NUCYNTA ER Drug Patent Profile

Which patents cover Nucynta Er, and when can generic versions of Nucynta Er launch?

Nucynta Er is a drug marketed by Collegium Pharm Inc and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has ninety-six patent family members in twenty-seven countries.

The generic ingredient in NUCYNTA ER 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 Er

Nucynta Er 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 December 27, 2025. This may change due to patent challenges or generic licensing.

There have been sixteen 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 ER

International Patents:	96
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	45
Clinical Trials:	6
Patent Applications:	352
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

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

NDA:

200533

Dosage:

TABLET, EXTENDED RELEASE;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 ER

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 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 three US patents.

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 ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-001	Aug 25, 2011		RX	Yes	No					Y
Collegium Pharm Inc	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-003	Aug 25, 2011		RX	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 ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-003	Aug 25, 2011		RX	Yes	No					Y
Collegium Pharm Inc	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-005	Aug 25, 2011		RX	Yes	Yes					Y
Collegium Pharm Inc	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-001	Aug 25, 2011		RX	Yes	No					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	200533-002	Aug 25, 2011
Collegium Pharm Inc	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-002	Aug 25, 2011
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 ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-005	Aug 25, 2011
Collegium Pharm Inc	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-005	Aug 25, 2011

International Patents for NUCYNTA ER

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

Country	Patent Number	Title	Estimated Expiration
Australia	2005256512	Crystalline forms of (-)-(1R,2R)-3-(3-dimethylamino-1-ethyl-2-methylpropyl)-phenol hydrochloride
Argentina	049083	PROCESO PARA LA PREPARACION DE UNA FORMA DE DOSIFICACION SOLIDA A PRUEBA DE ABUSO
Cyprus	1112320
Denmark	1612203
World Intellectual Property Organization (WIPO)	9521612
Poland	309734
Denmark	1439829

Supplementary Protection Certificates for NUCYNTA ER

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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	C00693475/01	Switzerland		PRODUCT NAME: TAPENTADOL; REGISTRATION NO/DATE: SWISSMEDIC 60530 20110222
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,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
0693475	CA 2010 00036	Denmark

Market Dynamics and Financial Trajectory for Nucynta ER

Introduction

Nucynta ER, developed by Collegium Pharmaceutical, Inc., is a tapentadol hydrochloride extended-release tablet designed for the management of severe and persistent pain in adults. This article delves into the market dynamics and financial trajectory of Nucynta ER, highlighting its approvals, market performance, financial highlights, and future outlook.

Approval and Exclusivity

Nucynta ER has received significant regulatory support. In June 2024, the FDA granted pediatric exclusivity for Nucynta and Nucynta ER, extending the brand exclusivity by an additional six months. This extension means that generic versions of these medications will be delayed until January 3, 2027, for Nucynta and December 27, 2025, for Nucynta ER[1].

Indications and Usage

Nucynta ER is approved for the management of severe and persistent pain in adults that requires an extended treatment period with a daily opioid analgesic. It is not indicated as an as-needed (prn) analgesic and is available in various strengths, including 50 mg, 100 mg, 150 mg, 200 mg, and 250 mg tablets[4].

Market Performance

Revenue Growth

Collegium Pharmaceutical, Inc. has reported robust revenue growth driven by its Nucynta franchise. For the year ended December 31, 2020, the Nucynta franchise generated net revenues of $182.0 million, contributing significantly to the company's total net product revenues of $310.0 million[2].

In 2023, the company achieved record net product revenues, with the Nucynta franchise continuing to be a stable contributor. The total net product revenues for 2023 were $566.8 million, representing a 22% increase year-over-year compared to 2022[5].

Market Share and Competition

Nucynta ER competes in the branded extended-release (ER) opioid market. Despite the competitive landscape, Collegium Pharmaceutical has managed to maintain a strong market presence. The company's Xtampza ER, another opioid product, has also shown significant growth, but Nucynta ER remains a key player in the pain management segment[3].

Financial Highlights

Revenue and Expenses

For the year ended December 31, 2023, Collegium Pharmaceutical reported GAAP operating expenses of $159.2 million, a 10% decrease from the previous year. Adjusted operating expenses, excluding stock-based compensation, were $123.6 million, indicating a stable cost structure[5].

The company's adjusted EBITDA for 2023 was $223.3 million, reflecting a strong financial performance. This was accompanied by a cash balance of over $200 million, positioning the company for future growth and strategic investments[5].

Profitability

The Nucynta franchise has been a stable profit contributor for Collegium Pharmaceutical. The company aims to leverage its cost structure to maintain profitability through the remaining lifecycle of the Nucynta franchise, which is expected to extend through mid-2025, with potential pediatric extensions further extending exclusivity[3].

Pharmacoeconomic Analysis

Cost-Effectiveness

Pharmacoeconomic reviews have analyzed the cost-effectiveness of Nucynta ER compared to other long-acting opioids. A CADTH Common Drug Review found that Nucynta ER was dominant (less costly and more effective) compared to oxycodone CR, with an incremental cost-utility ratio of $45,847 per QALY gained over a one-year time horizon[4].

Generic Alternatives

Generic medications, once available, are expected to significantly reduce costs for patients. Generic versions of Nucynta ER, however, are delayed due to the extended brand exclusivity. Generic medicines typically cost 80-85% less than their brand-name equivalents, making them a cost-effective alternative once they enter the market[1].

Future Outlook

Exclusivity and Patent Protection

The recent FDA grant for pediatric use extends the brand exclusivity of Nucynta ER, providing a temporary shield against generic competition. This extension is crucial for maintaining market share and revenue until generic alternatives become available[1].

Market Expansion and Diversification

Collegium Pharmaceutical is focused on business development and leveraging its balance sheet to create shareholder value. The company is exploring commercial-stage, pain-adjacent assets and diversifying its portfolio to ensure long-term growth beyond the Nucynta franchise[3].

Regulatory Environment

The opioid market is heavily regulated, and companies must navigate strict guidelines to ensure compliance. Collegium Pharmaceutical's ability to secure pediatric exclusivity highlights its commitment to regulatory compliance and its strategic approach to extending market exclusivity[1].

Conclusion

Nucynta ER has established itself as a significant player in the pain management market, driven by its strong regulatory support, robust revenue growth, and stable profitability. The extension of brand exclusivity through pediatric use grants ensures that the product will remain a key revenue generator for Collegium Pharmaceutical until at least 2025.

Key Takeaways

• Extended Exclusivity: Nucynta ER has received an additional six months of brand exclusivity due to pediatric use grants.
• Revenue Growth: The Nucynta franchise has contributed significantly to Collegium Pharmaceutical's revenue, with a 22% year-over-year increase in 2023.
• Cost-Effectiveness: Nucynta ER is pharmacoeconomically favorable compared to other long-acting opioids.
• Future Outlook: The company is focused on diversifying its portfolio and leveraging its balance sheet for future growth.
• Regulatory Compliance: Collegium Pharmaceutical has demonstrated a strong commitment to regulatory compliance, securing important exclusivity extensions.

FAQs

What is Nucynta ER used for?

Nucynta ER is used for the management of severe and persistent pain in adults that requires an extended treatment period with a daily opioid analgesic.

How long is the brand exclusivity for Nucynta ER extended?

The brand exclusivity for Nucynta ER has been extended by an additional six months due to pediatric use grants, until December 27, 2025.

What are the financial highlights for Collegium Pharmaceutical in 2023?

Collegium Pharmaceutical reported record net product revenues of $566.8 million in 2023, with adjusted EBITDA of $223.3 million and a cash balance of over $200 million.

How does Nucynta ER compare to other opioids in terms of cost-effectiveness?

Nucynta ER is found to be cost-effective compared to oxycodone CR, with an incremental cost-utility ratio of $45,847 per QALY gained over a one-year time horizon.

What is the impact of generic alternatives on Nucynta ER?

Generic alternatives, once available, are expected to reduce costs significantly, but their entry into the market is delayed due to the extended brand exclusivity of Nucynta ER.

Sources

1. MyMatrixx: Opioid Nucynta Gets Six-Month Extension of Exclusivity – Generic Options Hold[1].
2. Collegium Pharmaceutical, Inc.: Collegium Reports Record Full-Year 2020 Revenue of $310.0 Million[2].
3. Collegium Pharmaceutical, Inc.: Collegium Pharmaceutical, Inc. Corporate Overview[3].
4. CADTH Common Drug Review: Pharmacoeconomic Review Report for Nucynta Extended-Release[4].
5. Collegium Pharmaceutical, Inc.: Collegium Reports Record Fourth Quarter and Full-Year 2023[5].