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Ropivacaine hydrochloride - Generic Drug Details

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What are the generic sources for ropivacaine hydrochloride and what is the scope of ropivacaine hydrochloride patent protection?

Ropivacaine hydrochloride is the generic ingredient in two branded drugs marketed by Fresenius Kabi Usa, Akorn, Akorn Inc, Aurobindo Pharma Ltd, Hospira, Inforlife, Mylan Asi, Navinta Llc, and Somerset Theraps Llc, and is included in nine NDAs. There are four patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Ropivacaine hydrochloride has seventy-four patent family members in twenty countries.

There are thirteen drug master file entries for ropivacaine hydrochloride. Nine suppliers are listed for this compound.

Summary for ropivacaine hydrochloride

International Patents:	74
US Patents:	4
Tradenames:	2
Applicants:	9
NDAs:	9
Drug Master File Entries:	13
Suppliers / Packagers:	9
Bulk Api Vendors:	42
Clinical Trials:	490
Patent Applications:	246
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ropivacaine hydrochloride
DailyMed Link:	ropivacaine hydrochloride at DailyMed

Pharmacology for ropivacaine hydrochloride

Ingredient-type	Amides
Drug Class	Amide Local Anesthetic
Physiological Effect	Local Anesthesia

Synonyms for ropivacaine hydrochloride

(-)-1-Propyl-2',6'-dimethyl-2-piperidylcarboxyanilid

(-)-1-propyl-2',6'-dimethyl-2-piperidylcarboxyanilide

(-)-1-Propyl-2',6'-pipecoloxylidide

(-)-Ropivacaine

(2S)-2-[(2,6-dimethylphenyl)carbamoyl]-1-propylpiperidinium chloride

(2S)-2-[(2,6-dimethylphenyl)carbamoyl]-1-propylpiperidinium chloride--water(1/1)

(2S)-N-(2,6-dimethylphenyl)-1-propyl-2-piperidinecarboxamide

(2S)-N-(2,6-dimethylphenyl)-1-propyl-2-piperidinecarboxamide hydrochloride monohydrate

(2S)-N-(2,6-dimethylphenyl)-1-propyl-piperidine-2-carboxamide

(2S)-N-(2,6-dimethylphenyl)-1-propyl-piperidine-2-carboxamide hydrate hydrochloride

(2S)-N-(2,6-dimethylphenyl)-1-propyl-piperidine-2-carboxamide hydrochloride

(2S)-N-(2,6-dimethylphenyl)-1-propylpiperidine-2-carboxamide

(2S)-N-(2,6-dimethylphenyl)-1-propylpiperidine-2-carboxamide hydrate hydrochloride

(2S)-N-(2,6-dimethylphenyl)-1-propylpiperidine-2-carboxamide hydrochloride

(2S)-N-(2,6-dimethylphenyl)-1-propylpiperidine-2-carboxamide hydrochloride--water (1/1)

(S)-(--)-1-propyl-2',6'-pipecoloxylidide hydrochloride

(S)-(-)-1-propyl-2',6'-pipecoloxylidide

(S)-(-)-1-propyl-2',6'-pipecoloxylidine hydrochloride monohydrate

(S)-(-)-1-propylpiperidine-2-carboxylic acid (2,6-dimethylphenyl)amide hydrochloride monohydrate

(S)-1-propyl-2-piperidylformo-2',6'-xylidide hydrochloride

(S)-N-(2,6-Dimethylphenyl)-1-propylpiperidine-2-carboxamide

(S)-N-(2,6-dimethylphenyl)-1-propylpiperidine-2-carboxamide hydrochloride monohydrate

(S)-Ropivacaine

(S)-ropivacaine HCl

(S)-Ropivacaine hydrochloride

(S)-ropivacaine hydrochloride (anhydrous)

(S)-ropivacaine hydrochloride hydrate

(S)-ropivacaine hydrochloride monohydrate

(S)-ropivacaine monohydrochloride (anhydrous)

057R954

112R357

132112-35-7

2-Piperidinecarboxamide, N-(2,6-dimethylphenyl)-1-propyl-, (2S)-

2-Piperidinecarboxamide, N-(2,6-dimethylphenyl)-1-propyl-, (S)-(-)-

2-Piperidinecarboxamide, N-(2,6-dimethylphenyl)-1-propyl-, monohydrochloride, (S)-

2-Piperidinecarboxamide,N-(2,6-dimethylphenyl)-1-propyl-, (2S)-

2694AH

35504LBE2T

717R158

7IO5LYA57N

84057-95-4

98717-15-8

A840710

AB0004985

AB00698466_10

AB00698466-07

AB1007072

AC-2101

AC1L41QM

AC1L41QN

AC1OCF17

ACT04747

AJ-24263

AK117722

AK161933

AK326168

AKOS015900322

AKOS015918210

AKOS015950974

AKOS015994752

AKOS017343283

AL-281

AL-381

AN-14289

AN-9624

Anapaine

Anapeine

Anapeine (TN)

API0007295

B3377

BC209065

BIDD:GT0203

C07532

C17H26N2O.ClH

C17H26N2O.HCl

C17H26N2O.HCl.H2O

CAS-98717-15-8

CCG-101108

CHEBI:34954

CHEBI:60803

CHEBI:8890

CHEMBL1077896

CHEMBL1889140

CPD000469137

CS-0013146

CS-2672

D04048

D08490

D09RHQ

DB00296

DR000904

DSSTox_CID_28353

DSSTox_GSID_48379

DSSTox_RID_82753

DTXSID2048379

DTXSID4040187

ETI-211

F-93

FC1264

FT-0631143

FT-0674459

GTPL7602

H838

HE306542

HE395698

HY-B0563A

HY-B0563B

I14-176

I14-8019

K500

KB-60355

KB-60356

KS-5134

L-N-(2,6-dimethylphenyl)-1-propyl-2-piperidinocarboxamide hydrochloride monohydrate

L-N-n-propylpipecolic acid-2,6-xylidide

L-N-n-propylpipecolic acid-2,6-xylidide hydrochloride

L-ropivacaine HCl

L-ropivacaine hydrochloride

L-ropivacaine hydrochloride monohydrate

LEA 103

LS-113954

MFCD00864425

MFCD00946578

MFCD02102164

MLS001401363

MolPort-003-983-292

MolPort-005-935-350

MolPort-006-069-213

N-(2,6-dimethylphenyl)-1-propyl-piperidine-2-carboxamide; hydron; chloride

Narapin

Narop

Naropeine

Naropin

Naropin (TN)

Naropin hydrochloride monohydrate

Naropina

naropine

NC00358

NCGC00164597-01

NCGC00164597-02

NDNSIBYYUOEUSV-RSAXXLAASA-N

Noropine

PRF-108

Q-100126

Q-201677

Q-201678

Ropivacaina

Ropivacaina [INN-Spanish]

Ropivacaina [Spanish]

Ropivacaine

Ropivacaine (hydrochloride monohydrate)

Ropivacaine (INN)

Ropivacaine [INN:BAN]

Ropivacaine [INN]

Ropivacaine base

ROPIVACAINE HCl

Ropivacaine hydrochloride (USP)

Ropivacaine hydrochloride [USP]

Ropivacaine hydrochloride hydrate

Ropivacaine hydrochloride hydrate (JAN)

ROPIVACAINE HYDROCHLORIDE MONOHYDRATE

Ropivacaine hydrochloride monohydrate, >=98% (HPLC)

Ropivacaine hydrochloride monohydrate, European Pharmacopoeia (EP) Reference Standard

Ropivacaine hydrochloride, United States Pharmacopeia (USP) Reference Standard

Ropivacaine monohydrochloride

ropivacaine monohydrochloride,

ropivacaine monohydrochloride, (S)-isomer

ropivacaine monohydrochloride, (S)-isomer

Ropivacainehydrochloridehydrate

Ropivacainum

Ropivacainum [INN-Latin]

S-Ropivacaine

S-Ropivacaine hydrochloride

s4058

SAM001246524

SC-23114

SC-26798

SCHEMBL236432

SCHEMBL33292

SCHEMBL510838

SMR000469137

ST24049128

ST51051452

ST51054447

Tox21_112221

Tox21_112221_1

UNII-35504LBE2T

UNII-7IO5LYA57N

UNII-V910P86109

V910P86109

VSHFRHVKMYGBJL-CKUXDGONSA-N

ZINC897002

ZKMNUMMKYBVTFN-HNNXBMFYSA-N

US Patents and Regulatory Information for ropivacaine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Akorn Inc	ROPIVACAINE HYDROCHLORIDE	ropivacaine hydrochloride	SOLUTION;INJECTION	203955-001	Apr 11, 2016	AP	RX	No	No
Hospira	ROPIVACAINE HYDROCHLORIDE	ropivacaine hydrochloride	SOLUTION;INJECTION	090194-005	Sep 23, 2014	AP	RX	No	No
Inforlife	ROPIVACAINE HYDROCHLORIDE	ropivacaine hydrochloride	SOLUTION;INJECTION	206166-004	Jun 11, 2018	AP	RX	No	No
Hospira	ROPIVACAINE HYDROCHLORIDE	ropivacaine hydrochloride	SOLUTION;INJECTION	090194-006	Sep 23, 2014	AP	RX	No	No

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Expired US Patents for ropivacaine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-005	Sep 24, 1996
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-003	May 1, 1998
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-003	May 1, 1998
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-001	May 1, 1998

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International Patents for ropivacaine hydrochloride

Country	Document Number	Estimated Expiration
Brazil	0311342
Australia	2004281535
Portugal	1673135
China	1767799

Supplementary Protection Certificates for ropivacaine hydrochloride

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C/GB96/051	United Kingdom		PRODUCT NAME: (S)-(-)-1-PROPYL-2',6'-PIPECOLOXYLIDIDE HYDROCHLORIDE MONOHYDRATE (GENERIC NAME: ROPIVACAINE MONOHYDROCHLORIDE MONOHYDRATE); REGISTERED: SE 12319 19950915; SE 12322 19950915; SE 12323 19950915; UK 0017/0375 19960517; UK 0017/0376 19960517; UK 0017/0377 19960517; UK 0017/0378 19960517
C0042	Belgium		PRODUCT NAME: CHLORHYDRATE DE ROPIVACAINE MONOHYDRATE; NAT. REGISTRATION NO/DATE: 212 IS 216 F 12 19960806; FIRST REGISTRATION: SE 12319 19950915