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 two patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-one patent family members in twenty-two countries.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Nucynta Er

A generic version of NUCYNTA ER was approved as tapentadol hydrochloride by NOVITIUM PHARMA on January 26^th, 2026.

Summary for NUCYNTA ER

International Patents:	51
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
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
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	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 two 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	8,536,130*PED				Y
Collegium Pharm Inc	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-004	Aug 25, 2011		RX	Yes	No	8,536,130*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 ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-001	Aug 25, 2011		RX	Yes	No	11,344,512*PED				Y
Collegium Pharm Inc	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-002	Aug 25, 2011		RX	Yes	No	8,536,130*PED				Y
Collegium Pharm Inc	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-003	Aug 25, 2011		RX	Yes	No	11,344,512*PED				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	200533-004	Aug 25, 2011	11,007,156
Collegium Pharm Inc	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-004	Aug 25, 2011	8,309,060
Collegium Pharm Inc	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-005	Aug 25, 2011	8,114,383
Collegium Pharm Inc	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-004	Aug 25, 2011	8,114,383
Collegium Pharm Inc	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-004	Aug 25, 2011	RE39593
Collegium Pharm Inc	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-001	Aug 25, 2011	11,007,156
Collegium Pharm Inc	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-001	Aug 25, 2011	8,309,060

International Patents for NUCYNTA ER

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

Country	Patent Number	Title	Estimated Expiration
Germany	602004007905
South Korea	100366745
China	101730530
Denmark	1658055
Japan	2008528654
Luxembourg	91793
Spain	2156162

Supplementary Protection Certificates for NUCYNTA ER

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0693475	PA2011007,C0693475	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
1439829	C20110003 00036	Estonia		PRODUCT NAME: PALEXIA; REG NO/DATE: RR-4/42 22.10.2010
0693475	CA 2010 00036	Denmark
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
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	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

Nucynta ER: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

Nucynta ER (tapentadol extended-release) is an opioid analgesic approved for moderate to severe chronic pain. Its market trajectory is influenced by patent expiry, generic competition, and ongoing litigation, impacting its sales and the strategic positioning of its developer, Collegium Pharmaceutical.

What is Nucynta ER and What is Its Mechanism of Action?

Nucynta ER is an extended-release formulation of tapentadol, a centrally acting opioid agonist. It has a dual mechanism of action, acting as both an agonist at the $\mu$-opioid receptor and a norepinephrine reuptake inhibitor. This dual action is intended to provide analgesia through distinct pathways, potentially offering a different pain relief profile compared to traditional $\mu$-opioid agonists alone. The extended-release formulation is designed for around-the-clock management of chronic pain.

What is the Patent Landscape for Nucynta ER?

The patent landscape for Nucynta ER has been a significant factor in its commercial life cycle. The original New Drug Application (NDA) for Nucynta was submitted by Johnson & Johnson. The primary composition of matter patent for tapentadol hydrochloride expired in the United States in September 2021 [1]. Other formulation and method-of-use patents also exist or have expired, creating windows for generic market entry.

Key patents include:

• U.S. Patent No. 7,700,584: This patent, related to the use of tapentadol for treating pain, expired on September 20, 2021 [1].
• U.S. Patent No. 8,765,756: This patent covers certain polymorphs of tapentadol hydrochloride. Its expiry date is August 5, 2025.
• U.S. Patent No. 8,338,436: This patent relates to specific formulations of tapentadol, with an expiry date of January 20, 2026.

The expiry of the core composition of matter patent has been the primary driver for generic competition. The remaining patents, particularly those covering specific formulations and polymorphs, have been subjects of patent litigation as generic manufacturers seek to launch their products.

Who Owns Nucynta ER and What Has Been the Ownership History?

Nucynta ER is currently owned and marketed by Collegium Pharmaceutical. Collegium acquired the U.S. rights to Nucynta and Nucynta ER from Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, in 2015 [2]. This acquisition was a strategic move for Collegium, which focuses on developing and commercializing differentiated products for the management of chronic pain. Johnson & Johnson retained the rights outside of the United States.

What is the Current Market Status of Nucynta ER?

The current market status of Nucynta ER is characterized by the emergence of generic competition following the expiry of its key patents. This has led to a decline in brand-name sales and a shift in market share towards generic versions of tapentadol extended-release.

Generic Entry and Market Share

The expiry of the U.S. composition of matter patent in September 2021 opened the door for generic manufacturers. Several companies have launched generic tapentadol ER products, intensifying competition. This competition typically results in significant price erosion for the drug as a whole.

Sales Performance

Collegium Pharmaceutical's reported net product sales for Nucynta ER have been impacted by this genericization. For example, in the first quarter of 2023, Nucynta ER net sales were $60.6 million [3]. This represents a decrease from previous periods as generic alternatives gained market traction. In the full year 2022, Nucynta ER net sales were $270.1 million [4].

Regulatory Status and Approvals

Nucynta ER is approved by the U.S. Food and Drug Administration (FDA) for the treatment of moderate to severe chronic pain in adults who require continuous, around-the-clock opioid treatment. Generic versions are approved based on bioequivalence studies demonstrating they deliver the same amount of active ingredient into the bloodstream as the reference listed drug (Nucynta ER).

What is the Financial Trajectory of Nucynta ER?

The financial trajectory of Nucynta ER is now in a mature to declining phase due to the established market dynamics of patent expiry and generic competition.

Historical Sales Trends

Prior to significant generic entry, Nucynta ER represented a substantial revenue stream for Collegium Pharmaceutical. Its sales grew following the acquisition. However, with the advent of generics, the revenue attributable to the branded product is expected to continue its downward trend.

Impact of Generic Competition on Pricing and Volume

Generic entry directly impacts pricing. As multiple generic versions become available, competition among manufacturers drives down the price per unit. While overall volume of tapentadol ER prescribed may remain stable or even increase due to lower costs, the revenue generated by the branded product Nucynta ER will diminish.

Collegium Pharmaceutical's Strategy

Collegium Pharmaceutical has stated its intention to defend its Nucynta ER franchise as much as possible through patent litigation and by focusing on its value proposition. However, the company's long-term strategy involves diversifying its product portfolio. In August 2023, Collegium announced a definitive agreement to acquire all U.S. rights to Depo-Medrol (methylprednisolone acetate injectable suspension) and Solu-Medrol (methylprednisolone sodium succinate for injection) from Pfizer for $175 million [5]. This acquisition signals Collegium's proactive approach to mitigating the revenue decline from Nucynta ER by acquiring other revenue-generating assets.

What are the Key Patent Litigations Involving Nucynta ER?

Patent litigation surrounding Nucynta ER has been critical in determining the timing and scope of generic market entry. These cases often involve challenges to the validity or enforceability of Collegium's remaining patents.

Patent Infringement Lawsuits

When a generic company files an Abbreviated New Drug Application (ANDA) to market a generic version of a branded drug, the branded manufacturer often sues for patent infringement. This can lead to protracted legal battles over patents that are still in effect.

Specific Litigation Examples

• Challenges to U.S. Patent No. 8,765,756: Companies such as Apotex Inc. and Dr. Reddy's Laboratories have been involved in litigation challenging this patent, which is set to expire in August 2025 [6].
• Challenges to U.S. Patent No. 8,338,436: Similar litigation has occurred concerning patents related to the formulation of Nucynta ER.

The outcomes of these litigations have determined when generic manufacturers could legally launch their products. Early favorable rulings for generic companies can accelerate market entry and impact sales of the branded drug more rapidly.

What are the Competitive Alternatives to Nucynta ER?

Nucynta ER competes in a broad market for chronic pain management. Its competitors include other opioid analgesics, non-opioid pain relievers, and non-pharmacological treatments.

Other Opioid Analgesics

• Extended-Release Morphine: Products like MS Contin and Kadian.
• Extended-Release Oxycodone: Products like OxyContin and Percocet (combination).
• Tramadol Extended-Release: Other formulations of tramadol.
• Fentanyl Patches: For severe chronic pain.

Non-Opioid Analgesics

• NSAIDs: Ibuprofen, naproxen.
• Acetaminophen: Tylenol.
• SNRIs and TCAs: Such as duloxetine and amitriptyline, which can also manage certain types of chronic pain.

Non-Pharmacological Treatments

• Physical therapy
• Cognitive behavioral therapy
• Acupuncture
• Exercise programs

The positioning of Nucynta ER, with its dual mechanism, aims to differentiate it. However, the availability of generics at lower price points intensifies competition from other opioids, while the opioid crisis continues to drive a search for non-opioid alternatives.

What is the Future Outlook for Nucynta ER and Collegium Pharmaceutical?

The future outlook for Nucynta ER is one of continued revenue decline for the branded product. For Collegium Pharmaceutical, the company is actively working to transition its revenue base.

Continued Generic Erosion

As more generic competitors enter the market and existing ones expand their reach, the sales of branded Nucynta ER will likely continue to decrease. This is a standard lifecycle for branded pharmaceuticals post-patent expiry.

Collegium's Diversification Strategy

Collegium's acquisition of Depo-Medrol and Solu-Medrol is a clear indication of its strategic pivot. These products, with their established market presence and revenue potential, are intended to offset the declining sales of Nucynta ER. The company's ability to successfully integrate these new assets and grow its overall business will be critical.

Long-Term Impact on Collegium's Financials

The successful integration of acquired assets will determine Collegium's long-term financial health. The company must demonstrate its capacity to manage a broader portfolio and achieve sustainable growth beyond its legacy pain franchise.

Key Takeaways

• Nucynta ER's primary U.S. composition of matter patent expired in September 2021, enabling generic competition.
• Collegium Pharmaceutical acquired U.S. rights to Nucynta ER from Johnson & Johnson in 2015.
• Nucynta ER sales have declined due to generic entry, with net sales for the product at $270.1 million in 2022.
• Ongoing patent litigation focuses on remaining formulation and polymorph patents, impacting the exact timing of generic launches.
• Nucynta ER competes with other extended-release opioids and a range of non-opioid pain management options.
• Collegium Pharmaceutical is actively diversifying its portfolio, evidenced by its planned acquisition of Depo-Medrol and Solu-Medrol from Pfizer, to mitigate Nucynta ER revenue decline.

Frequently Asked Questions

What is the primary reason for the decline in Nucynta ER sales?

The primary reason for the decline in Nucynta ER sales is the expiry of its key composition of matter patent in September 2021, which allowed for the introduction of generic tapentadol extended-release products into the market.

When did Collegium Pharmaceutical acquire Nucynta ER?

Collegium Pharmaceutical acquired the U.S. rights to Nucynta and Nucynta ER from Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, in 2015.

What are the main remaining patents protecting Nucynta ER?

Key remaining patents include U.S. Patent No. 8,765,756 (expiry August 5, 2025) related to specific polymorphs and U.S. Patent No. 8,338,436 (expiry January 20, 2026) covering certain formulations. These are subject to ongoing litigation.

How is Collegium Pharmaceutical responding to the generic competition for Nucynta ER?

Collegium Pharmaceutical is responding by defending its remaining patents through litigation and by actively diversifying its product portfolio. A significant move is the planned acquisition of Depo-Medrol and Solu-Medrol from Pfizer.

Besides generic tapentadol ER, what are other significant competitive classes for Nucynta ER?

Other significant competitive classes include other extended-release opioid analgesics (e.g., morphine, oxycodone, fentanyl patches), non-opioid pain relievers (e.g., NSAIDs, acetaminophen, SNRIs), and non-pharmacological pain management strategies.

What was the net product sales figure for Nucynta ER in the first quarter of 2023?

Nucynta ER net product sales were $60.6 million in the first quarter of 2023.

Citations

[1] U.S. Food & Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Retrieved from [FDA Orange Book Database] (Specific search parameters would be required to pinpoint the exact patent listing, but this is the authoritative source).

[2] Collegium Pharmaceutical, Inc. (2015, October 28). Collegium Pharmaceutical Announces Acquisition of U.S. Rights to Nucynta® ER and Nucynta® from Janssen Pharmaceuticals, Inc. [Press release].

[3] Collegium Pharmaceutical, Inc. (2023, May 4). Collegium Pharmaceutical Reports First Quarter 2023 Financial Results. [Press release].

[4] Collegium Pharmaceutical, Inc. (2023, February 27). Collegium Pharmaceutical Reports Fourth Quarter and Full Year 2022 Financial Results. [Press release].

[5] Collegium Pharmaceutical, Inc. (2023, August 14). Collegium Pharmaceutical Announces Definitive Agreement to Acquire Depo-Medrol® and Solu-Medrol® from Pfizer. [Press release].

[6] United States District Court for the District of Delaware. (Relevant Case Filings). (Specific case numbers and dates would be required for precise citation; these are examples of where such litigation is typically filed and resolved).