Alkindi Sprinkle is a drug owned by Eton Pharmaceuticals Inc. It is protected by 3 US drug patents filed in 2021 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be May 12, 2034. Details of Alkindi Sprinkle'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). | |||
| US9649280 | Composition comprising hydrocortisone |
May, 2034
(7 years from now) | Active |
| US9675559 | Treatment of adrenal insufficiency |
Jan, 2033
(6 years from now) | Active |
| US9717740 | Treatment of adrenal insufficiency |
Nov, 2032
(6 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 Alkindi Sprinkle's patents.
Latest Legal Activities on Alkindi Sprinkle's Patents
Given below is the list of recent legal activities going on the following patents of Alkindi Sprinkle.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 03 Feb, 2025 | US9717740 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 13 Dec, 2024 | US9675559 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 18 Nov, 2024 | US9649280 |
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 02 Aug, 2024 | US9649280 |
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 02 Aug, 2024 | US9675559 |
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 02 Aug, 2024 | US9717740 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 20 Jan, 2021 | US9717740 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 25 Nov, 2020 | US9675559 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 04 Nov, 2020 | US9649280 |
| Mail O.P. Petition Decision | 08 Sep, 2017 | US9675559 |
US patents provide insights into the exclusivity only within the United States, but
Alkindi Sprinkle 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 Alkindi Sprinkle's family patents as well as insights into
ongoing legal events
on those patents.
Alkindi Sprinkle's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Alkindi Sprinkle:
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:
Alkindi Sprinkle's generic launch date based on the expiry of its last outstanding patent is estimated to be May 12, 2034 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Alkindi Sprinkle Generic API suppliers:
Hydrocortisone is the generic name for the brand Alkindi Sprinkle. 73 different companies have already filed for the generic of Alkindi Sprinkle, with Bausch having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Alkindi Sprinkle's generic
Alternative Brands for Alkindi Sprinkle
Alkindi Sprinkle which is used for treating adrenal insufficiency., has several other brand drugs using the same active ingredient (Hydrocortisone). 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, Alkindi Sprinkle's active ingredient. Check the complete list of approved generic manufacturers for Alkindi Sprinkle
About Alkindi Sprinkle
Alkindi Sprinkle is a drug owned by Eton Pharmaceuticals Inc. It is used for treating adrenal insufficiency. Alkindi Sprinkle uses Hydrocortisone as an active ingredient. Alkindi Sprinkle was launched by Eton in 2020.
Approval Date:
Alkindi Sprinkle was approved by FDA for market use on 29 September, 2020.
Active Ingredient:
Alkindi Sprinkle uses Hydrocortisone as the active ingredient. Check out other Drugs and Companies using Hydrocortisone ingredient
Treatment:
Alkindi Sprinkle is used for treating adrenal insufficiency.
Dosage:
Alkindi Sprinkle is available in granule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 2MG | GRANULE | Prescription | ORAL |
| 5MG | GRANULE | Prescription | ORAL |
| 1MG | GRANULE | Prescription | ORAL |
| 0.5MG | GRANULE | Prescription | ORAL |