Naproxen Sodium is a drug owned by Bionpharma Inc. It is protected by 5 US drug patents filed from 2018 to 2021 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 03, 2026. Details of Naproxen Sodium'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). | |||
| US9693979 | Liquid dosage forms of sodium naproxen |
Mar, 2026
(9 months from now) | Active |
| US9693978 | Solvent system for enhancing the solubility of pharmaceutical agents |
Mar, 2026
(9 months from now) | Active |
| US10028925 | Liquid dosage forms of sodium naproxen |
Mar, 2026
(9 months from now) | Active |
| US10022344 | Liquid dosage forms of sodium naproxen |
Mar, 2026
(9 months from now) | Active |
| US11090280 | Liquid dosage forms of sodium naproxen |
Mar, 2026
(9 months from now) | Active |
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 Naproxen Sodium's patents.
Latest Legal Activities on Naproxen Sodium's Patents
Given below is the list of recent legal activities going on the following patents of Naproxen Sodium.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 12 Jan, 2022 | US10028925 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 05 Jan, 2022 | US10022344 |
| Patent Issue Date Used in PTA Calculation Critical | 17 Aug, 2021 | US11090280 |
| Recordation of Patent Grant Mailed Critical | 17 Aug, 2021 | US11090280 |
| Email Notification Critical | 29 Jul, 2021 | US11090280 |
| Issue Notification Mailed Critical | 28 Jul, 2021 | US11090280 |
| Application Is Considered Ready for Issue Critical | 22 Jul, 2021 | US11090280 |
| Dispatch to FDC | 22 Jul, 2021 | US11090280 |
| Response to Reasons for Allowance | 13 Jul, 2021 | US11090280 |
| Issue Fee Payment Verified Critical | 13 Jul, 2021 | US11090280 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Naproxen Sodium and ongoing litigations to help you estimate the early arrival of Naproxen Sodium generic.
Naproxen Sodium's Litigations
Naproxen Sodium been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jan 14, 2018, against patent number US9693979. The petitioner Catalent Pharma Solutions, Inc., challenged the validity of this patent, with Patheon Softgels Inc. as the respondent. Click below to track the latest information on how companies are challenging Naproxen Sodium's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US11090280 | July, 2020 |
Decision
(24 May, 2021) | PATHEON SOFTGELS INC | |
| US9693978 | January, 2018 |
Terminated-Denied
(13 Aug, 2018) | Patheon Softgels Inc. | Catalent Pharma Solutions, Inc. |
| US9693979 | January, 2018 |
Terminated-Denied
(13 Aug, 2018) | Patheon Softgels Inc. | Catalent Pharma Solutions, Inc. |
Several oppositions have been filed on Naproxen Sodium's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Naproxen Sodium's generic, the next section provides detailed information on ongoing and past EP oppositions related to Naproxen Sodium patents.
Naproxen Sodium's Oppositions Filed in EPO
Naproxen Sodium has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jun 14, 2017, by Dieckhoff, Beate. This opposition was filed on patent number EP06737018A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP06737018A | Jun, 2017 | Dieckhoff, Beate | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Naproxen Sodium 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 Naproxen Sodium's family patents as well as insights into ongoing legal events on those patents.
Naproxen Sodium's Family Patents
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Generic Launch
Generic Release Date:
Naproxen Sodium's generic launch date based on the expiry of its last outstanding patent is estimated to be Mar 03, 2026 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Naproxen Sodium Generic API suppliers:
Naproxen Sodium is the generic name for the brand Naproxen Sodium. 33 different companies have already filed for the generic of Naproxen Sodium, with Teva having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Naproxen Sodium's generic
How can I launch a generic of Naproxen Sodium before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Naproxen Sodium's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Naproxen Sodium'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 Naproxen Sodium -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 200 mg | 15 Nov, 2017 | 1 | 03 Mar, 2026 | Extinguished |
Alternative Brands for Naproxen Sodium
Naproxen Sodium which is used for reducing fever., has several other brand drugs in the same treatment category and using the same active ingredient (Naproxen Sodium). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||
|---|---|---|---|---|
| Plx Pharma |
| |||
Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Naproxen Sodium. Given below is the list of those drugs and companies owning them.
Apart from brand drugs containing the same ingredient, some generics have also been filed for Naproxen Sodium, Naproxen Sodium's active ingredient. Check the complete list of approved generic manufacturers for Naproxen Sodium
About Naproxen Sodium
Naproxen Sodium is a drug owned by Bionpharma Inc. It is used for reducing fever. Naproxen Sodium uses Naproxen Sodium as an active ingredient. Naproxen Sodium was launched by Bionpharma in 2006.
Approval Date:
Naproxen Sodium was approved by FDA for market use on 17 February, 2006.
Active Ingredient:
Naproxen Sodium uses Naproxen Sodium as the active ingredient. Check out other Drugs and Companies using Naproxen Sodium ingredient
Treatment:
Naproxen Sodium is used for reducing fever.
Dosage:
Naproxen Sodium is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 200MG BASE | CAPSULE | Over the counter | ORAL |