Bethkis is a drug owned by Chiesi Usa Inc. 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 Mar 17, 2023. Details of Bethkis'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). | |||
| US7696178 | Optimised formulation of tobramycin for aerosolization |
Mar, 2023
(1 year, 9 months ago) |
Expired
|
| US6987094 | Optimized formulation of tobramycin for aerosolization |
Sep, 2022
(2 years ago) |
Expired
|
| US7939502 | Optimised formulation of tobramycin for aerosolization |
Jun, 2022
(2 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 Bethkis's patents.
Latest Legal Activities on Bethkis's Patents
Given below is the list of recent legal activities going on the following patents of Bethkis.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 12 Jun, 2023 | US7939502 |
| Maintenance Fee Reminder Mailed Critical | 26 Dec, 2022 | US7939502 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 13 Oct, 2021 | US7696178 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 12 Nov, 2018 | US7939502 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 13 Oct, 2017 | US7696178 |
| Recordation of Patent Grant Mailed Critical | 10 May, 2011 | US7939502 |
| Patent Issue Date Used in PTA Calculation Critical | 10 May, 2011 | US7939502 |
| Email Notification Critical | 21 Apr, 2011 | US7939502 |
| Issue Notification Mailed Critical | 20 Apr, 2011 | US7939502 |
| Dispatch to FDC | 04 Apr, 2011 | US7939502 |
US patents provide insights into the exclusivity only within the United States, but Bethkis 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 Bethkis's family patents as well as insights into ongoing legal events on those patents.
Bethkis's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Bethkis's generic launch date based on the expiry of its last outstanding patent is estimated to be Mar 17, 2023 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Bethkis Generic API suppliers:
Tobramycin is the generic name for the brand Bethkis. 20 different companies have already filed for the generic of Bethkis, with Mankind Pharma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Bethkis's generic
How can I launch a generic of Bethkis before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Bethkis's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Bethkis'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 Bethkis -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 300 mg/4 mL | 31 Aug, 2017 | 1 | 26 Jun, 2019 | 22 Sep, 2022 | Extinguished Eligible |
Alternative Brands for Bethkis
Bethkis which is used for managing cystic fibrosis patients., has several other brand drugs using the same active ingredient (Tobramycin). 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 | ||
|---|---|---|---|
| Bausch And Lomb |
| ||
| Harrow Eye |
| ||
| Mylan Speciality Lp |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Tobramycin, Bethkis's active ingredient. Check the complete list of approved generic manufacturers for Bethkis
About Bethkis
Bethkis is a drug owned by Chiesi Usa Inc. It is used for managing cystic fibrosis patients. Bethkis uses Tobramycin as an active ingredient. Bethkis was launched by Chiesi in 2012.
Approval Date:
Bethkis was approved by FDA for market use on 12 October, 2012.
Active Ingredient:
Bethkis uses Tobramycin as the active ingredient. Check out other Drugs and Companies using Tobramycin ingredient
Treatment:
Bethkis is used for managing cystic fibrosis patients.
Dosage:
Bethkis is available in solution form for inhalation use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 300MG/4ML | SOLUTION | Prescription | INHALATION |