Cresemba Generic: When Will Generic Isavuconazonium 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
Cresemba Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? During 2027 Sometime that year Why then?
- Has the FDA approved a generic? Not yet None in the FDA’s records yet Why not yet?
- When does the last FDA protection end? June 2031 FDA exclusivity: pediatric Why is a generic expected sooner?
- Can you buy a generic today? Not yet No company lists one for sale
Generic isavuconazonium sulfate is expected to be available sometime in 2027. None is for sale yet.
Why 2027?
The brand company and a generic maker settled their patent fight and agreed on when a generic can launch. We rate it probable: more likely than not, but it can still move.
If Cresemba’s last FDA protection runs to June 2031, how can a generic come sooner?
The 2 patents that run past the expected month, to March 2028 (10,206,879 and 10,603,280), cover the product’s formulation. 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. Its FDA protection (pediatric) also runs past the expected month, to June 2031. That protection covers only the use it was granted for, so a generic may be able to launch for other uses and leave that one off its label. Here, a settlement between the companies sets the date. Generic companies have been challenging Cresemba’s patents with the FDA since September 2024. 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, and more so as more companies sell one. 5 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 73% less once four companies sold a generic, which would take the $114.00 pharmacies pay per capsule for Cresemba today to about $30.78. See the price estimate
What should I do now?
Keep taking Cresemba 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
Our month is only an estimate based on available information, so we never name a day.
Cresemba by the Numbers
- Reason
- Settlement between companiesThe brand company and a generic maker settled their patent fight and agreed on when a generic can launch.
- How sure
- Probable More likely than not, but it can still move.
- Price competition
- Strong 5 companies have filed, 4 first in line
- Brand sales
- $461M a yearBig seller
- FDA approved 2015 March 2015 FDA Orange Book
- Patents listed 3 last runs to March 2028 A generic is expected sooner, sometime in 2027. See why FDA Orange Book
- Pharmacies pay $114.00 per capsule, up 6.4% in a year NADAC, October 2026
- Medicare Part D spent $176.7M in 2025, for 6,545 people CMS Part D Spending by Drug
- Medicaid prescriptions 5,862 in the last four reported quarters, $36.3M CMS Medicaid drug utilization, to Q1 2026
Cresemba’s Road to a Generic
Cresemba has had the market to itself since the FDA approved it in March 2015 (Astellas Pharma US Inc). Its FDA protection (pediatric) runs to June 2031. Its 3 listed patents run to March 2028 (1 already expired). Generic companies have challenged its patents with the FDA since September 2024.
The first generic of Cresemba is expected sometime in 2027.
Why that month: the brand company and a generic maker settled their patent fight and agreed on when a generic can launch.
Why a Generic Can Come Before June 2031
The last listed patent runs to March 2028, but it covers the product’s formulation, 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.
Cresemba Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Cresemba’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.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 6,812,238 | The active ingredient | April 2026 with the pediatric extension | Expired |
| 10,206,879 | The product’s formulation | March 2028 with the pediatric extension | Active |
| 10,603,280 | The product’s formulation | March 2028 with the pediatric extension | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| FDA exclusivity ODE* | A period of protection the FDA granted (code ODE*). | March 2022 | Ended |
| Orphan drug ODE-305 | Seven years of protection for a use in a rare disease. | March 2022 | Ended |
| Orphan drug ODE-90 | Seven years of protection for a use in a rare disease. | March 2022 | Ended |
| New patient population NPP | Three years of protection for a newly approved group of patients. | December 2026 | Active |
| Antibiotic incentive (GAIN) GAIN | Five more years for a medicine that treats a serious or life-threatening infection. | September 2027 | Active |
| Orphan drug ODE-453 | Seven years of protection for a use in a rare disease. | December 2030 | Active |
| Orphan drug ODE-454 | Seven years of protection for a use in a rare disease. | December 2030 | Active |
| Orphan drug ODE-458 | Seven years of protection for a use in a rare disease. | December 2030 | Active |
| Orphan drug ODE-459 | Seven years of protection for a use in a rare disease. | December 2030 | Active |
| Pediatric PED | Six more months, earned by studying the medicine in children. | June 2031 | Active |
Source: FDA Orange Book, application 207500, 207501. Patent numbers open the patent on Google Patents.
Patent Challenges to Cresemba
The first patent challenge to Cresemba reached the FDA in September 2024, from 4 companies on that first day. The FDA’s list has 3 entries for Cresemba, by form and strength. The FDA has not approved a first challenger’s generic yet.
What Is a Patent Challenge?
A generic company that wants to sell its version before Cresemba’s patents run out can tell the FDA that a patent is invalid, or that its version does not infringe it. The FDA calls this a “Paragraph IV certification.” The brand company usually sues, and the FDA then generally cannot approve that generic for up to 30 months while the case runs. To reward going first, the companies that challenge first can get a 180-day head start: the FDA cannot approve the generics that came after them until it ends.
| Product | First challenged | Companies that day | 180-day head start | First challenger’s generic | Challenged patents run to | |
|---|---|---|---|---|---|---|
| Approved | On sale | |||||
| Capsules, 186 mg | September 2024 | 4 companies | No decision yet | Not yet | Not yet | September 2027 |
| Capsules, 74.5 mg | September 2024 | 2 companies | No decision yet | Not yet | Not yet | September 2027 |
| For injection, 372 mg/vial | September 2024 | 2 companies | Head start no longer applies decided January 2026 | Not yet | Not yet | October 2025 |
Source: the FDA’s Paragraph IV Patent Certifications list, as of September 2026. The FDA began posting the 180-day decisions and the first challenger’s approval and first sale in June 2019: an older entry it has not updated since reads “Not posted”, and “Not yet” means the list records no such event. “Companies that day” is the FDA’s count of challenges that arrived on the first day.
Who Is Lined Up to Make Generic Isavuconazonium Sulfate
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
5 companies have applied to the FDA to make generic isavuconazonium sulfate.
The FDA names a company only once it approves its application, even tentatively, and it has not done that for these yet, so the companies are not named here. Names often come out in the brand company’s patent lawsuits or in the companies’ own announcements.
First in line. 4 of them were first in line, all filing on the first day any company did: they can share 180 days on the market before the other generics, which is why being first matters.
Generic companies have challenged Cresemba’s patents with the FDA since September 2024: see the patent challenges.
Approved by the FDA
Not yet. The FDA has not approved a generic isavuconazonium sulfate. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic isavuconazonium sulfate 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).
Cresemba Price: What Pharmacies Pay and What Generics Usually Do
What Pharmacies Pay for Cresemba 186 mg capsule
$114.00 per capsule in October 2026, up 6.4% from a year earlier.
Hover over or tap anywhere on the chart to see that month’s price.
See the numbers
| Month | Pharmacies paid per capsule |
|---|---|
| October 2026 | $114.00 |
| September 2026 | $114.00 |
| August 2026 | $113.98 |
| July 2026 | $114.05 |
| June 2026 | $114.06 |
| May 2026 | $114.13 |
| April 2026 | $114.12 |
| March 2026 | $114.12 |
| February 2026 | $114.12 |
| January 2026 | $114.12 |
| February 2024 | $107.12 |
| January 2024 | $107.12 |
NADAC: the national average price retail pharmacies pay to buy the medicine (CMS survey, updated weekly), the last price of each month for one package. It is not what you pay: that depends on your insurance or discount card.
What a Generic Could Cost
How we estimate it. We start from what pharmacies pay for Cresemba today: $114.00 per capsule for Cresemba 186 mg capsule in October 2026, from the national NADAC survey. Then we apply the FDA’s finding of how far that price 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). Cresemba has 5 companies lined up, so our estimate uses the figure for four companies. More companies would bring the price lower; fewer, less of a drop.
Dollar figures apply FDA’s median drops to the $114.00 pharmacies pay per capsule today. An estimate from the pattern, not a price quote: what you pay depends on your insurance or discount card.
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 Cresemba
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 Cresemba, before manufacturer rebates.
- $49.9M
- January to March 2026, the latest CMS has posted
For 3,745 people, about $6,224 per prescription fill - $176.7M
- 2025, the whole year
For 6,545 people, about $6,261 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $49,871,559 | 3,745 | $6,223.83 |
| 2025 | $176,682,891 | 6,545 | $6,260.69 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Cresemba only, so no generic is counted in it. What CMS says it is used for: This medication is used to treat certain serious fungal infections. This medication is known as an azole antifungal.
Medicaid Prescriptions by Quarter
5,862 prescriptions in the four quarters to Q1 2026, $36.3M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 1,542 | $9,674,923 |
| Q4 2025 | 1,436 | $8,843,254 |
| Q3 2025 | 1,544 | $9,558,740 |
| Q2 2025 | 1,340 | $8,232,877 |
| Q1 2025 | 1,461 | $8,410,889 |
Source: CMS Medicaid State Drug Utilization Data, over Cresemba’s own package codes.
Cresemba Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 186MG | Capsule | Oral | March 2015 | Prescription reference product |
| 372MG | Powder | Intravenous | March 2015 | Prescription reference product |
| 74.5MG | Capsule | Oral | November 2022 | Prescription reference product |
Source: FDA Orange Book, Astellas Pharma US Inc. Listed for sale today by Astellas Pharma US, Inc. (FDA NDC Directory).
Cresemba NDC Codes and Packages
Each Cresemba 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 |
|---|---|---|---|
| 00469-0520-02 | ISAVUCONAZONIUM SULFATE 100 mg/1 capsule | carton of 2 blister packs of 7 capsules | Astellas Pharma US, Inc. |
| 00469-0520-14 | ISAVUCONAZONIUM SULFATE 100 mg/1 capsule | carton of 4 cartons of 14 blister packs of 1 capsule | Astellas Pharma US, Inc. |
| 00469-2860-35 | ISAVUCONAZONIUM SULFATE 40 mg/1 capsule | carton of 35 blister packs of 1 capsule | Astellas Pharma US, Inc. |
| 00469-2860-35 | ISAVUCONAZONIUM SULFATE 40 mg/1 capsule | carton of 7 blister packs of 5 capsules | Astellas Pharma US, Inc. |
| 00469-0420-01 | ISAVUCONAZONIUM SULFATE 40 mg/mL injection, powder, lyophilized, for solution | vial of 5 mL | Astellas Pharma US, Inc. |
| 00469-0420-99 | ISAVUCONAZONIUM SULFATE 40 mg/mL injection, powder, lyophilized, for solution | carton of 10 cartons of 1 vial of 5 mL | Astellas Pharma US, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Cresemba’s own FDA approval (NDA 207500, NDA 207501) are listed, never a generic. Some codes belong to companies that repackage Cresemba: it is the same medicine in a different package.
What a Generic Cresemba Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Cresemba 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 Cresemba”. 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 Cresemba
Is there a generic for Cresemba right now?
No. As of October 9, 2026 no generic isavuconazonium sulfate is listed for sale in the FDA NDC Directory.
When will Cresemba go generic?
Sometime in 2027 is the expected window, and that is probable but not certain. The brand company and a generic maker settled their patent fight and agreed on when a generic can launch. The last listed patent runs to March 2028, but it covers the product’s formulation, not the medicine itself, which a generic can often work around or challenge.
Will generic isavuconazonium sulfate be the same as Cresemba?
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. 5 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 73% less once four companies sold a generic, which would take the $114.00 pharmacies pay per capsule for Cresemba today to about $30.78. That is a pattern from past launches, not a prediction for this one.
Has the FDA approved a generic Cresemba?
Not yet. The FDA Orange Book lists no approved generic version of Cresemba.
When does the Cresemba patent expire?
The FDA Orange Book lists 3 patents for Cresemba; the last runs to March 2028, counting a six-month pediatric extension. 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 window on this page (Sometime in 2027) weighs all of that.
Has anyone challenged the Cresemba patents?
Yes. The first patent challenge to Cresemba reached the FDA in September 2024, from 4 companies on that first day. The FDA has not approved a first challenger’s generic yet. A patent challenge (a “Paragraph IV certification”) is a generic company telling the FDA that a patent listed for the brand is invalid or will not be infringed by its version. The first companies to file one can earn a 180-day head start, during which the FDA cannot approve the generics that filed after them.
How much does Cresemba cost now?
Pharmacies paid about $114.00 per capsule for Cresemba 186 mg capsule in October 2026, by the national survey of what pharmacies pay (NADAC). That is the pharmacy’s cost, not your price: what you pay depends on your insurance or discount card.
Changes to This Projection
- First generic expected Sometime in 2027 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
- OsphenaOspemifene2026 to 2027
- XareltoRivaroxabanMarch 2027
- SymdekoIvacaftor and TezacaftorJuly 2031
- KorsuvaDifelikefalin AcetateJuly to December 2032
- ErleadaApalutamide2035 to 2036
- AzstarysDexmethylphenidate Hydrochloride and Serdexmethylphenidate ChlorideDecember 2037
About Cresemba
- Generic name isavuconazonium sulfate
- How it is taken By mouth
- Company Astellas Pharma US Inc
- Patent challenges Since September 2024 (FDA)
- More drugs Brand-name drugs starting with C
- Have a question? A pharmacist answers, free. Ask about Cresemba
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 Paragraph IV Patent Certifications list, NADAC (CMS), 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.