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Serving leading biopharmaceutical companies globally:

Accenture
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Federal Trade Commission
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Cerilliant
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Farmers Insurance
Chubb
Merck
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Generated: January 17, 2018

DrugPatentWatch Database Preview

ROPIVACAINE HYDROCHLORIDE - Generic Drug Details

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What are the generic sources for ropivacaine hydrochloride and what is the scope of ropivacaine hydrochloride patent protection?

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

Ropivacaine hydrochloride has seventy-four patent family members in twenty countries.

There are thirteen drug master file entries for ropivacaine hydrochloride. Nine suppliers are listed for this compound.
Summary for ROPIVACAINE HYDROCHLORIDE
Pharmacology for ROPIVACAINE HYDROCHLORIDE
Ingredient-typeAmides
Drug ClassAmide Local Anesthetic
Physiological EffectLocal Anesthesia

US Patents and Regulatory Information for ROPIVACAINE HYDROCHLORIDE

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 020533-007 Sep 24, 1996 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Aurobindo Pharma Ltd ROPIVACAINE HYDROCHLORIDE ropivacaine hydrochloride SOLUTION;INJECTION 205612-006 Jul 13, 2016 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Sagent Strides ROPIVACAINE HYDROCHLORIDE ropivacaine hydrochloride SOLUTION;INJECTION 090318-001 Sep 23, 2014 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Hospira ROPIVACAINE HYDROCHLORIDE ropivacaine hydrochloride SOLUTION;INJECTION 090194-004 Sep 23, 2014 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
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 020533-011 Sep 24, 1996 AP RX Yes Yes ➤ 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 020533-008 Sep 24, 1996 AP RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Navinta Llc ROPIVACAINE HYDROCHLORIDE ropivacaine hydrochloride SOLUTION;INJECTION 078601-003 Jul 17, 2014 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-005 Sep 24, 1996 AP RX Yes 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 ROPIVACAINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
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 020533-001 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 020533-004 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 020533-004 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 020533-001 May 1, 1998 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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International Patents for ROPIVACAINE HYDROCHLORIDE

Supplementary Protection Certificates for ROPIVACAINE HYDROCHLORIDE

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

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Covington
Teva
Farmers Insurance
Express Scripts
Fuji
Cantor Fitzgerald
Chinese Patent Office
McKinsey

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