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NAROPIN Drug Profile

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Naropin is a drug marketed by Fresenius Kabi Usa and is included in one NDA. It is available from three suppliers. There are four patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in NAROPIN is ropivacaine hydrochloride. There are twelve drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the ropivacaine hydrochloride profile page.

Summary for Tradename: NAROPIN

Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: see list3

Pharmacology for Tradename: NAROPIN

Ingredient-typeAmides
Drug ClassAmide Local Anesthetic
Physiological EffectLocal Anesthesia

Clinical Trials for: NAROPIN

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fresenius Kabi Usa
NAROPIN
ropivacaine hydrochloride
SOLUTION;INJECTION020533-010Jan 4, 2011RXNo<disabled><disabled>
Fresenius Kabi Usa
NAROPIN
ropivacaine hydrochloride
SOLUTION;INJECTION020533-007Sep 24, 1996RXNo7,857,802<disabled>Y <disabled>
Fresenius Kabi Usa
NAROPIN
ropivacaine hydrochloride
SOLUTION;INJECTION020533-005Sep 24, 1996RXNo<disabled><disabled>
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Expired Patents for Tradename: NAROPIN

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Fresenius Kabi Usa
NAROPIN
ropivacaine hydrochloride
SOLUTION;INJECTION020533-004Sep 24, 19965,670,524<disabled>
Fresenius Kabi Usa
NAROPIN
ropivacaine hydrochloride
SOLUTION;INJECTION020533-005Sep 24, 19965,670,524<disabled>
Fresenius Kabi Usa
NAROPIN
ropivacaine hydrochloride
SOLUTION;INJECTION020533-003May 1, 19985,834,489<disabled>
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Paragraph IV activity for: NAROPIN

Drugname Dosage Strength RLD Submissiondate
ropivacaine hydrochlorideInjection2 mg/mL, 5 mg/mL and 10 mg/mL, 20 mL, 30 mL and 20 mL vialsNaropin11/13/2006

International Patent Family for Tradename: NAROPIN

Country Document Number Estimated Expiration
South Korea100944420<disabled in preview>
European Patent Office1507502<disabled in preview>
Germany10223560<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: NAROPIN

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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