Skelaxin Patent Expiration

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, 3 months from now)

Active
US7714006 Methods of modifying the bioavailability of metaxalone
Dec, 2021

(2 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.

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

Activity Date Patent Number
Patent litigations
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 17 Dec, 2015 US7122566
Change in Power of Attorney (May Include Associate POA) 17 Dec, 2015 US7122566
Correspondence Address Change 16 Dec, 2015 US7122566
Correspondence Address Change 21 Jul, 2015 US7714006
Post Issue Communication - Certificate of Correction 26 Jul, 2010 US7714006
Patent Issue Date Used in PTA Calculation 11 May, 2010 US7714006

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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


Family Patents

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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 Generics:

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
Metaxalone


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