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

Last Updated: December 22, 2024

METHYLNALTREXONE BROMIDE Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


When do Methylnaltrexone Bromide patents expire, and when can generic versions of Methylnaltrexone Bromide launch?

Methylnaltrexone Bromide is a drug marketed by Actavis Llc and is included in one NDA.

The generic ingredient in METHYLNALTREXONE BROMIDE is methylnaltrexone bromide. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the methylnaltrexone bromide profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Methylnaltrexone Bromide

A generic version of METHYLNALTREXONE BROMIDE was approved as methylnaltrexone bromide by ACTAVIS LLC on August 26th, 2024.

  Subscribe

AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for METHYLNALTREXONE BROMIDE?
  • What are the global sales for METHYLNALTREXONE BROMIDE?
  • What is Average Wholesale Price for METHYLNALTREXONE BROMIDE?
Drug patent expirations by year for METHYLNALTREXONE BROMIDE
Recent Clinical Trials for METHYLNALTREXONE BROMIDE

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

SponsorPhase
University of Alabama at BirminghamN/A
Bausch Health Americas, Inc.Phase 2/Phase 3
Karolinska University HospitalPhase 4

See all METHYLNALTREXONE BROMIDE clinical trials

Paragraph IV (Patent) Challenges for METHYLNALTREXONE BROMIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
RELISTOR Tablets methylnaltrexone bromide 150 mg 208271 1 2016-09-06
RELISTOR Injection methylnaltrexone bromide 8 mg/0.4 mL, Single Dose Prefilled Syringe 021964 1 2015-09-08
RELISTOR Injection methylnaltrexone bromide 12 mg/0.6 mL, Single Dose Vial 021964 1 2015-07-22

US Patents and Regulatory Information for METHYLNALTREXONE BROMIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Actavis Llc METHYLNALTREXONE BROMIDE methylnaltrexone bromide SOLUTION;SUBCUTANEOUS 208112-001 Aug 26, 2024 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Actavis Llc METHYLNALTREXONE BROMIDE methylnaltrexone bromide SOLUTION;SUBCUTANEOUS 208112-002 Aug 26, 2024 AP RX 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

EU/EMA Drug Approvals for METHYLNALTREXONE BROMIDE

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Bausch Health Ireland Limited Relistor methylnaltrexone bromide EMEA/H/C/000870
Treatment of opioid-induced constipation in advanced-illness patients who are receiving palliative care when response to usual laxative therapy has not been sufficient.
Authorised no no no 2008-07-01
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

METHYLNALTREXONE BROMIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Methylnaltrexone Bromide

Introduction to Methylnaltrexone Bromide

Methylnaltrexone bromide, marketed under the brand name Relistor, is a peripherally acting mu-opioid receptor antagonist (PAMORA) used to treat opioid-induced constipation (OIC) in adults with chronic non-cancer pain and those with advanced illness[2].

Market Size and Growth

The opioid-induced constipation drugs market, which includes methylnaltrexone bromide, is experiencing significant growth. As of 2023, the global OIC drugs market was valued at USD 2.69 billion and is projected to reach USD 4.52 billion by 2031, with a Compound Annual Growth Rate (CAGR) of 6.7% during the forecast period of 2024 to 2031[1].

Segmentation and Market Share

The OIC drugs market is segmented based on active ingredients, treatment types, modes of administration, end-users, and distribution channels. Methylnaltrexone bromide is one of the key active ingredients in this market, alongside naloxegol, lubiprostone, and docusate sodium.

  • Active Ingredients: Methylnaltrexone bromide is part of the PAMORA class, which is gaining traction due to its efficacy in restoring normal bowel motility in constipated opioid-treated patients[2].
  • Market Share: While lubiprostone currently holds the largest market share due to its benefits and advantages, methylnaltrexone bromide remains a significant player. However, naloxegol is expected to grow at the fastest CAGR during the forecast period, potentially impacting the market share of methylnaltrexone bromide[5].

Financial Trajectory

The financial performance of methylnaltrexone bromide is closely tied to the overall growth of the OIC drugs market.

  • Revenue Growth: The increasing prevalence of chronic pain conditions and the expanding patient knowledge of OIC are key drivers of market growth. This trend is expected to continue, contributing to the financial success of methylnaltrexone bromide[3].
  • Cost-Effectiveness: Studies have shown that treating OIC with methylnaltrexone bromide plus standard care is cost-effective, particularly in advanced-illness patients. This cost-effectiveness can offset the higher costs of the drug, making it a viable option for healthcare providers and patients[4].

Distribution and End-Users

Methylnaltrexone bromide is distributed through various channels and used by different end-users.

  • Distribution Channels: The drug is available through hospital pharmacies, online pharmacies, and retail pharmacies. North America, with its robust market presence and significant healthcare expenditure, is a major distribution hub[1].
  • End-Users: The primary end-users include hospitals, homecare settings, and specialty centers. The drug's use in these settings is driven by the need for effective OIC treatment in patients undergoing long-term opioid therapy[1].

Regulatory and Safety Considerations

The regulatory landscape for methylnaltrexone bromide is complex due to safety concerns associated with PAMORAs.

  • FDA Approval: Methylnaltrexone bromide has received FDA approval for the treatment of OIC in adults with chronic non-cancer pain. However, the FDA has mandated post-marketing studies to investigate potential cardiovascular risks associated with PAMORAs[2].
  • Safety Concerns: The FDA has identified cardiovascular events as a potential risk with PAMORAs, including methylnaltrexone bromide. Ongoing studies are aimed at assessing the major adverse cardiovascular event (MACE) risk associated with these drugs[2].

Competitive Landscape

The competitive landscape for methylnaltrexone bromide includes other PAMORAs and traditional OIC treatments.

  • Competitors: Naloxegol (Movantik) and lubiprostone are significant competitors in the OIC market. Lubiprostone, in particular, is expected to overtake methylnaltrexone bromide’s market share due to its broader indications and patient population[5].
  • Innovative Therapeutics: The development of innovative therapeutics with fewer side effects is an emerging opportunity in the OIC market. Strategic partnerships and research initiatives focusing on personalized medicine could further shape the competitive landscape[3].

Regional Market Dynamics

The regional dynamics play a crucial role in the market trajectory of methylnaltrexone bromide.

  • North America: This region is expected to dominate the market due to the presence of major product manufacturers and significant healthcare expenditure. Research and development efforts in North America are driving the development of innovative OIC treatments[1].
  • Asia-Pacific: This region is expected to witness significant growth due to advanced healthcare infrastructure and earlier drug approvals. The accelerated drug approval initiatives by regulatory bodies are likely to propel market growth in this region[1].

Challenges and Opportunities

Despite the growth potential, there are challenges and opportunities that impact the financial trajectory of methylnaltrexone bromide.

  • Challenges: Regulatory hurdles, potential side effects, and high costs are significant challenges. Additionally, the social stigma associated with opioid use can negatively affect market growth[3].
  • Opportunities: The development of innovative therapeutics with fewer side effects and strategic partnerships in research initiatives offer opportunities for growth. Capitalizing on these opportunities can help firms navigate the challenges and maintain market competitiveness[3].

Key Takeaways

  • Market Growth: The OIC drugs market, including methylnaltrexone bromide, is projected to grow significantly, driven by increasing prevalence of chronic pain and advanced healthcare infrastructure.
  • Cost-Effectiveness: Methylnaltrexone bromide is cost-effective, particularly in advanced-illness patients, despite higher initial costs.
  • Regulatory Considerations: Ongoing studies are necessary to address cardiovascular safety concerns associated with PAMORAs.
  • Competitive Landscape: The market is competitive, with other PAMORAs and traditional treatments vying for market share.
  • Regional Dynamics: North America and Asia-Pacific are key regions driving market growth.

FAQs

Q1: What is methylnaltrexone bromide used for? Methylnaltrexone bromide is used to treat opioid-induced constipation (OIC) in adults with chronic non-cancer pain and those with advanced illness.

Q2: What is the projected market size for the OIC drugs market by 2031? The global OIC drugs market is projected to reach USD 4.52 billion by 2031, with a CAGR of 6.7% during the forecast period of 2024 to 2031.

Q3: What are the main competitors of methylnaltrexone bromide in the OIC market? The main competitors include naloxegol (Movantik) and lubiprostone, with lubiprostone expected to overtake methylnaltrexone bromide’s market share.

Q4: What are the regulatory concerns associated with methylnaltrexone bromide? The FDA has identified potential cardiovascular risks associated with PAMORAs, including methylnaltrexone bromide, and has mandated post-marketing studies to investigate these risks.

Q5: Is methylnaltrexone bromide cost-effective? Yes, treating OIC with methylnaltrexone bromide plus standard care is cost-effective, particularly in advanced-illness patients, as it reduces other constipation-related costs.

Sources

  1. Data Bridge Market Research: Global Opioid Induced Constipation Drugs Market Size & Statistics By 2031.
  2. FDA: Methylnaltrexone bromide oral tablet, Relistor® NDA 208271.
  3. GlobeNewswire: Opioid-Induced Constipation (OIC) Therapeutics Market Forecast 2025-2030.
  4. PubMed: Methylnaltrexone bromide for the treatment of opioid-induced constipation.
  5. Verified Market Research: Opioid Induced Constipation Market Size, Share, Opportunities.

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.