Oxbryta Generic: When Will Generic Voxelotor 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
Oxbryta Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? January 2034 About 7.5 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 brand’s protection end? October 2037 The last of 11 listed patents Why sooner?
- Can you buy a generic today? Not yet No company lists one for sale
Dr. Brian Staiger Explains
PharmD, BCPS · Clinical pharmacistGeneric voxelotor is expected to be available in January 2034, about 7.5 years away. None is for sale yet.
Why January 2034?
It is when Oxbryta’s patent 9,248,199 ends. That patent covers 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 Oxbryta’s protection runs to October 2037, how can a generic come sooner?
The 6 patents that run past the expected month, to October 2037 (9,447,071, 10,722,502, 11,452,720, 11,020,382 and 2 more), cover the active ingredient, the product’s formulation and a way of using it. 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. Generic companies have been challenging Oxbryta’s patents with the FDA since November 2023. 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. 2 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 44% less once two companies sold a generic. See the price pattern
What should I do now?
Keep taking Oxbryta 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
- tabletJanuary 2034Probable · patent expires
- tablet for oral suspensionJanuary 2034Probable · patent expires
Our month is only an estimate based on available information, so we never name a day.
Oxbryta 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
- Moderate 2 companies have filed, 2 first in line
- Brand sales
- Sales not reported
- FDA approved 2019 November 2019 FDA Orange Book
- Patents listed 11 last runs to October 2037 FDA Orange Book
Oxbryta’s Road to a Generic
Oxbryta has had the market to itself since the FDA approved it in November 2019 (Global Blood Therapeutics Inc). Its FDA protection (orphan drug) runs to December 2028. Its 11 listed patents run to October 2037. Generic companies have challenged its patents with the FDA since November 2023.
The first generic of Oxbryta is expected in January 2034.
Why that month: patent 9,248,199, on a way of using it, ends then. That is about 3.5 years before the last listed patent runs out, in October 2037.
Why a Generic Can Come Before October 2037
The last listed patent runs to October 2037; 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.
Oxbryta Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Oxbryta’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 9,248,199, which ends in January 2034, the month the first generic is expected. Why the later ones may not hold it back
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 10,017,491 | The product’s formulation | December 2032 | Active |
| 10,034,879 | The active ingredient; the product’s formulation | December 2032 | Active |
| 10,806,733 | The active ingredient | December 2032 | Active |
| 9,018,210 | The active ingredient; the product’s formulation | November 2033 | Active |
| 9,248,199 Sets the expected month of generic availability | A way of using it (U-2676, U-2715) | January 2034 | Active |
| 9,447,071 | The active ingredient; the product’s formulation | February 2035 | Active |
| 10,722,502 | The product’s formulation | February 2035 | Active |
| 11,452,720 | A way of using it (U-3459) | February 2035 | Active |
| 11,020,382 | A way of using it (U-3133, U-3134) | December 2036 | Active |
| 11,944,612 | A way of using it (U-3893) | December 2036 | Active |
| 10,493,035 | The product’s formulation | October 2037 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| FDA exclusivity ODE* | A period of protection the FDA granted (code ODE*). | November 2026 | Active |
| Orphan drug ODE-281 | Seven years of protection for a use in a rare disease. | November 2026 | Active |
| Orphan drug ODE-394 | Seven years of protection for a use in a rare disease. | December 2028 | Active |
Source: FDA Orange Book, application 216157, 213137. Patent numbers open the patent on Google Patents.
Patent Challenges to Oxbryta
The first patent challenge to Oxbryta reached the FDA in November 2023, from 2 companies on that first day. The FDA’s list has 2 entries for Oxbryta, 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 Oxbryta’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 | |||||
| Tablets, 300 mg and 500 mg | November 2023 | 2 companies | No decision yet | Not yet | Not yet | October 2037 |
| Tablets for oral suspension, 300 mg | November 2023 | 1 company | No decision yet | Not yet | Not yet | December 2036 |
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 Voxelotor
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
2 companies have applied to the FDA to make generic voxelotor.
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. 2 of them were first in line, both 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 Oxbryta’s patents with the FDA since November 2023: see the patent challenges.
Approved by the FDA
Not yet. The FDA has not approved a generic voxelotor. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic voxelotor 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).
Oxbryta 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 Oxbryta, 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.
Oxbryta Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 500MG | Tablet | Oral | November 2019 | Discontinued reference product |
| 300MG | Tablet, for suspension | Oral | December 2021 | Discontinued reference product |
| 300MG | Tablet | Oral | October 2022 | Discontinued reference product |
Source: FDA Orange Book, Global Blood Therapeutics Inc. Listed for sale today by Global Blood Therapeutics Inc. and Global Blood Therapeutics, Inc, A subsidiary of Pfizer Inc. (FDA NDC Directory).
Oxbryta NDC Codes and Packages
Each Oxbryta 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 |
|---|---|---|---|
| 72786-0102-02 | VOXELOTOR 300 mg/1 tablet, film coated | bottle of 60 tablets | Global Blood Therapeutics, Inc, A subsidiary of Pfizer Inc. |
| 72786-0102-02 | VOXELOTOR 300 mg/1 tablet, film coated | bottle of 60 tablets | Global Blood Therapeutics, Inc, A subsidiary of Pfizer Inc. |
| 72786-0102-03 | VOXELOTOR 300 mg/1 tablet, film coated | bottle of 90 tablets | Global Blood Therapeutics, Inc, A subsidiary of Pfizer Inc. |
| 72786-0102-03 | VOXELOTOR 300 mg/1 tablet, film coated | bottle of 90 tablets | Global Blood Therapeutics, Inc, A subsidiary of Pfizer Inc. |
| 72786-0111-02 | VOXELOTOR 300 mg/1 tablet, for suspension | bottle of 60 tablets | Global Blood Therapeutics, Inc, A subsidiary of Pfizer Inc. |
| 72786-0111-02 | VOXELOTOR 300 mg/1 tablet, for suspension | bottle of 60 tablets | Global Blood Therapeutics, Inc, A subsidiary of Pfizer Inc. |
| 72786-0111-03 | VOXELOTOR 300 mg/1 tablet, for suspension | bottle of 90 tablets | Global Blood Therapeutics, Inc, A subsidiary of Pfizer Inc. |
| 72786-0111-03 | VOXELOTOR 300 mg/1 tablet, for suspension | bottle of 90 tablets | Global Blood Therapeutics, Inc, A subsidiary of Pfizer Inc. |
| 72786-0101-01 | VOXELOTOR 500 mg/1 tablet, film coated | bottle of 90 tablets | Global Blood Therapeutics, Inc, A subsidiary of Pfizer Inc. |
| 72786-0101-01 | VOXELOTOR 500 mg/1 tablet, film coated | bottle of 90 tablets | Global Blood Therapeutics, Inc, A subsidiary of Pfizer Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Oxbryta’s own FDA approval (NDA 216157, NDA 213137) are listed, never a generic. Some codes belong to companies that repackage Oxbryta: it is the same medicine in a different package.
What a Generic Oxbryta Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Oxbryta 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 Oxbryta”. 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 Oxbryta
Is there a generic for Oxbryta right now?
No. As of October 9, 2026 no generic voxelotor is listed for sale in the FDA NDC Directory.
When will Oxbryta go generic?
January 2034 is the expected month, and that is probable but not certain. It is when Oxbryta’s patent 9,248,199 ends. That patent covers 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 October 2037; a court ruling or a settlement can bring a generic sooner.
Will generic voxelotor be the same as Oxbryta?
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. 2 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 44% less once two companies sold a generic. That is a pattern from past launches, not a prediction for this one.
Has the FDA approved a generic Oxbryta?
Not yet. The FDA Orange Book lists no approved generic version of Oxbryta.
When does the Oxbryta patent expire?
The FDA Orange Book lists 11 patents for Oxbryta; the last runs to October 2037. The one behind the expected month is patent 9,248,199, which ends in January 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 2034) weighs all of that.
Has anyone challenged the Oxbryta patents?
Yes. The first patent challenge to Oxbryta reached the FDA in November 2023, from 2 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.
Changes to This Projection
- First generic expected January 2034 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
- VelphoroFerric OxyhydroxideDuring 2026
- AddyiFlibanserinMay 2028
- ImbruvicaIbrutinibMarch 2032
- NetspotGallium Ga-68 DotatateAugust 2032
- RinvoqUpadacitinibApril 2037
- DaybueTrofinetide2038 to 2039
About Oxbryta
- Generic name voxelotor
- How it is taken By mouth
- Company Global Blood Therapeutics Inc
- Patent challenges Since November 2023 (FDA)
- More drugs Brand-name drugs starting with O
- Have a question? A pharmacist answers, free. Ask about Oxbryta
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, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.