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Last Updated: January 24, 2020

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FETZIMA Drug Profile

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Which patents cover Fetzima, and when can generic versions of Fetzima launch?

Fetzima is a drug marketed by Allergan and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-four patent family members in twenty-seven countries.

The generic ingredient in FETZIMA is levomilnacipran hydrochloride. There are eleven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the levomilnacipran hydrochloride profile page.

US ANDA Litigation and Generic Entry Outlook for Fetzima

Fetzima was eligible for patent challenges on December 31, 1968.

There have been eight patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for FETZIMA
Drug Prices for FETZIMA

See drug prices for FETZIMA

Recent Clinical Trials for FETZIMA

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

SponsorPhase
AllerganPhase 4
University of OttawaPhase 4
University of California, Los AngelesPhase 3

See all FETZIMA clinical trials

Recent Litigation for FETZIMA

Identify potential future generic entrants

District Court Litigation
Case NameDate
ALLERGAN SALES, LLC v. MICRO LABS LTD.2019-04-12
FOREST LABORATORIES, LLC v. AMNEAL PHARMACEUTICALS LLC2017-11-15
FOREST LABORATORIES, LLC v. AUROBINDO PHARMA USA, INC.2017-11-15

See all FETZIMA litigation

Synonyms for FETZIMA
(+)-(1S,2R)-MILNACIPRAN
(+)-Milnacipran
(1R,2S)-rel-2-(Aminomethyl)-N,N-diethyl-1-phenylcyclopropanecarboxamide hydrochloride
(1R,2S)-rel-2-(Aminomethyl)-N,N-diethyl-1-phenylcyclopropanecarboxamide monohydrochloride
(1S-cis)-Milnacipran Hydrochloride
(1S,2R)-2-(aminomethyl)-N,N-diethyl-1-phenylcyclopropane-1-carboxamide
(1S,2R)-2-(aminomethyl)-N,N-diethyl-1-phenylcyclopropane-1-carboxamide hydrochloride
(1S,2R)-2-(aminomethyl)-N,N-diethyl-1-phenylcyclopropane-1-carboxamide;hydrochloride
(1S,2R)-2-(aminomethyl)-N,N-diethyl-1-phenylcyclopropanecarboxamide
(1S,2R)-2-(Aminomethyl)-N,N-diethyl-1-phenylcyclopropanecarboxamide Hydrochloride
(1S,2R)-2-Aminomethyl-1-phenyl-cyclopropanecarboxylic acid diethylamide
(1S,2R)-milnacipran
(1S,2R)-Milnacipran Hydrochloride
101152-94-7
152M947
175131-60-9
371U2ZK31U
96847-54-0
96847-55-1
AC1OCEN6
AC1OCEN8
AK481450
AKOS025311514
API0003393
AS-12868
AT-28508
BDBM50032379
C15H22N2O.HCl
CCG-231710
CHEBI:136040
CHEMBL2105732
CHEMBL99946
cis-(+)-Milnacipran Hydrochloride
cis-2-(Aminomethyl)-N,N-diethyl-1-phenylcyclopropanecarboxamide Hydrochloride
CS-4972
Cyclopropanecarboxamide, 2-(aminomethyl)-N,N-diethyl-1-phenyl-, (1S,2R)-
D10072
D10133
Dalcipran
DB08918
F 2695
F 2695 hydrochloride
F-2207
F-2695
f2-695
Fetzima (TN)
GJJFMKBJSRMPLA-DZGCQCFKSA-N
GTPL7435
HY-B0168B
Ixel
J10386
Joncia
K-0218
Levomilnacipran
Levomilnacipran (USAN/INN)
Levomilnacipran [USAN:INN]
Levomilnacipran HCl
LEVOMILNACIPRAN HYDROCHLORIDE
Levomilnacipran hydrochloride (USAN)
Levomilnacipran hydrochloride [USAN]
M2133
MFCD00901293
Midalcipran hydrochloride
Milnacipram
Milnacipran ((1S-cis) hydrochloride)
Milnacipran HCl
Milnacipran hydrochloride
Milnacipran Hydrochloride 1.0 mg/ml in Methanol (as free base)
MolPort-019-939-251
rac-Milnacipran Hydrochloride
Savella
SB17447
SB17448
SCHEMBL1148742
SCHEMBL1414867
TN-912
Toledomin
UGM0326TXX
UNII-371U2ZK31U
UNII-G56VK1HF36 component GJJFMKBJSRMPLA-DZGCQCFKSA-N
UNII-RNZ43O5WW5 component XNCDYJFPRPDERF-NQQJLSKUSA-N
UNII-UGM0326TXX
ZINC506
Paragraph IV (Patent) Challenges for FETZIMA
Tradename Dosage Ingredient NDA Submissiondate
FETZIMA CAPSULE, EXTENDED RELEASE;ORAL levomilnacipran hydrochloride 204168 2017-07-25

US Patents and Regulatory Information for FETZIMA

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 RX Yes No   Start Trial   Start Trial   Start Trial
Allergan FETZIMA levomilnacipran hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 204168-002 Jul 25, 2013 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Allergan FETZIMA levomilnacipran hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 204168-001 Jul 25, 2013 RX Yes No   Start Trial   Start Trial   Start Trial
Allergan FETZIMA levomilnacipran hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 204168-003 Jul 25, 2013 RX Yes No   Start Trial   Start Trial   Start Trial
Allergan FETZIMA levomilnacipran hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 204168-002 Jul 25, 2013 RX Yes No   Start Trial   Start Trial   Start Trial
Allergan FETZIMA levomilnacipran hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 204168-004 Jul 25, 2013 RX Yes Yes   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:

Baxter
Johnson and Johnson
Express Scripts
Dow
Mallinckrodt
McKesson

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