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Profile for Tradename: NAROPIN

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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 five patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and four patent family members in thirty-seven countries.

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

Summary for Tradename: NAROPIN

Patents:5
Applicants:1
NDAs:1
Suppliers / Packagers: see list43

Pharmacology for Tradename: NAROPIN

Ingredient-typeAmides
Drug ClassAmide Local Anesthetic
Physiological EffectLocal Anesthesia

Clinical Trials for: NAROPIN

Intraperitoneal Ropivacaine Nebulization for Pain Control After Laparoscopic Surgery
Status: Completed Condition: Laparoscopic Cholecystectomy

Ropivacaine With Clonidine For Pediatric Rectus Sheath Blocks- The Magic Combination
Status: Not yet recruiting Condition: Postoperative Pain

Intraperitoneal Ropivacaine Nebulization for Pain Control After Gynecologic Laparoscopic Surgery
Status: Completed Condition: Ovarian Cysts

Ropivacaine Hypobaric Spinal Anaesthesia in Traumatic Hip Surgery
Status: Completed Condition: Femoral Neck Fracture

Surgical Pain Control With Ropivacaine by Atomized Delivery
Status: Recruiting Condition: Pain

A Comparison of Postoperative Analgesic Nerve Block Ropivacaine Concentrations
Status: Active, not recruiting Condition: Total Hip Arthroplasty; Postoperative Pain

A Comparison of Ropivacaine Alone Versus Combination of Dexamethasone and Clonidine for Block
Status: Recruiting Condition: Upper Extremity Fracture

The Minimum Effective Volume of Ropivacaine in Ultrasound-guided Supraclavicular Block
Status: Recruiting Condition: Supraclavicular Brachial Plexus Block

Ropivacaine Block Alone or With Perineural or Systemic Dexamethasone for Pain in Shoulder Surgery
Status: Completed Condition: Interscalene Blockade in Elective Arthroscopic Rotator Cuff Repair

Minimum Effective Dose of Ropivacaine for Spinal Anesthesia in Cesarean Section
Status: Recruiting Condition: Spinal Anesthesia

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
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
INJECTABLE;INJECTION020533-001Sep 24, 1996RXNo5,670,524<disabled>YY <disabled>
Fresenius Kabi Usa
NAROPIN
ropivacaine hydrochloride
INJECTABLE;INJECTION020533-004Sep 24, 1996RXNo5,670,524<disabled>YY <disabled>
Fresenius Kabi Usa
NAROPIN
ropivacaine hydrochloride
INJECTABLE;INJECTION020533-001Sep 24, 1996RXNo7,828,787<disabled>Y <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
INJECTABLE;INJECTION020533-004Sep 24, 19965,834,489<disabled>
Fresenius Kabi Usa
NAROPIN
ropivacaine hydrochloride
INJECTABLE;INJECTION020533-003Sep 24, 19965,670,524<disabled>
Fresenius Kabi Usa
NAROPIN
ropivacaine hydrochloride
INJECTABLE;INJECTION020533-003Sep 24, 19964,870,086<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

Non-Orange Book Patents for Tradename: NAROPIN

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,834,489 Methods and compositions for the treatment of pain utilizing ropivacaine<disabled in preview>
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International Patent Family for Tradename: NAROPIN

Country Document Number Publication Date
Canada2518617May 08, 2012
MexicoPA04011784Mar 31, 2005
Poland377727Feb 06, 2006
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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 information. There is no warranty that the information contained herein is error free. 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.

Copyright 2002-2016 thinkBiotech LLC
ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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