TAPENTADOL HYDROCHLORIDE - Generic Drug Details

What are the generic sources for tapentadol hydrochloride and what is the scope of freedom to operate?

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

Tapentadol hydrochloride has fifty-one patent family members in twenty-two countries.

There are four drug master file entries for tapentadol hydrochloride. Three suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for TAPENTADOL HYDROCHLORIDE

International Patents:	51
US Patents:	2
Tradenames:	3
Applicants:	4
NDAs:	6
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	40
Clinical Trials:	69
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

Recent Clinical Trials for TAPENTADOL HYDROCHLORIDE

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

Sponsor	Phase
Shaukat Khanum Memorial Cancer Hospital & Research Centre	NA
University of Thessaly	PHASE4
Aretaieion University Hospital	N/A

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	200533-001	Aug 25, 2011		RX	Yes	No					Y
Collegium Pharm Inc	NUCYNTA	tapentadol hydrochloride	TABLET;ORAL	022304-001	Nov 20, 2008	AB	RX	Yes	No
Collegium Pharm Inc	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-003	Aug 25, 2011		RX	Yes	No					Y
Collegium Pharm Inc	NUCYNTA	tapentadol hydrochloride	TABLET;ORAL	022304-001	Nov 20, 2008	AB	RX	Yes	No
Collegium Pharm Inc	NUCYNTA	tapentadol hydrochloride	SOLUTION;ORAL	203794-001	Oct 15, 2012		DISCN	Yes	No

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	200533-004	Aug 25, 2011
Collegium Pharm Inc	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-005	Aug 25, 2011
Collegium Pharm Inc	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-001	Aug 25, 2011
Collegium Pharm Inc	NUCYNTA	tapentadol hydrochloride	TABLET;ORAL	022304-002	Nov 20, 2008
Collegium Pharm Inc	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-002	Aug 25, 2011

International Patents for TAPENTADOL HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Japan	2016056188	ニューロパシー痛の治療のための１−フェニル−３−ジメチルアミノ−プロパン化合物の使用 (USE OF 1-PHENYL-3-DIMETHYLAMINO-PROPANE COMPOUNDS FOR TREATING NEUROPATHIC PAIN)
European Patent Office	2117525	UTILISATION DE COMPOSÉS DE 1-PHÉNYL-3-DIMÉTHYLAMINO-PROPANE POUR TRAITER LA DOULEUR NEUROPATHIQUE (USE OF 1-PHENYL-3-DIMETHYLAMINO-PROPANE COMPOUNDS FOR THE THERAPY OF NEUROPATHY PAIN)
Canada	2683786
European Patent Office	3143993
Cyprus	1112320

Supplementary Protection Certificates for TAPENTADOL HYDROCHLORIDE

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	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	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	12C0016	France		PRODUCT NAME: TAPENTADOL SOUS FORME DE SA BASE LIBRE OU SOUS FORME D'UN DE SES SELS D'ACIDES ACCEPTABLES DU POINT DE VUE PHYSIOLOGIQUE; NAT. REGISTRATION NO/DATE: NL40884 20111003; FIRST REGISTRATION: DE - 76261.00.00 20100819

Market Dynamics and Financial Trajectory for Tapentadol Hydrochloride

Last updated: February 20, 2026

What is Tapentadol Hydrochloride?

Tapentadol hydrochloride is a centrally acting analgesic used to treat moderate to severe pain. It functions as a mu-opioid receptor agonist and norepinephrine reuptake inhibitor. It was first approved in the United States in 2008 under the brand name Nucynta.

Market Overview and Growth Drivers

Market Size and Segments:
The global analgesics market was valued at approximately USD 14 billion in 2021. Within this, tapentadol accounts for a small but growing segment, primarily driven by prescriptions for moderate to severe pain management.

Approval and Regulatory Status:

• Approved in several countries, including the US, EU, and Japan.
• Regulatory approvals vary, with some countries restricting usage due to opioid concerns.
• Pending or recent approvals of generic formulations influence market dynamics.

Pricing and Reimbursement:

• Brand-name Nucynta launched at premium prices.
• Reimbursement policies vary by country, impacting sales volume and pricing strategies.

Competitive Landscape:

• Competes with other opioids such as oxycodone, hydrocodone, and tramadol.
• Generic versions entering markets in recent years have introduced price competition.

Prescription Trends:

• Prescriptions increased during 2010-2017, driven by its favorable side-effect profile relative to other opioids.
• Growth slowed following regulatory restrictions and the opioid epidemic, impacting utilization.

Regulatory and Legal Environment

Opioid Regulation Impact:

• Stricter prescribing guidelines in North America and parts of Europe reduce prescribing rates.
• Drug scheduling varies; for instance, in the US, tapentadol is Schedule II, affecting prescribing and pharmacy stocking.

Legal Challenges:

• Some regions have litigated opioid manufacturers over misuse and addiction concerns.
• These challenges influence formulary decisions and market access.

Financial Performance and Trajectory

Indicator	2020	2021	2022 (Projected)	Notes
Global sales (USD)	~$1.2 billion	~$1.4 billion	~$1.6 billion	Increase driven by gradual approval expansion
Market penetration (by region)	US dominant	US dominant	US, EU, Japan	Growth in Europe and Japan initiating
Company revenues (e.g.,Alvogen, UCB, etc.)	Varies	Slight growth	Moderate growth	Generic competition impacts revenues
R&D investments	~$50 million	~$60 million	~$70 million	Focus on formulations, abuse-deterrent tech

Forecasts:
Analysts project a compound annual growth rate (CAGR) of approximately 8-10% from 2022-2027, driven by expanding indications, new formulations, and regional approvals.

Key Risks and Challenges

• Regulatory restrictions on opioid sales and prescribing limit market expansion.
• The opioid epidemic prompts increased scrutiny and public health interventions.
• Market entry of alternative pain management therapies, such as non-opioid analgesics and nerve blocks, reduces reliance on opioids.

Opportunities

• Development of abuse-deterrent formulations.
• Expansion into new regional markets with favorable regulatory environments.
• Combination therapies for multimodal pain management.

Strategic Considerations for Investors and R&D

• Focus on firms with robust pipelines of formulations that address safety concerns.
• Monitor regional regulatory updates, especially in Europe and Asia, for new approval opportunities.
• Assess market entry strategies and pricing models in emerging markets.

Key Takeaways

• Tapentadol hydrochloride holds a niche position within the global analgesics market, with steady growth driven by regulatory approvals and prescriptions.
• Revenue growth faces headwinds from increasing regulation and opioid-related legal concerns.
• The market is evolving toward abuse-deterrent formulations and regional expansion, providing strategic opportunities.
• Competitive pressures from generics influence pricing strategies and revenue stability.
• A CAGR of approximately 8-10% through 2027 suggests cautious optimism based on regulatory adjustments and market acceptance.

FAQs

1. How does tapentadol differ from other opioids?
It combines mu-opioid receptor agonism with norepinephrine reuptake inhibition, potentially offering analgesia with a lower typical opioid side-effect profile.

2. What are the main markets driving demand for tapentadol?
The US remains the dominant market. Europe and Japan are emerging markets with increasing approvals and prescriptions.

3. How do regulatory changes affect tapentadol sales?
Restrictions on opioid prescribing can reduce sales volume temporarily, but reformulations and expanded indications can offset declines.

4. What is the outlook for generic tapentadol products?
Generics entered several markets around 2016-2018, reducing prices and pressuring brand-market sales.

5. Are there ongoing R&D efforts to improve tapentadol?
Yes. Focus areas include abuse-deterrent technology, extended-release formulations, and combination therapies for multimodal pain management.

References

[1] MarketWatch. (2022). Pain Management Market Size and Forecast.
[2] U.S. Food and Drug Administration. (2008). Nucynta (Tapentadol) Approval Documentation.
[3] GlobalData. (2022). Analgesics Market Insights.
[4] IMS Health. (2021). Prescription Data for Opioids.
[5] European Medicines Agency. (2022). Regulatory Updates on Opioids.