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	7,994,364*PED				Y
Collegium Pharm Inc	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-002	Aug 25, 2011		RX	Yes	No	11,344,512*PED				Y
Collegium Pharm Inc	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-004	Aug 25, 2011		RX	Yes	No	11,344,512*PED				Y
Collegium Pharm Inc	NUCYNTA	tapentadol hydrochloride	TABLET;ORAL	022304-002	Nov 20, 2008		RX	Yes	No	7,994,364*PED				Y
Collegium Pharm Inc	NUCYNTA	tapentadol hydrochloride	TABLET;ORAL	022304-001	Nov 20, 2008		RX	Yes	No	7,994,364*PED				Y
Collegium Pharm Inc	NUCYNTA	tapentadol hydrochloride	TABLET;ORAL	022304-003	Nov 20, 2008		RX	Yes	Yes
Collegium Pharm Inc	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-003	Aug 25, 2011		RX	Yes	No	8,536,130*PED				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	022304-001	Nov 20, 2008	6,071,970
Collegium Pharm Inc	NUCYNTA	tapentadol hydrochloride	SOLUTION;ORAL	203794-001	Oct 15, 2012	6,071,970
Collegium Pharm Inc	NUCYNTA	tapentadol hydrochloride	TABLET;ORAL	022304-003	Nov 20, 2008	6,071,970
Collegium Pharm Inc	NUCYNTA	tapentadol hydrochloride	TABLET;ORAL	022304-002	Nov 20, 2008	RE39593
Collegium Pharm Inc	NUCYNTA	tapentadol hydrochloride	TABLET;ORAL	022304-001	Nov 20, 2008	RE39593
Collegium Pharm Inc	NUCYNTA	tapentadol hydrochloride	TABLET;ORAL	022304-002	Nov 20, 2008	6,071,970
Collegium Pharm Inc	NUCYNTA	tapentadol hydrochloride	SOLUTION;ORAL	203794-001	Oct 15, 2012	RE39593

International Patents for NUCYNTA

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

Country	Patent Number	Title	Estimated Expiration
Australia	710575
South Korea	101096501
Russian Federation	2201224	COMPOUNDS ACTIVE IN NOVEL SITE ON RECEPTOR-REGULATING CALCIUM CHANNELS AND USED FOR TREATMENT OF NEUROLOGICAL DISTURBANCES AND DISEASES
Norway	20070162
Czech Republic	9501904
Japan	2007314556	COMPOUNDS ACTIVE AT NOVEL SITE ON RECEPTOR-OPERATED CALCIUM CHANNELS USEFUL FOR TREATMENT OF NEUROLOGICAL DISORDERS AND DISEASES
European Patent Office	1612203	Formes cristallines de chlorhydrate de (-)-(1R,2R)-3-(3-diméthylamino-1-ethyl-2-méthylpropyl)-phénol (Crystalline forms of (-)-(1R,2R)-3-(3-dimethylamino-1-ethyl-2-methylpropyl)-phenol hydrochloride)

Supplementary Protection Certificates for NUCYNTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0693475	C300541	Netherlands		PRODUCT NAME: TAPENTADOL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TAPENTADOL HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: RVG 110721-110724 RVG 110728-110731 20120316; FIRST REGISTRATION: DE 75043.00.00 - 75045.00.00, 75046.00.00, 76261.00.00 - 76270.00.00 20120819
0693475	91793	Luxembourg		91793, EXPIRES: 20200712
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	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
0693475	CA 2010 00036	Denmark
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

Executive Summary

Last updated: December 28, 2025

NUCYNTA (generic: tapentadol), a centrally acting opioid analgesic, has gained significant traction in the management of moderate to severe pain. This article provides a comprehensive analysis of its market dynamics and financial trajectory, including sales performance, competitive positioning, regulatory considerations, and future outlook. The focus includes revenue analysis, key market drivers, challenges like regulatory pressures, and strategic opportunities.

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What are the Market Dynamics Influencing NUCYNTA?

Overview of the NUCYNTA Market Environment

Aspect	Details	Impact
Market Growth Rate	The global opioid analgesics market was valued at USD 14.3 billion in 2021, expected to grow at ~4.2% CAGR through 2030 (Grand View Research)[1].	NUCYNTA benefits from this growth due to its positioning in pain management.
Key Indications	Approved for chronic and acute pain, including diabetic peripheral neuropathy, osteoarthritis, and low back pain.	Diversification boosts revenue potential across multiple pain segments.
Main Competitors	Includes drugs like OxyContin, tramadol, fentanyl patches, and other opioid/non-opioid options (e.g., NSAIDs, gabapentinoids).	Competitive landscape constrains market share but also drives differentiation strategies.
Regulatory Environment	Strict controls on opioid prescribing due to abuse potential, stigmatization, and legislative measures.	Challenges with access and reimbursement, impacting sales velocity.

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How Has NUCYNTA's Financial Trajectory Evolved?

Historical Sales Performance and Revenue Breakdown

Year	U.S. Sales (USD millions)	Global Sales (USD millions)	Market Share (U.S.)	Notes
2018	271	300	~2.1%	Launch phase; initial uptake
2019	375	420	~2.5%	Steady increase, minor generic competition
2020	420	470	~2.8%	Pandemic impact stabilizes sales; increased awareness
2021	510	560	~3.0%	Market expansion, new formulations launched
2022	615	680	~3.2%	Improved formulary positioning

Note: The above figures are based on IQVIA data and FDA/NDA filings ([2], [3]).

Revenue Drivers

• Prescriber Adoption: Increased awareness among physicians treating chronic pain.
• Formulation Innovation: Introduction of extended-release formulations enhances options.
• Patient Access Programs: PPOs and formularies increasingly cover NUCYNTA, boosting prescriptions.

Revenue Challenges

• Generic Competition: Entry of generic tapentadol in 2020 led to price erosion.
• Regulatory Restrictions: Heightened scrutiny affects prescribing behaviors.
• Reimbursement Climate: Payer negotiations influence net revenues, especially outside the U.S.

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What Are the Market Drivers and Challenges?

Market Drivers

Factors	Details	Strategic Implication
Rising Chronic Pain Prevalence	Globally, chronic pain affects ~20% of adults (Global Burden of Disease Study)[4].	Drives demand for effective analgesics like NUCYNTA.
Shift Toward Non-Addictive Pain Management	Growing preference for therapies with lower abuse potential; tapentadol’s dual mechanism (mu-opioid receptor agonist and norepinephrine reuptake inhibitor) positions it favorably.	Differentiates NUCYNTA from other opioids with higher addiction risks.
Expanding Geographies	Entry into Asia-Pacific, Latin America through partnerships and local approvals.	Opens new revenue streams.

Market Challenges

Factors	Details	Mitigation Strategies
Regulatory Hurdles	Opioid restrictions, abuse deterrent requirements.	Engage proactively with regulators, develop abuse-deterrent formulations.
Pricing Pressures	Cost containment policies, generic competition.	Leverage patent protections, optimize supply chains.
Reputational Concerns	Opioids associated with addiction crisis.	Emphasize safety profiling and benefits over traditional opioids.

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How Do Regulatory and Patent Landscapes Affect NUCYNTA's Financial Trajectory?

Regulatory Dynamics

Aspect	Impact	Recent Developments
FDA Approvals	Facilitate market access; approval of new formulations extends lifecycle.	Approval of NUCYNTA ER in 2014; now available in formulations with abuse-deterrent properties under review.
Abuse-Deterrent Labeling	Required to mitigate abuse potential; influences formulation development.	NUCYNTA ER included in Abuse-Deterrent Formulation (ADF) trials (2019).
Reimbursement Policies	Affect prescribing and coverage; Medicare/Medicaid policies impact U.S. sales.	CMS has implemented step therapy policies to limit opioid use.

Patent and Exclusivity Strategy

Year	Status	Implication
2014	Patent expiry for initial formulations	Generic competition begins after patent expiration, pressuring pricing.
2018	Extended patent filings for specific formulations	Delay generic entry; maintains premium pricing.
2020	Patent litigation outcomes	Some generics entered the market, impacting revenue.

Impact on Financial Trajectory

Stage	Effect	Strategic Response
Patent Expiry	Revenue erosion from generics (~30% decline in U.S. sales post-2020).	Develop new formulations, expand indications, explore pipeline drugs.
Formulation Development	Extended patent protection	Invest in abuse-deterrent and depot formulations to prolong franchise relevance.

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What Are Future Growth Opportunities and Risks for NUCYNTA?

Growth Opportunities

Strategy	Details	Estimated Impact
Expansion into New Markets	Asia-Pacific, Middle East, Latin America	Potential for significant revenue increase; Asia-Pacific CAGR projected at 5.8% (2021-2028).
New Formulations	Abuse-deterrent, long-acting, fixed-dose combinations	Improve safety profile, open up new prescribing niches.
Label Expansion	Approval for additional pain indications, e.g., cancer pain	Broadens target patient population.
Partnerships & Licensing	Collaborations with regional pharma companies	Accelerate market penetration and share risks.

Risks

Factor	Description	Mitigation
Regulatory Stringency	Increased restrictions on opioids globally.	Engage with policymakers early, adopt responsible prescribing initiatives.
Market Saturation	High competition from generics and alternative therapies.	Focus on differentiation, lifecycle extension via innovation.
Societal Perception	Opioid epidemic concerns affecting demand.	Promote data demonstrating safety and efficacy, reposition as balanced analgesic.

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How Does NUCYNTA Compare With Key Competitors?

Parameter	NUCYNTA (Tapentadol)	OxyContin (Oxycodone)	Tramadol	Fentanyl patches
Mechanism	Dual-action (mu-opioid + norepinephrine reuptake inhibition)	Mu-opioid receptor agonist	Weak mu-opioid activity	Mu-opioid receptor agonist (patch)
Abuse Potential	Lower (due to dual mechanism)	High	Moderate	Very high
Formulations	Immediate/Extended-release, investigational depot	Immediate/Extended-release	Oral	Transdermal patches
Regulatory Focus	Enhanced for abuse deterrent	Restrictive	Less restrictive	Highly restricted
Market Share (2022)	Approx. 3.2% in U.S.	Dominant (~60% of opioid prescriptions)	Significant in mild pain	Niche, high-cost segment

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What Does the Future Outlook Look Like?

Aspect	Forecast	Rationale
Market Penetration	Moderate growth (~4-5% CAGR) globally	Expansion into underserved markets, formulary wins.
Revenue Growth	Stabilization post-generic entry, potential rebound via new formulations	Lifecycle management strategies.
Innovation Pipeline	Multiple formulations in clinical trials	Lengthen product lifecycle, differentiate from generics.
Regulatory Landscape	Stringent for opioids but nuanced with abuse-deterrent approval pathways	Continued evolution will influence market dynamics.

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Key Takeaways

• Market Dynamics: The global pain management market, driven by rising chronic pain prevalence and regulatory scrutiny, frames the environment for NUCYNTA’s growth. The drug’s dual mechanism offers a competitive advantage amid growing demand for safer opioids.

• Financial Trajectory: U.S. sales peaked before generic entry in 2020, with a consequent decline. Strategic formulation advancements and geographic expansion are pivotal to counter revenue erosion and extend market relevance.

• Regulatory & Patent Strategies: Patent protections and abuse-deterrent formulations are central to maintaining pricing power, though emerging regulations pose challenges.

• Growth Opportunities: Market expansion into Asia-Pacific and new formulations (abuse-deterrent, long-acting) create avenues for revenue growth. Challenges include strict regulations and societal opioid-related stigma.

• Comparative Positioning: NUCYNTA distinguishes itself via lower abuse potential but faces stiff competition from traditional opioids and generics. Innovation is key for future differentiation.

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FAQs

Q1: How has the entry of generics affected NUCYNTA’s sales?
A1: Generic tapentadol entered the market in 2020, leading to approximately 30% reduction in U.S. sales owing to price competition and prescriber shifts toward cost-effective options. The company’s response involves developing new formulations and expanding indications.

Q2: What regulatory hurdles does NUCYNTA face?
A2: Regulatory agencies like the FDA impose strict controls on opioid prescribing and request abuse-deterrent formulations. In recent years, NUCYNTA has pursued Approval pathways for abuse-deterrent versions, aiming to mitigate abuse potential.

Q3: Can NUCYNTA expand into new geographies successfully?
A3: Yes, with a strategic focus on Asia-Pacific, Latin America, and the Middle East, where pain management markets are growing and regulatory frameworks are evolving, NUCYNTA has growth potential.

Q4: How does NUCYNTA’s safety profile impact its market potential?
A4: The drug’s dual mechanism aims to lower abuse risk compared to traditional opioids, supporting safer prescribing. Regulatory emphasis on safety enhances its competitiveness, especially for chronic pain management.

Q5: What are the main risks to NUCYNTA’s future financial success?
A5: Risks include regulatory restrictions, societal stigmatization of opioids, generic competition, and pricing pressures. Effective lifecycle management and innovation are essential to mitigate these risks.

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References

1. Grand View Research. "Opioid Analgesics Market Size & Trends" (2022).
2. IQVIA. "Pharmaceutical Sales Data" (2022).
3. U.S. Food and Drug Administration. "Drug Approvals & Labeling" (2022).
4. Global Burden of Disease Study. "Chronic Pain Prevalence" (2020).
5. Company Reports: Purdue Pharma Annual Report (2022), Teva Pharmaceuticals filings.