You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 22, 2024

ULTRAM Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


Which patents cover Ultram, and what generic alternatives are available?

Ultram is a drug marketed by Janssen Pharms and Valeant Pharms and is included in two NDAs.

The generic ingredient in ULTRAM is tramadol hydrochloride. There are thirty-six drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the tramadol hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Ultram

A generic version of ULTRAM was approved as tramadol hydrochloride by SUN PHARM INDS INC on June 19th, 2002.

  Subscribe

AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for ULTRAM?
  • What are the global sales for ULTRAM?
  • What is Average Wholesale Price for ULTRAM?
Summary for ULTRAM
US Patents:0
Applicants:2
NDAs:2
Raw Ingredient (Bulk) Api Vendors: 27
Clinical Trials: 21
Patent Applications: 186
Drug Prices: Drug price information for ULTRAM
What excipients (inactive ingredients) are in ULTRAM?ULTRAM excipients list
DailyMed Link:ULTRAM at DailyMed
Drug patent expirations by year for ULTRAM
Drug Prices for ULTRAM

See drug prices for ULTRAM

Drug Sales Revenue Trends for ULTRAM

See drug sales revenues for ULTRAM

Recent Clinical Trials for ULTRAM

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

SponsorPhase
Henry Ford Health SystemPhase 4
Medical College of WisconsinPhase 2
University of PennsylvaniaPhase 4

See all ULTRAM clinical trials

US Patents and Regulatory Information for ULTRAM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Pharms ULTRAM tramadol hydrochloride TABLET;ORAL 020281-002 Mar 3, 1995 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Valeant Pharms ULTRAM ER tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 021692-002 Sep 8, 2005 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Janssen Pharms ULTRAM tramadol hydrochloride TABLET;ORAL 020281-001 Mar 3, 1995 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Valeant Pharms ULTRAM ER tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 021692-001 Sep 8, 2005 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Valeant Pharms ULTRAM ER tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 021692-003 Sep 8, 2005 DISCN Yes 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

ULTRAM Market Analysis and Financial Projection Experimental

Tramadol Market Dynamics and Financial Trajectory: A Comprehensive Overview

Introduction

Tramadol, marketed under brand names such as Ultram, is a pivotal opioid analgesic used to treat moderate to moderately severe pain. The global tramadol market is experiencing significant growth, driven by various factors including increasing chronic pain prevalence, an aging population, and innovations in drug delivery systems.

Market Size and Forecast

As of 2022, the global tramadol market was valued at approximately USD 3.6 billion to USD 4.5 billion, depending on the source[2][3][5].

  • By 2028, the market is expected to reach USD 5.53 billion, growing at a Compound Annual Growth Rate (CAGR) of 6.95%[1].
  • More long-term projections indicate the market will reach USD 7.29 billion by 2030, with a CAGR of 4.41% to 6.87% during the forecast period[2][3][5].

Geographic Segmentation

The tramadol market is segmented geographically into several key regions:

  • North America: A significant market due to high healthcare spending and a large patient base.
  • Europe: Expected to witness robust growth prospects from 2022 to 2027[1].
  • Asia-Pacific: This region is experiencing rapid growth driven by improving healthcare infrastructure, rising disposable incomes, and increasing awareness about pain management. Countries like China and India offer substantial growth opportunities[4].
  • South America: Growing demand for pain management drugs in this region.
  • Middle East and Africa: Also showing potential for growth, though at a slower pace compared to other regions[1][4].

Key Players and Competitive Landscape

The tramadol market is dominated by several major pharmaceutical companies:

  • Grünenthal GmbH: Known for its extensive portfolio of pain management drugs, including tramadol.
  • Mundipharma: A significant player with a global presence in the tramadol market.
  • Labopharm: Contributing to market growth through various formulations of tramadol[2].
  • Pfizer Inc.: A leading company in the U.S. market.
  • J&J Innovative Medicine: Another major player in the U.S.
  • Teva Pharmaceuticals: Known for its strong distribution networks and R&D capabilities.
  • GSK plc: A key player in the UK and global markets[4].

Driving Factors

Several factors are driving the growth of the tramadol market:

  • Increasing Prevalence of Chronic Pain: Conditions such as arthritis, neuropathy, and fibromyalgia are becoming more common, driving the demand for pain management drugs. At least 10% of the world’s population is affected by chronic pain[3].
  • Aging Population: The rise in the geriatric population increases the demand for pain management solutions.
  • Innovations in Drug Delivery: Continuous innovation in drug delivery systems, such as IV formulations and other delivery methods, is stimulating market growth[2][3][4].
  • Expanding Regulatory Approvals: Simplified prescription regulations and approvals from agencies like the FDA, WHO, and EMA enhance market accessibility and demand[4].

Safety and Efficacy Concerns

Despite its benefits, tramadol use comes with several safety concerns:

  • Delayed Onset of Analgesia: The IV formulation of tramadol has a delayed onset of effect, which can increase 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[2].

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 in the U.S. due to concerns about delayed onset of analgesia and potential safety risks[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 market is promising:

  • The market is expected to grow from USD 5.26 billion in 2022 to USD 7.29 billion by 2030, and another estimate suggests it will reach USD 7.190 billion by 2032[2][3].
  • The CAGR for the market is estimated to be around 4.41% to 6.87% over the forecast periods, indicating steady and robust growth[2][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].

Market Segments

The tramadol market is segmented based on several criteria:

  • Dosage Form: Tablets, capsules, liquid suspensions, and other forms.
  • Route of Administration: Oral, parenteral, and other routes.
  • Distribution Channel: Hospital pharmacies, retail pharmacies, and online pharmacies[4].

Regional Growth

  • Asia Pacific: This region is witnessing rapid growth due to improving healthcare infrastructure, rising disposable incomes, and increasing awareness about pain management[4].
  • Europe: Expected to witness robust growth prospects from 2022 to 2027[1].

Impact of COVID-19

The COVID-19 pandemic had a moderately positive impact on the tramadol market:

  • Increased Demand: Safety restrictions and the closure of many clinics and pain services led to an increased adoption of pain management drugs, including tramadol[3].
"According to the Good Body stats, at least 10% of the world’s population is affected by chronic pain, and it has been estimated that 1 in every 5 adults suffer from pain and some acute pains which are undiagnosed till it becomes chronic."[3]

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[2].

2. Which regions are driving the growth of the tramadol market?

Europe and Asia Pacific are key regions driving market growth, with the Asia Pacific region witnessing rapid growth due to improving healthcare infrastructure and increasing awareness about pain management[1][4].

3. What are the primary driving factors of the tramadol market?

The primary driving factors include the increasing prevalence of chronic pain conditions, an aging population, and innovations in drug delivery systems[2][3][4].

4. What are the safety concerns associated with tramadol use?

Safety concerns include delayed onset of analgesia with the IV formulation and the potential for abuse and addiction, although tramadol has a lower risk compared to other opioids[2].

5. How is the regulatory landscape impacting the tramadol market?

The regulatory environment, including FDA approvals and global regulations, plays a crucial role in the market dynamics of tramadol, with varying regulations across different regions[2].

Sources:

  1. GlobeNewswire: Tramadol Market Growth USD 5531.15 Million by 2028.
  2. DrugPatentWatch: TRAMADOL HYDROCHLORIDE - Generic Drug Details.
  3. GMI Insights: Tramadol Drug Market Size & Trends Analysis Report, 2032.
  4. Stellar Market Research: Tramadol Market: Global Industry Analysis and Forecast (2024-2030).
  5. Business Research Insights: Tramadol Market 2024 To 2032.

More… ↓

⤷  Subscribe

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.