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FDA Orange Book · active-ingredient family

Ropivacaine hydrochloride

Ropivacaine hydrochloride is approved as 1 brand and 16 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:NAROPIN · NDA 020533

1

Brand (NDA)

16

Generics (ANDA)

1

Listed patents

0

Exclusivity periods

Brand (NDA) products · solution

ProductApplicantApplicationTEApproved
NAROPINRLD×13FRESENIUS KABI USANDA 020533APJan 04, 2011

Generic (ANDA) products (16)

ProductApplicantApplicationTEApproved
ROPIVACAINE HYDROCHLORIDE×5ANTHEA PHARMAANDA 219883APOct 08, 2025
ROPIVACAINE HYDROCHLORIDE×3HIKMAANDA 211907APAug 15, 2024
ROPIVACAINE HYDROCHLORIDE×7KINDOSANDA 218713APJul 30, 2024
ROPIVACAINE HYDROCHLORIDE×2MYLAN LABS LTDANDA 206091APOct 26, 2023
ROPIVACAINE HYDROCHLORIDE×4AMNEALANDA 216605APMar 07, 2023
ROPIVACAINE HYDROCHLORIDE×2GLANDANDA 210102APAug 18, 2022
ROPIVACAINE HYDROCHLORIDE×4HIKMAANDA 214074APJul 20, 2020
ROPIVACAINE HYDROCHLORIDE×6CAPLINANDA 212808APApr 09, 2020
ROPIVACAINE HYDROCHLORIDE×7SOMERSET THERAPS LLCANDA 207636APJun 15, 2018
ROPIVACAINE HYDROCHLORIDE×4INFORLIFEANDA 206166APJun 11, 2018
ROPIVACAINE HYDROCHLORIDE×2RISINGANDA 204636APMar 16, 2018
ROPIVACAINE HYDROCHLORIDE×7EUGIA PHARMAANDA 205612APJul 13, 2016
ROPIVACAINE HYDROCHLORIDERISINGANDA 203955APApr 11, 2016
ROPIVACAINE HYDROCHLORIDE×6HOSPIRAANDA 090194—Sep 23, 2014
ROPIVACAINE HYDROCHLORIDE×4RISINGANDA 090318—Sep 23, 2014
ROPIVACAINE HYDROCHLORIDE×2NAVINTA LLCANDA 078601APJul 17, 2014

Listed patents (1)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7857802Nov 28, 2026in 5 mo
Product

Ropivacaine hydrochloride — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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