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Last Updated: December 22, 2024

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN Drug Patent Profile


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Which patents cover Tramadol Hydrochloride And Acetaminophen, and when can generic versions of Tramadol Hydrochloride And Acetaminophen launch?

Tramadol Hydrochloride And Acetaminophen is a drug 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, and Zydus Pharms Usa Inc. and is included in eleven NDAs.

The generic ingredient in TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN is acetaminophen; tramadol hydrochloride. There are sixty-six drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the acetaminophen; tramadol hydrochloride profile page.

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Summary for TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
US Patents:0
Applicants:11
NDAs:11
Finished Product Suppliers / Packagers: 17
Raw Ingredient (Bulk) Api Vendors: 2
Clinical Trials: 82
Patent Applications: 3
What excipients (inactive ingredients) are in TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN?TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN excipients list
DailyMed Link:TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN at DailyMed
Drug patent expirations by year for TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
Recent Clinical Trials for TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN

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

SponsorPhase
University Hospital "Sestre Milosrdnice"N/A
Novartis PharmaceuticalsPhase 3
Bhupesh Parashar, MDPhase 2

See all TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN clinical trials

Pharmacology for TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists

US Patents and Regulatory Information for TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alkem Labs Ltd TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN acetaminophen; tramadol hydrochloride TABLET;ORAL 202076-001 Mar 30, 2012 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Micro Labs Ltd India TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN acetaminophen; tramadol hydrochloride TABLET;ORAL 201952-001 Dec 14, 2012 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Chartwell Rx TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN acetaminophen; tramadol hydrochloride TABLET;ORAL 076475-001 Apr 21, 2005 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Nostrum Labs Inc TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN acetaminophen; tramadol hydrochloride TABLET;ORAL 078778-001 Apr 7, 2014 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Tramadol Hydrochloride and Acetaminophen

Market Overview

The market for tramadol hydrochloride and its combinations, such as with acetaminophen, is robust and dynamic, driven by several key factors. Tramadol, an opioid analgesic, is widely used for treating moderate to moderately severe pain in adults. It is available under various brand names, including Ultram, Ultram ER, Conzip, and in combination with acetaminophen as Ultracet[1].

Market Size and Forecast

As of 2023, the global tramadol market was valued at USD 4.24 billion. It is expected to grow at a Compound Annual Growth Rate (CAGR) of 6.86% from 2024 to 2030, reaching approximately USD 6.75 billion by 2030. Another estimate suggests the market will grow from USD 3.462 billion in 2022 to USD 7.190 billion by 2032, with a CAGR of 6.87% during this period[1][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 conditions worldwide, particularly among aging populations, is a significant driver. Chronic diseases such as arthritis and neuropathy contribute to the demand for pain relief medicines like tramadol[1].

Aging Population

The global geriatric demographic is increasing, and older adults often seek pain management solutions, further driving the demand for tramadol[1].

Innovations in Drug Delivery Systems

Continuous innovation in drug delivery systems, such as extended-release formulations and IV formulations, is stimulating market growth. These innovations enhance the efficacy and convenience of tramadol, making it a preferred option for pain management[2][3].

Regulatory Approvals and Accessibility

Regulatory approvals from agencies like the FDA, WHO, and EMA for new formulations and indications of tramadol enhance its accessibility and market penetration. Simplified prescription regulations also contribute to the market's growth[1].

Market Segments

The tramadol hydrochloride market is segmented by:

Dosage Form

Oral, injection, and rectal forms are the primary dosage forms available in the market[3].

Route of Administration

The market includes various routes of administration, such as oral and intravenous, each catering to different patient needs and preferences[3].

Distribution Channel

Hospital pharmacies, retail pharmacies, and online pharmacies are the key distribution channels for tramadol hydrochloride[3].

Region

Europe and the Asia Pacific are the fastest-growing regions, driven by high healthcare expenditure and increasing product consumption, respectively[1][3].

Key Players and Market Competition

Major pharmaceutical companies such as Pfizer Inc., J&J Innovative Medicine, Teva Pharmaceuticals, GSK plc, and Cipla dominate the market. These companies leverage their extensive distribution networks and strong R&D capabilities to maintain a competitive advantage[1].

Public Health Impact

Tramadol fills a critical gap in pain management, providing an alternative to more potent opioids. 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][3].

Safety and Regulatory Aspects

While tramadol is effective, it is subject to stringent regulatory frameworks, particularly in the United States, due to its potential for abuse and dependence. Regulatory bodies closely monitor its use to ensure safety and compliance with quality standards and guidelines[1].

Adverse Events

Common adverse events associated with tramadol include nausea, dizziness, constipation, and vomiting. The IV formulation has a delayed onset of analgesia, which can lead to additional analgesic needs and potentially increase the risk of opioid stacking and related adverse reactions[2][5].

Financial Trajectory

The financial trajectory of the tramadol hydrochloride market is promising, with significant growth projected over the next decade. Here are some key financial highlights:

  • Market Size: Expected to reach USD 6.75 billion by 2030 from USD 4.24 billion in 2023[1].
  • CAGR: Estimated to be around 6.86% from 2024 to 2030[1].
  • Investment: Major pharmaceutical companies are investing heavily in research and development to expand the market and improve drug delivery systems[3].

Regional Growth

The Asia Pacific region is witnessing rapid growth due to improving healthcare infrastructure, rising disposable incomes, and increasing awareness about pain management. Emerging markets like China and India offer substantial growth opportunities due to their large and diverse patient populations[1].

Innovations and Future Outlook

Innovations in drug delivery systems and the increasing adoption of digital health solutions are shaping the future of the tramadol market. The development of new formulations and delivery methods, such as extended-release tablets, is expected to continue driving market growth[2][3].

"Tramadol fills a critical gap in pain management, especially for moderate to moderately severe pain, providing an alternative to more potent opioids"[3].

Key Takeaways

  • The tramadol hydrochloride market is growing due to the increasing prevalence of chronic pain, an aging population, and innovations in drug delivery systems.
  • Europe and the Asia Pacific are key regions driving market growth.
  • 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.
  • Regulatory approvals and simplified prescription regulations enhance market accessibility and demand.

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 6.75 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 the 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 dosage form, route of administration, distribution channel, and region[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. Stellar Market Research - Tramadol Market: Global Industry Analysis and Forecast (2024-2030)[1].
  2. PubMed - A randomized, double-blind, placebo-controlled, parallel-group study evaluating the efficacy and safety of extended-release tramadol hydrochloride and acetaminophen for chronic low back pain[2].
  3. Drug Patent Watch - Tramadol Hydrochloride Market Dynamics and Financial Trajectory[3].
  4. DailyMed - Tramadol Hydrochloride and Acetaminophen[4].
  5. FDA - ULTRACET (tramadol hydrochloride/acetaminophen) Tablets Full Prescribing Information[5].

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