Alkindi Sprinkle Generic: When Will Generic Hydrocortisone Be Available?
This page is aggregated from FDA records, court filings and company announcements. Coded and designed by Dr. Brian Staiger, PharmD, BCPS
Updated October 9, 2026 How we build our data
Alkindi Sprinkle Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? January 2033 About 6.5 years away Why then?
- Has the FDA approved a generic? August 1982 6 companies approved
- When does the last patent end? May 2034 3 patents listed with the FDA Why is a generic expected sooner?
- Can you buy a generic today? Yes 20 companies list one
It already is. A generic hydrocortisone is listed for sale by 20 companies, so ask your pharmacy whether it can fill your prescription with one.
Why January 2033?
It is when Alkindi Sprinkle’s patent 9,649,280 ends. That patent covers the product’s formulation and a way of using it, and once it ends, generics should be able to go on sale as soon as the FDA approves them. We rate it toss-up: still unsettled. Just as likely to slip as to hold.
If Alkindi Sprinkle’s last patent runs to May 2034, how can a generic come sooner?
The patent that runs to May 2034 (9,649,280) covers the product’s formulation and a way of using it. A patent like that protects one way of making or using the medicine, not the medicine itself. A generic company can often make its version a different way or leave that use off its label, or a court can rule the patent invalid or not infringed. That is why the expected month comes before the last protection ends. See the road to a generic
What should I do now?
Ask your pharmacy whether it can fill your prescription with a generic. It may look different from Alkindi Sprinkle, but the active ingredient, strength and form are the same. What a generic means for you
Our month is only an estimate based on available information, so we never name a day.
Alkindi Sprinkle by the Numbers
- Reason
- Patent expiresA patent that protects the brand runs out. After that, approved generics can be sold.
- How sure
- Toss-up Still unsettled. Just as likely to slip as to hold.
- Price competition
- None filed yet No filers on record
- Brand sales
- Sales not reported
- FDA approved 2020 September 2020 FDA Orange Book
- Patents listed 3 last runs to May 2034 FDA Orange Book
- Generics FDA-approved 6 companies, the first approved August 1982 FDA Orange Book
- Medicare Part D spent $37.5K in 2025 CMS Part D Spending by Drug
- Medicaid prescriptions 2,389 in the last four reported quarters, $7.4M CMS Medicaid drug utilization, to Q1 2026
Alkindi Sprinkle’s Road to a Generic
Alkindi Sprinkle has had the market to itself since the FDA approved it in September 2020 (Eton Pharmaceuticals Inc). Its 3 listed patents run to May 2034.
The first generic of Alkindi Sprinkle is expected in January 2033.
Why that month: patent 9,649,280, on the product’s formulation and a way of using it, ends then. That is about 1.5 years before the last listed patent runs out, in May 2034.
Why a Generic Can Come Before May 2034
The last listed patent runs to May 2034, but it covers the product’s formulation and a way of using it, not the medicine itself, which a generic can often work around or challenge. Dr. Brian explains
Each bar runs from the brand’s approval to the day that protection ends. The green band is our projection for the first generic: a month, never a day, because legal dates move and a generic reaches shelves days to weeks after it is allowed. Sources: FDA Orange Book; the expected month from court records and company announcements.
Alkindi Sprinkle Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Alkindi Sprinkle’s own applications. A protection running past the expected month does not mean the date is wrong: a settlement or a court ruling can let a generic in before a patent ends, and a patent on one formulation or use does not block every generic.
The one that matters for a generic launch: patent 9,649,280, which ends in May 2034. Why the later ones may not hold it back
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 9,717,740 | A way of using it (U-3075) | November 2032 | Active |
| 9,675,559 | A way of using it (U-3075) | January 2033 | Active |
| 9,649,280 Sets the expected month of generic availability | The product’s formulation; a way of using it (U-3075) | May 2034 | Active |
Source: FDA Orange Book, application 213876. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Hydrocortisone
Three steps stand between a brand and a generic you can buy: a company applies to the FDA, the FDA approves it, and the company starts selling it.
Applied to the FDA
No application count is on record for Alkindi Sprinkle, but the FDA has already approved 6 companies (step 2), and every approval starts with an application.
Approved by the FDA
The FDA has approved generic versions from 6 companies, the first in August 1982. Approved is not the same as on sale: patents, a settlement or the company’s own plans can still hold a launch.
For Sale in Pharmacies
Yes. A generic hydrocortisone is listed for sale by 20 companies. Ask your pharmacy whether it can fill your prescription with it.
American Health Packaging, Amneal Pharmaceuticals of New York LLC, ANI Pharmaceuticals, Inc., Asclemed USA, Inc., Aurobindo Pharma Limited, AvPAK and 14 more
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Impax Laboratories Inc | March 2007 | 5MG, 10MG, 20MG | AB |
| Strides Pharma Global Pte Ltd | April 2017 | 5MG, 10MG, 20MG | AB |
| Aurobindo Pharma Ltd | July 2023 | 5MG, 10MG, 20MG | AB |
| Hibrow Healthcare Private Ltd | November 2024 | 5MG, 10MG, 20MG | AB |
| Novitium Pharma LLC | May 2025 | 5MG, 10MG, 20MG | AB |
| Appco Pharma LLC | February 2026 | 5MG, 10MG, 20MG | AB |
| Purepac Pharmaceutical Co discontinued | August 1982 | 10MG, 20MG | – |
| Roxane Laboratories Inc discontinued | March 1984 | 10MG | – |
| Strides Pharma International AG discontinued | July 2007 | 5MG, 10MG, 20MG | – |
| Hikma International Pharmaceuticals LLC discontinued | February 2015 | 5MG, 10MG, 20MG | – |
| Barr Laboratories Inc discontinued | Not given | 20MG | – |
| Chartwell Molecular Holdings LLC discontinued | Not given | 20MG | – |
| Elkins Sinn Div Ah Robins Co Inc discontinued | Not given | 20MG | – |
| Inwood Laboratories Inc Sub Forest Laboratories Inc discontinued | Not given | 20MG | – |
| John J Ferrante discontinued | Not given | 10MG, 20MG | – |
| Nexgen Pharma Inc discontinued | Not given | 20MG | – |
| Parke Davis Div Warner Lambert Co discontinued | Not given | 20MG | – |
| Sandoz Inc discontinued | Not given | 20MG | – |
| Watson Laboratories Inc discontinued | Not given | 20MG | – |
| Whiteworth Towne Paulsen Inc discontinued | Not given | 10MG, 20MG | – |
Sources: how many companies have applied, from court records and company announcements; approved generics from the FDA Orange Book; tentative approvals from Drugs@FDA; what is for sale from the FDA NDC Directory. The FDA does not disclose an application before it approves it (21 CFR 314.430).
Alkindi Sprinkle Price: What Pharmacies Pay and What Generics Usually Do
What a Generic Could Cost
How we estimate it. The national survey of what pharmacies pay (NADAC) has no recent price for Alkindi Sprinkle, so we cannot show dollars. Here is the FDA’s finding of how far the price pharmacies pay usually falls as generic companies join: about 31% with one company, 44% with two, 73% with four and over 95% with six or more (the typical drop for every drug whose first generic came out from 2015 to 2017).
Median prices pharmacies paid for the generic (invoice prices), compared with the brand’s price before generic entry, from FDA’s 2019 analysis “Generic Competition and Drug Prices”. At the manufacturer’s price FDA found steeper drops (about 39%, 54%, 79% and over 95%), the figures quoted elsewhere on this tracker. A typical pattern, not a price quote for this medicine.
What Medicare and Medicaid Spend on Alkindi Sprinkle
Big public spending is part of why generic makers line up for a medicine, and why its first generic matters beyond the pharmacy counter. Figures are before manufacturer rebates, which are confidential.
Medicare Part D Spending
What Medicare drug plans spent on Alkindi Sprinkle, before manufacturer rebates.
- $37.5K
- 2025, the whole year
About $2,678 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| 2025 | $37,492 | – | $2,678.02 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Alkindi Sprinkle only, so no generic is counted in it. What CMS says it is used for: Hydrocortisone is a man-made version of a natural substance (cortisol) made by the adrenal gland. This drug is used to treat low cortisol levels caused by diseases of the adrenal gland (such as Addison's disease, adrenocortical insufficiency).
Medicaid Prescriptions by Quarter
2,389 prescriptions in the four quarters to Q1 2026, $7.4M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 519 | $1,746,685 |
| Q4 2025 | 670 | $2,065,483 |
| Q3 2025 | 609 | $1,728,189 |
| Q2 2025 | 591 | $1,822,441 |
| Q1 2025 | 535 | $1,549,433 |
Source: CMS Medicaid State Drug Utilization Data, over Alkindi Sprinkle’s own package codes.
Alkindi Sprinkle Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 0.5MG | Granule | Oral | September 2020 | Prescription reference product |
| 1MG | Granule | Oral | September 2020 | Prescription reference product |
| 2MG | Granule | Oral | September 2020 | Prescription reference product |
| 5MG | Granule | Oral | September 2020 | Prescription reference product |
Source: FDA Orange Book, Eton Pharmaceuticals Inc. Listed for sale today by Eton Pharmaceuticals, Inc. (FDA NDC Directory).
Alkindi Sprinkle NDC Codes and Packages
Each Alkindi Sprinkle package sold today has its own NDC, the product number printed on the box and on the pharmacy label. Open one to see that package’s details, what pharmacies pay for it and its patent timeline.
| NDC | Product | Package | Company |
|---|---|---|---|
| 71863-0109-50 | HYDROCORTISONE .5 mg/1 granule | bottle of 50 granules | Eton Pharmaceuticals, Inc. |
| 71863-0109-50 | HYDROCORTISONE .5 mg/1 granule | bottle of 50 granules | Eton Pharmaceuticals, Inc. |
| 71863-0110-50 | HYDROCORTISONE 1 mg/1 granule | bottle of 50 granules | Eton Pharmaceuticals, Inc. |
| 71863-0110-50 | HYDROCORTISONE 1 mg/1 granule | bottle of 50 granules | Eton Pharmaceuticals, Inc. |
| 71863-0111-50 | HYDROCORTISONE 2 mg/1 granule | bottle of 50 granules | Eton Pharmaceuticals, Inc. |
| 71863-0111-50 | HYDROCORTISONE 2 mg/1 granule | bottle of 50 granules | Eton Pharmaceuticals, Inc. |
| 71863-0112-50 | HYDROCORTISONE 5 mg/1 granule | bottle of 50 granules | Eton Pharmaceuticals, Inc. |
| 71863-0112-50 | HYDROCORTISONE 5 mg/1 granule | bottle of 50 granules | Eton Pharmaceuticals, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Alkindi Sprinkle’s own FDA approval (NDA 213876) are listed, never a generic. Some codes belong to companies that repackage Alkindi Sprinkle: it is the same medicine in a different package.
What a Generic Alkindi Sprinkle Means for You
Nothing Changes Until It Is in Pharmacies
A generic is listed for sale now, so your pharmacy may already be able to fill your prescription with it.
Your Pharmacy May Switch You Automatically
Every state lets pharmacists fill a brand-name prescription with an FDA-approved generic rated as equivalent to it, and about 19 states require them to, unless your prescriber writes “dispense as written” or “brand medically necessary” on the prescription. Some states ask the pharmacist to tell you, or to get your OK first. A study of every state’s law has the details.
It Will Probably Look Different
US trademark law does not let a generic look exactly like the brand, so the color, shape or markings usually change. The active ingredient, strength and form are the same. An “authorized generic,” made by or for the brand’s own company, can look identical. The FDA explains.
Your Insurance May Change Too
Once a lower-cost version is available, many insurance plans charge more for the brand, or stop covering it. Your plan’s drug list (formulary) says how.
Questions people ask about Alkindi Sprinkle
Is there a generic for Alkindi Sprinkle right now?
Yes. The FDA NDC Directory lists a generic hydrocortisone from 20 companies. Ask your pharmacy whether it can fill your prescription with it.
When will Alkindi Sprinkle go generic?
It already has. The FDA NDC Directory lists a generic hydrocortisone from 20 companies, so ask your pharmacy whether it can fill your prescription with one.
Will generic hydrocortisone be the same as Alkindi Sprinkle?
Yes in the ways that matter: the same active ingredient, strength and form, with proof that it reaches your blood the same way. Inactive ingredients can differ, which is why some people notice a different look or taste.
How much will the generic cost?
Nobody can say for sure before launch. The FDA has already approved 6 companies to make a generic, and how many of them launch decides how far the price falls.
Has the FDA approved a generic Alkindi Sprinkle?
Yes. The FDA Orange Book lists approved generic versions from 6 companies, the first approved in August 1982: Impax Laboratories Inc, Strides Pharma Global Pte Ltd, Aurobindo Pharma Ltd, Hibrow Healthcare Private Ltd and 2 more. Approved is not the same as on sale: patents, a settlement or the company’s own plans can still hold a launch.
When does the Alkindi Sprinkle patent expire?
The FDA Orange Book lists 3 patents for Alkindi Sprinkle; the last runs to May 2034. The one behind the expected month is patent 9,649,280, which ends in May 2034. A patent date is not the launch date: settlements and court rulings often bring a generic earlier, and FDA approval or a company’s own plans can make it later. The expected month on this page (January 2033) weighs all of that.
Changes to This Projection
- First generic expected January 2033 on this month’s schedule. A line is added here whenever a monthly update moves the month, the reason or how sure it is.
Every change to the expected month is logged here with the month we saw it.
Also Going Generic
- YonsaAbiraterone AcetateDuring 2026
- BrixadiBuprenorphineJuly 2032
- ForzinityElamipretide HydrochlorideFebruary 2039
- PosimirBupivacaineJanuary 2041
- LivtencityMaribavirNovember 2042
- TiglutikRiluzoleTBD no date yet
About Alkindi Sprinkle
- Generic name hydrocortisone
- How it is taken By mouth
- Company Eton Pharmaceuticals Inc
- More drugs Brand-name drugs starting with A
- Have a question? A pharmacist answers, free. Ask about Alkindi Sprinkle
Sources. The expected month: FDA Paragraph IV Patent Certifications list, federal court records, company announcements and securities filings (settlement dates, launch plans, sales). The record on this page: FDA Orange Book, Drugs@FDA (tentative approvals), FDA NDC Directory, CMS Medicare Part D Spending by Drug, Medicaid State Drug Utilization Data, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.