NUCYNTA Drug Patent Profile

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

Nucynta is a drug marketed by Collegium Pharm Inc and is included in three NDAs. There are three patents protecting this drug and two Paragraph IV challenges.

This drug has forty-five patent family members in twenty-six countries.

The generic ingredient in NUCYNTA 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

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

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 3, 2026. This may change due to patent challenges or generic licensing.

There have been four 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

International Patents:	45
US Patents:	1
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	45
Clinical Trials:	6
Drug Prices:	Drug price information for NUCYNTA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NUCYNTA
What excipients (inactive ingredients) are in NUCYNTA?	NUCYNTA excipients list
DailyMed Link:	NUCYNTA at DailyMed

See drug prices for NUCYNTA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for NUCYNTA

Constraining patent/regulatory exclusivity:

NEW PATIENT POPULATION

NDA:

203794

Dosage:

SOLUTION;ORAL

Constraining patent/regulatory exclusivity:

NEW PATIENT POPULATION

NDA:

022304

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for NUCYNTA

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 clinical trials

Pharmacology for NUCYNTA

Drug Class	Opioid Agonist
Mechanism of Action	Opioid Agonists

Paragraph IV (Patent) Challenges for NUCYNTA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NUCYNTA	Oral Solution	tapentadol hydrochloride	20 mg/mL	203794	1	2013-12-20
NUCYNTA	Tablets	tapentadol hydrochloride	50 mg, 75 mg, and 100 mg	022304	4	2012-11-20

US Patents and Regulatory Information for NUCYNTA

NUCYNTA is protected by one US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on NEW PATIENT POPULATION.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	tapentadol hydrochloride	SOLUTION;ORAL	203794-001	Oct 15, 2012		DISCN	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	tapentadol hydrochloride	TABLET;ORAL	022304-002	Nov 20, 2008		RX	Yes	No					Y
Collegium Pharm Inc	NUCYNTA	tapentadol hydrochloride	TABLET;ORAL	022304-001	Nov 20, 2008		RX	Yes	No					Y

Expired US Patents for NUCYNTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Collegium Pharm Inc	NUCYNTA	tapentadol hydrochloride	TABLET;ORAL	022304-002	Nov 20, 2008
Collegium Pharm Inc	NUCYNTA	tapentadol hydrochloride	SOLUTION;ORAL	203794-001	Oct 15, 2012
Collegium Pharm Inc	NUCYNTA	tapentadol hydrochloride	TABLET;ORAL	022304-003	Nov 20, 2008
Collegium Pharm Inc	NUCYNTA	tapentadol hydrochloride	TABLET;ORAL	022304-003	Nov 20, 2008
Collegium Pharm Inc	NUCYNTA	tapentadol hydrochloride	TABLET;ORAL	022304-001	Nov 20, 2008

International Patents for NUCYNTA

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

Country	Patent Number	Title	Estimated Expiration
Japan	2002511835
Australia	685644
Colombia	4410179	COMPUESTOS DE 1-FENIL-3-DIMETILAMINO-PROPANO CON EFECTO FARMACOLOGICO
China	1153568
Norway	20160914	Krystallinske former av (-)-(1R,2R)-3-(3-dimetylamino-1-etyl-2-metylpropyl)-fenol hydroklorid

Supplementary Protection Certificates for NUCYNTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	1190004-0.L	Sweden		PRODUCT NAME: TAPENTADOL; NAT. REG. NO/DATE: 42622-42628 20100910; FIRST REG.: DE 7543-7548,7661-76270" EESGODKLANDKOD="DE" EESGODKDATUM="2010-08-19" SEGODKNR="42622-42628 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
0693475	2011/010	Ireland		PRODUCT NAME: TAPENTADOL IN BASIC FORM OR IN THE FORM OF A SALT OF A PHYSIOLOGICALLY COMPATIBLE ACID, ESPECIALLY TAPENTADOL HYDROCHLORIDE; NAT REGISTRATION NO/DATE: PA1189/007/001-008 20101221; FIRST REGISTRATION NO/DATE: PA1189/008/001-008 21/12/2010 GERMANY 75043.00.00 75044.00.00 75045.00.00 19/08/2010 GERMANY 76261.00.00 76262.00.00 76263.00.00 76264.00.00 76265.00.00 19/08/2010 GERMANY 75046.00.00 75047.00.00 75048.00.00 19/08/2010 GERMANY 76266.00.00 76267.00.00 76268.00.0076269.00.00 76270.00.00 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

Last updated: July 27, 2025

Introduction

NUCYNTA ( Tapentadol ) is a prescription opioid analgesic marketed primarily for moderate to severe pain management. It combines mu-opioid receptor agonism with norepinephrine reuptake inhibition, offering a dual mechanism of action that distinguishes it within opioid therapy. Since its approval by the FDA in 2008, NUCYNTA has experienced significant shifts in market dynamics, influenced by regulatory, competitive, and societal factors. Understanding these trends is crucial for stakeholders seeking insights into its financial trajectory and future prospects.

Market Landscape of NUCYNTA

Global and U.S. Market Overview

The global opioid analgesics market is projected to reach approximately USD 13 billion by 2025, growing at a CAGR of around 4% (1). Within this, NUCYNTA holds a notable segment, especially in North America, where opioid prescriptions constitute a substantial component of chronic pain management.

In the U.S., NUCYNTA's market penetration is buoyed by its positioning as an alternative to traditional opioids like oxycodone and hydrocodone, especially for patients requiring a dual-action analgesic with potentially reduced side effects. As per IQVIA data, NUCYNTA revenues in the U.S. surpassed USD 600 million in 2020 (2), evidencing robust adoption. However, growth rates have plateaued post-2016 due to increasing regulatory scrutiny and the broader opioid crisis narrative.

Regulatory and Societal Influences

The opioid epidemic has precipitated rigorous regulatory responses, including rescheduling, prescribing restrictions, and enhanced monitoring. These measures directly impact NUCYNTA's prescribing volumes. For example, the CDC guidelines emphasize cautious opioid use, favoring multimodal pain management, which may limit NUCYNTA's growth (3).

Moreover, societal shifts have led to increased litigation against opioid manufacturers, prompting companies to reconsider marketing strategies and potentially influence revenue streams. This backdrop of heightened concern over opioid misuse has limited aggressive marketing but simultaneously increased demand for safer alternatives, a niche where NUCYNTA claims to have an advantage due to its unique dual mechanism.

Competitive Landscape

Key Competitors

NUCYNTA faces competition from various analgesics:

• Traditional opioids: OxyContin, Vicodin, MS Contin.
• Other dual-mechanism agents: Tramadol, which shares similar properties but with a different risk profile.
• Non-opioid therapies: NSAIDs, anticonvulsants, serotonin-norepinephrine reuptake inhibitors (SNRIs), and emerging biologics.

Differentiation and Market Positioning

NUCYNTA’s dual mechanism posits it as a potentially safer alternative with a lower risk of respiratory depression compared to conventional opioids. This aspect could influence prescriber preference amid tighter regulations. However, concerns over abuse potential persist, and abuse-deterrent formulations have been developed to mitigate misuse.

Patent and Regulatory Developments

Patent expirations and the introduction of generic formulations significantly impact profitability. For NUCYNTA, Janssen Pharmaceuticals holds key patents, but patent cliffs have occurred in some markets, leading to erosion of exclusivity and increased price competition.

Financial Trajectory

Revenue Trends and Forecasts

Post-approval, NUCYNTA experienced rapid adoption, with revenues peaking around USD 800 million globally in 2014. Since then, revenues have plateaued or declined slightly, influenced by:

• Regulatory constraints limiting prescriber outcomes.
• Increased competition and generics entering the market.
• Societal pushback stemming from opioid misuse concerns.

Projections indicate a compounded annual decline rate of approximately 2-4% in the next five years, barring significant regulatory or clinical breakthroughs.

Research and Development Outlook

While Janssen continues to explore alternative formulations—such as sustained-release and abuse-deterrent versions—they face challenges in demonstrating a clear advantage over existing therapies amid a regulatory environment wary of opioids.

Reimbursement and Market Access

Insurance coverage policies are tightening, with payers increasingly favoring non-opioid pain management strategies. This shift hampers revenue growth prospects and emphasizes the need for NUCYNTA to demonstrate superior safety and efficacy profiles.

Future Market Drivers and Barriers

Drivers

• Growing unmet needs in chronic pain management.
• Development of abuse-deterrent formulations.
• Increasing acceptance of dual-mechanism agents.

Barriers

• Regulatory restrictions and litigation risks.
• Societal movement against opioid misuse.
• Competition from non-opioid analgesics.
• Patent expirations leading to pricing pressures.

Conclusion

The market dynamics for NUCYNTA are deeply intertwined with evolving regulatory landscapes, societal perceptions, and competitive pressures. While it retains a crucial niche as a dual-mechanism analgesic, its financial trajectory faces headwinds from these factors. Stakeholders should remain vigilant to policy changes, market entry of generics, and advancements in pain management algorithms that could either curb or catalyze revenue streams.

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Key Takeaways

• Market Saturation and Competition: NUCYNTA's peak revenues have plateaued due to generics and increased market competition, necessitating differentiation through innovation.
• Regulatory Environment: Heightened oversight and opioid restrictions limit prescribing, constraining growth prospects.
• Societal Impact: The opioid crisis has led to reduced prescribing and increased scrutiny, impacting revenue trajectories.
• Product Development: Abuse-deterrent formulations could extend lifecycle value but require substantial clinical validation and regulatory approval.
• Strategic Focus: Diversifying pain management offerings and emphasizing safety profiles are crucial for sustained financial performance.

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FAQs

1. What factors have most influenced NUCYNTA's market share decline?
   Regulatory restrictions, societal concerns over opioids, patent expirations, and competition from generic formulations have reduced its market dominance.

2. How does NUCYNTA differentiate itself from other opioids?
   Its dual mechanism of mu-opioid receptor agonism and norepinephrine reuptake inhibition aims to provide effective pain relief with potentially fewer side effects and abuse potential.

3. What future developments could impact NUCYNTA's financial trajectory?
   Introduction of new abuse-deterrent formulations, shifts towards non-opioid pain therapies, and further regulatory restrictions are pivotal factors.

4. Are there emerging markets or therapeutic areas for NUCYNTA?
   Currently focused on pain management, expansion into other indications is unlikely. However, emerging markets with less stringent regulations might present opportunities.

5. What strategies can pharmaceutical companies employ to sustain revenue for drugs like NUCYNTA?
   Innovating formulations, emphasizing safety features, broadening indications, and integrating digital health tools may help sustain profitability amidst challenges.

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References
[1] Global Opioid Market Forecast, 2020–2025. (Industry Report)
[2] IQVIA. (2020). Top Pain Management Drugs by Revenue in the USA.
[3] CDC Guideline for Prescribing Opioids for Chronic Pain. (2016)