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Last Updated: March 19, 2024

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 Abbvie, Amneal Pharms Co, Aurobindo Pharma Ltd, Hikma, and Prinston Inc, and is included in five 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 ten drug master file entries for levomilnacipran hydrochloride. Two suppliers are listed for this compound.

Summary for levomilnacipran hydrochloride
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 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
Prinston Inc LEVOMILNACIPRAN HYDROCHLORIDE levomilnacipran hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 210771-004 Mar 20, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Abbvie FETZIMA levomilnacipran hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 204168-004 Jul 25, 2013 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Abbvie FETZIMA levomilnacipran hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 204168-003 Jul 25, 2013 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Hikma LEVOMILNACIPRAN HYDROCHLORIDE levomilnacipran hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 210732-001 Nov 5, 2020 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Abbvie FETZIMA levomilnacipran hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 204168-003 Jul 25, 2013 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Abbvie FETZIMA levomilnacipran hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 204168-004 Jul 25, 2013 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Prinston Inc LEVOMILNACIPRAN HYDROCHLORIDE levomilnacipran hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 210771-001 Mar 20, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for levomilnacipran hydrochloride

Country Patent Number Title Estimated Expiration
New Zealand 541733 Use of the enantiomer (1S,2R) of milnacipran for the preparation of a medicament ⤷  Try a Trial
Canada 2514948 UTILISATION DE L'ENANTIOMERE (1S, 2R) DU MILNACIPRAN POUR LAPREPARATION D'UN MEDICAMENT (USE OF THE ENANTIOMER (1S, 2R) OF MILNACIPRAN FOR THE PREPARATION OF A MEDICAMENT) ⤷  Try a Trial
Hong Kong 1115329 USE OF (1S, 2R) ENANTIOMER OF MILNACIPRAN FOR THE PREPARATION OF A MEDICINE ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2011057176 ⤷  Try a Trial
Japan 2013517290 ⤷  Try a Trial
Japan 2013510176 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2011088331 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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