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Details for Generic Name: ropivacaine hydrochloride

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

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

There are eleven drug master file entries for ropivacaine hydrochloride. Three suppliers are listed for this compound.

Summary for Generic Name: ropivacaine hydrochloride

Tradenames:2
Patents:4
Applicants:4
NDAs:4
Drug Master File Entries: see list11
Suppliers / Packaging: see list43

Pharmacology for Ingredient: ropivacaine hydrochloride

Ingredient-typeAmides
Drug ClassAmide Local Anesthetic
Physiological EffectLocal Anesthesia

Clinical Trials for: ropivacaine hydrochloride

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

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

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

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

Continuous Infusion of Ropivacaine Hydrochloride in Reducing Pain After Surgery in Patients With Bladder Cancer
Status: Not yet recruiting Condition: Bladder Carcinoma; Post-operative Pain

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, 1996RXNo7,857,802<disabled>Y <disabled>
Fresenius Kabi Usa
NAROPIN
ropivacaine hydrochloride
INJECTABLE;INJECTION020533-001Sep 24, 1996RXNo8,162,915<disabled>Y <disabled>
Hospira
ROPIVACAINE HYDROCHLORIDE
ropivacaine hydrochloride
INJECTABLE;INJECTION090194-001Sep 23, 2014RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: ropivacaine hydrochloride

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Fresenius Kabi Usa
NAROPIN
ropivacaine hydrochloride
INJECTABLE;INJECTION020533-005Sep 24, 19965,834,489<disabled>
Fresenius Kabi Usa
NAROPIN
ropivacaine hydrochloride
INJECTABLE;INJECTION020533-003Sep 24, 19964,695,576<disabled>
Fresenius Kabi Usa
NAROPIN
ropivacaine hydrochloride
INJECTABLE;INJECTION020533-004Sep 24, 19965,670,524<disabled>
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International Patent Family for Ingredient: ropivacaine hydrochloride

Country Document Number Publication Date
Austria407653Sep 15, 2008
European Patent Office1673135Jan 30, 2013
South Africa200602538May 30, 2007
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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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