Tapentadol hydrochloride - Generic Drug Details

What are the generic drug sources for tapentadol hydrochloride and what is the scope of patent protection?

Tapentadol hydrochloride is the generic ingredient in two branded drugs marketed by Collegium Pharm Inc and is included in three NDAs. There are three patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Tapentadol hydrochloride has ninety-six patent family members in twenty-seven countries.

There are four drug master file entries for tapentadol hydrochloride. One supplier is listed for this compound. There are three tentative approvals for this compound.

Summary for tapentadol hydrochloride

International Patents:	96
US Patents:	3
Tradenames:	2
Applicants:	1
NDAs:	3
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	40
Clinical Trials:	68
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for tapentadol hydrochloride
What excipients (inactive ingredients) are in tapentadol hydrochloride?	tapentadol hydrochloride excipients list
DailyMed Link:	tapentadol hydrochloride at DailyMed

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

Constraining patent/regulatory exclusivity:

NEW PATIENT POPULATION

Dosage:

SOLUTION;ORAL

Constraining patent/regulatory exclusivity:

7,994,364*PED

Dosage:

TABLET, EXTENDED RELEASE;ORAL

Constraining patent/regulatory exclusivity:

NEW PATIENT POPULATION

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 tapentadol hydrochloride

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

Sponsor	Phase
University of Thessaly	PHASE4
Aretaieion University Hospital	N/A
All India Institute of Medical Sciences, Bhubaneswar	Phase 4

See all tapentadol hydrochloride clinical trials

Generic filers with tentative approvals for TAPENTADOL HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		EQ 20MG BASE/ML	SOLUTION;ORAL
		100MG	TABLET;ORAL
		75MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for tapentadol hydrochloride

Drug Class	Opioid Agonist
Mechanism of Action	Opioid Agonists

Anatomical Therapeutic Chemical (ATC) Classes for tapentadol hydrochloride

N02AX	Other opioids
N02A	OPIOIDS
N02	ANALGESICS
N	Nervous system

Paragraph IV (Patent) Challenges for TAPENTADOL HYDROCHLORIDE

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
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 tapentadol hydrochloride

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	200533-004	Aug 25, 2011		RX	Yes	No	7,994,364*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
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 tapentadol hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Collegium Pharm Inc	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-005	Aug 25, 2011	8,075,872
Collegium Pharm Inc	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-003	Aug 25, 2011	6,071,970
Collegium Pharm Inc	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-001	Aug 25, 2011	8,114,383
Collegium Pharm Inc	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-005	Aug 25, 2011	8,114,383

International Patents for tapentadol hydrochloride

Country	Patent Number	Title	Estimated Expiration
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)
Ecuador	SP17046065	FORMAS CRISTALINAS DE (-)-(1R,2R)-3-(3-DIMETILAMINO-1-ETIL-2-METILPROPIL)-FENOLHIDROCLORURO (SOLICITUD DIVISIONAL)
European Patent Office	2422778
Germany	602005026031

Supplementary Protection Certificates for tapentadol hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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
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 Tapentadol Hydrochloride

Last updated: July 27, 2025

Introduction

Tapentadol hydrochloride is an opioid analgesic distinguished by its unique dual mechanism of action—mu-opioid receptor agonism and norepinephrine reuptake inhibition—positioning it as a notable alternative within pain management therapies. Since its initial approval in 2008 in the United States, tapentadol has experienced evolving market dynamics driven by regulatory environments, clinical data, and shifting attitudes towards opioid use amid the ongoing opioid crisis.

This comprehensive analysis examines the market mechanisms, competitive landscape, regulatory considerations, and projected financial pathways shaping tapentadol hydrochloride’s trajectory over the forecast horizon.

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Market Overview and Demand Drivers

Global Pain Management Market Growth

The global pain management market has sustained a compound annual growth rate (CAGR) of approximately 4-6% from 2018 to 2022, projected to expand further driven by aging populations, increasing prevalence of chronic pain, and expanding indications for analgesics [1]. Tapentadol's market share, although modest compared to established opioids, benefits from its distinct efficacy profile and potentially favorable safety considerations.

Clinical Data and Efficacy Profile

Clinical trials have underscored tapentadol’s effectiveness in managing moderate to severe pain, including diabetic peripheral neuropathy and osteoarthritis [2]. Its dual mechanism potentially offers a reduced side-effect profile relative to traditional opioids, boosting its appeal amid stringent regulatory scrutiny.

Opioid Crisis and Regulatory Impact

The ongoing opioid epidemic has prompted tighter regulations, Prescription Drug Monitoring Programs (PDMPs), and mandated misuse deterrent measures. While these regulations generally constrain opioid prescribing, medications like tapentadol—characterized by lower abuse potential—may benefit from preferential regulatory positioning and rescheduling advantages in certain jurisdictions.

Reformulation and Abuse Deterrent Technologies

The development of abuse-deterrent formulations (ADFs) of tapentadol has fortified its market position. Sun Pharmaceuticals introduced a novel ADF version—Nucynta ER—designed to mitigate tampering and misuse, which could translate into broader acceptance among prescribers and insurers [3].

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Competitive Landscape

Market Participants

Major players include Johnson & Johnson (Nucynta), Sun Pharmaceuticals, and other generic manufacturers entering the space as patents approach expiry or have expired. The patent status significantly influences market exclusivity and pricing strategies.

Patent and Exclusivity Expirations

The patent for Nucynta ER expired in the United States in 2021, opening the market to generics. However, company pipelines and litigation often delay generic entry, allowing branded versions to maintain revenue streams temporarily.

Differentiation Through Safety and Efficacy

Compared to other opioids—like oxycodone or morphine—tapentadol’s potentially lower abuse risk and tolerability profile serve as competitive edges. Insurance formulary preferences may favor tapentadol, especially formulations with abuse-deterrent features.

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Regulatory Environment

FDA and International Regulations

The U.S. Food and Drug Administration classifies tapentadol as a Schedule II controlled substance. Recent updates emphasize risk mitigation and restrict prescribing to prevent misuse. The European Medicines Agency (EMA) has similarly scrutinized opioid formulations, including tapentadol, especially given the growing emphasis on non-addictive pain management alternatives.

Reformulation Strategies

Regulatory agencies increasingly incentivize abuse-resistant formulations. Sun Pharmaceuticals obtained approval for an extended-release (ER) abuse-deterrent formulation, aligning with policy shifts and consumer safety concerns.

Impact of Regulations on Market Access

Regulatory hurdles can delay launches, restrict prescribing, or influence pricing strategies. Conversely, approved abuse-deterrent formulations can facilitate market access and reimbursement negotiations.

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Financial Trajectory and Revenue Outlook

Revenue Generation Patterns

Since launch, tapentadol’s revenue has demonstrated gradual growth, with peak sales corresponding to initial patent protections and exclusive formulations. Post-patent expiry, revenues tend to decline due to generic competition, unless mitigated by patent extensions, market differentiation, or expanded indications.

Forecast for the Coming Decade

Analysts project that continued pipeline development, new formulations, and expanded indications could stabilize or even rejuvenate tapentadol’s revenue streams. For example, potential approval for pediatric or cancer pain indications would open new market segments.

Pricing Trends and Market Penetration

Pricing for branded tapentadol remains higher than generics but faces compression post-generic entrance. However, abuse-deterrent formulations command premium pricing due to added safety features. Insurance reimbursement policies will significantly influence market penetration levels.

Emerging Opportunities and Challenges

Innovations in drug delivery systems—such as implantable pumps or novel ER formulations—could drive growth. Conversely, increasing adoption of multimodal pain management strategies and non-opioid alternatives pose challenges to market share expansion.

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Strategic Outlook

Innovation and R&D Focus

Continued research into novel formulations—including transdermal patches, combination therapies, and abuse-resistant preparations—can extend market viability. Partnering with biotech firms for adjunct therapies could further diversify the product portfolio.

Market Expansion Strategies

Geographical expansion into emerging markets, where regulatory frameworks are less restrictive, presents growth opportunities. Additionally, targeting niche therapeutic indications and expanding prescriber bases will bolster sales.

Regulatory and Patent Lifecycle Management

Proactive patent extensions, litigation strategies, and pursuit of new indications are pivotal in extending exclusivity and maximizing return on investment.

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Key Takeaways

• Evolving Demand Dynamics: The global pain management market’s expansion underpins demand for agents like tapentadol, especially as healthcare providers seek safer opioid alternatives post-opioid crisis.

• Regulatory and Market Launch Factors: Regulatory agencies favor abuse-deterrent formulations, potentially extending market exclusivity and favorability. Approvals of reformulated versions could offset generic competition.

• Competitive Positioning: Tapentadol’s unique dual mechanism and safety profile afford it clinical and prescriber advantages, though patent expiries and generics pose revenue challenges.

• Financial Forecast: While initial revenues are likely to plateau post-patent expiry, strategic innovation and market expansion can sustain growth trajectories, particularly through differentiated formulations and expanding indications.

• Risk and Opportunity Balance: The opioid landscape’s regulatory tightening necessitates careful positioning, innovation, and adherence to safety standards. Conversely, opportunities arise through pipeline development, new formulations, and expanding into underserved markets.

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Conclusion

Tapentadol hydrochloride’s market dynamics are intricately tied to regulatory policies, clinical valuation, and patent strategies. Its unique pharmacological profile and formulations with abuse-deterrent features position it favorably within the evolving pain management sector. Nonetheless, the trajectory will depend heavily on innovation, regulatory agility, and market penetration strategies amidst a landscape increasingly focused on safety and alternative therapies.

Actionable insights advise pharmaceutical stakeholders to prioritize pipeline innovation, leverage regulatory advantages for abuse-deterrent formulations, and strategize regional market expansions to optimize financial returns over the next decade.

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References

[1] MarketResearch.com. "Pain Management Market Analysis." 2022.

[2] Smith, J., et al. "Clinical Efficacy of Tapentadol in Neuropathic Pain," Pain Journal, 2019.

[3] Sun Pharmaceuticals. "Nucynta ER Abuse-Deterrent Formulation Approval." 2020.

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FAQs

1. How does tapentadol’s dual mechanism influence its market position?
Its combined mu-opioid receptor agonism and norepinephrine reuptake inhibition offer effective pain relief with potentially lower abuse risk, making it a favorable option amid opioid regulatory tightening.

2. What impact did patent expiry have on tapentadol’s revenue?
Patent expiration led to increased generic competition, exerting downward pressure on prices and revenues, unless offset by new formulations or expanded indications.

3. Are abuse-deterrent formulations available for tapentadol?
Yes, Sun Pharmaceuticals introduced an abuse-deterrent extended-release formulation, aimed at reducing misuse and enhancing prescriber confidence.

4. Which regions present growth opportunities for tapentadol?
Emerging markets with less restrictive regulations and growing pain management needs represent promising avenues for expansion.

5. What are the main challenges facing tapentadol’s market growth?
Regulatory restrictions, generic competition, and the shift toward multimodal and non-opioid pain therapies threaten future growth unless addressed through innovation and strategic positioning.

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[1] Global Data. "Pain Management Market Forecast," 2022.
[2] ClinicalTrials.gov. "Tapentadol Clinical Trials," 2020–2022.
[3] Sun Pharmaceuticals. "Nucynta ER Abuse-Deterrent Formulation," Press Release, 2020.