Naropin Patent Expiration

Naropin is a drug owned by Fresenius Kabi Usa Llc. It is protected by 6 US drug patents filed from 2013 to 2016. Out of these, 2 drug patents are active and 4 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 28, 2026. Details of Naropin's patents and their expiration are given in the table below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US7857802 Connector for medical liquid-containing packages and medical liquid-containing packages
Nov, 2026

(2 years from now)

Active
US7828787 Connector for packaging containing medical fluids and packaging for medical fluids
Oct, 2025

(1 year, 3 days from now)

Active
US8162915 Connector for packings containing medical liquids, and corresponding packing for medical liquids
May, 2024

(4 months ago)

Expired
US8118802 Connector for packaging containing medical fluids and packaging for medical fluids
May, 2023

(1 year, 4 months ago)

Expired
US5670524 Methods and compositions for the treatment of pain utilizing ropivacaine
Sep, 2014

(10 years ago)

Expired
US5834489 Methods and compositions for the treatment of pain utilizing ropivacaine
May, 2014

(10 years ago)

Expired


A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Naropin's patents.

Given below is the list of recent legal activities going on the following patents of Naropin.

Activity Date Patent Number
Patent litigations
Expire Patent 27 May, 2024 US8162915 (Litigated)
Expire Patent 25 Mar, 2024 US8118802 (Litigated)
Maintenance Fee Reminder Mailed 11 Dec, 2023 US8162915 (Litigated)
Maintenance Fee Reminder Mailed 09 Oct, 2023 US8118802 (Litigated)
Payment of Maintenance Fee, 12th Year, Large Entity 13 May, 2022 US7857802
Payment of Maintenance Fee, 12th Year, Large Entity 22 Apr, 2022 US7828787 (Litigated)
Payment of Maintenance Fee, 8th Year, Large Entity 23 Sep, 2019 US8162915 (Litigated)
Payment of Maintenance Fee, 8th Year, Large Entity 08 Jul, 2019 US8118802 (Litigated)
Payment of Maintenance Fee, 8th Year, Large Entity 25 May, 2018 US7857802
Payment of Maintenance Fee, 8th Year, Large Entity 27 Apr, 2018 US7828787 (Litigated)

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US patents provide insights into the exclusivity only within the United States, but Naropin is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Naropin's family patents as well as insights into ongoing legal events on those patents.

Naropin's Family Patents

Naropin has patent protection in a total of 20 countries. It's US patent count contributes only to 6.1% of its total global patent coverage. Click below to unlock the full patent family tree for Naropin.

Family Patents

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Generic Launch

Generic Release Date:

Naropin's generic launch date based on the expiry of its last outstanding patent is estimated to be Nov 28, 2026 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Naropin Generics:

Ropivacaine Hydrochloride is the generic name for the brand Naropin. 12 different companies have already filed for the generic of Naropin, with Kindos having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Naropin's generic

How can I launch a generic of Naropin before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Naropin's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Naropin's sponsor is invalid, unenforceable, or will not be infringed by your generic product.

Given below are the details of the already filed Para IV certificates on Naropin -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
2 mg/mL, 5 mg/mL and 10 mg/mL, 20 mL, 30 mL and 20 mL vials 13 Nov, 2006 1 17 Jul, 2014 23 Sep, 2014 Extinguished
2 mg/mL, 100 mL 30 Jan, 2015 1 13 Jul, 2016 28 Nov, 2026 Eligible
2 mg/mL, 200 mL 03 Sep, 2015 1 16 Mar, 2018 28 Nov, 2026 Extinguished





About Naropin

Naropin is a drug owned by Fresenius Kabi Usa Llc. It is used for pain management. Naropin uses Ropivacaine Hydrochloride as an active ingredient. Naropin was launched by Fresenius Kabi Usa in 2011.

Approval Date:

Naropin was approved by FDA for market use on 04 January, 2011.

Active Ingredient:

Naropin uses Ropivacaine Hydrochloride as the active ingredient. Check out other Drugs and Companies using Ropivacaine Hydrochloride ingredient

Treatment:

Naropin is used for pain management.

Dosage:

Naropin is available in solution form for injection use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
400MG/200ML (2MG/ML) SOLUTION Prescription INJECTION
20MG/10ML (2MG/ML) SOLUTION Prescription INJECTION
200MG/100ML (2MG/ML) SOLUTION Prescription INJECTION
150MG/20ML (7.5MG/ML) SOLUTION Prescription INJECTION
100MG/20ML (5MG/ML) SOLUTION Prescription INJECTION
100MG/10ML (10MG/ML) SOLUTION Prescription INJECTION