Skelaxin is a drug owned by King Pharmaceuticals Research And Development Llc A Sub Of Pfizer Inc. It is protected by 2 US drug patents filed in 2013. Out of these, 1 drug patents are active and 1 has expired. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 06, 2026. Details of Skelaxin'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). | |||
| US7122566 | Metaxalone products, method of manufacture, and method of use |
Feb, 2026
(1 year, 1 month from now) | Active |
| US7714006 | Methods of modifying the bioavailability of metaxalone |
Dec, 2021
(3 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 Skelaxin's patents.
Latest Legal Activities on Skelaxin's Patents
Given below is the list of recent legal activities going on the following patents of Skelaxin.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 14 Oct, 2021 | US7714006 |
| 11.5 yr surcharge- late pmt w/in 6 mo, Large Entity | 03 May, 2018 | US7122566 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 03 May, 2018 | US7122566 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 16 Oct, 2017 | US7714006 |
| Email Notification Critical | 17 Dec, 2015 | US7122566 |
| Change in Power of Attorney (May Include Associate POA) Critical | 17 Dec, 2015 | US7122566 |
| Correspondence Address Change Critical | 16 Dec, 2015 | US7122566 |
| Correspondence Address Change Critical | 21 Jul, 2015 | US7714006 |
| Post Issue Communication - Certificate of Correction | 26 Jul, 2010 | US7714006 |
| Patent Issue Date Used in PTA Calculation Critical | 11 May, 2010 | US7714006 |
US patents provide insights into the exclusivity only within the United States, but Skelaxin 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 Skelaxin's family patents as well as insights into ongoing legal events on those patents.
Skelaxin's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Skelaxin's generic launch date based on the expiry of its last outstanding patent is estimated to be Feb 06, 2026 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Skelaxin Generic API suppliers:
Metaxalone is the generic name for the brand Skelaxin. 8 different companies have already filed for the generic of Skelaxin, with Sciegen Pharms Inc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Skelaxin's generic
How can I launch a generic of Skelaxin before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Skelaxin's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Skelaxin'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 Skelaxin -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 400 mg | |||||
| 800 mg | 04 Nov, 2004 | 1 | 31 Mar, 2010 | 03 Dec, 2021 | Non-Forfeiture |
Alternative Brands for Skelaxin
Skelaxin which is used for relieving muscle pain and stiffness associated with musculoskeletal conditions., has several other brand drugs using the same active ingredient (Metaxalone). 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 | |
|---|---|---|
| Primus Pharms |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Metaxalone, Skelaxin's active ingredient. Check the complete list of approved generic manufacturers for Skelaxin
About Skelaxin
Skelaxin is a drug owned by King Pharmaceuticals Research And Development Llc A Sub Of Pfizer Inc. It is used for relieving muscle pain and stiffness associated with musculoskeletal conditions. Skelaxin uses Metaxalone as an active ingredient. Skelaxin was launched by King Pharms in 1982.
Approval Date:
Skelaxin was approved by FDA for market use on 01 January, 1982.
Active Ingredient:
Skelaxin uses Metaxalone as the active ingredient. Check out other Drugs and Companies using Metaxalone ingredient
Treatment:
Skelaxin is used for relieving muscle pain and stiffness associated with musculoskeletal conditions.
Dosage:
Skelaxin is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |