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:	73
Clinical Trials:	7
Patent Applications:	44
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
Allergan	Phase 4
University of Ottawa	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		RX	Yes	No	8,481,598
Abbvie	FETZIMA	levomilnacipran hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	204168-002	Jul 25, 2013		RX	Yes	No	8,865,937		Y	Y
Abbvie	FETZIMA	levomilnacipran hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	204168-001	Jul 25, 2013		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)	2011088331
Morocco	27655	UTILISATION DE L'ENANTIOMERE (1S,2R) DU MILNACIPRAN POUR LA PREPARATION D'UN 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 (Levomilnacipran)

Overview of Fetzima

Fetzima, known generically as levomilnacipran, is a serotonin-norepinephrine reuptake inhibitor (SNRI) approved by the US Food and Drug Administration (FDA) in July 2013 for the treatment of major depressive disorder (MDD)[1][4].

Market Landscape

The market for major depressive disorder treatments is highly competitive, with over 30 marketed products available. This includes established SNRIs like Effexor (venlafaxine), Cymbalta (duloxetine), Pristiq (desvenlafaxine), and Savella (milnacipran), many of which have generic versions available[4].

Competitive Positioning

Fetzima faces significant competition due to its late market entry and lack of differentiation within the SNRI class. Despite its long patent life, it is forecast to exhibit unremarkable growth over the long term. The drug's "me-too" clinical profile compared to established SNRIs limits its market opportunity[1].

Financial Performance

Revenue Trends

In the third quarter of 2019, Fetzima, along with another Allergan product, Viibryd, generated net revenues of $105.1 million, representing an 18.8% increase from the prior year quarter[2].

For the full year 2019, the combined net revenues for Viibryd and Fetzima continued to show growth, contributing to Allergan's overall financial performance. However, the specific revenue figures for Fetzima alone are not separately disclosed in these reports[5].

Overall Financial Health of Allergan

Allergan's financial reports for 2019 indicate a mixed performance. While the company saw increases in total net revenues and non-GAAP operating income, it also reported significant operating losses and impairments. The financial health of Allergan, which acquired Forest Laboratories (the developer of Fetzima) in 2014, is crucial for the continued marketing and development of Fetzima[2][5].

Sales Forecast and Market Analysis

Sales Projections

The sales forecast for Fetzima from 2013 to 2023 was expected to be modest. Given the crowded and competitive nature of the MDD market, Fetzima's sales were not anticipated to significantly outperform other SNRIs. The imminent patent expiries of top-selling products like Cymbalta and the introduction of new pipeline products further complicated the market dynamics for Fetzima[4].

Market Analysis

The MDD market is entering a dynamic phase with several key factors influencing the sales of Fetzima:

• Patent Expiries: The expiration of patents for top-selling antidepressants opens the market to generic competition, which can impact Fetzima's market share.
• New Product Launches: The introduction of new antidepressants, such as Lundbeck/Takeda's Brintellix, adds to the competitive landscape.
• Generic Competition: The availability of cheap generic versions of established SNRIs continues to pose a significant challenge for branded products like Fetzima[4].

Safety and Efficacy Profile

Safety Concerns

Fetzima is associated with several safety concerns, including an increased risk of bone fractures, particularly in elderly patients and those with risk factors for bone fractures. Other notable side effects include sustained hypertension, increases in heart rate, and the potential for falls due to dizziness and orthostatic hypotension[3].

Efficacy

Clinical studies have shown that Fetzima is effective in providing short-term symptomatic relief for MDD. However, its efficacy profile is not significantly differentiated from other SNRIs, which limits its market appeal[1][4].

Strategic Implications

SWOT Analysis

• Strengths: Long patent life, FDA approval for MDD treatment.
• Weaknesses: Late market entry, lack of differentiation, generic competition.
• Opportunities: Potential for expanded indications, though none are currently planned.
• Threats: Competitive market, patent expiries of other products, introduction of new treatments[1][4].

Key Takeaways

• Fetzima operates in a highly competitive MDD market with limited differentiation.
• Financial performance is modest, with revenue growth but significant competition from generics.
• Safety concerns and lack of unique efficacy features hinder market dominance.
• The drug's long patent life is a positive factor, but it is not enough to drive significant growth.

FAQs

Q: What is Fetzima used for?

A: Fetzima (levomilnacipran) is used for the treatment of major depressive disorder (MDD) in the US.

Q: When was Fetzima approved by the FDA?

A: Fetzima was approved by the FDA in July 2013.

Q: What are the main safety concerns associated with Fetzima?

A: The main safety concerns include an increased risk of bone fractures, sustained hypertension, and increases in heart rate.

Q: How does Fetzima perform financially?

A: Fetzima generates modest revenues, with an 18.8% increase in the third quarter of 2019, but its growth is limited by competition and lack of differentiation.

Q: What is the competitive landscape for Fetzima?

A: The MDD market is highly competitive with over 30 marketed products, including established SNRIs and generic versions, making it challenging for Fetzima to stand out.

Sources

1. Research and Markets: Fetzima (levomilnacipran; Allergan) Drug Overview 2019.
2. PR Newswire: Allergan Reports Third Quarter 2019 Financial Results.
3. Canada's Drug Agency: FETZIMA (levomilnacipran extended-release capsules) Monograph.
4. PR Newswire: Fetzima (Major Depressive Disorder) - Forecast and Market Analysis to 2023.
5. Abbvie News: Allergan Reports Fourth Quarter and Full-Year 2019 Financial Results.