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Last Updated: May 27, 2024

Ropivacaine hydrochloride - Generic Drug Details


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What are the generic 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 three 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. Fifteen 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
⤷  Sign Up⤷  Sign Up150MG/30ML (5MG/ML)SOLUTION;INJECTION
⤷  Sign Up⤷  Sign Up100MG/20ML (5MG/ML)SOLUTION;INJECTION
⤷  Sign Up⤷  Sign Up40MG/20ML (2MG/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
Anatomical Therapeutic Chemical (ATC) Classes for ropivacaine hydrochloride
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 ⤷  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
Mylan Labs Ltd ROPIVACAINE HYDROCHLORIDE ropivacaine hydrochloride SOLUTION;INJECTION 206091-001 Oct 26, 2023 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hikma ROPIVACAINE HYDROCHLORIDE ropivacaine hydrochloride SOLUTION;INJECTION 214074-002 Jul 20, 2020 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  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 ropivacaine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-007 Sep 24, 1996 ⤷  Sign Up ⤷  Sign Up
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-005 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 020533-001 May 1, 1998 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for ropivacaine hydrochloride

Country Patent Number Title Estimated Expiration
Japan 4533887 ⤷  Sign Up
Germany 10223560 Konnektor für medizinische Flüssigkeiten enthaltende Verpackungen und Verpackung für medizinische Flüssigkeiten ⤷  Sign Up
European Patent Office 1507502 RACCORD POUR EMBALLAGES CONTENANT DES LIQUIDES MEDICINAUX ET EMBALLAGE POUR LIQUIDES MEDICINAUX (CONNECTOR FOR PACKAGING CONTAINING MEDICAL FLUIDS AND PACKAGING FOR MEDICAL FLUIDS) ⤷  Sign Up
Hong Kong 1085372 Connector for packings containing medical liquids,and corresponding packing for medical liquids ⤷  Sign Up
>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 ⤷  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.