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
(1 year, 6 months from now) | Active |
| US7828787 | Connector for packaging containing medical fluids and packaging for medical fluids |
Oct, 2025
(5 months from now) | Active |
| US8162915 | Connector for packings containing medical liquids, and corresponding packing for medical liquids |
May, 2024
(11 months ago) |
Expired
|
| US8118802 | Connector for packaging containing medical fluids and packaging for medical fluids |
May, 2023
(1 year, 11 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.
Latest 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 |
|---|---|---|
 | ||
| Expire Patent Critical | 27 May, 2024 | US8162915 (Litigated) |
| Expire Patent Critical | 25 Mar, 2024 | US8118802 (Litigated) |
| Maintenance Fee Reminder Mailed Critical | 11 Dec, 2023 | US8162915 (Litigated) |
| Maintenance Fee Reminder Mailed Critical | 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) |
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
Explore Our Curated Drug Screens
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 Generic API suppliers:
Ropivacaine Hydrochloride is the generic name for the brand Naropin. 13 different companies have already filed for the generic of Naropin, with Hikma 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 |
|---|---|---|---|
| 200MG/100ML (2MG/ML) | SOLUTION | Prescription | INJECTION |
| 400MG/200ML (2MG/ML) | SOLUTION | Prescription | INJECTION |
| 20MG/10ML (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 |