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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Boehringer Ingelheim
Federal Trade Commission
Farmers Insurance
Medtronic
Accenture
Covington
Moodys
Baxter
Healthtrust

Generated: January 23, 2018

DrugPatentWatch Database Preview

NAROPIN Drug Profile

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Which patents cover Naropin, and what generic 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.

The generic ingredient in NAROPIN is ropivacaine hydrochloride. There are thirteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the ropivacaine hydrochloride profile page.
Drug patent expirations by year for NAROPIN
Pharmacology for NAROPIN
Ingredient-typeAmides
Drug ClassAmide Local Anesthetic
Physiological EffectLocal Anesthesia

US Patents and Regulatory Information for NAROPIN

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;INJECTION 020533-010 Jan 4, 2011 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-007 Sep 24, 1996 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-005 Sep 24, 1996 AP RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-002 Sep 24, 1996 AP RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-006 Sep 24, 1996 AP RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-004 Sep 24, 1996 AP RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-009 Jan 4, 2011 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-007 Sep 24, 1996 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-011 Sep 24, 1996 AP RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-013 May 1, 1998 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for NAROPIN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-005 Sep 24, 1996 ➤ Subscribe ➤ Subscribe
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-004 Sep 24, 1996 ➤ Subscribe ➤ Subscribe
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-005 Sep 24, 1996 ➤ Subscribe ➤ Subscribe
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-001 May 1, 1998 ➤ Subscribe ➤ Subscribe
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-004 Sep 24, 1996 ➤ Subscribe ➤ Subscribe
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-003 May 1, 1998 ➤ Subscribe ➤ Subscribe
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-003 May 1, 1998 ➤ Subscribe ➤ Subscribe
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-005 Sep 24, 1996 ➤ Subscribe ➤ Subscribe
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-004 Sep 24, 1996 ➤ Subscribe ➤ Subscribe
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-003 May 1, 1998 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for NAROPIN
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Injection 2 mg/mL, 100 mL ➤ Subscribe 1/30/2015
➤ Subscribe Injection 2 mg/mL, 200 mL ➤ Subscribe 9/3/2015
➤ Subscribe Injection 2 mg/mL, 5 mg/mL and 10 mg/mL, 20 mL, 30 mL and 20 mL vials ➤ Subscribe 11/13/2006

International Patents for NAROPIN

Supplementary Protection Certificates for NAROPIN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB96/051 United Kingdom ➤ Subscribe 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
C0042 Belgium ➤ Subscribe PRODUCT NAME: CHLORHYDRATE DE ROPIVACAINE MONOHYDRATE; NAT. REGISTRATION NO/DATE: 212 IS 216 F 12 19960806; FIRST REGISTRATION: SE 12319 19950915
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
US Army
Teva
Medtronic
Fuji
Colorcon
Healthtrust
Merck
UBS

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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