MILNACIPRAN HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for milnacipran hydrochloride and what is the scope of patent protection?

Milnacipran hydrochloride is the generic ingredient in two branded drugs marketed by Amneal Pharms, Hetero Labs Ltd V, Oryza, and Abbvie, and is included in four NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Milnacipran hydrochloride has thirty-three patent family members in twenty-three countries.

There are twenty-six drug master file entries for milnacipran hydrochloride. Three suppliers are listed for this compound. There are five tentative approvals for this compound.

Summary for MILNACIPRAN HYDROCHLORIDE

International Patents:	33
US Patents:	1
Tradenames:	2
Applicants:	4
NDAs:	4
Drug Master File Entries:	26
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	187
Clinical Trials:	56
Patent Applications:	689
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MILNACIPRAN HYDROCHLORIDE
What excipients (inactive ingredients) are in MILNACIPRAN HYDROCHLORIDE?	MILNACIPRAN HYDROCHLORIDE excipients list
DailyMed Link:	MILNACIPRAN HYDROCHLORIDE at DailyMed

Recent Clinical Trials for MILNACIPRAN HYDROCHLORIDE

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

Sponsor	Phase
Mansoura University	N/A
Yousra Hisham Abdel Fattah	N/A
Allergan	Phase 4

See all MILNACIPRAN HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for MILNACIPRAN HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		100MG	TABLET;ORAL
		50MG	TABLET;ORAL
		25MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for MILNACIPRAN HYDROCHLORIDE

Drug Class	Serotonin and Norepinephrine Reuptake Inhibitor
Mechanism of Action	Norepinephrine Uptake Inhibitors Serotonin Uptake Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for MILNACIPRAN HYDROCHLORIDE

N06AX	Other antidepressants
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

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
Hetero Labs Ltd V	MILNACIPRAN HYDROCHLORIDE	milnacipran hydrochloride	TABLET;ORAL	205147-002	Oct 3, 2024	AB	RX	No	No
Abbvie	SAVELLA	milnacipran hydrochloride	TABLET;ORAL	022256-003	Jan 14, 2009	AB	RX	Yes	Yes
Amneal Pharms	MILNACIPRAN HYDROCHLORIDE	milnacipran hydrochloride	TABLET;ORAL	205081-002	Apr 22, 2016		DISCN	No	No
Abbvie	SAVELLA	milnacipran hydrochloride	TABLET;ORAL	022256-002	Jan 14, 2009	AB	RX	Yes	No
Amneal Pharms	MILNACIPRAN HYDROCHLORIDE	milnacipran hydrochloride	TABLET;ORAL	205081-003	Apr 22, 2016		DISCN	No	No
Oryza	MILNACIPRAN HYDROCHLORIDE	milnacipran hydrochloride	TABLET;ORAL	205071-003	Jan 27, 2016		DISCN	No	No
Amneal Pharms	MILNACIPRAN HYDROCHLORIDE	milnacipran hydrochloride	TABLET;ORAL	205081-001	Apr 22, 2016		DISCN	No	No

Expired US Patents for MILNACIPRAN HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	SAVELLA	milnacipran hydrochloride	TABLET;ORAL	022256-003	Jan 14, 2009
Abbvie	SAVELLA	milnacipran hydrochloride	TABLET;ORAL	022256-001	Jan 14, 2009
Abbvie	SAVELLA	milnacipran hydrochloride	TABLET;ORAL	022256-004	Jan 14, 2009
Abbvie	SAVELLA	milnacipran hydrochloride	TABLET;ORAL	022256-004	Jan 14, 2009
Abbvie	SAVELLA	milnacipran hydrochloride	TABLET;ORAL	022256-004	Jan 14, 2009
Abbvie	SAVELLA	milnacipran hydrochloride	TABLET;ORAL	022256-002	Jan 14, 2009
Abbvie	SAVELLA	milnacipran hydrochloride	TABLET;ORAL	022256-003	Jan 14, 2009

International Patents for MILNACIPRAN HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Costa Rica	9882	MILNACIPRAN PARA EL TRATAMIENTO A LARGO PLAZO DEL SINDROME DE FIBROMIALGIA
Ukraine	94721	СПОСІБ ЛІКУВАННЯ ФІБРОМІАЛГІЇ[СПОСОБ ЛЕЧЕНИЯ ФИБРОМИАЛГИИ (METHODS FOR THE TREATMENT OF FIBROMYALGIA SYNDROME)
Japan	2009510080
World Intellectual Property Organization (WIPO)	2007038620
Japan	6014702
Israel	228904	שימוש במילנקיפרן, או מלח מתאים פרמצבטי, בהכנת תרופה לטיפול בפיברומילג'יה (Use of milnacipran or a pharmaceutically acceptable salt thereof in the preparation of a medicament for treating fibromyalgia)
Brazil	PI0617541	uso de um medicamento e uso de pelo menos inibidor dual de recaptaÇço (dri)

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].