Crenessity Generic: When Will Generic Crinecerfont 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
Crenessity Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? June 2041 About 14.5 years away Why then?
- Has the FDA approved a generic? Not yet None in the FDA’s records yet Why not yet?
- When does the last patent end? January 2043 5 patents listed with the FDA Why is a generic expected sooner?
- Can you buy a generic today? Not yet No company lists one for sale
Generic crinecerfont is expected to be available in June 2041, about 14.5 years away. None is for sale yet.
Why June 2041?
It is when Crenessity’s patent 12,128,033 ends. That patent covers the active ingredient 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 probable: more likely than not, but it can still move.
If Crenessity’s last patent runs to January 2043, how can a generic come sooner?
The patent that runs to January 2043 (12,582,634) covers the active ingredient. A generic can still come sooner if a court rules a patent invalid or not infringed, or if the companies settle on an earlier date. That is why the expected month comes before the last protection ends. See the road to a generic
Why hasn’t the FDA approved a generic yet?
That is normal before a launch. The FDA usually can’t give a generic its final approval while a patent or exclusivity still blocks it, so final approval often comes close to the day the generic can be sold. No company holds a “tentative” approval yet either (the FDA’s word for a generic that is ready but still blocked).
Will the generic cost less?
Usually, but no company is recorded as having applied to make one yet, and a single company usually brings only a modest drop. See the price pattern
What should I do now?
Keep taking Crenessity as prescribed. When a generic arrives, your pharmacy may switch you to it automatically, and it may look different. What a generic means for you
- oral solutionJune 2041Probable · patent expires
- capsuleJune 2041Probable · patent expires
Our month is only an estimate based on available information, so we never name a day.
Crenessity by the Numbers
- Reason
- Patent expiresA patent that protects the brand runs out. After that, approved generics can be sold.
- How sure
- Probable More likely than not, but it can still move.
- Price competition
- None filed yet No filers on record
- Brand sales
- Sales not reported
- FDA approved 2024 December 2024 FDA Orange Book
- Patents listed 5 last runs to January 2043 A generic is expected sooner, in June 2041. See why FDA Orange Book
- Medicare Part D spent $5.1M in 2025, for 25 people CMS Part D Spending by Drug
- Medicaid prescriptions 2,025 in the last four reported quarters, $79.7M CMS Medicaid drug utilization, to Q1 2026
Crenessity’s Road to a Generic
Crenessity has had the market to itself since the FDA approved it in December 2024 (Neurocrine Biosciences Inc). Its FDA protection (orphan drug) runs to December 2031. Its 5 listed patents run to January 2043.
The first generic of Crenessity is expected in June 2041.
Why that month: patent 12,128,033, on the active ingredient and a way of using it, ends then. That is about 1.5 years before the last listed patent runs out, in January 2043.
Why a Generic Can Come Before January 2043
The last listed patent runs to January 2043; a court ruling or a settlement can bring a generic sooner. 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.
Crenessity Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Crenessity’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 12,128,033, which ends in June 2041, the month the first generic is expected. Why the later ones may not hold it back
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 10,905,690 | A way of using it (U-4049) | January 2035 | Active |
| 11,311,544 | A way of using it (U-4049) | January 2035 | Active |
| 11,730,739 | A way of using it (U-4049) | January 2035 | Active |
| 12,128,033 Sets the expected month of generic availability | The active ingredient; a way of using it (U-4049) | June 2041 | Active |
| 12,582,634 | The active ingredient | January 2043 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| New chemical entity NCE | Five years of protection for a medicine whose active ingredient the FDA had never approved before. | December 2029 | Active |
| Orphan drug ODE-503 | Seven years of protection for a use in a rare disease. | December 2031 | Active |
Source: FDA Orange Book, application 218808, 218820. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Crinecerfont
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 company is recorded as having applied to the FDA to make a generic Crenessity yet.
Approved by the FDA
Not yet. The FDA has not approved a generic crinecerfont. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic crinecerfont for sale with the FDA.
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).
Crenessity 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 Crenessity, 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 Crenessity
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 Crenessity, before manufacturer rebates.
- $2.1M
- January to March 2026, the latest CMS has posted
For 23 people, about $42,315 per prescription fill - $5.1M
- 2025, the whole year
For 25 people, about $42,141 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $2,115,764 | 23 | $42,315.29 |
| 2025 | $5,141,238 | 25 | $42,141.30 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Crenessity only, so no generic is counted in it. What CMS says it is used for: This medication is used with a corticosteroid medication to control androgen levels in people with a certain adrenal gland problem (classic congenital adrenal hyperplasia - CAH).
Medicaid Prescriptions by Quarter
2,025 prescriptions in the four quarters to Q1 2026, $79.7M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 721 | $28,447,814 |
| Q4 2025 | 720 | $28,442,196 |
| Q3 2025 | 427 | $16,628,229 |
| Q2 2025 | 157 | $6,208,968 |
| Q1 2025 | 13 | $498,460 |
Source: CMS Medicaid State Drug Utilization Data, over Crenessity’s own package codes.
Crenessity Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 100MG | Capsule | Oral | December 2024 | Prescription reference product |
| 25MG | Capsule | Oral | December 2024 | Prescription reference product |
| 50MG | Capsule | Oral | December 2024 | Prescription reference product |
| 50MG/ML | Solution | Oral | December 2024 | Prescription reference product |
Source: FDA Orange Book, Neurocrine Biosciences Inc. Listed for sale today by Neurocrine Biosciences, Inc. (FDA NDC Directory).
Crenessity NDC Codes and Packages
Each Crenessity 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 |
|---|---|---|---|
| 70370-5100-01 | CRINECERFONT 100 mg/1 capsule | bottle of 30 capsules | Neurocrine Biosciences, Inc. |
| 70370-5025-01 | CRINECERFONT 25 mg/1 capsule | bottle of 60 capsules | Neurocrine Biosciences, Inc. |
| 70370-5050-01 | CRINECERFONT 50 mg/1 capsule | bottle of 60 capsules | Neurocrine Biosciences, Inc. |
| 70370-5250-01 | CRINECERFONT 50 mg/mL solution | bottle of 30 mL | Neurocrine Biosciences, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Crenessity’s own FDA approval (NDA 218808, NDA 218820) are listed, never a generic. Some codes belong to companies that repackage Crenessity: it is the same medicine in a different package.
What a Generic Crenessity Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Crenessity as usual. When one arrives, there is nothing you need to sign up for.
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.
Until a generic is on US pharmacy shelves, be careful with websites that offer “generic Crenessity”. The FDA warns that unlicensed online pharmacies sell counterfeit and unapproved medicines; its BeSafeRx page shows how to check a pharmacy.
Questions people ask about Crenessity
Is there a generic for Crenessity right now?
No. As of October 9, 2026 no generic crinecerfont is listed for sale in the FDA NDC Directory.
When will Crenessity go generic?
June 2041 is the expected month, and that is probable but not certain. It is when Crenessity’s patent 12,128,033 ends. That patent covers the active ingredient 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. The last listed patent runs to January 2043; a court ruling or a settlement can bring a generic sooner.
Will generic crinecerfont be the same as Crenessity?
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. No company is recorded as having applied to the FDA to make one yet, and a single company usually brings only a modest drop.
Has the FDA approved a generic Crenessity?
Not yet. The FDA Orange Book lists no approved generic version of Crenessity.
When does the Crenessity patent expire?
The FDA Orange Book lists 5 patents for Crenessity; the last runs to January 2043. The one behind the expected month is patent 12,128,033, which ends in June 2041. 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 (June 2041) weighs all of that.
Changes to This Projection
- First generic expected June 2041 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
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- XaraCollBupivacaine HydrochlorideMay 2029
- AzmiroTestosterone CypionateMarch 2039
- KomziftiZiftomenibNovember 2039
- SymbravoMeloxicam and RizatriptanMay 2040
- OsmoprepSodium Phosphate, Dibasic, Anhydrous and Sodium Phosphate, Monobasic, MonohydrateTBD no date yet
About Crenessity
- Generic name crinecerfont
- How it is taken By mouth
- Company Neurocrine Biosciences Inc
- More drugs Brand-name drugs starting with C
- Have a question? A pharmacist answers, free. Ask about Crenessity
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.