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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 Fresenius Kabi Usa, Hospira, Navinta Llc, and Sagent Strides, and is included in four NDAs. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has one hundred and three patent family members in thirty-six 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:5
Applicants:4
NDAs:4
Drug Master File Entries: see list11
Suppliers / Packaging: see list43
Formulation / Manufacturing:see details

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

Routine Irrigation With Ropivacaine vs. Lidocaine vs. Saline of Surgical Bed in Sleeve Gastrectomy
Status: Not yet recruiting Condition: Overweight and Obesity

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

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
Sagent Strides
ROPIVACAINE HYDROCHLORIDE
ropivacaine hydrochloride
INJECTABLE;INJECTION090318-001Sep 23, 2014RXNo<disabled><disabled>
Fresenius Kabi Usa
NAROPIN
ropivacaine hydrochloride
INJECTABLE;INJECTION020533-001Sep 24, 1996RXNo7,828,787<disabled>Y<disabled>
Hospira
ROPIVACAINE HYDROCHLORIDE
ropivacaine hydrochloride
INJECTABLE;INJECTION090194-002Sep 23, 2014RXNo<disabled><disabled>
Fresenius Kabi Usa
NAROPIN
ropivacaine hydrochloride
INJECTABLE;INJECTION020533-001Sep 24, 1996RXNo8,118,802<disabled>Y<disabled>
Fresenius Kabi Usa
NAROPIN
ropivacaine hydrochloride
INJECTABLE;INJECTION020533-001Sep 24, 1996RXNo8,162,915<disabled>Y<disabled>
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International Patent Family for Ingredient: ropivacaine hydrochloride

Country Document Number Publication Date
European Patent Office1507502Feb 23, 2005
Japan4526382Aug 18, 2010
European Patent Office1673135Jun 28, 2006
European Patent Office1507502Jun 02, 2010
Austria407653Sep 15, 2008
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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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