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

Tapentadol hydrochloride has two hundred and seventy-two patent family members in thirty-one 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:	272
US Patents:	4
Tradenames:	2
Applicants:	1
NDAs:	3
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	40
Clinical Trials:	67
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
Aretaieion University Hospital	N/A
All India Institute of Medical Sciences, Bhubaneswar	Phase 4
Oslo University Hospital	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
		75MG	TABLET;ORAL
		100MG	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	200533-003	Aug 25, 2011		RX	Yes	No	11,344,512*PED				Y
Collegium Pharm Inc	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-003	Aug 25, 2011		RX	Yes	No	8,536,130*PED				Y
Collegium Pharm Inc	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-001	Aug 25, 2011		RX	Yes	No	8,114,383		Y		Y
Collegium Pharm Inc	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-005	Aug 25, 2011		RX	Yes	Yes	7,994,364*PED				Y
Collegium Pharm Inc	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-003	Aug 25, 2011		RX	Yes	No	7,994,364*PED				Y
Collegium Pharm Inc	NUCYNTA	tapentadol hydrochloride	TABLET;ORAL	022304-001	Nov 20, 2008		RX	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	8,075,872
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	200533-004	Aug 25, 2011	8,114,383
Collegium Pharm Inc	NUCYNTA	tapentadol hydrochloride	TABLET;ORAL	022304-001	Nov 20, 2008	RE39593
Collegium Pharm Inc	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-002	Aug 25, 2011	8,075,872
Collegium Pharm Inc	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-002	Aug 25, 2011	8,309,060

International Patents for TAPENTADOL HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Hungary	E032099
World Intellectual Property Organization (WIPO)	2006082099
Poland	2117525
European Patent Office	3603630	TITRATION DE TAPENTADOL (TITRATION OF TAPENTADOL)
New Zealand	545202	Abuse-proofed dosage form comprising opiods and a high molecular weight polyethylene oxide
Russian Federation	2006106725	ЗАЩИЩЕННАЯ ОТ ПРИМЕНЕНИЯ НЕ ПО НАЗНАЧЕНИЮ ЛЕКАРСТВЕННАЯ ФОРМА

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	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	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	SPC/GB11/031	United Kingdom		PRODUCT NAME: TAPENTADOL IN THE FORM OF ITS BASE OR A SALT OF A PHYSIOLOGICALLY COMPATIBLE ACID, ESPECIALLY THE HYDROCHLORIDE SALT.; REGISTERED: DE 75043 20100819; UK PL 21727/0032 - 0050 20110204
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	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

TAPENTADOL HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Tapentadol Hydrochloride: Market Dynamics and Financial Trajectory

Introduction to Tapentadol Hydrochloride

Tapentadol hydrochloride, marketed under the brand name Nucynta ER among others, is a dual-mode analgesic that acts as both a norepinephrine reuptake inhibitor and a mu-opioid receptor agonist. It is primarily used for the treatment of moderate to severe chronic pain and acute musculoskeletal pain.

Market Drivers

High Occurrence of Chronic Musculoskeletal Pain

The growing prevalence of chronic diseases, such as arthritis and musculoskeletal disorders, is a significant driver for the tapentadol market. Chronic musculoskeletal pain affects a large portion of the population, particularly the elderly, leading to an increased demand for effective pain management solutions like tapentadol[1][3][4].

Rising Demand for Over-the-Counter Painkillers

In emerging economies, especially in the Asia Pacific region, there is a rising demand for over-the-counter painkillers. This trend is expected to boost the demand for tapentadol as consumers become more aware of and seek better treatment options for pain management[1][3].

Escalating Prevalence of Diabetes

The increasing incidence of diabetes, which often leads to painful diabetic peripheral neuropathy, is another factor driving the demand for tapentadol. The drug's efficacy in treating neuropathic pain makes it a preferred choice for managing diabetes-related pain[1][3].

Market Restraints

Side Effects Associated with Tapentadol

Despite its efficacy, tapentadol is associated with several side effects, including dizziness, nausea, constipation, and central nervous system (CNS) sedation. These side effects can impair cognitive and physical abilities, which may limit its widespread adoption[1][2][4].

Stringent Government Regulations

Tapentadol is classified as a Schedule II controlled substance due to its potential for abuse and misuse. This classification subjects the drug to stringent government regulations, which can restrict its market growth. The need for a Risk Evaluation and Mitigation Strategy (REMS) to manage these risks adds another layer of complexity[2][4].

Availability of Substitutes

The presence of other pain management alternatives, both pharmacologic and non-pharmacologic, poses a significant challenge to the tapentadol market. Competitors like oxycodone and other opioids, as well as non-opioid pain treatments, can divert market share away from tapentadol[4].

Market Opportunities

Advancements in Treatment and Therapeutics Development

There are significant opportunities for research and development in the tapentadol market. Innovations such as modified-release formulations, targeted delivery systems, and combination therapies could enhance bioavailability and reduce side effects, making tapentadol a more attractive option for pain management[4].

Exponential Availability Through Online Pharmacies

The increasing availability of tapentadol through online pharmacies is expected to expand its reach and accessibility. This trend can particularly benefit regions with limited access to traditional healthcare facilities[4].

Market Challenges

Regulatory Scrutiny

The tapentadol market faces continuous regulatory scrutiny due to its classification as a controlled substance. This scrutiny can lead to delays in market approvals and restrictions on its distribution, affecting its financial trajectory[2][4].

Competition from Other Pain Management Alternatives

The market for pain management is highly competitive, with numerous alternatives available. Tapentadol must compete with established brands and newer, potentially safer alternatives, which can impact its market share and revenue growth[4].

Regional Analysis

North America

North America, particularly the United States, is the leading market for tapentadol. The high demand is driven by a large elderly population and a well-established healthcare system. The U.S. market is dominated by brands like Nucynta ER from Janssen Pharmaceuticals[1][3].

Europe

Europe is another significant market for tapentadol, with countries like Germany, France, and the UK contributing substantially to the regional demand. The market here is driven by similar factors as in North America, including an aging population and high healthcare standards[1][3].

Asia Pacific

The Asia Pacific region is projected to be at the forefront of growth in the tapentadol market. Countries such as China, India, and Japan are expected to show a high rate of increase in consumers due to their growing population, rapid urbanization, and increasing consumer awareness of better treatment options[1][3].

Competitive Landscape

Key Players

The tapentadol market is dominated by large pharmaceutical companies with established brands. Key players include Johnson & Johnson Pharmaceutical Research & Development, L.L.C., IPCA Laboratories Ltd., Lupin Laboratories Ltd., Ranbaxy Laboratories Ltd., and others. These companies are investing in research and development and using strategic acquisitions and mergers to maintain their competitive edge[1][3][4].

Strategic Acquisitions and Mergers

Companies are leveraging strategic acquisitions and mergers to expand their presence in emerging economies and to develop new grades of tapentadol. This approach helps them stay competitive in a dynamic market landscape[1][3].

Financial Trajectory

Current Market Size

The global tapentadol market has seen significant growth in recent years, driven by the increasing demand for effective pain management solutions. The market size is expected to continue growing, albeit at a moderate pace, due to the factors mentioned above[1][4].

Future Growth Prospects

Despite the challenges, the tapentadol market is expected to grow due to advancements in treatment and therapeutics development, exponential availability through online pharmacies, and increasing consumer awareness. The Asia Pacific region is anticipated to be a key driver of this growth[1][3][4].

Revenue Forecast

The revenue forecast for the tapentadol market indicates steady growth over the next decade. This growth will be fueled by the rising prevalence of chronic pain conditions, an increasing geriatric population, and innovations in drug formulations. However, the market will need to navigate stringent regulations and competition from other pain management alternatives[4].

Key Takeaways

• Growing Demand: The tapentadol market is driven by the high occurrence of chronic musculoskeletal pain and the rising incidence of diabetes.
• Regulatory Challenges: Stringent government regulations and the potential for abuse and misuse are significant restraints.
• Innovation Opportunities: Advancements in treatment and therapeutics development offer opportunities for growth.
• Regional Growth: North America and Europe are current leaders, while the Asia Pacific region is expected to drive future growth.
• Competitive Landscape: The market is dominated by large pharmaceutical companies with a focus on research and development and strategic acquisitions.

FAQs

What is tapentadol hydrochloride used for?

Tapentadol hydrochloride is used for the treatment of moderate to severe chronic pain and acute musculoskeletal pain. It is also effective in managing neuropathic pain and cancer pain[1][2][3].

What are the common side effects of tapentadol?

Common side effects include dizziness, nausea, constipation, and central nervous system (CNS) sedation. It can also impair cognitive and physical abilities[1][2][4].

Which regions are leading the tapentadol market?

North America, particularly the United States, and Europe are the current leaders. However, the Asia Pacific region is projected to be at the forefront of growth in the coming years[1][3].

What are the key challenges facing the tapentadol market?

The market faces challenges such as stringent government regulations, side effects associated with the drug, and competition from other pain management alternatives[2][4].

Who are the key players in the tapentadol market?

Key players include Johnson & Johnson Pharmaceutical Research & Development, L.L.C., IPCA Laboratories Ltd., Lupin Laboratories Ltd., and Ranbaxy Laboratories Ltd., among others[1][3][4].

Sources

1. Biospace: Tapentadol Market Size | Shares | Trends | Growth | Global Industry Analysis 2020-2030
2. FDA: 200533Orig1s000 - Nucynta ER (Tapentadol extended-release)
3. Biospace: Tapentadol Market Key Players and Competitive Landscape Report
4. Research and Markets: Tapentadol Market Size, Competitors & Forecast to 2030