FETZIMA Drug Patent Profile

When do Fetzima patents expire, and what generic alternatives are available?

Fetzima is a drug marketed by Abbvie and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-four patent family members in twenty-seven countries.

The generic ingredient in FETZIMA is levomilnacipran hydrochloride. There are eleven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the levomilnacipran hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Fetzima

A generic version of FETZIMA was approved as levomilnacipran hydrochloride by PRINSTON INC on March 20^th, 2023.

Summary for FETZIMA

International Patents:	54
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	75
Clinical Trials:	7
Patent Applications:	179
Drug Prices:	Drug price information for FETZIMA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FETZIMA
What excipients (inactive ingredients) are in FETZIMA?	FETZIMA excipients list
DailyMed Link:	FETZIMA at DailyMed

See drug prices for FETZIMA

Recent Clinical Trials for FETZIMA

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

Sponsor	Phase
University of Ottawa	Phase 4
Allergan	Phase 4
National Institute of Mental Health (NIMH)	Phase 4

See all FETZIMA clinical trials

Pharmacology for FETZIMA

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

Paragraph IV (Patent) Challenges for FETZIMA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FETZIMA	Extended-release Capsules	levomilnacipran hydrochloride	20 mg, 40 mg, 80 mg and 120 mg	204168	6	2017-07-25

US Patents and Regulatory Information for FETZIMA

FETZIMA is protected by three US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	FETZIMA	levomilnacipran hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	204168-001	Jul 25, 2013	AB	RX	Yes	No
Abbvie	FETZIMA	levomilnacipran hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	204168-002	Jul 25, 2013	AB	RX	Yes	No			Y	Y
Abbvie	FETZIMA	levomilnacipran hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	204168-001	Jul 25, 2013	AB	RX	Yes	No
Abbvie	FETZIMA	levomilnacipran hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	204168-003	Jul 25, 2013	AB	RX	Yes	No

International Patents for FETZIMA

When does loss-of-exclusivity occur for FETZIMA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Canada

European Patent Office

Japan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering FETZIMA around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	1601349
European Patent Office	2496079	NOUVELLES FORMES CRISTALLINES DU (1S,2R)-2-(AMINOMÉTHYL)-N,N-DIÉTHYL-1-PHÉNYLCYCLOPROPANECARBOXAMIDE (NOVEL CRYSTALLINE FORMS OF (1S,2R)-2-(AMINO METHYL)-N,N-DIETHYL-1-PHENYL CYCLOPROPANE CARBOXAMIDE)
South Korea	20050096190	USE OF THE ENANTIOMER (1S,2R) OF MILNACIPRAN FOR THE PREPARATION OF A MEDICAMENT
New Zealand	541733	Use of the enantiomer (1S,2R) of milnacipran for the preparation of a medicament

Market Dynamics and Financial Trajectory for FETZIMA

Last updated: July 27, 2025

Introduction

FETZIMA (levomilnacipran), an SNRI (serotonin-norepinephrine reuptake inhibitor), is positioned within the expanding landscape of major depressive disorder (MDD) and other neuropsychiatric treatments. Approved by the U.S. Food and Drug Administration (FDA) in 2013, FETZIMA offers a differentiated mechanism of action aimed at providing better symptom management. Understanding its market dynamics and financial trajectory necessitates an analysis of recent growth factors, competitive landscape, regulatory environment, and strategic initiatives shaping its future.

Market Overview and Growth Drivers

Increasing Prevalence of Depression and Comorbidities

Depression remains among the leading causes of disability worldwide, with the World Health Organization (WHO) estimating over 264 million individuals affected globally [1]. The high unmet medical need and the rising awareness of mental health foster continuous demand for effective pharmacological interventions. The approval and subsequent commercialization of FETZIMA align with this upward trend, targeting a segment increasingly receptive to novel therapeutic options.

Differentiated Pharmacological Profile

FETZIMA's dual mechanism—particularly its strong norepinephrine reuptake inhibition—distinguishes it from other antidepressants such as SSRIs (selective serotonin reuptake inhibitors), potentially translating to improved efficacy in alleviating certain depressive symptoms. This positioning supports its adoption among clinicians seeking alternatives with rapid onset or specific symptom relief.

Expanding Indications and Off-label Uses

Beyond MDD, FETZIMA is being studied for indications like generalized anxiety disorder, fibromyalgia, and chronic pain. While not yet universally approved for these conditions, successful expansion could significantly expand its addressable market.

Healthcare Infrastructure and Access

Broader insurance coverage and increased prescribing in outpatient settings reinforce FETZIMA’s market penetration. The shift toward outpatient mental health management, particularly during and post-COVID-19 pandemic, enhances drug utilization.

Competitive Landscape

Major Competitors

FETZIMA faces competition primarily from established antidepressants including SSRIs (e.g., fluoxetine, sertraline), other SNRIs (venlafaxine, duloxetine), atypical agents (bupropion, mirtazapine), and emerging novel compounds.

Market Share Dynamics

Despite strong competition, FETZIMA's market share continues to grow, supported by its unique efficacy profile. However, market penetration remains challenged by patient and clinician familiarity with existing standards, generic availability, and marketing efforts by competitors.

Pricing and Reimbursement

Pricing strategies significantly influence adoption. FETZIMA is positioned in the premium segment relative to generics but seeks favorable coverage policies. Demonstrating value through efficacy and tolerability enhances reimbursement prospects, especially in competitive outpatient settings.

Regulatory and Policy Environment

FDA and Global Approvals

FDA approval functions as a market gateway, while subsequent approvals elsewhere (e.g., EU) can broaden footprint. Regulatory hurdles for additional indications (e.g., anxiety, chronic pain) can unlock revenue streams but require rigorous clinical evidence.

Pricing and Reimbursement Policies

Healthcare policy reforms emphasizing value-based care impact drug pricing strategies. Higher-cost medications necessitate clear evidence of superior efficacy and safety to secure favorable formulary placement.

Financial Trajectory and Revenue Outlook

Historical Revenue Performance

Since its market launch, FETZIMA has demonstrated steady revenue growth, though it remains behind blockbuster antidepressants like Cymbalta and Prozac in total sales. Initial revenues benefited from early adopters, with subsequent growth driven by increased prescriber acceptance and expanded indications.

Future Revenue Drivers

• Market Penetration: Expanding prescriber awareness, patient access, and expanding indications will directly augment revenues.
• Geographic Expansion: Entry into international markets—particularly Europe and Asia—can significantly scale revenue streams.
• Pipeline and Line Extensions: Development of formulations with improved convenience (e.g., once-daily dosing) or combination products can unlock new segments.
• Pricing Flexibility: Optimize reimbursement arrangements to balance revenue and market access.

Financial Challenges and Risks

• Generic Competition: While FETZIMA remains under patent protection, imminent patent expirations could lead to generic erosion.
• Market Saturation: The mature antidepressant market may limit growth without significant innovation or new indications.
• Regulatory Delays: Setbacks in approval processes for additional indications or regulatory hurdles could impede growth.

Strategic Initiatives Influencing Market Trajectory

• Clinical Trials for Adjunct Use: FETZIMA's exploration for chronic pain and anxiety could open valuable new markets, supported by positive trial data.
• Partnerships and Alliances: Collaborations with healthcare providers, payers, and patient advocacy groups strengthen market presence.
• Digital Health Integration: Incorporation of telemedicine and digital monitoring could enhance treatment adherence and outcomes, indirectly impacting sales.

Conclusion

FETZIMA’s market dynamics are shaped by its unique pharmacological profile, growing mental health burden, and strategic positioning amid strong competition. Its financial trajectory hinges on sustained market penetration, geographic expansion, and successful indication growth. While challenges from patent cliffs and market saturation persist, strategic investments in clinical development, market access, and innovation are pivotal for amplifying revenue streams.

Key Takeaways

• Growing Demand: The rising prevalence of depression and mental health awareness underpin sustained demand for FETZIMA.
• Market Differentiation: Its distinct mechanism positions FETZIMA as an attractive alternative, especially for treatment-resistant cases.
• Competition & Pricing: Effective differentiation and favorable reimbursement strategies are vital to capturing market share amid established competitors.
• Pipeline & Expansion: Diversification into related indications and international markets offers significant growth pathways.
• Risk Management: Vigilance against patent expiration and regulatory developments is essential for safeguarding revenues.

---

FAQs

1. What distinguishes FETZIMA from other antidepressants?
FETZIMA uniquely provides potent norepinephrine reuptake inhibition, which may result in improved management of certain depressive symptoms and offers an alternative for patients unresponsive to SSRIs or traditional SNRIs.

2. How has FETZIMA’s market share evolved since its approval?
While initial sales were modest, FETZIMA’s market share has increased through prescriber education, expanding indications (pending approvals), and its positioning in treatment-resistant depression segments.

3. What licensing opportunities exist for FETZIMA?
Potential exists for approvals in generalized anxiety disorder, fibromyalgia, and chronic pain, each expanding its addressable patient base and revenue potential.

4. How does pricing impact FETZIMA's market adoption?
As a branded medication, FETZIMA commands premium pricing; reimbursement negotiations and demonstration of clinical value are critical to maximize market penetration.

5. What is the long-term outlook for FETZIMA’s financial success?
With strategic indication expansion, geographic growth, and innovation, FETZIMA faces promising long-term growth prospects; however, patent protection and competitive dynamics require ongoing management.

---

Sources:

[1] World Health Organization, "Depression," 2021.