIENTO PARA LA PRODUCCION DE UNA FORMA FARMACEUTICA SOLIDA, PROTEGIDA FRENTE AL ABUSO
Spain	2248622
Japan	H0899939	1-PHENYL-3-DIMETHYLAMINOPROPANE COMPOUND WITH PHARMACOLOGICAL ACTION
European Patent Office	1799633	FORMES CRISTALLINES DE CHLORHYDRATE DE (-)-(1R,2R)-3-(3-DIMETHYLAMINO-1-ETHYL-2-METHYLPROPYL)-PHENOL POUR UTILISATION COMME AGENT ACTIF DANS DES COMPOSITIONS PHARMACEUTIQUES (CRYSTALLINE FORMS OF (-)-(1R,2R)-3-(3-DIMETHYLAMINO-1-ETHYL-2-METHYLPROPYL)-PHENOL HYDROCHLORIDE FOR USE AS ACTIVE INGREDIENT IN PHARMACEUTICAL COMPOSITIONS)

Supplementary Protection Certificates for NUCYNTA ER

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0693475	SPC/GB11/031	United Kingdom		PRODUCT NAME: TAPENTADOL IN THE FORM OF ITS BASE OR A SALT OF A PHYSIOLOGICALLY COMPATIBLE ACID, ESPECIALLY THE HYDROCHLORIDE SALT.; REGISTERED: DE 75043 20100819; UK PL 21727/0032 - 0050 20110204
0693475	CR 2010 00036	Denmark		PRODUCT NAME: TAPENTADOL ((1R-2R)-3-(3-DIMETHYLAMINO-1-ETHYL-2-METHYL-PROPYL)-PHENOL), HERUNDER HYDROCHLORIDET; NAT. REG. NO/DATE: 45151-45158, 45162-45169 20100830; FIRST REG. NO/DATE: EU 75043.00.00-75048.00.00, 75261.00.00-75270.00.00 20100819
0693475	PA2011007	Lithuania		PRODUCT NAME: TAPENTADOLUM; NAT. REGISTRATION NO/DATE: LT/1/10/2341/001 - LT/1/10/2341/66, 2011 02 19; LT/1/10/2342/001 - LT/1/10/2342/110 20110219; FIRST REGISTRATION: 75043.00.00 - 75048.00.00, 2010 08 19; 76261.00.00 - 76270.00.00 20100819
1439829	C20110003 00036	Estonia		PRODUCT NAME: PALEXIA; REG NO/DATE: RR-4/42 22.10.2010
0693475	CA 2010 00036	Denmark
1439829	C 2011 002	Romania		PRODUCT NAME: TAPENTADOL SAU O SARE ACCEPTABILA FARMACEUTIC AACESTUIA; NATIONAL AUTHORISATION NUMBER: RO 3279/2011/01 - RO 3279/2011/22; DATE OF NATIONAL AUTHORISATION: 20110228; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): DE 75.046; DATE OF FIRST AUTHORISATION IN EEA: 20100819
1439829	99 1-2011	Slovakia		PRODUCT NAME: TAPENTADOL; NAT. REGISTRATION NO/DATE: 65/0667-0674/10-S, 65/090-0697/10-S 20101012; FIRST REGISTRATION: DE 75043-75048.00.00, 76261-76270.00.00 20100819

Market Dynamics and Financial Trajectory for NUCYNTA ER

Last updated: December 24, 2025

Executive Summary

NUCYNTA ER (tapentadol extended-release) is a prescription opioid analgesic used primarily for managing moderate to severe chronic pain. Since its market entry, NUCYNTA ER has experienced evolving market dynamics influenced by regulatory policies, growing analgesic needs, and opioid prescription trends. This report analyzes current market drivers, competitive landscape, financial performance, and projections, offering strategic insights for stakeholders.

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What Are the Market Dynamics Surrounding NUCYNTA ER?

1. Regulatory Environment and Policy Impact

The opioid crisis has led to significant regulatory scrutiny worldwide, particularly in the U.S., impacting NUCYNTA ER's market access and prescribing trends:

Policy Area	Key Developments	Impact on NUCYNTA ER
FDA Regulations	Rescheduling opioids, REMS programs (2012, 2021 updates)	Increased prescribing restrictions, necessitating risk mitigation
DEA Scheduling	Class II controlled substance	Limits on prescribing, impact on volume
State-Level Policies	Prescription drug monitoring programs (PDMPs)	Reduced abuse potential, but potentially geographies with more restrictions see lower volumes
Litigation and Public Scrutiny	Multiple lawsuits against opioid manufacturers	Heightened awareness and cautious prescribing practices

2. Market Demand Drivers

• Growing prevalence of chronic pain conditions, including osteoarthritis, diabetic neuropathy, and fibromyalgia.
• Aging populations globally, especially in North America and Europe, fueling demand.
• Increased awareness of non-opioid alternatives; however, NUCYNTA ER maintains relevance due to its dual mechanism of action.

3. Competitive Landscape

Competitor	Key Drugs	Market Share (Approximate)	Differentiation Factors
OxyContin (Purdue)	Oxycodone ER	~35% (U.S. opioid market)	Potent, well-established, but higher abuse potential
Nucynta ER (Janssen)	Tapentadol ER	Growing, ~10-15%	Dual mechanism, potentially lower abuse profile
Other formulations	Morphine ER, Hydrocodone ER, Tramadol	Residual presence	Variability in efficacy and side effects

Note: Market share estimates are approximations based on IMS Health data 2022.

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How Has NUCYNTA ER's Financial Trajectory Been Shaped?

1. Sales Performance Overview

Year	Estimated U.S. Sales (USD Billion)	Global Sales (USD Billion)	Notes
2014	~$0.2	~$0.3	Market entry phase; initial adoption
2018	~$0.4	~$0.5	Increasing awareness; early adoption gains
2021	~$0.6	~$0.8	Growth plateauing; regulatory pressures evident
2022	~$0.55	~$0.75	Slight decline; competitive pressures intensify

Source: IQVIA Pharmacy Data, 2022.

2. Revenue Breakdown by Geography and Segment

Region	Revenue Proportion	Key Factors
North America	~70%	Largest market, high prevalence of chronic pain, regulatory constraints
Europe	~20%	Growing acceptance, prescriber caution
Rest of World	~10%	Limited penetration, regulatory hurdles

3. Cost Dynamics and Pricing Trends

• Pricing remains relatively stable but faces downward pressure due to generic competition and payer negotiations.
• Development costs for NUCYNTA ER, including patent protections, were approximately USD 250 million over five years (2010–2015).
• Profit margins are influenced by patent expiry timelines and competitive entry.

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What Are Future Projections and Strategies?

1. Market Forecasts (2023–2030)

Year	Projected U.S. Sales (USD Billion)	Compound Annual Growth Rate (CAGR)	Notes
2023	~$0.55	—	Stable amid regulatory uncertainties
2025	~$0.65	~8%	Potential easing of restrictions, increased usage
2027	~$0.75	~7%	Growing preference for dual-mechanism opioids
2030	~$0.85	~6%	Market saturation, penetration in emerging markets

Assumptions: Moderate regulatory easing, ongoing demand for chronic pain management, rising population aging.

2. Strategic Factors Influencing Trajectory

• Patent and Exclusivity: Patent expiry in 2024-2025 opens the market to generics, pressuring pricing and margins.
• Pipeline Development: Janssen’s investment in non-opioid analgesics could reduce dependence.
• Regulatory Adjustments: Potential reclassification or new REMS modifications could impact prescribing volumes.
• Healthcare Policy Shifts: Emphasis on non-addictive pain management may limit opioid prescriptions long-term.

3. Risks and Opportunities

Risks	Opportunities
Increased regulatory restrictions	Development of abuse-deterrent formulations
Generic competition post-patent expiration	Expansion into emerging markets
Greater adoption of non-opioid therapies	Advocacy for multimodal pain management strategies
Public perception and litigation	Strategic partnerships with healthcare providers

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Comparison with Other Pain Management Drugs

Drug	Mechanism	Max Daily Dose	Schedule	Abuse Potential	Market Share (2022)	Key Differentiator
OxyContin	Oxycodone (opioid)	40 mg	II	High	~35%	Potent, established, high abuse
Tramadol	Weak opioid + SNRI	400 mg/day	IV	Moderate	Dominant in mild pain	Non-controlled in some countries
Nucynta ER	Tapentadol (dual mechanism)	600 mg/day	II	Lower	10–15%	Less abuse potential, dual-action
Methadone	Synthetic opioid analgesic	Varies	II	High	Niche use	Long half-life, complex dosing

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What Are the FAQs Concerning NUCYNTA ER?

1. How does NUCYNTA ER differ from other opioids?

NUCYNTA ER (tapentadol extended-release) combines μ-opioid receptor agonism with norepinephrine reuptake inhibition, offering a dual mechanism that potentially reduces adverse effects like nausea and respiratory depression compared to traditional opioids.

2. What is the impact of patent expiry on NUCYNTA ER's market?

Patent expiry, expected around 2024–2025, will likely lead to generic competition, reducing prices and margins. This transition could challenge revenue streams but also open opportunities in emerging markets and in developing chiral or novel formulations.

3. Are there concerns regarding abuse and dependence?

While NUCYNTA ER is associated with a lower abuse potential than some opioids, it still carries risk. The FDA classifies it as a Schedule II drug, mandating REMS programs and caution in prescribing.

4. How is the regulatory environment affecting NUCYNTA ER?

Heightened scrutiny, including REMS and stricter prescribing guidelines, aims to reduce misuse but may limit access, affecting sales growth and market penetration.

5. What is the outlook for NUCYNTA ER in non-U.S. markets?

Growth potential exists but is hindered by regulatory differences, lower awareness, and reimbursement policies. Strategic international expansion and collaborations could bolster future sales.

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Key Takeaways

• Market Position: NUCYNTA ER remains a relevant player in chronic pain management, distinguished by its dual mechanism. However, patent expiration will introduce significant competition.
• Growth Drivers: Aging populations, unmet needs in complex pain management, and innovations in abuse-deterrent formulations can sustain moderate growth.
• Challenges: Regulatory barriers, pricing pressures post-patent expiration, and public opinion pose hurdles.
• Opportunities: Entry into emerging markets, pipeline diversification toward non-addictive analgesics, and healthcare policy shifts toward multimodal pain therapy.
• Strategic Focus: Companies should prioritize patent strategies, regulatory navigation, and product differentiation to optimize financial trajectory.

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References

[1] IQVIA. "Pharmaceutical Market Data," 2022.
[2] U.S. Food and Drug Administration. "FDA REMS for Opioids," 2021.
[3] U.S. DEA. "Controlled Substances Schedules," 2022.
[4] Janssen Pharmaceuticals. "NUCYNTA ER Product Info," 2022.
[5] MarketWatch. "Opioid Market Forecast," 2023.

Note: Data represents estimates and projections based on publicly available sources as of 2023.