Pyrukynd Generic: When Will Generic Mitapivat 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
Pyrukynd Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? 2038 to 2039 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? July 2041 9 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 mitapivat sulfate is expected to be available between 2038 and 2039. None is for sale yet.
Why 2038 to 2039?
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 Pyrukynd’s last patent runs to July 2041, how can a generic come sooner?
The patent that runs to July 2041 (11,878,049) covers a way of using it. 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. Here, the companies are expected to settle on a date. Generic companies have been challenging Pyrukynd’s patents with the FDA since February 2026. 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. One company has applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 31% less once one company sold a generic. See the price pattern
What should I do now?
Keep taking Pyrukynd 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.
Pyrukynd 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
- Low 1 company has filed, 1 first in line
- Brand sales
- $59M a yearSmaller seller
- FDA approved 2022 February 2022 FDA Orange Book
- Patents listed 9 last runs to July 2041 A generic is expected sooner, between 2038 and 2039. See why FDA Orange Book
- Medicare Part D spent $10.7M in 2025, for 44 people CMS Part D Spending by Drug
- Medicaid prescriptions 172 in the last four reported quarters, $5.1M CMS Medicaid drug utilization, to Q1 2026
Pyrukynd’s Road to a Generic
Pyrukynd has had the market to itself since the FDA approved it in February 2022 (Agios Pharmaceuticals Inc). Its FDA protection (orphan drug) runs to December 2032. Its 9 listed patents run to July 2041. Generic companies have challenged its patents with the FDA since February 2026.
The first generic of Pyrukynd is expected between 2038 and 2039.
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 July 2041
The last listed patent runs to July 2041, but it covers a way of using it, 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.
Pyrukynd Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Pyrukynd’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 |
|---|---|---|---|
| 9,682,080 | A way of using it (U-4392, U-3319) | May 2032 | Active |
| 9,980,961 | A way of using it (U-3319) | May 2032 | Active |
| 10,632,114 | A way of using it (U-4391, U-3320) | May 2032 | Active |
| 9,193,701 | A way of using it (U-4393, U-3319) | October 2032 | Active |
| 11,793,806 | A way of using it (U-3320) | April 2033 | Active |
| RE49582 | The active ingredient; the product’s formulation | April 2035 | Active |
| 11,234,976 | A way of using it (U-3321) | October 2038 | Active |
| 11,254,652 | The active ingredient; the product’s formulation | November 2038 | Active |
| 11,878,049 | A way of using it (U-4390, U-3782) | July 2041 | 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. | February 2027 | Active |
| New product NP | Three years of protection for a change that needed new clinical studies. | December 2028 | Active |
| Orphan drug ODE-392 | Seven years of protection for a use in a rare disease. | February 2029 | Active |
| Orphan drug ODE-522 | Seven years of protection for a use in a rare disease. | December 2032 | Active |
Source: FDA Orange Book, application 216196. Patent numbers open the patent on Google Patents.
Patent Challenges to Pyrukynd
The first patent challenge to Pyrukynd reached the FDA in February 2026, from one company on that first day. 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 Pyrukynd’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, 5 mg, 20 mg and 50 mg | February 2026 | 1 company | No decision yet | Not yet | Not yet | July 2041 |
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 Mitapivat 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
One company has applied to the FDA to make generic mitapivat sulfate.
The FDA names a company only once it approves its application, even tentatively, and it has not done that for this one yet, so the company is not named here. Names often come out in the brand company’s patent lawsuits or in the companies’ own announcements.
First in line. One of them was first in line: the first company to challenge the brand’s patents can earn 180 days on the market before the other generics, which is why being first matters.
Generic companies have challenged Pyrukynd’s patents with the FDA since February 2026: see the patent challenges.
Approved by the FDA
Not yet. The FDA has not approved a generic mitapivat 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 mitapivat 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).
Pyrukynd 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 Pyrukynd, 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 Pyrukynd
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 Pyrukynd, before manufacturer rebates.
- $3.4M
- January to March 2026, the latest CMS has posted
For 42 people, about $29,562 per prescription fill - $10.7M
- 2025, the whole year
For 44 people, about $30,196 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $3,399,652 | 42 | $29,562.19 |
| 2025 | $10,659,285 | 44 | $30,196.27 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Pyrukynd only, so no generic is counted in it. What CMS says it is used for: This medication is used to treat hemolytic anemia. It works by slowing the breakdown of red blood cells.
Medicaid Prescriptions by Quarter
172 prescriptions in the four quarters to Q1 2026, $5.1M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 65 | $1,906,861 |
| Q4 2025 | 48 | $1,443,001 |
| Q3 2025 | 40 | $1,236,884 |
| Q2 2025 | 19 | $541,151 |
| Q1 2025 | 18 | $463,861 |
Source: CMS Medicaid State Drug Utilization Data, over Pyrukynd’s own package codes.
Pyrukynd Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 20MG BASE | Tablet | Oral | February 2022 | Prescription reference product |
| EQ 50MG BASE | Tablet | Oral | February 2022 | Prescription reference product |
| EQ 5MG BASE | Tablet | Oral | February 2022 | Prescription reference product |
Source: FDA Orange Book, Agios Pharmaceuticals Inc. Listed for sale today by Agios Pharmaceuticals, Inc. (FDA NDC Directory).
Pyrukynd NDC Codes and Packages
Each Pyrukynd 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 |
|---|---|---|---|
| 71334-0210-20 | MITAPIVAT 20 mg/1 tablet, film coated | carton of 4 blister packs of 14 tablets | Agios Pharmaceuticals, Inc. |
| 71334-0210-20 | MITAPIVAT 20 mg/1 tablet, film coated | carton of 4 blister packs of 14 tablets | Agios Pharmaceuticals, Inc. |
| 71334-0205-05 | MITAPIVAT 5 mg/1 tablet, film coated | carton of 4 blister packs of 14 tablets | Agios Pharmaceuticals, Inc. |
| 71334-0205-05 | MITAPIVAT 5 mg/1 tablet, film coated | carton of 4 blister packs of 14 tablets | Agios Pharmaceuticals, Inc. |
| 71334-0220-11 | MITAPIVAT 5 mg/1 tablet, film coated | blister pack of 7 tablets | Agios Pharmaceuticals, Inc. |
| 71334-0220-11 | MITAPIVAT 5 mg/1 tablet, film coated | blister pack of 7 tablets | Agios Pharmaceuticals, Inc. |
| 71334-0215-50 | MITAPIVAT 50 mg/1 tablet, film coated | carton of 4 blister packs of 14 tablets | Agios Pharmaceuticals, Inc. |
| 71334-0215-50 | MITAPIVAT 50 mg/1 tablet, film coated | carton of 4 blister packs of 14 tablets | Agios Pharmaceuticals, Inc. |
Show the other 4 Pyrukynd packages
| NDC | Product | Package | Company |
|---|---|---|---|
| 71334-0225-12 | kit | 1 KIT in 1 CARTON * 7 TABLET, FILM COATED in 1 BLISTER PACK * 7 TABLET, FILM COATED in 1 BLISTER PACK | Agios Pharmaceuticals, Inc. |
| 71334-0225-12 | kit | 1 KIT in 1 CARTON * 7 TABLET, FILM COATED in 1 BLISTER PACK * 7 TABLET, FILM COATED in 1 BLISTER PACK | Agios Pharmaceuticals, Inc. |
| 71334-0230-13 | kit | 1 KIT in 1 CARTON * 7 TABLET, FILM COATED in 1 BLISTER PACK * 7 TABLET, FILM COATED in 1 BLISTER PACK | Agios Pharmaceuticals, Inc. |
| 71334-0230-13 | kit | 1 KIT in 1 CARTON * 7 TABLET, FILM COATED in 1 BLISTER PACK * 7 TABLET, FILM COATED in 1 BLISTER PACK | Agios Pharmaceuticals, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Pyrukynd’s own FDA approval (NDA 216196) are listed, never a generic. Some codes belong to companies that repackage Pyrukynd: it is the same medicine in a different package.
What a Generic Pyrukynd Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Pyrukynd 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 Pyrukynd”. 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 Pyrukynd
Is there a generic for Pyrukynd right now?
No. As of October 9, 2026 no generic mitapivat sulfate is listed for sale in the FDA NDC Directory.
When will Pyrukynd go generic?
2038 to 2039 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 July 2041, but it covers a way of using it, not the medicine itself, which a generic can often work around or challenge.
Will generic mitapivat sulfate be the same as Pyrukynd?
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. One company has applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 31% less once one company sold a generic. That is a pattern from past launches, not a prediction for this one.
Has the FDA approved a generic Pyrukynd?
Not yet. The FDA Orange Book lists no approved generic version of Pyrukynd.
When does the Pyrukynd patent expire?
The FDA Orange Book lists 9 patents for Pyrukynd; the last runs to July 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 window on this page (2038 to 2039) weighs all of that.
Has anyone challenged the Pyrukynd patents?
Yes. The first patent challenge to Pyrukynd reached the FDA in February 2026, from one company 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 2038 to 2039 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
- Elepsia XRLevetiracetamOctober 2027
- VraylarCariprazine HydrochlorideMarch 2030
- SlyndDrospirenoneJanuary to June 2031
- OmeprazoleOmeprazoleDecember 2036
- JascaydNerandomilast2037 to 2038
- ArbliLosartan PotassiumOctober 2041
About Pyrukynd
- Generic name mitapivat sulfate
- How it is taken By mouth
- Company Agios Pharmaceuticals Inc
- Patent challenges Since February 2026 (FDA)
- More drugs Brand-name drugs starting with P
- Have a question? A pharmacist answers, free. Ask about Pyrukynd
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, 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.