Khindivi 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
Khindivi Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? February 2043 About 16.5 years away Why then?
- Has the FDA approved a generic? August 1982 6 companies approved
- When does the last patent end? February 2043 2 patents listed with the FDA
- 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 February 2043?
It is when Khindivi’s patents 11,904,046 and 12,133,914 end. They cover the product’s formulation and a way of using it, and once they end, generics can 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.
What should I do now?
Ask your pharmacy whether it can fill your prescription with a generic. It may look different from Khindivi, 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.
Khindivi 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 2025 May 2025 FDA Orange Book
- Patents listed 2 last runs to February 2043 FDA Orange Book
- Generics FDA-approved 6 companies, the first approved August 1982 FDA Orange Book
Khindivi’s Road to a Generic
Khindivi has had the market to itself since the FDA approved it in May 2025 (Eton Pharmaceuticals Inc). Its 2 listed patents run to February 2043.
The first generic of Khindivi is expected in February 2043.
Why that month: patents 11,904,046 and 12,133,914, on the product’s formulation and a way of using it, end then.
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.
Khindivi Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Khindivi’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: patents 11,904,046 and 12,133,914, which end in February 2043, the month the first generic is expected.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 11,904,046 Sets the expected month of generic availability | The product’s formulation; a way of using it (U-4216) | February 2043 | Active |
| 12,133,914 Sets the expected month of generic availability | A way of using it (U-4215) | February 2043 | Active |
Source: FDA Orange Book, application 218980. 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 Khindivi, 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).
Khindivi 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 Khindivi, 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.
Khindivi Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 1MG/ML | Solution | Oral | May 2025 | Prescription reference product |
Source: FDA Orange Book, Eton Pharmaceuticals Inc. Listed for sale today by Eton Pharmaceuticals, Inc. (FDA NDC Directory).
Khindivi NDC Codes and Packages
Each Khindivi 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 |
|---|---|---|---|
| 71863-0116-16 | HYDROCORTISONE 1 mg/mL solution | bottle of 1 mL | Eton Pharmaceuticals, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Khindivi’s own FDA approval (NDA 218980) are listed, never a generic. Some codes belong to companies that repackage Khindivi: it is the same medicine in a different package.
What a Generic Khindivi 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 Khindivi
Is there a generic for Khindivi 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 Khindivi 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 Khindivi?
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 Khindivi?
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 Khindivi patent expire?
The FDA Orange Book lists 2 patents for Khindivi; the last runs to February 2043. The one behind the expected month is patents 11,904,046 and 12,133,914, which end in February 2043. 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 (February 2043) weighs all of that.
Changes to This Projection
- First generic expected February 2043 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
- Cresemba IVIsavuconazonium Sulfate2026 to 2027
- IbrancePalbociclibJuly to September 2027
- MultrysCupric Sulfate, Manganese Sulfate, Selenious Acid, and Zinc Sulfate2034 to 2035
- RevuforjRevumenibNovember 2038
- UzedyRisperidoneMarch 2042
- ZycuboCopper HistidinateMarch 2042
About Khindivi
- Generic name hydrocortisone
- How it is taken By mouth
- Company Eton Pharmaceuticals Inc
- More drugs Brand-name drugs starting with K
- Have a question? A pharmacist answers, free. Ask about Khindivi
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, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.