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Last Updated: February 19, 2020

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Ropivacaine hydrochloride - Generic Drug Details

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What are the generic drug sources for ropivacaine hydrochloride and what is the scope of 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. Eight suppliers are listed for this compound.

Recent Clinical Trials for ropivacaine hydrochloride

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

SponsorPhase
Camille Ladanyi MDN/A
Carilion ClinicPhase 4
Karolinska University HospitalPhase 3

See all ropivacaine hydrochloride clinical trials

Recent Litigation for ropivacaine hydrochloride

Identify potential future generic entrants

District Court Litigation
Case NameDate
Unknown Case Title2019-11-15
Fresenius Kabi USA, LLC v. Custopharm, Inc.2018-08-06
Fresenius Kabi USA, LLC v. Mylan Laboratories Limited2015-10-19

See all ropivacaine hydrochloride litigation

Pharmacology for ropivacaine hydrochloride
Drug ClassAmide Local Anesthetic
Physiological EffectLocal Anesthesia
Synonyms for ropivacaine hydrochloride
(2S)-N-(2,6-dimethylphenyl)-1-propyl-piperidine-2-carboxamide hydrochloride
(2S)-N-(2,6-dimethylphenyl)-1-propylpiperidine-2-carboxamide hydrochloride
(S)-N-(2,6-dimethylphenyl)-1-propylpiperidine-2-carboxamide hydrochloride
(S)-Ropivacaine hydrochloride
(S)-ropivacaine hydrochloride (anhydrous)
132112-35-7
2-Piperidinecarboxamide, N-(2,6-dimethylphenyl)-1-propyl-, monohydrochloride, (S)-
2694AH
35504LBE2T
717R158
98717-15-8
AC1L41QM
ACT04747
AKOS015900322
AKOS015994752
AN-9624
API0007295
C17H26N2O.ClH
C17H26N2O.HCl
C17H26N2O.HCl.H2O
CAS-98717-15-8
CCG-101108
CHEBI:60803
CHEMBL1889140
CPD000469137
CS-0013146
DSSTox_CID_28353
DSSTox_GSID_48379
DSSTox_RID_82753
DTXSID2048379
FC1264
FT-0674459
H838
HY-B0563B
I14-176
KS-5134
LS-113954
MLS001401363
MolPort-006-069-213
N-(2,6-dimethylphenyl)-1-propyl-piperidine-2-carboxamide; hydron; chloride
Naropin
NC00358
NCGC00164597-01
NCGC00164597-02
NDNSIBYYUOEUSV-RSAXXLAASA-N
Q-201678
ROPIVACAINE HCl
Ropivacaine hydrochloride hydrate
ROPIVACAINE HYDROCHLORIDE MONOHYDRATE
Ropivacaine monohydrochloride
ropivacaine monohydrochloride,
ropivacaine monohydrochloride, (S)-isomer
S-Ropivacaine hydrochloride
s4058
SAM001246524
SC-26798
SCHEMBL236432
SMR000469137
ST24049128
SW197738-2
Tox21_112221
Tox21_112221_1
UNII-35504LBE2T
Paragraph IV (Patent) Challenges for ROPIVACAINE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
NAROPIN SOLUTION;INJECTION ropivacaine hydrochloride 020533 2015-09-03
NAROPIN SOLUTION;INJECTION ropivacaine hydrochloride 020533 2015-01-30
NAROPIN SOLUTION;INJECTION ropivacaine hydrochloride 020533 2006-11-13

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
Inforlife ROPIVACAINE HYDROCHLORIDE ropivacaine hydrochloride SOLUTION;INJECTION 206166-003 Jun 11, 2018 AP RX No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd ROPIVACAINE HYDROCHLORIDE ropivacaine hydrochloride SOLUTION;INJECTION 205612-006 Jul 13, 2016 AP RX No No   Start Trial   Start Trial   Start Trial
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-004 Sep 24, 1996 AP RX Yes No   Start Trial   Start Trial   Start Trial
Somerset Theraps Llc ROPIVACAINE HYDROCHLORIDE ropivacaine hydrochloride SOLUTION;INJECTION 207636-007 Jun 15, 2018 AP RX No No   Start Trial   Start Trial   Start Trial
Hospira ROPIVACAINE HYDROCHLORIDE ropivacaine hydrochloride SOLUTION;INJECTION 090194-006 Sep 23, 2014 AP RX No No   Start Trial   Start Trial   Start Trial
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-009 Jan 4, 2011 AP RX Yes No   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

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 020533-004 Sep 24, 1996   Start Trial   Start Trial
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-001 May 1, 1998   Start Trial   Start Trial
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-001 May 1, 1998   Start Trial   Start Trial
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-005 Sep 24, 1996   Start Trial   Start Trial
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-004 Sep 24, 1996   Start Trial   Start Trial
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-003 May 1, 1998   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for ropivacaine hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0239710 96C0042 Belgium   Start Trial PRODUCT NAME: CHLORHYDRATE DE ROPIVACAINE MONOHYDRATE; NAT. REGISTRATION NO/DATE: 212 IS 216 F 12 19960806; FIRST REGISTRATION: SE 12319 19950915
0239710 SPC/GB96/051 United Kingdom   Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Johnson and Johnson
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