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Last Updated: February 26, 2021

DrugPatentWatch Database Preview

Levomilnacipran hydrochloride - Generic Drug Details

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What are the generic drug sources for levomilnacipran hydrochloride and what is the scope of freedom to operate?

Levomilnacipran hydrochloride is the generic ingredient in two branded drugs marketed by Allergan, Amneal Pharms Co, and Hikma, and is included in three NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Levomilnacipran hydrochloride has fifty-four patent family members in twenty-seven countries.

There are eleven drug master file entries for levomilnacipran hydrochloride. Two suppliers are listed for this compound.

Recent Clinical Trials for levomilnacipran hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
AllerganPhase 3
AllerganPhase 4
University of OttawaPhase 4

See all levomilnacipran hydrochloride clinical trials

Pharmacology for levomilnacipran hydrochloride
Paragraph IV (Patent) Challenges for LEVOMILNACIPRAN HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
FETZIMA CAPSULE, EXTENDED RELEASE;ORAL levomilnacipran hydrochloride 204168 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
Allergan FETZIMA levomilnacipran hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 204168-001 Jul 25, 2013 AB RX Yes No   Start Trial   Start Trial   Start Trial
Amneal Pharms Co LEVOMILNACIPRAN HYDROCHLORIDE levomilnacipran hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 210790-003 Feb 4, 2019 DISCN No No   Start Trial   Start Trial   Start Trial
Allergan FETZIMA levomilnacipran hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 204168-003 Jul 25, 2013 AB RX Yes 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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Serving leading biopharmaceutical companies globally:

Merck
McKinsey
AstraZeneca
McKesson
Dow
Boehringer Ingelheim

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