Karbinal Er is a drug owned by Aytu Bioscience Inc. It is protected by 2 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 Mar 29, 2029. Details of Karbinal Er'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). | |||
| US8062667 | Modified release formulations containing drug-ion exchange resin complexes |
Mar, 2029
(3 years from now) | Active |
| US9522191 | Modified release formulations containing drug—ion exchange resin complexes |
Jun, 2027
(2 years 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 Karbinal Er's patents.
Latest Legal Activities on Karbinal Er's Patents
Given below is the list of recent legal activities going on the following patents of Karbinal Er.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 10 May, 2023 | US8062667 (Litigated) |
| Payment of Maintenance Fee, 4th Year, Large Entity | 05 Jun, 2020 | US9522191 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 09 May, 2019 | US8062667 (Litigated) |
| Patent Issue Date Used in PTA Calculation Critical | 20 Dec, 2016 | US9522191 |
| Recordation of Patent Grant Mailed Critical | 20 Dec, 2016 | US9522191 |
| Email Notification Critical | 01 Dec, 2016 | US9522191 |
| Issue Notification Mailed Critical | 30 Nov, 2016 | US9522191 |
| Dispatch to FDC | 15 Nov, 2016 | US9522191 |
| Application Is Considered Ready for Issue Critical | 14 Nov, 2016 | US9522191 |
| Issue Fee Payment Received Critical | 11 Nov, 2016 | US9522191 |
US patents provide insights into the exclusivity only within the United States, but Karbinal Er 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 Karbinal Er's family patents as well as insights into ongoing legal events on those patents.
Karbinal Er's Family Patents
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Generic Launch
Generic Release Date:
Karbinal Er's generic launch date based on the expiry of its last outstanding patent is estimated to be Mar 29, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Karbinal Er Generic API suppliers:
Carbinoxamine Maleate is the generic name for the brand Karbinal Er. 8 different companies have already filed for the generic of Karbinal Er, with Genus having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Karbinal Er's generic
About Karbinal Er
Karbinal Er is a drug owned by Aytu Bioscience Inc. Karbinal Er uses Carbinoxamine Maleate as an active ingredient. Karbinal Er was launched by Aytu in 2013.
Approval Date:
Karbinal Er was approved by FDA for market use on 28 March, 2013.
Active Ingredient:
Karbinal Er uses Carbinoxamine Maleate as the active ingredient. Check out other Drugs and Companies using Carbinoxamine Maleate ingredient
Dosage:
Karbinal Er is available in suspension, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 4MG/5ML | SUSPENSION, EXTENDED RELEASE | Prescription | ORAL |