ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE - Generic Drug Details

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

Acetaminophen; tramadol hydrochloride is the generic ingredient in two branded drugs marketed by Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma, Chartwell Rx, Graviti Pharms, Macleods Pharms Ltd, Micro Labs Ltd India, Nostrum Labs Inc, Rising, Sun Pharm Inds Inc, Zydus Pharms Usa Inc, and Janssen Pharms, and is included in twelve NDAs. Additional information is available in the individual branded drug profile pages.

Seventeen suppliers are listed for this compound.

Summary for ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

US Patents:	0
Tradenames:	2
Applicants:	12
NDAs:	12
Finished Product Suppliers / Packagers:	17
Clinical Trials:	82
DailyMed Link:	ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE at DailyMed

Recent Clinical Trials for ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

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

Sponsor	Phase
University Hospital "Sestre Milosrdnice"	N/A
Novartis Pharmaceuticals	Phase 3
Bhupesh Parashar, MD	Phase 2

See all ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE clinical trials

Pharmacology for ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

Anatomical Therapeutic Chemical (ATC) Classes for ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

N02AX	Other opioids
N02A	OPIOIDS
N02	ANALGESICS
N	Nervous system

US Patents and Regulatory Information for ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chartwell Rx	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	acetaminophen; tramadol hydrochloride	TABLET;ORAL	076475-001	Apr 21, 2005		DISCN	No	No
Graviti Pharms	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	acetaminophen; tramadol hydrochloride	TABLET;ORAL	076914-001	Jul 26, 2006		DISCN	No	No
Alkem Labs Ltd	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	acetaminophen; tramadol hydrochloride	TABLET;ORAL	202076-001	Mar 30, 2012	AB	RX	No	No
Micro Labs Ltd India	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	acetaminophen; tramadol hydrochloride	TABLET;ORAL	201952-001	Dec 14, 2012	AB	RX	No	No
Rising	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	acetaminophen; tramadol hydrochloride	TABLET;ORAL	077858-001	Sep 26, 2008	AB	RX	No	No

Expired US Patents for ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	ULTRACET	acetaminophen; tramadol hydrochloride	TABLET;ORAL	021123-001	Aug 15, 2001	5,336,691
Janssen Pharms	ULTRACET	acetaminophen; tramadol hydrochloride	TABLET;ORAL	021123-001	Aug 15, 2001	RE39221

ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Acetaminophen; Tramadol Hydrochloride

Market Size and Forecast

The global market for tramadol hydrochloride, often combined with acetaminophen, is experiencing significant growth. As of 2022, the 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][3].

Driving Factors

Several key factors are driving the growth of this market:

Increasing Prevalence of Chronic Pain

Chronic pain, particularly conditions like lower back pain and osteoarthritis, is a major health concern affecting a significant portion of the population. Tramadol, combined with acetaminophen, is an effective medication for managing chronic pain, making it a crucial driver of market growth[1][5].

Aging Population

The growing geriatric population is more prone to chronic pain and other age-related conditions that require pain management. This demographic shift is expected to increase the demand for tramadol and other pain management drugs[1].

Demand for Effective Pain Management

There is a global demand for effective pain management drugs that can provide long-lasting relief. Tramadol, with its lower risk of addiction compared to other opioid medications, is a popular choice[1].

Market Segmentation

By Type

The market is segmented into oral and injection types. The oral type is the most widely used route of administration for tramadol, accounting for the largest revenue share due to its easy availability, low price, and minimal side effects[1].

By Application

The market is segmented into hospital pharmacy, retail pharmacy, and online pharmacy. The hospital pharmacy segment holds a significant revenue share due to the increasing number of inpatient admissions for chronic pain management. The online pharmacy segment is expected to grow at the fastest CAGR due to the proliferation of online pharmacies and increased internet drug shopping[1].

Geographic Analysis

Europe

Europe is expected to maintain a major stake in the global tramadol drug market due to high healthcare expenditure, favorable government initiatives for opioid substitution therapy, and a high prevalence of chronic pain and back pain[1].

Asia Pacific

The Asia Pacific region is 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 developing countries like China and India[1].

Market Dynamics

Drivers

• Increasing Chronic Pain Prevalence: Chronic pain is a significant health concern, and tramadol's efficacy in managing it drives market growth.
• Aging Population: The growing geriatric population increases the demand for pain management drugs.
• Innovations in Drug Delivery: Continuous innovation in drug delivery systems and formulations, such as extended-release and IV formulations, stimulates market growth[1][2][5].

Restraints

• Safety Concerns: Adverse events such as nausea, dizziness, constipation, and vomiting are common with tramadol use, which can act as a restraint[2].
• Regulatory Scrutiny: Tramadol, being a Schedule IV drug, is subject to regulatory scrutiny, which can impact market dynamics[4].

Opportunities

• Emerging Markets: There is significant potential for growth in emerging markets due to the increasing prevalence of chronic pain and rising healthcare expenditure[1].
• Research and Development: Investments in research and development to improve drug delivery systems and formulations present opportunities for market expansion[2][5].

Public Health Impact

Pain Management

Tramadol fills a critical gap in pain management, especially for moderate to moderately severe pain, providing an alternative to more potent opioids. The combination of tramadol and acetaminophen has been shown to provide rapid and long-lasting analgesic effects, improving quality of life and functional improvements for patients with chronic pain[2][4].

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. This makes tramadol a valuable option for pain management while mitigating the risks associated with opioid addiction[4].

Financial Trajectory

Investment and Innovation

Major pharmaceutical companies are investing heavily in the development and marketing of tramadol hydrochloride. Innovations in drug delivery systems, such as extended-release formulations and IV formulations, are driving market growth. Companies are also expanding their product lines and entering new markets, particularly in developing countries[1][3].

Pricing Analysis

The pricing of tramadol hydrochloride is influenced by factors such as the cost of production, regulatory approvals, and market competition. The oral type, being the most widely used, is generally priced lower than the injection type, contributing to its higher revenue share[1].

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.

FAQs

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 hydrochloride market?

The primary drivers include the increasing prevalence of chronic pain, the growing geriatric population, and innovations in drug delivery systems[1].

3. Which regions are expected to drive the growth of the tramadol hydrochloride market?

Europe and the Asia Pacific are expected to be the key regions driving market growth due to high healthcare expenditure and growing demand for pain management drugs[1].

4. What are the common adverse events associated with tramadol use?

Common adverse events include nausea, dizziness, constipation, and vomiting[2].

5. How does the combination of tramadol and acetaminophen benefit patients?

The combination provides better pain relief than either medicine used alone, with a synergistic effect that offers a longer duration of action and faster onset of pain relief[2][5].

Sources:

1. Verified Market Research - Tramadol Drug Market Size, Share, Trends, Growth And Forecast
2. PubMed - A randomized, double-blind, placebo-controlled, parallel study
3. Drug Patent Watch - TRAMADOL HYDROCHLORIDE - Generic Drug Details
4. Mayo Clinic - Tramadol and acetaminophen (oral route)
5. Google Patents - Extended release oral acetaminophen/tramadol dosage form