Mucinex Dm 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 Dm'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). | |||
| 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
|
| US6372252 | Guaifenesin sustained release formulation and tablets |
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 Dm's patents.
Latest Legal Activities on Mucinex Dm's Patents
Given below is the list of recent legal activities going on the following patents of Mucinex Dm.
| 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 Dm 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 Dm's family patents as well as insights into ongoing legal events on those patents.
Mucinex Dm's Family Patents
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Generic Launch
Generic Release Date:
Mucinex Dm'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 Dm Generic API suppliers:
Dextromethorphan Hydrobromide; Guaifenesin is the generic name for the brand Mucinex Dm. 6 different companies have already filed for the generic of Mucinex Dm, with Actavis Labs Fl having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Mucinex Dm's generic
How can I launch a generic of Mucinex Dm before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Mucinex Dm's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Mucinex Dm'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 Dm -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 600 mg/30 mg and 1200 mg/60 mg | 17 Dec, 2008 | 1 | 31 Aug, 2015 | 28 Apr, 2020 | Deferred |
About Mucinex Dm
Mucinex Dm is a drug owned by Rb Health Us Llc. It is used for treating cough and promoting the removal of mucus from the respiratory tract. Mucinex Dm uses Dextromethorphan Hydrobromide; Guaifenesin as an active ingredient. Mucinex Dm was launched by Rb Hlth in 2004.
Approval Date:
Mucinex Dm was approved by FDA for market use on 29 April, 2004.
Active Ingredient:
Mucinex Dm uses Dextromethorphan Hydrobromide; Guaifenesin as the active ingredient. Check out other Drugs and Companies using Dextromethorphan Hydrobromide; Guaifenesin ingredient
Treatment:
Mucinex Dm is used for treating cough and promoting the removal of mucus from the respiratory tract.
Dosage:
Mucinex Dm is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 60MG;1.2GM | TABLET, EXTENDED RELEASE | Over the counter | ORAL |
| 30MG;600MG | TABLET, EXTENDED RELEASE | Over the counter | ORAL |