Meloxicam is a drug owned by Avondale Pharmaceuticals Llc. It is protected by 2 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 25, 2019. Details of Meloxicam'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). | |||
|
US6184220 (Pediatric) | Oral suspension of pharmaceutical substance |
Sep, 2019
(5 years ago) |
Expired
|
| US6184220 | Oral suspension of pharmaceutical substance |
Mar, 2019
(5 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 Meloxicam's patents.
Latest Legal Activities on Meloxicam's Patents
Given below is the list of recent legal activities going on the following patents of Meloxicam.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Yr, Small Entity | 07 May, 2021 | US9808468 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 17 Mar, 2021 | US8545879 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 16 Nov, 2020 | US9649318 |
| Applicant Has Filed a Verified Statement of Small Entity Status in Compliance with 37 CFR 1.27 | 16 Oct, 2020 | US9649318 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 29 Jun, 2020 | US9526734 |
| Applicant Has Filed a Verified Statement of Small Entity Status in Compliance with 37 CFR 1.27 | 22 May, 2020 | US9526734 |
| Patent Issue Date Used in PTA Calculation Critical | 07 Nov, 2017 | US9808468 |
| Recordation of Patent Grant Mailed Critical | 07 Nov, 2017 | US9808468 |
| Email Notification Critical | 19 Oct, 2017 | US9808468 |
| Issue Notification Mailed Critical | 18 Oct, 2017 | US9808468 |
FDA has granted several exclusivities to Meloxicam. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Meloxicam, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Meloxicam.
Exclusivity Information
Meloxicam holds 2 exclusivities. All of its exclusivities have expired in 2013. Details of Meloxicam's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| Orphan Drug Exclusivity(ODE) | Aug 11, 2012 |
| Pediatric Exclusivity(PED) | Feb 11, 2013 |
US patents provide insights into the exclusivity only within the United States, but Meloxicam 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 Meloxicam's family patents as well as insights into ongoing legal events on those patents.
Meloxicam's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Meloxicam's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 25, 2019 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Meloxicam Generic API suppliers:
Meloxicam is the generic name for the brand Meloxicam. 25 different companies have already filed for the generic of Meloxicam, with Aiping Pharm Inc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Meloxicam's generic
How can I launch a generic of Meloxicam before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Meloxicam's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Meloxicam'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 Meloxicam -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 7.5 mg/5 mL | 17 Dec, 2009 | 1 | 25 Sep, 2019 | Extinguished |
Alternative Brands for Meloxicam
There are several other brand drugs using the same active ingredient (Meloxicam) as Meloxicam. 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 | |
|---|---|---|
| Baudax |
| |
| Heron Theraps Inc |
| |
| Iceutica Operations |
| |
| Tersera |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Meloxicam, Meloxicam's active ingredient. Check the complete list of approved generic manufacturers for Meloxicam
About Meloxicam
Meloxicam is a drug owned by Avondale Pharmaceuticals Llc. Meloxicam uses Meloxicam as an active ingredient. Meloxicam was launched by Avondale Pharms in 2004.
Approval Date:
Meloxicam was approved by FDA for market use on 01 June, 2004.
Active Ingredient:
Meloxicam uses Meloxicam as the active ingredient. Check out other Drugs and Companies using Meloxicam ingredient
Dosage:
Meloxicam is available in suspension form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 7.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION | Prescription | ORAL |