Is there a generic for Levomilnacipran hydrochloride?

Yes. The FDA Orange Book lists 4 approved generic (ANDA) applications for Levomilnacipran hydrochloride, referencing the brand FETZIMA. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Levomilnacipran hydrochloride?

FETZIMA (NDA 204168, ABBVIE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Levomilnacipran hydrochloride?

The Orange Book lists 3 patents against Levomilnacipran hydrochloride products, with the earliest listed expiry in 2026. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Does Levomilnacipran hydrochloride have FDA marketing exclusivity?

Yes. The Orange Book records 4 marketing-exclusivity periods for Levomilnacipran hydrochloride. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

What dosage forms of Levomilnacipran hydrochloride are approved?

Levomilnacipran hydrochloride is approved in the following dosage form: capsule, extended release.

FDA Orange Book · active-ingredient family

Levomilnacipran hydrochloride

Levomilnacipran hydrochloride: 1 brand, 4 generics; first approved Jul 25, 2013; generic available.

Generic available4 exclusivity periodsHas discontinued products

Generic status & protection

Generic available — 4 ANDA applications approved.

Earliest patent expiry Jan 11, 2026Latest exclusivity ends Mar 24, 2026

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Jan 11, 2026

6 mo ago

Originator applications

Brand (NDA) products

FETZIMARLD

ABBVIENDA 20416820134 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 20MG BASE	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB
EQ 40MG BASE	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB
EQ 80MG BASE	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB
EQ 120MG BASE	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB

Abbreviated applications

Generic (ANDA) products (4)

LEVOMILNACIPRAN HYDROCHLORIDE

PRINSTON INCANDA 21077120234 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 20MG BASE	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB
EQ 40MG BASE	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB
EQ 80MG BASE	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB
EQ 120MG BASE	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB

LEVOMILNACIPRAN HYDROCHLORIDE

AUROBINDO PHARMA LTDANDA 21082620234 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 20MG BASE	CAPSULE, EXTENDED RELEASE	ORAL	Discontinued	—
EQ 40MG BASE	CAPSULE, EXTENDED RELEASE	ORAL	Discontinued	—
EQ 80MG BASE	CAPSULE, EXTENDED RELEASE	ORAL	Discontinued	—
EQ 120MG BASE	CAPSULE, EXTENDED RELEASE	ORAL	Discontinued	—

LEVOMILNACIPRAN HYDROCHLORIDE

HIKMAANDA 21073220204 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 20MG BASE	CAPSULE, EXTENDED RELEASE	ORAL	Discontinued	—
EQ 40MG BASE	CAPSULE, EXTENDED RELEASE	ORAL	Discontinued	—
EQ 80MG BASE	CAPSULE, EXTENDED RELEASE	ORAL	Discontinued	—
EQ 120MG BASE	CAPSULE, EXTENDED RELEASE	ORAL	Discontinued	—

LEVOMILNACIPRAN HYDROCHLORIDE

AMNEAL PHARMS COANDA 21079020194 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 20MG BASE	CAPSULE, EXTENDED RELEASE	ORAL	Discontinued	—
EQ 40MG BASE	CAPSULE, EXTENDED RELEASE	ORAL	Discontinued	—
EQ 80MG BASE	CAPSULE, EXTENDED RELEASE	ORAL	Discontinued	—
EQ 120MG BASE	CAPSULE, EXTENDED RELEASE	ORAL	Discontinued	—

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

Hatch-Waxman

Marketing exclusivity

Marketing exclusivity (4)

M-304New use / labeling-change exclusivity (3 years)
Mar 24, 2026
4 mo ago
M-304New use / labeling-change exclusivity (3 years)
Mar 24, 2026
4 mo ago
M-304New use / labeling-change exclusivity (3 years)
Mar 24, 2026
4 mo ago
M-304New use / labeling-change exclusivity (3 years)
Mar 24, 2026
4 mo ago

Orange Book patent file

Listed patents

Listed patents (3)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
RE43879	Jan 11, 2026	6 mo ago	U-839
8481598	Mar 02, 2031	in 4 yr 9 mo	U-839
8865937	May 23, 2032	in 5 yr 11 mo	SubstanceProduct

FDA approval span

Approval history

First approval

Jul 25, 2013

13 yr 2 mo ago

Most recent approval

Mar 20, 2023

3 yr 4 mo ago

Approvals span 2013–2023 across 5 FDA applications.

Brand (NDA) 120%

Generic (ANDA) 480%

Levomilnacipran hydrochloride — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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