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Last Updated: September 18, 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, Caplin, Hikma, Hospira, Inforlife, Mylan Asi, Navinta Llc, and Somerset Theraps Llc, and is included in eleven 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-five patent family members in twenty countries.

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

Recent Clinical Trials for ropivacaine hydrochloride

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

SponsorPhase
Beijing Sanbo Brain HospitalPhase 4
Xuanwu Hospital, BeijingPhase 4
University of MinnesotaPhase 4

See all ropivacaine hydrochloride clinical trials

Pharmacology for ropivacaine hydrochloride
Drug ClassAmide Local Anesthetic
Physiological EffectLocal Anesthesia
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
Hikma ROPIVACAINE HYDROCHLORIDE ropivacaine hydrochloride SOLUTION;INJECTION 214074-003 Jul 20, 2020 AP RX No No   Start Trial   Start Trial   Start Trial
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-006 Sep 24, 1996 AP RX Yes No   Start Trial   Start Trial Y   Start Trial
Hospira ROPIVACAINE HYDROCHLORIDE ropivacaine hydrochloride SOLUTION;INJECTION 090194-001 Sep 23, 2014 AP RX No No   Start Trial   Start Trial   Start Trial
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-007 Sep 24, 1996 AP RX Yes No   Start Trial   Start Trial Y   Start Trial
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-013 May 1, 1998 DISCN No No   Start Trial   Start Trial   Start Trial
Akorn ROPIVACAINE HYDROCHLORIDE ropivacaine hydrochloride SOLUTION;INJECTION 204636-002 Mar 16, 2018 AP RX No 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 020533-005 Sep 24, 1996   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 020533-001 May 1, 1998   Start Trial   Start Trial
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-003 May 1, 1998   Start Trial   Start Trial
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-001 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 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
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Harvard Business School

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