Last Updated: August 2, 2026

LEVOMILNACIPRAN HYDROCHLORIDE Drug Patent Profile


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Which patents cover Levomilnacipran Hydrochloride, and what generic alternatives are available?

Levomilnacipran Hydrochloride is a drug marketed by Amneal Pharms Co, Aurobindo Pharma Ltd, Hikma, and Prinston Inc. and is included in four NDAs.

The generic ingredient in LEVOMILNACIPRAN HYDROCHLORIDE is levomilnacipran hydrochloride. There are eleven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the levomilnacipran hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Levomilnacipran Hydrochloride

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

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Summary for LEVOMILNACIPRAN HYDROCHLORIDE
Paragraph IV (Patent) Challenges for LEVOMILNACIPRAN HYDROCHLORIDE
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 LEVOMILNACIPRAN HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amneal Pharms Co LEVOMILNACIPRAN HYDROCHLORIDE levomilnacipran hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 210790-001 Feb 4, 2019 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Aurobindo Pharma Ltd LEVOMILNACIPRAN HYDROCHLORIDE levomilnacipran hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 210826-003 Jan 6, 2023 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Amneal Pharms Co LEVOMILNACIPRAN HYDROCHLORIDE levomilnacipran hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 210790-004 Feb 4, 2019 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Hikma LEVOMILNACIPRAN HYDROCHLORIDE levomilnacipran hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 210732-004 Nov 5, 2020 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Aurobindo Pharma Ltd LEVOMILNACIPRAN HYDROCHLORIDE levomilnacipran hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 210826-004 Jan 6, 2023 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Prinston Inc LEVOMILNACIPRAN HYDROCHLORIDE levomilnacipran hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 210771-004 Mar 20, 2023 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Prinston Inc LEVOMILNACIPRAN HYDROCHLORIDE levomilnacipran hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 210771-002 Mar 20, 2023 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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