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Last Updated: June 23, 2024

NAROPIN Drug Patent Profile


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

Naropin is a drug marketed by Fresenius Kabi Usa and is included in one NDA. There are three patents protecting this drug and three Paragraph IV challenges.

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

The generic ingredient in NAROPIN is ropivacaine hydrochloride. There are thirteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the ropivacaine hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Naropin

A generic version of NAROPIN was approved as ropivacaine hydrochloride by NAVINTA LLC on July 17th, 2014.

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Drug patent expirations by year for NAROPIN
Drug Prices for NAROPIN

See drug prices for NAROPIN

Recent Clinical Trials for NAROPIN

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

SponsorPhase
Hartford HospitalPhase 4
United States Department of DefensePhase 2
The University of Texas Health Science Center at San AntonioPhase 2

See all NAROPIN clinical trials

Pharmacology for NAROPIN
Drug ClassAmide Local Anesthetic
Physiological EffectLocal Anesthesia
Anatomical Therapeutic Chemical (ATC) Classes for NAROPIN
Paragraph IV (Patent) Challenges for NAROPIN
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
NAROPIN Injection ropivacaine hydrochloride 2 mg/mL, 200 mL 020533 1 2015-09-03
NAROPIN Injection ropivacaine hydrochloride 2 mg/mL, 100 mL 020533 1 2015-01-30
NAROPIN Injection ropivacaine hydrochloride 2 mg/mL, 5 mg/mL and 10 mg/mL, 20 mL, 30 mL and 20 mL vials 020533 1 2006-11-13

US Patents and Regulatory Information for NAROPIN

NAROPIN is protected by three US patents.

Patents protecting NAROPIN

Connector for packaging containing medical fluids and packaging for medical fluids
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Connector for medical liquid-containing packages and medical liquid-containing packages
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Connector for packings containing medical liquids, and corresponding packing for medical liquids
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-010 Jan 4, 2011 AP RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-005 Sep 24, 1996 AP RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-002 Sep 24, 1996 AP RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-006 Sep 24, 1996 AP RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-004 Sep 24, 1996 AP RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-007 Sep 24, 1996 AP RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-007 Sep 24, 1996 AP RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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 NAROPIN

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

International Patents for NAROPIN

See the table below for patents covering NAROPIN around the world.

Country Patent Number Title Estimated Expiration
Japan 2007508081 ⤷  Sign Up
Germany 10348016 Konnektor für medizinische Flüssigkeiten enthaltende Verpackungen und Verpackung für medizinische Flüssigkeiten ⤷  Sign Up
Cyprus 1680 (S)-(-)-1-PROPYL-2',6'-PIPECOLOXYLIDIDE HYDROCHLORIDE MONOHYDRATE,PROCESS FOR ITS PREPARATION AND PHARMACEUTICAL PREPARATION CONTAINING IT ⤷  Sign Up
Lithuania 3449 NEW USE OF ROPIVACAINE ⤷  Sign Up
Slovenia 1605891 ⤷  Sign Up
Norway 328168 ⤷  Sign Up
Mexico PA05010292 CONECTOR PARA ENVASES QUE CONTIENEN LIQUIDOS MEDICOS, Y ENVASE CORRESPONDIENTE PARA LIQUIDOS MEDICOS. (CONNECTOR FOR PACKINGS CONTAINING MEDICAL LIQUIDS, AND CORRESPONDING PACKING FOR MEDICAL LIQUIDS.) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for NAROPIN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0239710 C960005 Netherlands ⤷  Sign Up PRODUCT NAME: ROPIVACAINI HYDROCHLORIDUM MONOHYDRICUM; NAT. REGISTRATION NO/DATE: RVG 18437, RVG 18440, RVG 18441 19951003; FIRST REGISTRATION: SE 12319, 12322, 12323 19950915
0239710 SPC/GB96/051 United Kingdom ⤷  Sign Up 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 ⤷  Sign Up 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.