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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

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, 1996RXNo8,162,915<disabled>Y<disabled>
Hospira
ROPIVACAINE HYDROCHLORIDE
ropivacaine hydrochloride
INJECTABLE;INJECTION090194-001Sep 23, 2014RXNo<disabled><disabled>
Sagent Strides
ROPIVACAINE HYDROCHLORIDE
ropivacaine hydrochloride
INJECTABLE;INJECTION090318-004Sep 23, 2014RXNo<disabled><disabled>
Fresenius Kabi Usa
NAROPIN
ropivacaine hydrochloride
INJECTABLE;INJECTION020533-001Sep 24, 1996RXNo5,670,524<disabled>YY<disabled>
Fresenius Kabi Usa
NAROPIN
ropivacaine hydrochloride
INJECTABLE;INJECTION020533-001Sep 24, 1996RXNo7,857,802<disabled>Y<disabled>
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International Patent Family for Ingredient: ropivacaine hydrochloride

Country Document Number Publication Date
MexicoPA06004241Jun 28, 2006
Russian Federation2152215Jul 10, 2000
Israel110006Nov 11, 1994
Japan3725541Dec 14, 2005
Japan4533887Sep 01, 2010
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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.

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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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