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Last Updated: February 25, 2024

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, Amneal, Caplin, Eugia Pharma, Gland Pharma Ltd, Hikma, Hospira, Inforlife, Mylan Labs Ltd, Navinta Llc, Rising, and Somerset Theraps Llc, and is included in fourteen 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-six patent family members in twenty countries.

There are ten drug master file entries for ropivacaine hydrochloride. Thirteen suppliers are listed for this compound. There is one tentative approval for this compound.

Recent Clinical Trials for ropivacaine hydrochloride

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

SponsorPhase
Fayoum University HospitalN/A
The University of Texas Health Science Center at San AntonioPhase 2
National Trauma CenterN/A

See all ropivacaine hydrochloride clinical trials

Generic filers with tentative approvals for ROPIVACAINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial200MG/20ML (10MG/ML)SOLUTION;INJECTION
⤷  Try a Trial⤷  Try a Trial150MG/30ML (5MG/ML)SOLUTION;INJECTION
⤷  Try a Trial⤷  Try a Trial100MG/20ML (5MG/ML)SOLUTION;INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for ropivacaine hydrochloride
Drug ClassAmide Local Anesthetic
Physiological EffectLocal Anesthesia
Paragraph IV (Patent) Challenges for ROPIVACAINE HYDROCHLORIDE
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 ropivacaine hydrochloride

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 020533-006 Sep 24, 1996 AP RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-004 Sep 24, 1996 AP RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Caplin ROPIVACAINE HYDROCHLORIDE ropivacaine hydrochloride SOLUTION;INJECTION 212808-001 Apr 9, 2020 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-007 Sep 24, 1996 AP RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Eugia Pharma ROPIVACAINE HYDROCHLORIDE ropivacaine hydrochloride SOLUTION;INJECTION 205612-002 Jul 13, 2016 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amneal ROPIVACAINE HYDROCHLORIDE ropivacaine hydrochloride SOLUTION;INJECTION 216605-003 Mar 7, 2023 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 ⤷  Try a Trial ⤷  Try a Trial
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-006 Sep 24, 1996 ⤷  Try a Trial ⤷  Try a Trial
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-001 May 1, 1998 ⤷  Try a Trial ⤷  Try a Trial
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-001 May 1, 1998 ⤷  Try a Trial ⤷  Try a Trial
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-003 May 1, 1998 ⤷  Try a Trial ⤷  Try a Trial
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-007 Sep 24, 1996 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for ropivacaine hydrochloride

Country Patent Number Title Estimated Expiration
China 1655750 Connector for packaging containing medical fluids and packaging for medical fluids ⤷  Try a Trial
Canada 2487551 RACCORD POUR EMBALLAGES CONTENANT DES LIQUIDES MEDICINAUX ETEMBALLAGE POUR LIQUIDES MEDICINAUX (CONNECTOR FOR PACKAGING CONTAINING MEDICAL FLUIDS AND PACKAGING FOR MEDICAL FLUIDS) ⤷  Try a Trial
Japan 2005527301 ⤷  Try a Trial
European Patent Office 2191807 Raccord pour emballages contenant des liquides médicinaux et emballage pour liquides médicinaux (Connector for packaging containing medical fluids and packaging for medical fluids) ⤷  Try a Trial
Portugal 1507502 ⤷  Try a Trial
India 1252DEN2012 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ropivacaine hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0239710 SPC/GB96/051 United Kingdom ⤷  Try a 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 ⤷  Try a 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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