Mucinex is a drug owned by Rb Health Us Llc. It is protected by 3 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 Apr 28, 2020. Details of Mucinex'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). | |||
| US6372252 | Guaifenesin sustained release formulation and tablets |
Apr, 2020
(4 years ago) |
Expired
|
| US6955821 | Sustained release formulations of guaifenesin and additional drug ingredients |
Apr, 2020
(4 years ago) |
Expired
|
| US7838032 | Sustained release of guaifenesin |
Apr, 2020
(4 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 Mucinex's patents.
Latest Legal Activities on Mucinex's Patents
Given below is the list of recent legal activities going on the following patents of Mucinex.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 26 Dec, 2022 | US7838032 (Litigated) |
| Maintenance Fee Reminder Mailed Critical | 11 Jul, 2022 | US7838032 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 10 May, 2018 | US7838032 (Litigated) |
| Recordation of Patent Grant Mailed Critical | 23 Nov, 2010 | US7838032 (Litigated) |
| Patent Issue Date Used in PTA Calculation Critical | 23 Nov, 2010 | US7838032 (Litigated) |
| Issue Notification Mailed Critical | 03 Nov, 2010 | US7838032 (Litigated) |
| PARALEGAL OR ELECTRONIC TERMINAL DISCLAIMER APPROVED Critical | 18 Oct, 2010 | US7838032 (Litigated) |
| Dispatch to FDC | 15 Oct, 2010 | US7838032 (Litigated) |
| Printer Rush- No mailing | 15 Oct, 2010 | US7838032 (Litigated) |
| Amendment after Notice of Allowance (Rule 312) Critical | 13 Oct, 2010 | US7838032 (Litigated) |
US patents provide insights into the exclusivity only within the United States, but Mucinex 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 Mucinex's family patents as well as insights into ongoing legal events on those patents.
Mucinex's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Mucinex's generic launch date based on the expiry of its last outstanding patent is estimated to be Apr 28, 2020 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Mucinex Generic API suppliers:
Guaifenesin is the generic name for the brand Mucinex. 9 different companies have already filed for the generic of Mucinex, with Perrigo R And D having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Mucinex's generic
How can I launch a generic of Mucinex before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Mucinex's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Mucinex'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 Mucinex -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 600 mg and 1.2 gm | 09 Jun, 2006 | 1 | 28 Apr, 2020 | Extinguished |
Alternative Brands for Mucinex
Mucinex which is used for treating respiratory conditions by promoting the expulsion of mucus from the lungs., has several other brand drugs using the same active ingredient (Guaifenesin). 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 | ||
|---|---|---|---|
| Rb Hlth |
| ||
| Sovereign Pharms |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Guaifenesin, Mucinex's active ingredient. Check the complete list of approved generic manufacturers for Mucinex
About Mucinex
Mucinex is a drug owned by Rb Health Us Llc. It is used for treating respiratory conditions by promoting the expulsion of mucus from the lungs. Mucinex uses Guaifenesin as an active ingredient. Mucinex was launched by Rb Hlth in 2002.
Approval Date:
Mucinex was approved by FDA for market use on 18 December, 2002.
Active Ingredient:
Mucinex uses Guaifenesin as the active ingredient. Check out other Drugs and Companies using Guaifenesin ingredient
Treatment:
Mucinex is used for treating respiratory conditions by promoting the expulsion of mucus from the lungs.
Dosage:
Mucinex is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 600MG | TABLET, EXTENDED RELEASE | Over the counter | ORAL |
| 1.2GM | TABLET, EXTENDED RELEASE | Over the counter | ORAL |