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Last Updated: October 15, 2019

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Milnacipran hydrochloride - Generic Drug Details

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

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

Milnacipran hydrochloride has forty-eight patent family members in twenty-six countries.

There are twenty-eight drug master file entries for milnacipran hydrochloride. Five suppliers are listed for this compound. There are four tentative approvals for this compound.

Recent Clinical Trials for milnacipran hydrochloride

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

SponsorPhase
Yousra Hisham Abdel FattahN/A
University of OttawaPhase 4
AllerganPhase 4

See all milnacipran hydrochloride clinical trials

Recent Litigation for milnacipran hydrochloride

Identify potential future generic entrants

District Court Litigation
Case NameDate
FOREST LABORATORIES HOLDINGS, LTD. v. STRIDES PHARMA GLOBAL PTE LIMITED2017-10-06
Forest Laboratories Holdings, Ltd. v. Strides Pharma Global PTE Limited2017-10-05
Forest Laboratories Inc. v. Lupin Limited2013-09-23

See all milnacipran hydrochloride litigation

Generic filers with tentative approvals for MILNACIPRAN HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  See Pricing  See Pricing100MGTABLET;ORAL
  See Pricing  See Pricing50MGTABLET;ORAL
  See Pricing  See Pricing25MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for milnacipran hydrochloride
Synonyms for milnacipran hydrochloride
(+-)-cis-2-Aminomethyl-N,N-diethyl-1-phenylcyclopropanecarboxamide hydrochloride
(1R-cis)-Milnacipran Hydrochloride
(1R,2S)-2-(aminomethyl)-N,N-diethyl-1-phenyl-cyclopropanecarboxamide hydrochloride
(1R,2S)-2-(aminomethyl)-N,N-diethyl-1-phenylcyclopropane-1-carboxamide hydrochloride
(1R,2S)-2-(Aminomethyl)-N,N-diethyl-1-phenylcyclopropanecarboxamide Hydrochloride
(1R,2S)-rel-2-(Aminomethyl)-N,N-diethyl-1-phenylcyclopropanecarboxamide hydrochloride
(1R,2S)-rel-2-(Aminomethyl)-N,N-diethyl-1-phenylcyclopropanecarboxamide monohydrochloride
(1R,2S)-rel-2-(Aminomethyl)-N,N-diethyl-1-phenylcyclopropanecarboxamide monohydrochloride; F 2207; Midalcipran; Toledomin
(1RS,2SR)-2-(aminomethyl)-N,N-diethyl-1-phenylcyclopropanecarboxamide hydrochloride
(1S-cis)-Milnacipran Hydrochloride
(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 Hydrochloride
(1S,2R)-Milnacipran Hydrochloride
(Z)-2-(Aminomethyl)-N,N-diethyl-1-phenylcyclopropanecarboxamide hydrochloride
1-Phenyl-1-(diethylaminocarbonyl)-2-(aminomethyl)cyclopropane hydrochloride
1-phenyl-1-diethyl-amino-carbonyl-2-aminomethylcyclopropane hydrochloride
101152-94-7
105310-47-2
1159813-27-0
152M947
175131-60-9
175131-61-0
2-(aminomethyl)-N,N-diethyl-1-phenyl-1-cyclopropanecarboxamide hydrochloride
2-(aminomethyl)-N,N-diethyl-1-phenyl-cyclopropane-1-carboxamide hydrochloride
2-(aminomethyl)-N,N-diethyl-1-phenylcyclopropanecarboxamide hydrochloride
371U2ZK31U
4CH-002025
86181-08-0
A800340
AB0097998
AB0108218
AB1004578
AC-1532
AC1L4TFV
AC1OCEN6
ACT02608
AK481450
AKOS015950801
AKOS025311514
AKOS025401404
AN-14832
ANW-43127
AOB6178
API0003393
AS-12868
AT-28508
BC219330
BCP05817
C15H22N2O.HCl
CAS-101152-94-7
CCG-101034
CCG-213316
CCG-231710
CHEBI:31854
CHEMBL1237129
CHEMBL2105732
cis-(-)-Milnacipran Hydrochloride
cis-(+-)-2-(Aminomethyl)-N,N-diethyl-1-phenylcyclopropanecarboxamide monohydrochloride
cis-(+)-Milnacipran Hydrochloride
cis-2-(Aminomethyl)-N,N-diethyl-1-phenylcyclopropanecarboxamide Hydrochloride
CPD000449266
CS-2010
CS-4972
CTK8B3761
Cyclopropanecarboxamide, 2-(aminomethyl)-N,N-diethyl-1-phenyl-, (Z)-, monohydrochloride
Cyclopropanecarboxamide, 2-(aminomethyl)-N,N-diethyl-1-phenyl-, hydrochloride (1:1), (1R,2S)-rel-
Cyclopropanecarboxamide, 2-(aminomethyl)-N,N-diethyl-1-phenyl-, monohydrochloride, (1R,2S)-rel-
Cyclopropanecarboxamide, 2-(aminomethyl)-N,N-diethyl-1-phenyl-, monohydrochloride, cis-(+-)-
D01107
D10133
Dalcipran
DSSTox_CID_26785
DSSTox_GSID_46785
DSSTox_RID_81903
DTXSID4046785
F 2207
F 2695 hydrochloride
F-2207
F2207
Fetzima
Fetzima (TN)
HY-B0168A
HY-B0168B
Ixel
J-011063
J10386
Joncia
K-0218
KS-00000XLX
KS-1274
Levomilnacipran HCl
LEVOMILNACIPRAN HYDROCHLORIDE
Levomilnacipran hydrochloride (USAN)
Levomilnacipran hydrochloride [USAN]
LS-58540
LS-58541
M2133
MFCD00901293
MFCD00901293 (97%)
Midalcipran hydrochloride
Milnacipran ((1S-cis) hydrochloride)
Milnacipran (hydrochloride)
Milnacipran HCl
Milnacipran hydrochloride (JAN/USAN)
Milnacipran hydrochloride [USAN]
Milnacipran Hydrochloride 1.0 mg/ml in Methanol (as free base)
Milnacipran hydrochloride solution, 1.0 mg/mL in methanol (as free base), ampule of 1 mL, certified reference material
Milnacipran hydrochloride, >=98% (HPLC), solid
MLS000758229
MLS001424149
MolPort-005-940-369
MolPort-006-666-270
MolPort-019-939-251
NC00284
NCGC00168780-01
NSC-759806
NSC759806
Pharmakon1600-01504815
QC-10074
rac-Milnacipran Hydrochloride
RTR-000332
s3140
SAM001247035
Savella
Savella (TN)
SB17448
SC-15864
SCHEMBL1148742
SCHEMBL1156056
SCHEMBL161558
SMR000449266
SW197664-2
SY069684
TN-912
Toledomin
Toledomin (TN)
Tox21_112641
TR-000332
UNII-371U2ZK31U
UNII-RNZ43O5WW5 component XNCDYJFPRPDERF-NQQJLSKUSA-N
UNII-RNZ43O5WW5 component XNCDYJFPRPDERF-PBCQUBLHSA-N
Z-2 Aminomethyl-1-phenyl-N,N-diethylcyclopropane-carboxamide hydrochloride

US Patents and Regulatory Information for milnacipran 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 MILNACIPRAN HYDROCHLORIDE milnacipran hydrochloride TABLET;ORAL 205081-003 Apr 22, 2016 DISCN No No   See Pricing   See Pricing   See Pricing
Allergan Sales Llc SAVELLA milnacipran hydrochloride TABLET;ORAL 022256-002 Jan 14, 2009 RX Yes No   See Pricing   See Pricing   See Pricing
Allergan Sales Llc SAVELLA milnacipran hydrochloride TABLET;ORAL 022256-002 Jan 14, 2009 RX Yes No   See Pricing   See Pricing   See Pricing
Allergan Sales Llc SAVELLA milnacipran hydrochloride TABLET;ORAL 022256-003 Jan 14, 2009 RX Yes Yes   See Pricing   See Pricing   See Pricing
Allergan Sales Llc SAVELLA milnacipran hydrochloride TABLET;ORAL 022256-004 Jan 14, 2009 RX Yes No   See Pricing   See Pricing   See Pricing
Allergan Sales Llc SAVELLA milnacipran hydrochloride TABLET;ORAL 022256-001 Jan 14, 2009 RX Yes No   See Pricing   See Pricing   See Pricing
>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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