Acetadote is a drug owned by Cumberland Pharmaceuticals Inc. It is protected by 6 US drug patents filed from 2013 to 2016 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 10, 2035. Details of Acetadote'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). | |||
| US8952065 | Acetylcysteine composition and uses thereof |
Feb, 2035
(10 years from now) | Active |
| US8722738 | Acetycysteine compositions and methods of use thereof |
Apr, 2032
(7 years from now) | Active |
| US9327028 | Acetylcysteine compositions and methods of use thereof |
Jul, 2031
(6 years from now) | Active |
| US8148356 | Acetylcysteine composition and uses therefor |
May, 2026
(1 year, 6 months from now) | Active |
| US8399445 | Acetylcysteine composition and uses thereof |
Aug, 2025
(9 months from now) | Active |
| US8653061 | Acetylcysteine composition and uses thereof |
Aug, 2025
(9 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 Acetadote's patents.
Latest Legal Activities on Acetadote's Patents
Given below is the list of recent legal activities going on the following patents of Acetadote.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 20 Sep, 2023 | US8148356 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 03 Sep, 2020 | US8399445 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 20 Sep, 2019 | US8148356 (Litigated) |
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 22 Jan, 2018 | US8148356 (Litigated) |
| Post Issue Communication - Certificate of Correction | 15 Apr, 2014 | US8399445 (Litigated) |
| Post Issue Communication - Certificate of Correction | 15 May, 2013 | US8399445 (Litigated) |
| Patent Issue Date Used in PTA Calculation Critical | 19 Mar, 2013 | US8399445 (Litigated) |
| Recordation of Patent Grant Mailed Critical | 19 Mar, 2013 | US8399445 (Litigated) |
| Email Notification Critical | 28 Feb, 2013 | US8399445 (Litigated) |
| Issue Notification Mailed Critical | 27 Feb, 2013 | US8399445 (Litigated) |
US patents provide insights into the exclusivity only within the United States, but Acetadote 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 Acetadote's family patents as well as insights into ongoing legal events on those patents.
Acetadote's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Acetadote's generic launch date based on the expiry of its last outstanding patent is estimated to be Feb 10, 2035 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Acetadote Generic API suppliers:
Acetylcysteine is the generic name for the brand Acetadote. 15 different companies have already filed for the generic of Acetadote, with Roxane having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Acetadote's generic
How can I launch a generic of Acetadote before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Acetadote's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Acetadote'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 Acetadote -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 200 mg/mL, 30 mL vials | 04 Apr, 2012 | 3 | 07 Nov, 2012 | 21 May, 2026 | Eligible |
Alternative Brands for Acetadote
Acetadote which is used for treating acetaminophen overdose with acetylcysteine solutions to provide a reduction in side effects for human patients., has several other brand drugs in the same treatment category and using the same active ingredient (Acetylcysteine). 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 | Treatment Area | ||
|---|---|---|---|---|
| Arbor Pharms Llc |
| |||
Apart from brand drugs containing the same ingredient, some generics have also been filed for Acetylcysteine, Acetadote's active ingredient. Check the complete list of approved generic manufacturers for Acetadote
About Acetadote
Acetadote is a drug owned by Cumberland Pharmaceuticals Inc. It is used for treating acetaminophen overdose with acetylcysteine solutions to provide a reduction in side effects for human patients. Acetadote uses Acetylcysteine as an active ingredient. Acetadote was launched by Cumberland Pharms in 2004.
Approval Date:
Acetadote was approved by FDA for market use on 23 January, 2004.
Active Ingredient:
Acetadote uses Acetylcysteine as the active ingredient. Check out other Drugs and Companies using Acetylcysteine ingredient
Treatment:
Acetadote is used for treating acetaminophen overdose with acetylcysteine solutions to provide a reduction in side effects for human patients.
Dosage:
Acetadote is available in injectable form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 6GM/30ML (200MG/ML) | INJECTABLE | Prescription | INTRAVENOUS |