Mucinex D 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 D'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
|
| US7838032 | Sustained release of guaifenesin |
Apr, 2020
(4 years ago) |
Expired
|
| US6955821 | Sustained release formulations of guaifenesin and additional drug ingredients |
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 D's patents.
Latest Legal Activities on Mucinex D's Patents
Given below is the list of recent legal activities going on the following patents of Mucinex D.
| 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 D 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 D's family patents as well as insights into ongoing legal events on those patents.
Mucinex D's Family Patents
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Generic Launch
Generic Release Date:
Mucinex D'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 D Generic API suppliers:
Guaifenesin; Pseudoephedrine Hydrochloride is the generic name for the brand Mucinex D. 6 different companies have already filed for the generic of Mucinex D, 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 D's generic
How can I launch a generic of Mucinex D before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Mucinex D's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Mucinex D'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 D -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 600 mg/60 mg and 1200 mg/120 mg | 29 Dec, 2008 | 1 | 27 May, 2015 | 28 Apr, 2020 | Deferred |
About Mucinex D
Mucinex D is a drug owned by Rb Health Us Llc. It is used for treating symptoms of respiratory congestion and congestion in the nasal passages. Mucinex D uses Guaifenesin; Pseudoephedrine Hydrochloride as an active ingredient. Mucinex D was launched by Rb Hlth in 2004.
Approval Date:
Mucinex D was approved by FDA for market use on 22 June, 2004.
Active Ingredient:
Mucinex D uses Guaifenesin; Pseudoephedrine Hydrochloride as the active ingredient. Check out other Drugs and Companies using Guaifenesin; Pseudoephedrine Hydrochloride ingredient
Treatment:
Mucinex D is used for treating symptoms of respiratory congestion and congestion in the nasal passages.
Dosage:
Mucinex D is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 600MG;60MG | TABLET, EXTENDED RELEASE | Over the counter | ORAL |
| 1.2GM;120MG | TABLET, EXTENDED RELEASE | Over the counter | ORAL |