Fetzima Generic: When Will Generic Levomilnacipran Be Available?

Dr. Brian Staiger, PharmD, BCPS

This page is aggregated from FDA records, court filings and company announcements. Coded and designed by

Updated October 9, 2026 How we build our data

Fetzima Generic at a Glance

Four quick answers from FDA records and our estimate.

  1. When is the first generic expected? 2029 to 2030 A wide window Why then?
  2. Has the FDA approved a generic? February 2019 1 company approved
  3. When does the last patent end? May 2032 3 patents listed with the FDA Why is a generic expected sooner?
  4. Can you buy a generic today? Yes 1 company lists one

Explains

PharmD, BCPS · Clinical pharmacist Updated

It already is. A generic levomilnacipran hydrochloride is listed for sale by 1 company, so ask your pharmacy whether it can fill your prescription with one.

Why 2029 to 2030?

The brand company and a generic maker settled their patent fight and agreed on when a generic can launch. We rate it probable: more likely than not, but it can still move.

If Fetzima’s last patent runs to May 2032, how can a generic come sooner?

The 2 patents that run past the expected month, to May 2032 (8,481,598 and 8,865,937), cover a way of using it, the active ingredient and the product’s formulation. A generic can still come sooner if a court rules a patent invalid or not infringed, or if the companies settle on an earlier date. Here, a settlement between the companies sets the date. Generic companies have been challenging Fetzima’s patents with the FDA since July 2017. That is why the expected month comes before the last protection ends. See the road to a generic

What should I do now?

Ask your pharmacy whether it can fill your prescription with a generic. It may look different from Fetzima, but the active ingredient, strength and form are the same. What a generic means for you

Our month is only an estimate based on available information, so we never name a day.

Fetzima by the Numbers

Reason
Settlement between companiesThe brand company and a generic maker settled their patent fight and agreed on when a generic can launch.
How sure
Probable More likely than not, but it can still move.
Price competition
Very strong 8 companies have filed, 7 first in line
Brand sales
$74M a yearSmaller seller
  • FDA approved 2013 July 2013 FDA Orange Book
  • Patents listed 3 last runs to May 2032 FDA Orange Book
  • Generics FDA-approved 1 company, approved February 2019 FDA Orange Book
  • Pharmacies pay $17.61 each, up 9.2% in a year NADAC, October 2026
  • Medicare Part D spent $26.3M in 2025, for 5,584 people CMS Part D Spending by Drug
  • Medicaid prescriptions 17.8K in the last four reported quarters, $10.1M CMS Medicaid drug utilization, to Q1 2026

Fetzima’s Road to a Generic

Fetzima has had the market to itself since the FDA approved it in July 2013 (Abbvie Inc). Its FDA protections on record ended by March 2026. Its 3 listed patents run to May 2032 (1 already expired). Generic companies have challenged its patents with the FDA since July 2017.

The first generic of Fetzima is expected between 2029 and 2030.

Why that month: the brand company and a generic maker settled their patent fight and agreed on when a generic can launch.

Brand alone on the market Since FDA approval, July 2013
New clinical information Ended March 2026
Patent RE43879 Expired January 2026
Patent 8,481,598 Expires March 2031
Patent 8,865,937 Expires May 2032
Brand alone on the market FDA exclusivity Patent on the active ingredient Patent on a use First generic expected Swipe the chart sideways to see every year.

Why a Generic Can Come Before May 2032

The last listed patent runs to May 2032; a court ruling or a settlement can bring a generic sooner. Dr. Brian explains

Each bar runs from the brand’s approval to the day that protection ends. The green band is our projection for the first generic: a month, never a day, because legal dates move and a generic reaches shelves days to weeks after it is allowed. Sources: FDA Orange Book; the expected month from court records and company announcements.

Fetzima Patents and FDA Protections

Every patent and exclusivity the FDA Orange Book lists for Fetzima’s own applications. A protection running past the expected month does not mean the date is wrong: a settlement or a court ruling can let a generic in before a patent ends, and a patent on one formulation or use does not block every generic.

Patents listed with the FDA (3)
PatentWhat it coversProtects untilStatus
RE43879 A way of using it (U-839) January 2026 Expired
8,481,598 A way of using it (U-839) March 2031 Active
8,865,937 The active ingredient; the product’s formulation May 2032 Active
FDA exclusivities (1)
ExclusivityWhat it meansEndsStatus
New clinical information M-304Three years of protection for a change backed by new clinical studies.March 2026Ended

Source: FDA Orange Book, application 204168. Patent numbers open the patent on Google Patents.

Patent Challenges to Fetzima

The first patent challenge to Fetzima reached the FDA in July 2017, from 6 companies on that first day. The FDA approved a first challenger’s generic in February 2019, and the list records no sale by a first challenger yet.

What Is a Patent Challenge?

A generic company that wants to sell its version before Fetzima’s patents run out can tell the FDA that a patent is invalid, or that its version does not infringe it. The FDA calls this a “Paragraph IV certification.” The brand company usually sues, and the FDA then generally cannot approve that generic for up to 30 months while the case runs. To reward going first, the companies that challenge first can get a 180-day head start: the FDA cannot approve the generics that came after them until it ends.

Patent challenges on the FDA’s list (1)
ProductFirst challengedCompanies that day180-day head startFirst challenger’s genericChallenged patents run to
ApprovedOn sale
Extended-release capsules, 20 mg, 40 mg, 80 mg and 120 mg July 2017 6 companies First challenger eligible decided May 2020 February 2019 Not yet March 2031

Source: the FDA’s Paragraph IV Patent Certifications list, as of September 2026. The FDA began posting the 180-day decisions and the first challenger’s approval and first sale in June 2019: an older entry it has not updated since reads “Not posted”, and “Not yet” means the list records no such event. “Companies that day” is the FDA’s count of challenges that arrived on the first day.

Who Is Lined Up to Make Generic Levomilnacipran Hydrochloride

Three steps stand between a brand and a generic you can buy: a company applies to the FDA, the FDA approves it, and the company starts selling it.

1

Applied to the FDA

8 companies have applied to the FDA to make generic levomilnacipran hydrochloride.

The FDA keeps the other applications private until it acts on them, so those companies are not named here.

First in line. 7 of them were first in line, all filing on the first day any company did: they can share 180 days on the market before the other generics, which is why being first matters.

Generic companies have challenged Fetzima’s patents with the FDA since July 2017: see the patent challenges.

2

Approved by the FDA

The FDA has approved generic versions from 1 company, the first in February 2019. Approved is not the same as on sale: patents, a settlement or the company’s own plans can still hold a launch.

3

For Sale in Pharmacies

Yes. A generic levomilnacipran hydrochloride is listed for sale by 1 company. Ask your pharmacy whether it can fill your prescription with it.

Amneal Pharmaceuticals LLC

Generic versions the FDA has approved (4 companies)
CompanyFirst approvedStrengthsRated
Prinston Pharmaceutical Inc March 2023EQ 20MG BASE, EQ 40MG BASE, EQ 80MG BASE, EQ 120MG BASEAB
Amneal Pharmaceuticals Co GmbH discontinued February 2019EQ 20MG BASE, EQ 40MG BASE, EQ 80MG BASE, EQ 120MG BASE–
Hikma Pharmaceuticals USA Inc discontinued November 2020EQ 20MG BASE, EQ 40MG BASE, EQ 80MG BASE, EQ 120MG BASE–
Aurobindo Pharma Ltd discontinued January 2023EQ 20MG BASE, EQ 40MG BASE, EQ 80MG BASE, EQ 120MG BASE–

Sources: how many companies have applied, from court records and company announcements; approved generics from the FDA Orange Book; tentative approvals from Drugs@FDA; what is for sale from the FDA NDC Directory. The FDA does not disclose an application before it approves it (21 CFR 314.430).

Fetzima Price: What Pharmacies Pay and What Generics Usually Do

What Pharmacies Pay for Fetzima 20-40 mg titration pak

$17.61 each in October 2026, up 9.2% from a year earlier.

Hover over or tap anywhere on the chart to see that month’s price.

  • Fetzima 20-40 mg titration pak $17.61 each
  • Fetzima ER 20 mg capsule $17.60 per capsule
  • Fetzima ER 40 mg capsule $17.61 per capsule
  • Fetzima ER 80 mg capsule $17.59 per capsule
  • Fetzima ER 120 mg capsule $17.59 per capsule
See the numbers
MonthPharmacies paid each
October 2026$17.61
September 2026$17.61
August 2026$17.61
July 2026$17.61
June 2026$17.61
May 2026$17.61
April 2026$17.61
March 2026$17.61
February 2026$17.61
January 2026$17.61
February 2024$16.13
January 2024$16.13

NADAC: the national average price retail pharmacies pay to buy the medicine (CMS survey, updated weekly), the last price of each month for one package. It is not what you pay: that depends on your insurance or discount card.

What a Generic Could Cost

What Pharmacies Pay for Fetzima Today$17.61each · October 2026
Our Estimate for Generic Fetzimaunder $0.88each, once generics reach pharmacies, over 95% less than today

How we estimate it. We start from what pharmacies pay for Fetzima today: $17.61 each for Fetzima 20-40 mg titration pak in October 2026, from the national NADAC survey. Then we apply the FDA’s finding of how far that price usually falls as generic companies join: about 31% with one company, 44% with two, 73% with four and over 95% with six or more (the typical drop for every drug whose first generic came out from 2015 to 2017). Fetzima has 8 companies lined up, so our estimate uses the figure for six or more companies. More companies would bring the price lower; fewer, less of a drop.

Dollar figures apply FDA’s median drops to the $17.61 pharmacies pay each today. An estimate from the pattern, not a price quote: what you pay depends on your insurance or discount card.

Median prices pharmacies paid for the generic (invoice prices), compared with the brand’s price before generic entry, from FDA’s 2019 analysis “Generic Competition and Drug Prices”. At the manufacturer’s price FDA found steeper drops (about 39%, 54%, 79% and over 95%), the figures quoted elsewhere on this tracker. A typical pattern, not a price quote for this medicine.

What Medicare and Medicaid Spend on Fetzima

Big public spending is part of why generic makers line up for a medicine, and why its first generic matters beyond the pharmacy counter. Figures are before manufacturer rebates, which are confidential.

Medicare Part D Spending

What Medicare drug plans spent on Fetzima, before manufacturer rebates.

$6.5M
January to March 2026, the latest CMS has posted
For 3,999 people, about $698 per prescription fill
$26.3M
2025, the whole year
For 5,584 people, about $666 per prescription fill
See the numbers
PeriodSpendingPeoplePer fill
January to March 2026$6,455,8793,999$697.93
2025$26,257,3915,584$665.99

Source: CMS Medicare Part D Spending by Drug, matched by the brand name Fetzima only, so no generic is counted in it. What CMS says it is used for: This medication is used to treat depression. Levomilnacipran belongs to a class of drugs known as serotonin-norepinephrine reuptake inhibitors (SNRIs).

Medicaid Prescriptions by Quarter

17,828 prescriptions in the four quarters to Q1 2026, $10.1M paid.

See the numbers
QuarterPrescriptionsMedicaid paid
Q1 20263,963$2,338,251
Q4 20254,496$2,533,285
Q3 20254,734$2,643,965
Q2 20254,635$2,597,104
Q1 20254,622$2,625,100

Source: CMS Medicaid State Drug Utilization Data, over Fetzima’s own package codes.

Fetzima Strengths and Forms

StrengthFormHow it is takenApprovedStatus
EQ 120MG BASECapsule, extended releaseOralJuly 2013Prescription reference product
EQ 20MG BASECapsule, extended releaseOralJuly 2013Prescription reference product
EQ 40MG BASECapsule, extended releaseOralJuly 2013Prescription reference product
EQ 80MG BASECapsule, extended releaseOralJuly 2013Prescription reference product

Source: FDA Orange Book, Abbvie Inc. Listed for sale today by Allergan, Inc. (FDA NDC Directory).

Fetzima NDC Codes and Packages

Each Fetzima package sold today has its own NDC, the product number printed on the box and on the pharmacy label. Open one to see that package’s details, what pharmacies pay for it and its patent timeline.

Fetzima packages (20)
NDCProductPackageCompany
00456-2212-30LEVOMILNACIPRAN HYDROCHLORIDE 120 mg/1 capsule, extended releasebottle of 30 capsulesAllergan, Inc.
00456-2212-30LEVOMILNACIPRAN HYDROCHLORIDE 120 mg/1 capsule, extended releasebottle of 30 capsulesAllergan, Inc.
00456-2212-90LEVOMILNACIPRAN HYDROCHLORIDE 120 mg/1 capsule, extended releasebottle of 90 capsulesAllergan, Inc.
00456-2212-90LEVOMILNACIPRAN HYDROCHLORIDE 120 mg/1 capsule, extended releasebottle of 90 capsulesAllergan, Inc.
00456-2220-07LEVOMILNACIPRAN HYDROCHLORIDE 20 mg/1 capsule, extended releasebottle of 40 capsulesAllergan, Inc.
00456-2220-07LEVOMILNACIPRAN HYDROCHLORIDE 20 mg/1 capsule, extended releasebottle of 40 capsulesAllergan, Inc.
00456-2220-30LEVOMILNACIPRAN HYDROCHLORIDE 20 mg/1 capsule, extended releasebottle of 30 capsulesAllergan, Inc.
00456-2220-30LEVOMILNACIPRAN HYDROCHLORIDE 20 mg/1 capsule, extended releasebottle of 30 capsulesAllergan, Inc.
Show the other 12 Fetzima packages
NDCProductPackageCompany
00456-2240-30LEVOMILNACIPRAN HYDROCHLORIDE 40 mg/1 capsule, extended releasebottle of 30 capsulesAllergan, Inc.
00456-2240-30LEVOMILNACIPRAN HYDROCHLORIDE 40 mg/1 capsule, extended releasebottle of 30 capsulesAllergan, Inc.
00456-2240-90LEVOMILNACIPRAN HYDROCHLORIDE 40 mg/1 capsule, extended releasebottle of 90 capsulesAllergan, Inc.
00456-2240-90LEVOMILNACIPRAN HYDROCHLORIDE 40 mg/1 capsule, extended releasebottle of 90 capsulesAllergan, Inc.
00456-2280-30LEVOMILNACIPRAN HYDROCHLORIDE 80 mg/1 capsule, extended releasebottle of 30 capsulesAllergan, Inc.
00456-2280-30LEVOMILNACIPRAN HYDROCHLORIDE 80 mg/1 capsule, extended releasebottle of 30 capsulesAllergan, Inc.
00456-2280-90LEVOMILNACIPRAN HYDROCHLORIDE 80 mg/1 capsule, extended releasebottle of 90 capsulesAllergan, Inc.
00456-2280-90LEVOMILNACIPRAN HYDROCHLORIDE 80 mg/1 capsule, extended releasebottle of 90 capsulesAllergan, Inc.
00456-2200-07kit1 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK * 2 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK * 5 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACKAllergan, Inc.
00456-2200-07kit1 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK * 2 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK * 5 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACKAllergan, Inc.
00456-2202-28kitblister pack of 1 kitAllergan, Inc.
00456-2202-28kitblister pack of 1 kitAllergan, Inc.

Source: the FDA NDC Directory, current listings only. Only packages sold under Fetzima’s own FDA approval (NDA 204168) are listed, never a generic. Some codes belong to companies that repackage Fetzima: it is the same medicine in a different package.

What a Generic Fetzima Means for You

Nothing Changes Until It Is in Pharmacies

A generic is listed for sale now, so your pharmacy may already be able to fill your prescription with it.

Your Pharmacy May Switch You Automatically

Every state lets pharmacists fill a brand-name prescription with an FDA-approved generic rated as equivalent to it, and about 19 states require them to, unless your prescriber writes “dispense as written” or “brand medically necessary” on the prescription. Some states ask the pharmacist to tell you, or to get your OK first. A study of every state’s law has the details.

It Will Probably Look Different

US trademark law does not let a generic look exactly like the brand, so the color, shape or markings usually change. The active ingredient, strength and form are the same. An “authorized generic,” made by or for the brand’s own company, can look identical. The FDA explains.

Your Insurance May Change Too

Once a lower-cost version is available, many insurance plans charge more for the brand, or stop covering it. Your plan’s drug list (formulary) says how.

Questions people ask about Fetzima

Is there a generic for Fetzima right now?

Yes. The FDA NDC Directory lists a generic levomilnacipran hydrochloride from 1 company. Ask your pharmacy whether it can fill your prescription with it.

When will Fetzima go generic?

It already has. The FDA NDC Directory lists a generic levomilnacipran hydrochloride from 1 company, so ask your pharmacy whether it can fill your prescription with one.

Will generic levomilnacipran hydrochloride be the same as Fetzima?

Yes in the ways that matter: the same active ingredient, strength and form, with proof that it reaches your blood the same way. Inactive ingredients can differ, which is why some people notice a different look or taste.

How much will the generic cost?

Nobody can say for sure before launch. 8 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid over 95% less once six or more companies sold a generic, which would take the $17.61 pharmacies pay each for Fetzima today to under $0.88. That is a pattern from past launches, not a prediction for this one.

Has the FDA approved a generic Fetzima?

Yes. The FDA Orange Book lists approved generic versions from 1 company, the first approved in February 2019: Prinston Pharmaceutical Inc. Approved is not the same as on sale: patents, a settlement or the company’s own plans can still hold a launch.

When does the Fetzima patent expire?

The FDA Orange Book lists 3 patents for Fetzima; the last runs to May 2032. A patent date is not the launch date: settlements and court rulings often bring a generic earlier, and FDA approval or a company’s own plans can make it later. The expected window on this page (2029 to 2030) weighs all of that.

Has anyone challenged the Fetzima patents?

Yes. The first patent challenge to Fetzima reached the FDA in July 2017, from 6 companies on that first day. The FDA approved a first challenger’s generic in February 2019, and the list records no sale by a first challenger yet. A patent challenge (a “Paragraph IV certification”) is a generic company telling the FDA that a patent listed for the brand is invalid or will not be infringed by its version. The first companies to file one can earn a 180-day head start, during which the FDA cannot approve the generics that filed after them.

How much does Fetzima cost now?

Pharmacies paid about $17.61 each for Fetzima 20-40 mg titration pak in October 2026, by the national survey of what pharmacies pay (NADAC). That is the pharmacy’s cost, not your price: what you pay depends on your insurance or discount card.

Changes to This Projection

  • First generic expected 2029 to 2030 on this month’s schedule. A line is added here whenever a monthly update moves the month, the reason or how sure it is.

Every change to the expected month is logged here with the month we saw it.

Also Going Generic

All upcoming generics

About Fetzima

Sources. The expected month: FDA Paragraph IV Patent Certifications list, federal court records, company announcements and securities filings (settlement dates, launch plans, sales). The record on this page: FDA Orange Book, Drugs@FDA (tentative approvals), FDA NDC Directory, FDA Paragraph IV Patent Certifications list, NADAC (CMS), CMS Medicare Part D Spending by Drug, Medicaid State Drug Utilization Data, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.