Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Chubb
Colorcon
McKinsey
Fuji
Healthtrust
UBS
Queensland Health
Boehringer Ingelheim
Cerilliant
Dow

Generated: February 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020533

« Back to Dashboard

NDA 020533 describes NAROPIN, which is a drug marketed by Fresenius Kabi Usa and is included in one NDA. It is available from three suppliers. There are four patents protecting this drug and three Paragraph IV challenges. Additional details are available on the NAROPIN profile page.

The generic ingredient in NAROPIN is ropivacaine hydrochloride. There are thirteen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the ropivacaine hydrochloride profile page.
Summary for 020533
Tradename:NAROPIN
Applicant:Fresenius Kabi Usa
Ingredient:ropivacaine hydrochloride
Patents:4
Formulation / Manufacturing:see details
Pharmacology for NDA: 020533
Ingredient-typeAmides
Physiological EffectLocal Anesthesia
Suppliers and Packaging for NDA: 020533
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533 NDA General Injectables & Vaccines, Inc 52584-286 N 52584-286-35
NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533 NDA Fresenius Kabi USA, LLC 63323-285 N 63323-285-13

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INJECTIONStrength20MG/10ML (2MG/ML)
Approval Date:May 1, 1998TE:APRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INJECTIONStrength40MG/20ML (2MG/ML)
Approval Date:Sep 24, 1996TE:APRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INJECTIONStrength100MG/20ML (5MG/ML)
Approval Date:May 1, 1998TE:APRLD:Yes

Expired US Patents for NDA 020533

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-004 Sep 24, 1996 ➤ Sign Up ➤ Sign Up
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-001 May 1, 1998 ➤ Sign Up ➤ Sign Up
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-001 May 1, 1998 ➤ Sign Up ➤ Sign Up
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-005 Sep 24, 1996 ➤ Sign Up ➤ Sign Up
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-004 Sep 24, 1996 ➤ Sign Up ➤ Sign Up
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-003 May 1, 1998 ➤ Sign Up ➤ Sign Up
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-003 May 1, 1998 ➤ Sign Up ➤ Sign Up
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-005 Sep 24, 1996 ➤ Sign Up ➤ Sign Up
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-003 May 1, 1998 ➤ Sign Up ➤ Sign Up
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-003 May 1, 1998 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Moodys
Express Scripts
AstraZeneca
Accenture
Fish and Richardson
Dow
Deloitte
Cantor Fitzgerald
Federal Trade Commission

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 data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. 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.

botpot