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Last Updated: January 30, 2023

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, Caplin, Eugia Pharma, Gland Pharma Ltd, Hikma, Hospira, Inforlife, Navinta Llc, Rising, and Somerset Theraps Llc, and is included in twelve 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.

Recent Clinical Trials for ropivacaine hydrochloride

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

SponsorPhase
Beijing Friendship HospitalN/A
Aga Khan University Hospital, PakistanPhase 4
Security Forces HospitalPhase 4

See all ropivacaine hydrochloride clinical trials

Pharmacology for ropivacaine hydrochloride
Drug ClassAmide Local Anesthetic
Physiological Effect Local 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 020533-007 Sep 24, 1996 AP RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Caplin ROPIVACAINE HYDROCHLORIDE ropivacaine hydrochloride SOLUTION;INJECTION 212808-004 Apr 9, 2020 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-006 Sep 24, 1996 AP RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Eugia Pharma ROPIVACAINE HYDROCHLORIDE ropivacaine hydrochloride SOLUTION;INJECTION 205612-002 Jul 13, 2016 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Gland Pharma Ltd ROPIVACAINE HYDROCHLORIDE ropivacaine hydrochloride SOLUTION;INJECTION 210102-001 Aug 18, 2022 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Inforlife ROPIVACAINE HYDROCHLORIDE ropivacaine hydrochloride SOLUTION;INJECTION 206166-004 Jun 11, 2018 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hospira ROPIVACAINE HYDROCHLORIDE ropivacaine hydrochloride SOLUTION;INJECTION 090194-006 Sep 23, 2014 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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

International Patents for ropivacaine hydrochloride

Country Patent Number Title Estimated Expiration
Germany 502004008025 See Plans and Pricing
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) See Plans and Pricing
South Korea 100944420 See Plans and Pricing
Poland 373496 Łącznik do opakowań zawierających płyny stosowanew medycynie i opakowanie płynów stosowanych w medycynie (CONNECTOR FOR PACKAGING CONTAINING MEDICAL FLUIDS AND PACKAGING FOR MEDICAL FLUIDS) See Plans and Pricing
Poland 209530 See Plans and Pricing
Austria 407653 See Plans and Pricing
Slovenia 1507502 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ropivacaine hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0239710 96C0042 Belgium See Plans and Pricing 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 See Plans and Pricing 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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