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Generated: November 19, 2017

DrugPatentWatch Database Preview

NAROPIN Drug Profile

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Which patents cover Naropin, and what generic Naropin alternatives 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 seventy-four patent family members in twenty countries and two supplementary protection certificates in two 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.

Pharmacology for NAROPIN

Ingredient-typeAmides
Drug ClassAmide Local Anesthetic
Physiological EffectLocal Anesthesia
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;INJECTION020533-010Jan 4, 2011RXYesNo► Subscribe► Subscribe► Subscribe
Fresenius Kabi Usa
NAROPIN
ropivacaine hydrochloride
SOLUTION;INJECTION020533-007Sep 24, 1996RXYesNo► Subscribe► SubscribeY ► Subscribe
Fresenius Kabi Usa
NAROPIN
ropivacaine hydrochloride
SOLUTION;INJECTION020533-005Sep 24, 1996APRXYesNo► Subscribe► Subscribe► Subscribe
Fresenius Kabi Usa
NAROPIN
ropivacaine hydrochloride
SOLUTION;INJECTION020533-002Sep 24, 1996APRXYesNo► Subscribe► Subscribe► Subscribe
Fresenius Kabi Usa
NAROPIN
ropivacaine hydrochloride
SOLUTION;INJECTION020533-006Sep 24, 1996APRXYesNo► Subscribe► SubscribeY ► Subscribe
Fresenius Kabi Usa
NAROPIN
ropivacaine hydrochloride
SOLUTION;INJECTION020533-004Sep 24, 1996APRXYesNo► Subscribe► Subscribe► Subscribe
Fresenius Kabi Usa
NAROPIN
ropivacaine hydrochloride
SOLUTION;INJECTION020533-009Jan 4, 2011RXYesNo► Subscribe► Subscribe► Subscribe
Fresenius Kabi Usa
NAROPIN
ropivacaine hydrochloride
SOLUTION;INJECTION020533-007Sep 24, 1996RXYesNo► Subscribe► SubscribeY ► Subscribe
Fresenius Kabi Usa
NAROPIN
ropivacaine hydrochloride
SOLUTION;INJECTION020533-011Sep 24, 1996APRXYesYes► Subscribe► Subscribe► Subscribe
Fresenius Kabi Usa
NAROPIN
ropivacaine hydrochloride
SOLUTION;INJECTION020533-013May 1, 1998DISCNNoNo► Subscribe► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for NAROPIN

Drugname Dosage Strength RLD Submissiondate
ropivacaine hydrochlorideInjection2 mg/mL, 100 mLNaropin1/30/2015
ropivacaine hydrochlorideInjection2 mg/mL, 200 mLNaropin9/3/2015
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
South Korea101160278► Subscribe
Poland209530► Subscribe
Canada2487551► Subscribe
Japan2006521124► Subscribe
Norway20053981► Subscribe
Portugal1605891► Subscribe
MexicoPA06004241► Subscribe
Denmark1605891► Subscribe
South Korea20050012753► Subscribe
MexicoPA05010292► 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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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Johnson and Johnson
Cerilliant
Julphar
US Department of Justice
Medtronic
Healthtrust
Chubb
Boehringer Ingelheim
Moodys

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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