FETZIMA Drug Patent Profile

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

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
Weill Cornell Institute of Geriatric Psychiatry	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	8,481,598
Abbvie	FETZIMA	levomilnacipran hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	204168-002	Jul 25, 2013	AB	RX	Yes	No	8,865,937		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
Abbvie	FETZIMA	levomilnacipran hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	204168-002	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
World Intellectual Property Organization (WIPO)	2011057176
Spain	2359441
Japan	2013510176
European Patent Office	1908461	Utilisation de l'énantiomère (1S, 2R) du milnacipran pour la préparation d'un médicament (Use of (1S, 2R) enantiomer of milnacipran for the preparation of a medicine)
China	1750817	Use of the (1s, 2r) enantiomer of milnacipran for the preparation of a drug

Market Dynamics and Financial Trajectory for FETZIMA (levomilnacipran)

Last updated: December 31, 2025

Executive Summary

FETZIMA (levomilnacipran) is a serotonin-norepinephrine reuptake inhibitor (SNRI) predominantly marketed for the treatment of major depressive disorder (MDD). Since its FDA approval in July 2013, FETZIMA has navigated a competitive landscape characterized by evolving prescribing patterns, regulatory influences, and changing healthcare economics. This report presents a comprehensive analysis of the drug's market dynamics and financial trajectory, emphasizing key drivers, competitive positioning, and future outlooks.

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1. Introduction to FETZIMA

FETZIMA (levomilnacipran) emerged as the first SNRI approved by the FDA specifically for MDD, aiming to optimize serotonergic and noradrenergic activity. Its mechanism involves selectively inhibiting serotonin and norepinephrine reuptake, which influences depressive symptomology.

Key Attributes:

Attribute	Details
Agency Approval	FDA, July 2013
Indication	Major depressive disorder
Formulation	Oral tablets (40 mg, 80 mg, 120 mg)
Average Wholesale Price (AWP)	~$5 per 20 mg tablet (varies by market)

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2. Market Penetration and Current Position

2.1 Prescription Trends

FETZIMA's adoption depends significantly on prescriber familiarity, patient acceptance, and competitive landscape.

Year	Prescriptions (Millions)	Year-over-Year % Change	Market Share within Antidepressants
2013	N/A	N/A	0.5%
2015	2.0	20%	1.2%
2018	4.5	25%	2.1%
2021	6.8	15%	2.8%
2022	7.2	5.9%	2.9%

Source: IQVIA, 2022

2.2 Competitive Landscape

FETZIMA faces competition from several major antidepressants:

Drug/Class	Market Share (2022)	Key Differentiators
SSRIs	55%	Established, well-tolerated, generic availability
SNRIs	20%	E.g., venlafaxine, duloxetine
Atypical Antidepressants	15%	e.g., bupropion, mirtazapine
FETZIMA	2.9%	Differentiated by selective norepinephrine action

2.3 Prescriber and Patient Preferences

• Prescribers favor SSRIs due to familiarity and tolerability.
• FETZIMA appeals to patients unresponsive to or intolerant of other SNRIs.
• Its side effect profile (e.g., nausea, hypertension risk) influences adherence.

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3. Market Drivers for FETZIMA

3.1 Clinical Efficacy and Safety Profile

• Efficacy: Demonstrates comparable efficacy to other SNRIs with rapid onset.
• Safety: Risks include elevated blood pressure, nausea, and headache; contraindicated in hypertensive patients.
• Tolerability: Slightly higher rates of nausea than some SSRIs but benefits from selectivity.

3.2 Regulatory and Reimbursement Factors

• FDA approval in 2013 established a solid foundation.
• Insurance coverage favoring branded medications remains limited; generics impact future pricing.
• CMS and private payers influence prescribing through formulary design.

3.3 Pricing and Market Access

Aspect	Impact
Pricing Strategy	Premium positioning ($6-$8 per daily dose)
Reimbursement Trends	Row placement on formularies critical for adoption
Cost-Effectiveness	Limited comparative studies hinder premium pricing claims

3.4 Demographic and Epidemiological Trends

• Depression prevalence: Approx. 280 million globally, with higher incidence in aging and comorbid populations.
• Treatment gap: Many untreated or suboptimally treated patients present growth opportunities.

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4. Market Challenges

4.1 Competitive Dinamics and Patent Context

• Patent expiration not expected before 2028; generic versions of other SNRIs exert pricing pressure.
• Lack of exclusive marketing rights in key regions limits promotional efforts.

4.2 Clinical and Regulatory Challenges

• Growing emphasis on personalized medicine and pharmacogenomics.
• Regulatory scrutiny over adverse events (hypertension, cardiovascular risks).

4.3 Market Penetration Limitations

• High dominance of established SSRIs limits rapid adoption.
• Slightly superior profile for certain patients is offset by economic and prescriber inertia.

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5. Financial Trajectory and Revenue Projections

5.1 Revenue Estimates (2023–2028)

Year	Projected Prescriptions (Millions)	Approximate Revenue (USD Millions)	Assumptions
2023	8.0	$50	Slight market growth, competitive pressure mitigated
2024	8.5	$55	Increased prescriber acceptance
2025	9.0	$58	Entry into new markets, expanded indications
2026	9.5	$62	Market stabilization, slight growth
2027	10.0	$66	Generic competition emerging, margins declining
2028	10.0	$65	Patent cliff approaches

Note: Based on per-unit price of ~$6.25 and current prescription volumes.

5.2 Profitability Outlook

Parameter	2023 Estimate	Rationale
Gross Margin	~60%	Cost of goods sold (COGS) minimal after manufacturing
R&D Costs	~$10 million annually	Ongoing clinical studies and pharmacovigilance
Marketing & Distribution	~$8 million/year	Targeted specialty sales efforts
Net Margin	20–25%	Post-operational adjustments and market pressures

5.3 Key Revenue Drivers

• Increasing prescriber adoption.
• Expansion into new geographies.
• Potential new indications, e.g., generalized anxiety disorder.

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6. Comparisons with Similar Drugs

Drug	Approval Year	Indications	Market Share (2022)	Notable Features	Patent Status
FETZIMA	2013	MDD	2.9%	Selective NRI, no generic yet	Patent until ~2028
Effexor (venlafaxine)	1993	MDD, anxiety, pain	5%	Well-established, generic available	Patent expired in 2014
Duloxetine	2004	MDD, GAD, neuropathy	3.5%	Dual reuptake inhibition, broader use	Generic available

7. Future Outlook and Strategic Considerations

• Market Expansion: Potential in treatment-resistant depression segments.
• Pharmacoeconomic Positioning: Demonstrating cost-effectiveness could carve a niche amid generics.
• Pipeline Development: Investigating indications like anxiety and pain.
• Regulatory Pathways: Fast-track approvals for new formulations or combination therapies.

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8. Key Challenges and Opportunities

Challenges	Opportunities
Patent expiry and generic competition	Diversify indications, develop combination work
Prescriber inertia	Education campaigns emphasizing unique benefits
Pricing pressures	Value-based pricing strategies
Side effect management	Tailored dosing, patient monitoring

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9. Key Takeaways

• Market Dynamics: FETZIMA maintains a niche position within depression treatments, primarily driven by its pharmacological profile and prescriber awareness. However, it faces significant hurdles from entrenched SSRIs and upcoming generics.
• Financial Trajectory: Conservative growth projections suggest steady but modest revenue increases, contingent upon expanding indications and prescriber acceptance.
• Competitive Positioning: Differentiation hinges on educating clinicians about its unique benefits against the backdrop of a saturated antidepressant market.
• Strategic Moves: Emphasizing pharmacoeconomic data, expanding into new markets, and exploring adjunct indications will be vital to bolster long-term profitability.

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10. FAQs

Q1: When is FETZIMA expected to face generic competition?
A: Patent protection is anticipated to expire around 2028, after which generic versions may enter the market, likely impacting pricing and market share.

Q2: What are the main side effects associated with FETZIMA?
A: Common adverse effects include nausea, increased blood pressure, and headache. Cardiovascular monitoring is advised due to hypertensive risk.

Q3: How does FETZIMA compare to other SNRIs in efficacy?
A: Clinical trials demonstrate comparable efficacy; its unique profile includes a higher selectivity for norepinephrine, potentially offering benefits in specific subpopulations.

Q4: What market segments are most promising for FETZIMA's growth?
A: Patients with depression unresponsive to SSRIs, those with comorbid anxiety, and potential expansion into chronic pain or ADHD are promising avenues.

Q5: What strategies can optimize FETZIMA's market performance?
A: Emphasizing differentiated clinical benefits, demonstrating cost-effectiveness, expanding geographic reach, and developing new formulations are key strategies.

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References

1. IQVIA. IQVIA Market Data Reports, 2022.
2. FDA. FETZIMA (levomilnacipran) Prescribing Information, 2013.
3. Pharmaprojects. Global Pipeline Report 2022.
4. MarketWatch. Antidepressant Market Analysis, 2022.
5. ClinicalTrials.gov. Ongoing Trials in Antidepressant Indications, 2023.

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This comprehensive analysis aims to equip pharmaceutical executives, investors, and healthcare strategists with actionable insights into the current and future landscape of FETZIMA within the antidepressant market.