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 are two Paragraph IV patent challenges for this drug. This may lead to patent invalidation or a license for generic production.

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
Patent Applications:	352
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	TABLET;ORAL	022304-001	Nov 20, 2008		RX	Yes	No					Y
Collegium Pharm Inc	NUCYNTA	tapentadol hydrochloride	TABLET;ORAL	022304-002	Nov 20, 2008		RX	Yes	No					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	200533-002	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	tapentadol hydrochloride	SOLUTION;ORAL	203794-001	Oct 15, 2012		DISCN	Yes	No					Y

Expired US Patents for NUCYNTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Collegium Pharm Inc	NUCYNTA	tapentadol hydrochloride	SOLUTION;ORAL	203794-001	Oct 15, 2012
Collegium Pharm Inc	NUCYNTA	tapentadol hydrochloride	TABLET;ORAL	022304-002	Nov 20, 2008
Collegium Pharm Inc	NUCYNTA	tapentadol hydrochloride	TABLET;ORAL	022304-003	Nov 20, 2008
Collegium Pharm Inc	NUCYNTA	tapentadol hydrochloride	TABLET;ORAL	022304-002	Nov 20, 2008
Collegium Pharm Inc	NUCYNTA	tapentadol hydrochloride	TABLET;ORAL	022304-001	Nov 20, 2008
Collegium Pharm Inc	NUCYNTA	tapentadol hydrochloride	SOLUTION;ORAL	203794-001	Oct 15, 2012

International Patents for NUCYNTA

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

Country	Patent Number	Title	Estimated Expiration
Argentina	116052	FORMA CRISTALINA DE CLORHIDRATO DE (-)-(1R,2R)-3-(3-DIMETILAMINO-1-ETIL-2-METILPROPIL)-FENOL
Australia	716122
Brazil	122018014454	forma cristalina sólida a do cloridrato de (-)-(1r,2r)-3-(3-dimetilamino-1-etil-2-metilpropil)-fenol
New Zealand	272623	1-PHENYL-3-DIMETHYLAMINOPROPANE COMPOUNDS, PREPARATION AND PHARMACEUTICAL COMPOSITIONS THEREOF
Russian Federation	95113154
South Korea	101096501

Supplementary Protection Certificates for NUCYNTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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
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
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	CA 2010 00036	Denmark
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

Market Dynamics and Financial Trajectory for Nucynta

Introduction

Nucynta, a brand of tapentadol hydrochloride, is a potent opioid analgesic used for the management of acute and chronic pain. The drug is marketed by Collegium Pharmaceutical, Inc., following its acquisition of the U.S. rights to the Nucynta franchise in 2020. Here, we delve into the market dynamics and financial trajectory of Nucynta.

Market Overview

Global Tapentadol Market

The global tapentadol market is driven by several key factors, including a growing elderly population and increasing consumer awareness about pain management. North America, particularly the U.S., leads the market due to a higher percentage of elderly individuals who form a significant consumer base for tapentadol[4].

Regional Growth

Asia Pacific is projected to be a high-growth region for tapentadol, driven by rapid urbanization and a growing population in countries like China, India, and other Southeast Asian nations. This regional growth is expected to contribute significantly to the overall market expansion[4].

Market Dynamics for Nucynta

Competitive Landscape

Nucynta operates in a competitive opioid analgesic market, with other branded and generic opioids available. However, Nucynta's unique formulation and therapeutic benefits help it maintain a strong market position. For instance, it is indicated for the management of acute adult pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate[1].

Prescriber Base and Market Share

Collegium Pharmaceutical has successfully expanded the prescriber base for Nucynta. As of Q4 2022, the company reported a significant number of unique prescribers, contributing to its strong market share. The company's strategies to maximize profitability through contracting and maintaining strong commercial coverage have been instrumental in this growth[3].

Financial Factors Influencing Nucynta

Pricing and Cost Structure

The pricing of Nucynta is influenced by a broad range of financial and non-financial factors, including changing market dynamics, costs of labor and goods, post-market requirements, and support for marketing and sales. Collegium Pharmaceutical has incurred substantial costs to obtain and maintain regulatory approval, as well as general and administrative costs associated with its operations[1].

Revenue and EBITDA

The acquisition of the Nucynta franchise has been accretive to Collegium Pharmaceutical's financial performance. The company reported illustrative pro forma annualized product revenues from Nucynta of $193.155 million, resulting in significant royalties due to Assertio and Grunenthal[2].

In the fourth quarter of 2023, Collegium Pharmaceutical reported record financial results, with total revenues of $149.7 million, a 16% increase year-over-year. Adjusted EBITDA for the quarter was $104.2 million, representing a 36% increase year-over-year[5].

Operating Expenses

The company has managed to reduce its operating expenses. GAAP operating expenses decreased by 13% year-over-year to $32.9 million in the fourth quarter of 2023, while adjusted operating expenses, excluding stock-based compensation and other adjustments, decreased by 20% to $25.9 million[5].

Strategic Initiatives

Integration and Synergies

Following the acquisition, Collegium Pharmaceutical executed a seamless integration with no disruptions to core operations. The company achieved day one field force readiness and realized the majority of targeted run rate synergies, which have contributed to its financial performance[3].

Growth Drivers

Collegium Pharmaceutical's strategy includes growing prescriptions for Nucynta, Belbuca, and Xtampza ER, and maximizing the value of the Nucynta franchise and Symproic. The company aims to generate strong cash flow from its pain portfolio, leverage its cost structure, and conduct business development focused on commercial-stage assets[3].

Future Outlook

Market Growth Potential

The tapentadol market, including Nucynta, is expected to grow driven by increasing consumer awareness, better treatment options, and an increase in life expectancy. Asia Pacific is anticipated to be at the forefront of this growth, with countries like China and India showing a high rate of increase in consumers[4].

Financial Projections

Collegium Pharmaceutical is positioned for continued growth, with a strong track record of successful business development and a solid financial foundation. The company's focus on maximizing profitability, growing prescriptions, and managing its cost structure is expected to drive future financial performance[3].

Key Takeaways

• Market Leadership: Nucynta holds a strong position in the opioid analgesic market, driven by its unique therapeutic benefits and a growing prescriber base.
• Financial Performance: The acquisition of the Nucynta franchise has been financially accretive, with significant revenue and EBITDA growth.
• Cost Management: Collegium Pharmaceutical has effectively managed its operating expenses, contributing to improved financial metrics.
• Growth Potential: The tapentadol market, particularly in Asia Pacific, offers significant growth opportunities for Nucynta.
• Strategic Initiatives: The company's focus on integration, synergies, and growth drivers is crucial for its continued success.

FAQs

What is Nucynta used for?

Nucynta is used for the management of acute and chronic pain in adults, particularly pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate[1].

Who acquired the U.S. rights to the Nucynta franchise?

Collegium Pharmaceutical, Inc. acquired the U.S. rights to the Nucynta franchise in February 2020[2].

What are the key factors influencing the pricing of Nucynta?

The pricing of Nucynta is influenced by changing market dynamics, costs of labor and goods, post-market requirements, support for marketing and sales, and reinvestment in the product[1].

How has the acquisition of Nucynta impacted Collegium Pharmaceutical's financial performance?

The acquisition has been accretive, with significant revenue and EBITDA growth. In the fourth quarter of 2023, Collegium reported a 16% increase in revenues and a 36% increase in adjusted EBITDA year-over-year[5].

What are the growth drivers for Nucynta?

The growth drivers include growing prescriptions, maximizing the value of the Nucynta franchise, strong commercial coverage, and effective cost management[3].

Sources

1. Insurance.nd.gov: Collegium Pharmaceutical Inc. - Nucynta ER Filings.
2. GlobeNewswire: Collegium to Acquire U.S. Rights to Nucynta Franchise.
3. Collegium Pharmaceutical: Investor Presentation.
4. BioSpace: Tapentadol Market Key Players and Competitive Landscape Report.
5. Collegium Pharmaceutical: Record Fourth Quarter and Full-Year 2023 Financial Results.