Naprelan is a drug owned by Twi Pharmaceuticals Inc. It is protected by 1 US drug patent filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 10, 2014. Details of Naprelan'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). | |||
| US5637320 | Controlled absorption naproxen formulation for once-daily administration |
Jun, 2014
(10 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Naprelan 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 Naprelan's family patents as well as insights into ongoing legal events on those patents.
Naprelan's Family Patents
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Generic Launch
Generic Release Date:
Naprelan's generic launch date based on the expiry of its last outstanding patent is estimated to be Jun 10, 2014 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Naprelan Generic API suppliers:
Naproxen Sodium is the generic name for the brand Naprelan. 33 different companies have already filed for the generic of Naprelan, with Teva having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Naprelan's generic
How can I launch a generic of Naprelan before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Naprelan's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Naprelan'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 Naprelan -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 375 mg (base) and 500 mg (base) |
Alternative Brands for Naprelan
There are several other brand drugs using the same active ingredient (Naproxen Sodium) as Naprelan. 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 | |
|---|---|---|
| Bionpharma |
| |
| Currax |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Naproxen Sodium, Naprelan's active ingredient. Check the complete list of approved generic manufacturers for Naprelan
About Naprelan
Naprelan is a drug owned by Twi Pharmaceuticals Inc. Naprelan uses Naproxen Sodium as an active ingredient. Naprelan was launched by Twi Pharms in 1996.
Approval Date:
Naprelan was approved by FDA for market use on 05 January, 1996.
Active Ingredient:
Naprelan uses Naproxen Sodium as the active ingredient. Check out other Drugs and Companies using Naproxen Sodium ingredient
Dosage:
Naprelan is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 500MG BASE | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| EQ 750MG BASE | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| EQ 375MG BASE | TABLET, EXTENDED RELEASE | Prescription | ORAL |