Khindivi is a drug owned by Eton Pharmaceuticals Inc. It is protected by 2 US drug patents filed in 2025 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 23, 2043. Details of Khindivi'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). | |||
| US11904046 | NA |
Feb, 2043
(16 years from now) | Active |
| US12133914 | Hydrocortisone Oral Liquid Formulations |
Feb, 2043
(16 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 Khindivi's patents.
Latest Legal Activities on Khindivi's Patents
Given below is the list of recent legal activities going on the following patents of Khindivi.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Patent eGrant Notification | 05 Nov, 2024 | US12133914 |
| Email Notification | 05 Nov, 2024 | US12133914 |
| Recordation of Patent eGrant | 05 Nov, 2024 | US12133914 |
| Recordation of Patent Grant Mailed | 05 Nov, 2024 | US12133914 |
| Patent Issue Date Used in PTA Calculation | 05 Nov, 2024 | US12133914 |
| Mail Patent eGrant Notification | 05 Nov, 2024 | US12133914 |
| Email Notification | 16 Oct, 2024 | US12133914 |
| Issue Notification Mailed | 16 Oct, 2024 | US12133914 |
| Email Notification | 01 Oct, 2024 | US12133914 |
| Mail Response to 312 Amendment (PTO-271) | 01 Oct, 2024 | US12133914 |
US patents provide insights into the exclusivity only within the United States, but
Khindivi 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 Khindivi's family patents as well as insights into
ongoing legal events
on those patents.
Khindivi's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Khindivi:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
Generic Launch
Generic Release Date:
Khindivi's generic launch date based on the expiry of its last outstanding patent is estimated to be Feb 23, 2043 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Khindivi Generic API suppliers:
Hydrocortisone is the generic name for the brand Khindivi. 73 different companies have already filed for the generic of Khindivi, with Bausch having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Khindivi's generic
Alternative Brands for Khindivi
There are several other brand drugs using the same active ingredient (Hydrocortisone) as Khindivi. 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 |
| ||
| Eton |
| ||
| Precision Dermat |
| ||
| Sandoz |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Hydrocortisone, Khindivi's active ingredient. Check the complete list of approved generic manufacturers for Khindivi
About Khindivi
Khindivi is a drug owned by Eton Pharmaceuticals Inc. Khindivi uses Hydrocortisone as an active ingredient. Khindivi was launched by Eton in 2025.
Approval Date:
Khindivi was approved by FDA for market use on 28 May, 2025.
Active Ingredient:
Khindivi uses Hydrocortisone as the active ingredient. Check out other Drugs and Companies using Hydrocortisone ingredient
Dosage:
Khindivi is available in solution form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1MG/ML | SOLUTION | Prescription | ORAL |