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SAVELLA Drug Profile

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When do Savella patents expire, and when can generic versions of Savella launch?

Savella is a drug marketed by Allergan Sales Llc and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has forty-seven patent family members in twenty-six countries.

The generic ingredient in SAVELLA is milnacipran hydrochloride. There are twenty-six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the milnacipran hydrochloride profile page.

Summary for SAVELLA

International Patents:	47
US Patents:	4
Applicants:	1
NDAs:	1
Suppliers / Packagers:	6
Bulk Api Vendors:	106
Clinical Trials:	20
Patent Applications:	284
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SAVELLA
DailyMed Link:	SAVELLA at DailyMed

Pharmacology for SAVELLA

Drug Class	Serotonin and Norepinephrine Reuptake Inhibitor
Mechanism of Action	Norepinephrine Uptake Inhibitors Serotonin Uptake Inhibitors

Synonyms for SAVELLA

(+-)-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 HCl

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

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-, 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

F2695

Fetzima (TN)

HY-B0168A

HY-B0168B

Ixel

J-011063

J10386

Joncia

K-0218

KS-00000XLX

KS-1274

L-Milnacipran Hydrochloride

Levomilnacipran HCl

LEVOMILNACIPRAN HYDROCHLORIDE

Levomilnacipran hydrochloride (USAN)

Levomilnacipran hydrochloride [USAN]

LS-58540

LS-58541

M2133

MFCD00901293

MFCD01735755

MFCD18433402

Midalcipran hydrochloride

Milnacipran ((1S-cis) hydrochloride)

Milnacipran (1S-cis) hydrochloride

Milnacipran (hydrochloride)

Milnacipran HCl

Milnacipran hydrochloride

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

OR063822

OR147048

Pharmakon1600-01504815

QC-10074

RTR-000332

s3140

SAM001247035

Savella (TN)

SC-15864

SCHEMBL1148742

SCHEMBL1156056

SCHEMBL161558

SMR000449266

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 SAVELLA

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	SAVELLA	milnacipran hydrochloride	TABLET;ORAL	022256-001	Jan 14, 2009	AB	RX	Yes	No
Allergan Sales Llc	SAVELLA	milnacipran hydrochloride	TABLET;ORAL	022256-002	Jan 14, 2009	AB	RX	Yes	No
Allergan Sales Llc	SAVELLA	milnacipran hydrochloride	TABLET;ORAL	022256-001	Jan 14, 2009	AB	RX	Yes	No
Allergan Sales Llc	SAVELLA	milnacipran hydrochloride	TABLET;ORAL	022256-003	Jan 14, 2009	AB	RX	Yes	Yes

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Paragraph IV (Patent) Challenges for SAVELLA

Drugname	Dosage	Strength	RLD	Date
	Tablets	12.5 mg, 25 mg, 50 mg, and 100 mg

Non-Orange Book US Patents for SAVELLA

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
6,635,675	Method of treating chronic fatigue syndrome
7,915,246	Methods of treating fibromyalgia syndrome, chronic fatigue syndrome and pain
7,820,643	Methods of treating fibromyalgia syndrome, chronic fatigue syndrome and pain

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International Patents for SAVELLA

Country	Document Number	Estimated Expiration
European Patent Office	2682114
China	101355930
Singapore	183735
Israel	228904