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NAROPIN Drug Profile

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Which patents cover Naropin, and what substitute generic drugs are available?

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

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

The generic ingredient in NAROPIN is ropivacaine hydrochloride. There are thirteen 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
Bulk Api Vendors: see list85
Clinical Trials: see list103
Patent Applications: see list2,869
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:NAROPIN at DailyMed

Pharmacology for Tradename: NAROPIN

Ingredient-typeAmides
Drug ClassAmide Local Anesthetic
Physiological EffectLocal Anesthesia
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fresenius Kabi Usa
NAROPIN
ropivacaine hydrochloride
SOLUTION;INJECTION020533-010Jan 4, 2011RXYesNo► Subscribe► Subscribe
Fresenius Kabi Usa
NAROPIN
ropivacaine hydrochloride
SOLUTION;INJECTION020533-007Sep 24, 1996RXYesNo7,857,802► SubscribeY ► Subscribe
Fresenius Kabi Usa
NAROPIN
ropivacaine hydrochloride
SOLUTION;INJECTION020533-005Sep 24, 1996RXYesNo► Subscribe► Subscribe
Fresenius Kabi Usa
NAROPIN
ropivacaine hydrochloride
SOLUTION;INJECTION020533-002Sep 24, 1996RXYesNo► Subscribe► Subscribe
Fresenius Kabi Usa
NAROPIN
ropivacaine hydrochloride
SOLUTION;INJECTION020533-006Sep 24, 1996RXYesNo8,118,802► SubscribeY ► Subscribe
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Expired Patents for Tradename: NAROPIN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Fresenius Kabi Usa
NAROPIN
ropivacaine hydrochloride
SOLUTION;INJECTION020533-004Sep 24, 19965,834,489► Subscribe
Fresenius Kabi Usa
NAROPIN
ropivacaine hydrochloride
SOLUTION;INJECTION020533-005Sep 24, 19965,834,489► Subscribe
Fresenius Kabi Usa
NAROPIN
ropivacaine hydrochloride
SOLUTION;INJECTION020533-001May 1, 19984,695,576► Subscribe
Fresenius Kabi Usa
NAROPIN
ropivacaine hydrochloride
SOLUTION;INJECTION020533-005Sep 24, 19964,870,086► Subscribe
Fresenius Kabi Usa
NAROPIN
ropivacaine hydrochloride
SOLUTION;INJECTION020533-004Sep 24, 19964,695,576► Subscribe
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Paragraph IV activity for: NAROPIN

Drugname Dosage Strength RLD Submissiondate
ropivacaine hydrochloride Injection2 mg/mL, 200 mL Naropin  9/3/2015
ropivacaine hydrochloride Injection2 mg/mL, 100 mLNaropin  1/30/2015
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
Austria469630► Subscribe
Canada2542408► Subscribe
Australia2004224795► Subscribe
Slovenia1673135► Subscribe
Canada2487551► Subscribe
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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► SubscribePRODUCT 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► SubscribePRODUCT NAME: CHLORHYDRATE DE ROPIVACAINE MONOHYDRATE; NAT. REGISTRATION NO/DATE: 212 IS 216 F 12 19960806; FIRST REGISTRATION: SE 12319 19950915
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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 verifification 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.

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