Ogsiveo Generic: When Will Generic Nirogacestat 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
Ogsiveo Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? 2037 to 2038 A wide window 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? May 2043 29 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 nirogacestat is expected to be available between 2037 and 2038. None is for sale yet.
Why 2037 to 2038?
The patent fight is likely to end in an agreement that sets the launch. The terms are not public yet. We rate it probable: more likely than not, but it can still move.
If Ogsiveo’s last patent runs to May 2043, how can a generic come sooner?
The 28 patents that run past the expected month, to May 2043 (10,590,087, 10,710,966, 10,941,118, 11,820,748 and 24 more), cover the active ingredient, a way of using it and the product’s formulation. 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. Here, the companies are expected to settle on a 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 Ogsiveo 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.
Ogsiveo by the Numbers
- Reason
- Settlement expectedThe patent fight is likely to end in an agreement that sets the launch. The terms are not public yet.
- How sure
- Probable More likely than not, but it can still move.
- Price competition
- None filed yet No filers on record
- Brand sales
- $334M a yearBig seller
- FDA approved 2023 November 2023 FDA Orange Book
- Patents listed 29 last runs to May 2043 A generic is expected sooner, between 2037 and 2038. See why FDA Orange Book
- Medicare Part D spent $35.1M in 2025, for 222 people CMS Part D Spending by Drug
- Medicaid prescriptions 732 in the last four reported quarters, $20.8M CMS Medicaid drug utilization, to Q1 2026
Ogsiveo’s Road to a Generic
Ogsiveo has had the market to itself since the FDA approved it in November 2023 (Springworks Therapeutics Inc). Its FDA protection (orphan drug) runs to November 2030. Its 29 listed patents run to May 2043.
The first generic of Ogsiveo is expected between 2037 and 2038.
Why that month: the patent fight is likely to end in an agreement that sets the launch. The terms are not public yet.
Why a Generic Can Come Before May 2043
The last listed patent runs to May 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.
Ogsiveo Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Ogsiveo’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 |
|---|---|---|---|
| 7,795,447 | The active ingredient | August 2030 | Active |
| 10,590,087 | The active ingredient | August 2039 | Active |
| 10,710,966 | The active ingredient; a way of using it (U-3754) | August 2039 | Active |
| 10,941,118 | The active ingredient; a way of using it (U-3754) | August 2039 | Active |
| 11,820,748 | The product’s formulation | August 2039 | Active |
| 11,845,732 | The active ingredient; a way of using it (U-3754) | August 2039 | Active |
| 11,884,634 | The product’s formulation | August 2039 | Active |
| 11,884,635 | The product’s formulation | August 2039 | Active |
| 11,905,255 | The product’s formulation | August 2039 | Active |
| 12,116,347 | The product’s formulation | August 2039 | Active |
| 12,297,177 | The product’s formulation | August 2039 | Active |
| 11,504,354 | The product’s formulation | July 2042 | Active |
| 11,612,588 | The product’s formulation; a way of using it (U-3754) | July 2042 | Active |
| 12,110,277 | The product’s formulation | July 2042 | Active |
| 12,234,210 | The product’s formulation | July 2042 | Active |
| 12,247,012 | The product’s formulation | July 2042 | Active |
| 12,599,587 | The product’s formulation | July 2042 | Active |
| 11,807,611 | The product’s formulation; a way of using it (U-3754) | September 2042 | Active |
| 11,844,780 | The product’s formulation; a way of using it (U-3754) | September 2042 | Active |
| 11,872,211 | A way of using it (U-3754) | May 2043 | Active |
| 11,925,619 | A way of using it (U-3754) | May 2043 | Active |
| 11,925,620 | A way of using it (U-3754) | May 2043 | Active |
| 11,938,116 | A way of using it (U-3754) | May 2043 | Active |
| 11,951,096 | A way of using it (U-3754) | May 2043 | Active |
| 11,957,662 | A way of using it (U-3754) | May 2043 | Active |
| 12,011,434 | A way of using it (U-3754) | May 2043 | Active |
| 12,011,435 | A way of using it (U-3754) | May 2043 | Active |
| 12,036,207 | A way of using it (U-3754) | May 2043 | Active |
| 12,138,246 | A way of using it (U-3754) | May 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. | November 2028 | Active |
| FDA exclusivity ODE* | A period of protection the FDA granted (code ODE*). | November 2030 | Active |
| Orphan drug ODE-452 | Seven years of protection for a use in a rare disease. | November 2030 | Active |
Source: FDA Orange Book, application 217677. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Nirogacestat
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 Ogsiveo yet.
Approved by the FDA
Not yet. The FDA has not approved a generic nirogacestat. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic nirogacestat 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).
Ogsiveo 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 Ogsiveo, 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 Ogsiveo
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 Ogsiveo, before manufacturer rebates.
- $10.3M
- January to March 2026, the latest CMS has posted
For 157 people, about $28,231 per prescription fill - $35.1M
- 2025, the whole year
For 222 people, about $26,655 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $10,332,516 | 157 | $28,230.92 |
| 2025 | $35,131,777 | 222 | $26,655.37 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Ogsiveo only, so no generic is counted in it. What CMS says it is used for: This medication is used to treat desmoid tumors. Nirogacestat works by slowing or stopping the growth of tumor cells.
Medicaid Prescriptions by Quarter
732 prescriptions in the four quarters to Q1 2026, $20.8M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 185 | $5,603,321 |
| Q4 2025 | 191 | $5,380,534 |
| Q3 2025 | 202 | $5,440,508 |
| Q2 2025 | 154 | $4,379,697 |
| Q1 2025 | 82 | $2,331,930 |
Source: CMS Medicaid State Drug Utilization Data, over Ogsiveo’s own package codes.
Ogsiveo Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 100MG BASE | Tablet | Oral | April 2024 | Prescription reference product |
| EQ 150MG BASE | Tablet | Oral | April 2024 | Prescription reference product |
| EQ 50MG BASE | Tablet | Oral | November 2023 | Discontinued reference product |
Source: FDA Orange Book, Springworks Therapeutics Inc. Listed for sale today by SpringWorks Therapeutics, Inc. (FDA NDC Directory).
Ogsiveo NDC Codes and Packages
Each Ogsiveo 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 |
|---|---|---|---|
| 82448-0050-18 | 50 mg tablet, film coated | bottle of 180 tablets | SpringWorks Therapeutics, Inc. |
| 82448-0100-14 | NIROGACESTAT 100 mg/1 tablet, film coated | blister pack of 14 tablets | SpringWorks Therapeutics, Inc. |
| 82448-0150-14 | NIROGACESTAT 150 mg/1 tablet, film coated | blister pack of 14 tablets | SpringWorks Therapeutics, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Ogsiveo’s own FDA approval (NDA 217677) are listed, never a generic. Some codes belong to companies that repackage Ogsiveo: it is the same medicine in a different package.
What a Generic Ogsiveo Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Ogsiveo 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 Ogsiveo”. 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 Ogsiveo
Is there a generic for Ogsiveo right now?
No. As of October 9, 2026 no generic nirogacestat is listed for sale in the FDA NDC Directory.
When will Ogsiveo go generic?
2037 to 2038 is the expected window, and that is probable but not certain. The patent fight is likely to end in an agreement that sets the launch. The terms are not public yet. The last listed patent runs to May 2043; a court ruling or a settlement can bring a generic sooner.
Will generic nirogacestat be the same as Ogsiveo?
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 Ogsiveo?
Not yet. The FDA Orange Book lists no approved generic version of Ogsiveo.
When does the Ogsiveo patent expire?
The FDA Orange Book lists 29 patents for Ogsiveo; the last runs to May 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 window on this page (2037 to 2038) weighs all of that.
Changes to This Projection
- First generic expected 2037 to 2038 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
- ProcysbiCysteamine BitartrateMarch 2030
- CabometyxCabozantinib S-MalateJanuary 2031
- ZelsuvmiBerdazimer Sodium2035 to 2036
- LumakrasSotorasibAugust 2040
- FyarroSirolimusOctober 2040
- TrifericFerric Pyrophosphate CitrateTBD no date yet
About Ogsiveo
- Generic name nirogacestat
- How it is taken By mouth
- Company Springworks Therapeutics Inc
- More drugs Brand-name drugs starting with O
- Have a question? A pharmacist answers, free. Ask about Ogsiveo
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.