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Ropivacaine hydrochloride - Generic Drug Details

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Ropivacaine hydrochloride is the generic ingredient in two branded drugs marketed by Navinta Llc, Aurobindo Pharma Ltd, Sagent Strides, Fresenius Kabi Usa, Akorn Inc, and Hospira, and is included in six NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has sixty-four patent family members in twenty countries.

There are twelve drug master file entries for ropivacaine hydrochloride. Eight suppliers are listed for this compound.

Summary for Generic Name: ropivacaine hydrochloride

Tradenames:2
Patents:4
Applicants:6
NDAs:6
Drug Master File Entries: see list12
Suppliers / Packaging: see list8
Formulation / Manufacturing:see details

Pharmacology for Ingredient: ropivacaine hydrochloride

Ingredient-typeAmides
Drug ClassAmide Local Anesthetic
Physiological EffectLocal Anesthesia

Clinical Trials for: ropivacaine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sagent Strides
ROPIVACAINE HYDROCHLORIDE
ropivacaine hydrochloride
SOLUTION;INJECTION090318-001Sep 23, 2014RXNo<disabled><disabled>
Fresenius Kabi Usa
NAROPIN
ropivacaine hydrochloride
SOLUTION;INJECTION020533-009Jan 4, 2011RXNo<disabled><disabled>
Fresenius Kabi Usa
NAROPIN
ropivacaine hydrochloride
SOLUTION;INJECTION020533-002Sep 24, 1996RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: ropivacaine hydrochloride

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Fresenius Kabi Usa
NAROPIN
ropivacaine hydrochloride
SOLUTION;INJECTION020533-005Sep 24, 19964,695,576<disabled>
Fresenius Kabi Usa
NAROPIN
ropivacaine hydrochloride
SOLUTION;INJECTION020533-001May 1, 19985,834,489<disabled>
Fresenius Kabi Usa
NAROPIN
ropivacaine hydrochloride
SOLUTION;INJECTION020533-004Sep 24, 19965,834,489<disabled>
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International Patent Family for Ingredient: ropivacaine hydrochloride

Country Document Number Estimated Expiration
Hong Kong1081430<disabled in preview>
Slovenia1507502<disabled in preview>
Germany50312773<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: ROPIVACAINE HYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB96/051United Kingdom<disabled>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
C0042Belgium<disabled>PRODUCT NAME: CHLORHYDRATE DE ROPIVACAINE MONOHYDRATE; NAT. REGISTRATION NO/DATE: 212 IS 216 F 12 19960806; FIRST REGISTRATION: SE 12319 19950915
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