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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Cipla
McKesson
Julphar
AstraZeneca
Chubb
Daiichi Sankyo
Cantor Fitzgerald
Covington

Generated: April 22, 2018

DrugPatentWatch Database Preview

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 Sales Llc 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 nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the levomilnacipran hydrochloride profile page.
Summary for FETZIMA
International Patents:54
US Patents:3
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 43
Clinical Trials: 5
Patent Applications: 9
Drug Prices:see details
DailyMed Link:FETZIMA at DailyMed
Drug patent expirations by year for FETZIMA
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
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)-
D02XOK
D10072
D10133
Dalcipran
DB08918
F 2695
F 2695 hydrochloride
F-2207
F-2695
f2-695
F2695
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
MFCD18433402
Midalcipran hydrochloride
Milnacipram
Milnacipran ((1S-cis) hydrochloride)
Milnacipran (1S-cis) hydrochloride
Milnacipran HCl
Milnacipran hydrochloride
Milnacipran Hydrochloride 1.0 mg/ml in Methanol (as free base)
MolPort-019-939-251
Savella
SCHEMBL1148742
SCHEMBL1414867
TN-912
Toledomin
UGM0326TXX
UNII-371U2ZK31U
UNII-G56VK1HF36 component GJJFMKBJSRMPLA-DZGCQCFKSA-N
UNII-RNZ43O5WW5 component XNCDYJFPRPDERF-NQQJLSKUSA-N
UNII-UGM0326TXX
ZINC506

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 Sales Llc FETZIMA levomilnacipran hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 204168-001 Jul 25, 2013 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Allergan Sales Llc FETZIMA levomilnacipran hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 204168-002 Jul 25, 2013 RX Yes No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Allergan Sales Llc FETZIMA levomilnacipran hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 204168-001 Jul 25, 2013 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Allergan Sales Llc FETZIMA levomilnacipran hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 204168-003 Jul 25, 2013 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
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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Paragraph IV (Patent) Challenges for FETZIMA
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Extended-release Capsules 20 mg, 40 mg, 80 mg and 120 mg ➤ Subscribe 2017-07-25

Non-Orange Book US Patents for FETZIMA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,005,452 Use of the dextrogyral enantiomer of milnacipran for the preparation of a drug ➤ Sign Up
7,074,833 Use of the (1S,2R) enantiomer of milnacipran for the preparation of a drug ➤ Sign Up
9,259,403 Crystalline forms of (1S,2R)-2-(amino methyl)-N,N-diethyl-1-phenyl cyclopropane carboxamide ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Merck
Moodys
Chinese Patent Office
Dow
US Department of Justice
Cantor Fitzgerald
McKinsey
Express Scripts
McKesson

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