Tramadol hydrochloride - Generic Drug Details

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

Tramadol hydrochloride is the generic ingredient in seven branded drugs marketed by Cipher Pharms Inc, Athena, Purdue Pharma, Actavis Elizabeth, Aurobindo Pharma Ltd, Endo Operations, Lupin Ltd, Mylan, Strides Pharma, Sun Pharm, Valeant Pharms, Shionogi Inc, Accord Hlthcare, Amneal Pharms, Apotex, Asta, Cspc Ouyi Pharm Co, Graviti Pharms, Ipca Labs Ltd, Ivax Sub Teva Pharms, Macleods Pharms Ltd, Merro Pharm Usa, Mylan Pharms Inc, Northstar Hlthcare, Pliva, Rubicon, Specgx Llc, Sun Pharm Inds Inc, Sun Pharm Industries, Teva, Unichem, Watson Labs, Zydus Pharms Usa Inc, and Janssen Pharms, and is included in thirty-nine NDAs. There are two patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Tramadol hydrochloride has one patent family member in one country.

There are thirty-four drug master file entries for tramadol hydrochloride. Forty-seven suppliers are listed for this compound.

Summary for tramadol hydrochloride

International Patents:	1
US Patents:	2
Tradenames:	7
Applicants:	34
NDAs:	39
Drug Master File Entries:	34
Finished Product Suppliers / Packagers:	47
Raw Ingredient (Bulk) Api Vendors:	93
Clinical Trials:	464
Patent Applications:	3,627
What excipients (inactive ingredients) are in tramadol hydrochloride?	tramadol hydrochloride excipients list
DailyMed Link:	tramadol hydrochloride at DailyMed

Recent Clinical Trials for tramadol hydrochloride

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

Sponsor	Phase
University Hospital "Sestre Milosrdnice"	N/A
Damascus University	N/A
Baskent University	Phase 4

See all tramadol hydrochloride clinical trials

Pharmacology for tramadol hydrochloride

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

Medical Subject Heading (MeSH) Categories for tramadol hydrochloride

Analgesics, Opioid

Narcotics

Anatomical Therapeutic Chemical (ATC) Classes for tramadol hydrochloride

N02AX	Other opioids
N02A	OPIOIDS
N02	ANALGESICS
N	Nervous system

Paragraph IV (Patent) Challenges for TRAMADOL HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
QDOLO	Oral Solution	tramadol hydrochloride	5 mg/mL	214044	1	2024-09-16
RYZOLT	Extended-release Tablets	tramadol hydrochloride	100 mg, 200 mg and 300 mg	021745	1	2009-06-18
ULTRAM ER	Extended-release Tablets	tramadol hydrochloride	300 mg	021692	1	2007-09-25
ULTRAM ER	Extended-release Tablets	tramadol hydrochloride	200 mg	021692	1	2007-03-28
ULTRAM ER	Extended-release Tablets	tramadol hydrochloride	100 mg	021692	1	2007-01-08

US Patents and Regulatory Information for tramadol hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Purdue Pharma	RYZOLT	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021745-002	Dec 30, 2008		DISCN	Yes	No
Mylan	TRAMADOL HYDROCHLORIDE	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205257-002	Dec 22, 2015		DISCN	No	No
Pliva	TRAMADOL HYDROCHLORIDE	tramadol hydrochloride	TABLET;ORAL	075982-001	Jul 1, 2002		DISCN	No	No
Rubicon	TRAMADOL HYDROCHLORIDE	tramadol hydrochloride	TABLET;ORAL	208708-001	Jun 28, 2019	AB	RX	No	No
Accord Hlthcare	TRAMADOL HYDROCHLORIDE	tramadol hydrochloride	TABLET;ORAL	202390-001	May 16, 2013		DISCN	No	No
Teva	TRAMADOL HYDROCHLORIDE	tramadol hydrochloride	TABLET;ORAL	075977-001	Jun 19, 2002	AB	RX	No	No
Graviti Pharms	TRAMADOL HYDROCHLORIDE	tramadol hydrochloride	TABLET;ORAL	075968-001	Jun 25, 2002		DISCN	No	No

Expired US Patents for tramadol hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	ULTRAM	tramadol hydrochloride	TABLET;ORAL	020281-002	Mar 3, 1995
Purdue Pharma	RYZOLT	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021745-002	Dec 30, 2008
Valeant Pharms	ULTRAM ER	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021692-001	Sep 8, 2005
Shionogi Inc	RYBIX ODT	tramadol hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021693-001	May 5, 2005
Janssen Pharms	ULTRAM	tramadol hydrochloride	TABLET;ORAL	020281-001	Mar 3, 1995
Purdue Pharma	RYZOLT	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021745-003	Dec 30, 2008
Purdue Pharma	RYZOLT	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021745-001	Dec 30, 2008

International Patents for tramadol hydrochloride

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2021092406

Supplementary Protection Certificates for tramadol hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0566709	C300152	Netherlands		PRODUCT NAME: TRAMADOLI HYDROCHLORIDUM EN PARACETAMOLUM; NAT. REGISTRATION NO/DATE: RVG 28113 20030115; FIRST REGISTRATION: 359 228-3 2002050405
0566709	SPC/GB04/012	United Kingdom		PRODUCT NAME: TRAMADOL HYDROCHLORIDE, PARACETAMOL; REGISTERED: FR NL 25970 20020405; UK PL 00242/0384 20030925

Tramadol hydrochloride Market Analysis and Financial Projection Experimental

Tramadol Hydrochloride Market Dynamics and Financial Trajectory

Market Size and Forecast

The tramadol hydrochloride market is experiencing significant growth, driven by several key factors. As of 2022, the global tramadol drug market was valued at USD 5.26 billion and is projected to reach USD 7.29 billion by 2030, growing at a Compound Annual Growth Rate (CAGR) of 4.41% from 2023 to 2030[1].

Another report indicates that the global tramadol market size was USD 3.462 billion in 2022 and is expected to grow to USD 7.190 billion by 2032, exhibiting a CAGR of 6.87% during this period[3].

Driving Factors

Several factors are driving the growth of the tramadol hydrochloride market:

• Increasing Prevalence of Chronic Pain: The rising incidence of chronic pain, particularly among the aging population, is a significant driver. Chronic pain conditions such as back pain and other musculoskeletal disorders are becoming more common, increasing the demand for effective pain management drugs like tramadol[1][3].
• Growing Geriatric Population: The global population is aging, and older adults are more likely to suffer from chronic pain, thereby increasing the demand for tramadol[1].
• Globalization and Innovations in Drug Delivery: Advances in drug delivery systems, such as the development of intravenous formulations, are expanding the market. For instance, the IV formulation of tramadol hydrochloride is being considered for managing moderate to moderately severe pain in medically supervised settings[2][4].
• Favorable Government Initiatives: Government initiatives, especially those related to opioid substitution therapy, are also contributing to the market growth. In regions like Europe, these initiatives are expected to maintain a major stake in the global tramadol market[1].

Geographical Segmentation

The global tramadol hydrochloride market is segmented geographically into several regions:

• Europe: Expected to maintain a significant share due to high healthcare expenditure, favorable government initiatives, and a large consumer base for tramadol[1].
• Asia Pacific: Anticipated to see lucrative growth due to increasing product consumption by patients suffering from chronic pain and other disorders, along with growing disposable income levels in countries like China and India[1].
• North America, Latin America, Middle East, and Africa: These regions also contribute to the market, although to a lesser extent compared to Europe and Asia Pacific[1].

Market Segmentation by Type and Application

The tramadol market is segmented based on type and application:

• Type: Includes oral, injection (intramuscular), and rectal administration. The oral type is the most common, but the injection type, particularly the IV formulation, is gaining traction[3][4].
• Application: Segmented into hospital pharmacy, retail pharmacy, and online pharmacy. Hospital pharmacies are a significant segment due to the use of tramadol in postoperative pain management[3].

Key Players and Competitive Landscape

The market is dominated by several key players:

• Grünenthal GmbH: Known for its extensive portfolio of pain management drugs, including tramadol.
• Mundipharma: Another major player with a significant presence in the global tramadol market.
• Labopharm: Also a key player, contributing to the market growth through various formulations of tramadol[4].

Safety and Efficacy Concerns

The use of tramadol, especially the IV formulation, has raised some safety concerns:

• Delayed Onset of Analgesia: The IV formulation of tramadol has a delayed onset of effect, which can lead to the need for additional analgesics, potentially increasing the risk of opioid stacking and related adverse reactions[2].
• Abuse and Addiction: Although tramadol has a lower risk of addiction compared to other opioids, it still poses a risk, especially with prolonged use. The effects of tramadol can last up to 20-40 hours after the last dose, and its half-life is around 6-8 hours[5].

Regulatory Landscape

The regulatory environment plays a crucial role in the market dynamics of tramadol:

• FDA Approval: The IV formulation of tramadol hydrochloride has faced regulatory hurdles. Despite showing efficacy in clinical trials, concerns about delayed onset of analgesia and potential safety risks have led to disputes and denials of approval[2].
• Global Regulations: Different regions have varying regulations regarding the use of tramadol. For example, in some countries outside the U.S., tramadol IV is already in use, highlighting the need for consistent global regulatory standards[2].

Financial Projections

The financial trajectory of the tramadol hydrochloride market is promising:

• Market Growth: The market is expected to grow significantly, with projections indicating a rise from USD 5.26 billion in 2022 to USD 7.29 billion by 2030, and another estimate suggesting it will reach USD 7.190 billion by 2032[1][3].
• CAGR: The CAGR for the market is estimated to be around 4.41% to 6.87% over the forecast periods, indicating steady and robust growth[1][3].

Investment and Innovation

Major pharmaceutical companies are investing heavily in the development and marketing of tramadol hydrochloride:

• Research and Development: Continuous innovation in drug delivery systems and formulations is driving market growth. The development of IV formulations and other delivery methods is expected to stimulate further investment[2][4].
• Market Expansion: Companies are expanding their product lines and entering new markets, particularly in developing countries where there is a growing demand for pain management drugs[1][4].

Public Health Impact

The approval and use of tramadol hydrochloride have significant public health implications:

• Pain Management: Tramadol fills a critical gap in pain management, especially for moderate to moderately severe pain, providing an alternative to more potent opioids[2].
• Abuse Potential: As a Schedule IV drug, tramadol has less abuse potential than Schedule II opioids, which could help in reducing the overall opioid abuse crisis[2].

Key Takeaways

• The tramadol hydrochloride market is growing due to increasing chronic pain prevalence, an aging population, and innovations in drug delivery.
• Europe and Asia Pacific are key regions driving market growth.
• Safety concerns, particularly around the IV formulation, are being addressed through regulatory reviews.
• Major pharmaceutical companies are investing in research and development to expand the market.
• Tramadol has a lower abuse potential compared to other opioids, making it a valuable option for pain management.

Frequently Asked Questions

1. What is the projected market size of the tramadol hydrochloride market by 2030? The global tramadol drug market is projected to reach USD 7.29 billion by 2030[1].

2. What are the primary drivers of the tramadol market growth? The primary drivers include the increasing prevalence of chronic pain, the growing geriatric population, and innovations in drug delivery systems[1][3].

3. Which regions are expected to see significant growth in the tramadol market? Europe and Asia Pacific are expected to see significant growth due to high healthcare expenditure and increasing product consumption, respectively[1].

4. What are the key market segments for tramadol hydrochloride? The market is segmented by type (oral, injection, rectal) and application (hospital pharmacy, retail pharmacy, online pharmacy)[3].

5. What are the safety concerns associated with the IV formulation of tramadol hydrochloride? The IV formulation has a delayed onset of analgesia, which can lead to the need for additional analgesics and potentially increase the risk of opioid stacking and related adverse reactions[2].

Sources:

1. Verified Market Research, Tramadol Drug Market Size, Share, Trends, Growth And Forecast.
2. FDA, Tramadol Hydrochloride 50 mg/mL injection (tramadol IV) - FDA.
3. Business Research Insights, Tramadol Market 2024 To 2032 | [111] Pages Report.
4. EIN Presswire, Tramadol Hcl Market Comprehensive Study by Key Players Grnenthal GmbH, Mundipharma, Labopharm.
5. Alina Lodge, How Long Does Tramadol Stay in Your System?.