Amrix is a drug owned by Teva Pharmaceuticals International Gmbh. It is protected by 8 US drug patents filed from 2013 to 2018. Out of these, 1 drug patents are active and 7 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 26, 2025. Details of Amrix'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 active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8877245 | Modified release dosage forms of skeletal muscle relaxants |
Nov, 2023
(8 months ago) |
Expired
|
| US9399025 | Modified release dosage forms of skeletal muscle relaxants |
Nov, 2023
(8 months ago) |
Expired
|
| US7790199 | Modified release dosage forms of skeletal muscle relaxants |
Nov, 2023
(8 months ago) |
Expired
|
| US9375410 | Modified release dosage forms of skeletal muscle relaxants |
Nov, 2023
(8 months ago) |
Expired
|
| US7829121 | Modified release dosage forms of skeletal muscle relaxants |
Nov, 2023
(8 months ago) |
Expired
|
| US7544372 | Modified release dosage forms of skeletal muscle relaxants |
Nov, 2023
(8 months ago) |
Expired
|
| US7820203 | Modified release dosage forms of skeletal muscle relaxants |
Nov, 2023
(8 months ago) |
Expired
|
| US7387793 | Modified release dosage forms of skeletal muscle relaxants |
Feb, 2025
(6 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 Amrix's patents.
Latest Legal Activities on Amrix's Patents
Given below is the list of recent legal activities going on the following patents of Amrix.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Expire Patent | 12 Dec, 2022 | US8877245 (Litigated) |
| Expire Patent | 12 Dec, 2022 | US7829121 (Litigated) |
| Expire Patent | 28 Nov, 2022 | US7820203 (Litigated) |
| Expire Patent | 10 Oct, 2022 | US7790199 (Litigated) |
| Maintenance Fee Reminder Mailed | 27 Jun, 2022 | US8877245 (Litigated) |
| Maintenance Fee Reminder Mailed | 27 Jun, 2022 | US7829121 (Litigated) |
| Maintenance Fee Reminder Mailed | 13 Jun, 2022 | US7820203 (Litigated) |
| Maintenance Fee Reminder Mailed | 25 Apr, 2022 | US7790199 (Litigated) |
| Expire Patent | 12 Jul, 2021 | US7544372 (Litigated) |
| Maintenance Fee Reminder Mailed | 25 Jan, 2021 | US7544372 (Litigated) |
US patents provide insights into the exclusivity only within the United States, but Amrix 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 Amrix's family patents as well as insights into ongoing legal events on those patents.
Amrix's family patents
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Generic Launch
Generic Release Date:
Amrix's generic launch date based on the expiry of its last outstanding patent is estimated to be Feb 26, 2025 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Amrix Generics:
Cyclobenzaprine Hydrochloride is the generic name for the brand Amrix. 21 different companies have already filed for the generic of Amrix, with Chartwell Rx having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Amrix's generic
How can I launch a generic of Amrix before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Amrix's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Amrix'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 Amrix -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 15 mg and 30 mg | 11 Aug, 2008 | 1 | 26 Feb, 2025 | Extinguished Non-Forfeiture |
About Amrix
Amrix is a drug owned by Teva Pharmaceuticals International Gmbh. It is used for relieving muscle spasms. Amrix uses Cyclobenzaprine Hydrochloride as an active ingredient. Amrix was launched by Teva Pharms Intl in 2007.
Market Authorisation Date:
Amrix was approved by FDA for market use on 01 February, 2007.
Active Ingredient:
Amrix uses Cyclobenzaprine Hydrochloride as the active ingredient. Check out other Drugs and Companies using Cyclobenzaprine Hydrochloride ingredient
Treatment:
Amrix is used for relieving muscle spasms.
Dosage:
Amrix is available in capsule, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 15MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |
| 30MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |