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Last Updated: December 27, 2024

MILNACIPRAN HYDROCHLORIDE Drug Patent Profile


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Which patents cover Milnacipran Hydrochloride, and when can generic versions of Milnacipran Hydrochloride launch?

Milnacipran Hydrochloride is a drug marketed by Amneal Pharms, Hetero Labs Ltd V, and Oryza. and is included in three NDAs.

The generic ingredient in MILNACIPRAN HYDROCHLORIDE is milnacipran hydrochloride. There are twenty-eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the milnacipran hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Milnacipran Hydrochloride

A generic version of MILNACIPRAN HYDROCHLORIDE was approved as milnacipran hydrochloride by HETERO LABS LTD V on October 3rd, 2024.

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Drug patent expirations by year for MILNACIPRAN HYDROCHLORIDE
Recent Clinical Trials for MILNACIPRAN HYDROCHLORIDE

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SponsorPhase
Mansoura UniversityN/A
Yousra Hisham Abdel FattahN/A
University of OttawaPhase 4

See all MILNACIPRAN HYDROCHLORIDE clinical trials

Pharmacology for MILNACIPRAN HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for MILNACIPRAN HYDROCHLORIDE
Paragraph IV (Patent) Challenges for MILNACIPRAN HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
SAVELLA Tablets milnacipran hydrochloride 12.5 mg, 25 mg, 50 mg, and 100 mg 022256 8 2013-01-14

US Patents and Regulatory Information for MILNACIPRAN HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amneal Pharms MILNACIPRAN HYDROCHLORIDE milnacipran hydrochloride TABLET;ORAL 205081-001 Apr 22, 2016 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hetero Labs Ltd V MILNACIPRAN HYDROCHLORIDE milnacipran hydrochloride TABLET;ORAL 205147-003 Oct 3, 2024 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Amneal Pharms MILNACIPRAN HYDROCHLORIDE milnacipran hydrochloride TABLET;ORAL 205081-004 Apr 22, 2016 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

MILNACIPRAN HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Milnacipran Hydrochloride

Introduction

Milnacipran hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI), is a drug primarily used to treat fibromyalgia and major depressive disorder. The market for this drug is influenced by several key factors, including increasing prevalence of chronic pain conditions, advancements in pharmaceutical formulations, and changing healthcare landscapes.

Market Drivers

Increasing Prevalence of Fibromyalgia and Chronic Pain

The rising number of people diagnosed with fibromyalgia and other chronic pain syndromes is a significant driver for the milnacipran hydrochloride market. As awareness and identification of these disorders increase, so does the demand for effective therapeutic options[1].

Advancements in Pharmaceutical Formulations

Continuous research aimed at improving the efficacy of milnacipran hydrochloride and developing better formulations is another key driver. This includes the development of cost-effective chiral HPLC methods for enantiomeric separation, which enhances the drug's potency and reduces side effects[4].

Regulatory Approvals and Clinical Research

Regulatory approvals and ongoing clinical research play a crucial role in the market's growth. The focus on creating better formulations and extending indications for milnacipran hydrochloride has strengthened its market prospects[1].

Market Size and Growth Prospects

The milnacipran hydrochloride market is anticipated to experience robust growth, with a compound annual growth rate (CAGR) of 15.47% from 2024 to 2031. The market is expected to transition from a valuation of USD 2.1 billion in 2024 to USD 5.75 billion by 2031[1].

Geographical Market Analysis

Asia-Pacific

The Asia-Pacific region is a rapidly growing market for milnacipran hydrochloride, driven by countries such as China, Japan, India, and South Korea. Factors like a large population, rising disposable income, and increasing urbanization contribute to the region's growth[1].

Latin America

Latin America presents both opportunities and challenges. Countries like Brazil, Mexico, and Argentina are key players, but economic fluctuations and political instability can impact market dynamics and consumer behavior[1].

Middle East and Africa

The Middle East and Africa represent emerging markets, with countries like the UAE, Saudi Arabia, South Africa, and Nigeria showing promising growth potential. Economic diversification efforts, urbanization, and a young population are driving demand in this region[1].

Key Players and Market Strategies

Mergers and Acquisitions

The milnacipran hydrochloride market is witnessing a wave of mergers and acquisitions as companies seek to consolidate their market positions, expand their product portfolios, and leverage synergies to drive growth and competitiveness. Key players include Solara Active Pharma Sciences, Unichem Laboratories, Mylan Laboratories, and Zhejiang Dongdong Pharmaceutical[1].

Access to New Technologies

Acquisitions provide companies with access to new technologies, intellectual property, and talent, enabling them to innovate faster and stay ahead of market trends. This strategic consolidation is a significant factor in the market's growth[1].

Financial Impact and Healthcare Spending

Healthcare Infrastructure and Spending

Higher healthcare spending has improved market penetration by facilitating access to cutting-edge therapies, especially in developed regions. The growing healthcare infrastructure, particularly in emerging markets, is expected to propel the market forward[1].

Economic Benefits

The economic benefits of milnacipran hydrochloride are not limited to the pharmaceutical companies. Improved healthcare outcomes and reduced healthcare costs due to effective treatment options also benefit private insurance companies and the broader healthcare system[2].

Challenges and Opportunities

Sustainability and Regulatory Compliance

Growing environmental concerns and stringent regulations are fostering a shift towards sustainable alternatives. This trend is expected to boost the demand for eco-friendly milnacipran hydrochloride products and services, presenting both challenges and opportunities for manufacturers[1].

Demographic Factors

The growing senior population, which is more prone to chronic pain, and the increasing incidence of stress-related diseases are key factors driving market expansion. However, these demographic changes also present challenges in terms of healthcare resource allocation and accessibility[1].

Production Cost Analysis

The production cost of milnacipran hydrochloride involves various factors including manufacturing process, capital investment, and raw material costs. Understanding these costs is crucial for manufacturers to maintain profitability and competitiveness in the market[3].

Key Takeaways

  • The milnacipran hydrochloride market is driven by the increasing prevalence of fibromyalgia and chronic pain, advancements in pharmaceutical formulations, and regulatory approvals.
  • The market is expected to grow significantly, with a CAGR of 15.47% from 2024 to 2031.
  • Asia-Pacific and other emerging regions are key drivers of market growth.
  • Mergers and acquisitions, access to new technologies, and higher healthcare spending are critical strategies and factors influencing the market.
  • Sustainability and demographic changes present both challenges and opportunities for the market.

Frequently Asked Questions (FAQs)

  1. What is the current market size and future growth prospects of the milnacipran hydrochloride market?

    • The milnacipran hydrochloride market is valued at USD 2.1 billion in 2024 and is expected to reach USD 5.75 billion by 2031, growing at a CAGR of 15.47%[1].
  2. Who are the key players in the milnacipran hydrochloride market?

    • Key players include Solara Active Pharma Sciences, Unichem Laboratories, Mylan Laboratories, and Zhejiang Dongdong Pharmaceutical[1].
  3. What are the main drivers of the milnacipran hydrochloride market?

    • The main drivers include the increasing prevalence of fibromyalgia and chronic pain, advancements in pharmaceutical formulations, and regulatory approvals[1].
  4. How does the geographical distribution impact the milnacipran hydrochloride market?

    • The Asia-Pacific region is a significant driver, followed by emerging markets in Latin America, the Middle East, and Africa[1].
  5. What are the challenges and opportunities in the milnacipran hydrochloride market?

    • Challenges include sustainability and regulatory compliance, while opportunities arise from demographic changes and the growing healthcare infrastructure[1].

Cited Sources:

  1. OpenPR: Milnacipran Hydrochloride Market Size, Share and Forecast[1].
  2. Tandfonline: Full article: ABSTRACTS[2].
  3. Procurement Resource: Milnacipran Hydrochloride Production Cost Analysis Reports 2024[3].
  4. ChemRxiv: Chromatographic and Computational Studies on the Chiral Recognition of Sulfated Cyclodextrin on Enantiomeric Separation of Milnacipran[4].

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