Naproxen Sodium Patent Expiration

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).
US10028925 Liquid dosage forms of sodium naproxen
Mar, 2026

(1 year, 3 months from now)

Active
US10022344 Liquid dosage forms of sodium naproxen
Mar, 2026

(1 year, 3 months from now)

Active
US11090280 Liquid dosage forms of sodium naproxen
Mar, 2026

(1 year, 3 months from now)

Active
US9693979 Liquid dosage forms of sodium naproxen
Mar, 2026

(1 year, 3 months from now)

Active
US9693978 Solvent system for enhancing the solubility of pharmaceutical agents
Mar, 2026

(1 year, 3 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.

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

Activity Date Patent Number
Patent litigations
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 17 Aug, 2021 US11090280
Recordation of Patent Grant Mailed 17 Aug, 2021 US11090280
Email Notification 29 Jul, 2021 US11090280
Issue Notification Mailed 28 Jul, 2021 US11090280
Application Is Considered Ready for Issue 22 Jul, 2021 US11090280
Dispatch to FDC 22 Jul, 2021 US11090280
Response to Reasons for Allowance 13 Jul, 2021 US11090280
Issue Fee Payment Verified 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.

Last updated on November 19, 2024
Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
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.

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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
Patent litigations
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

Naproxen Sodium has patent protection in a total of 13 countries. It's US patent count contributes only to 39.1% of its total global patent coverage. 1 country has all of their patents expired or invalidated which has opened up potential generic launch opportunities in this particular country. Click below to unlock the full patent family tree for Naproxen Sodium.

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
Vazalore Used for targeting release to the small intestine, reducing fever, and relieving minor aches and pains.

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.

Drug Owner Drug Name
Currax
Treximet
Twi Pharms
Naprelan


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