Truqap Generic: When Will Generic Capivasertib Be Available?

Dr. Brian Staiger, PharmD, BCPS

This page is aggregated from FDA records, court filings and company announcements. Coded and designed by

Updated October 9, 2026 How we build our data

Truqap Generic at a Glance

Four quick answers from FDA records and our estimate.

  1. When is the first generic expected? March 2035 About 8.5 years away Why then?
  2. Has the FDA approved a generic? Not yet None in the FDA’s records yet Why not yet?
  3. When does the last patent end? April 2033 9 patents listed with the FDA
  4. Can you buy a generic today? Not yet No company lists one for sale

Explains

PharmD, BCPS · Clinical pharmacist Updated

Generic capivasertib is expected to be available in March 2035, about 8.5 years away. None is for sale yet.

Why March 2035?

It is when Truqap’s patent 8,101,623 ends. That patent covers the active ingredient, the product’s formulation and a way of using it, and once it ends, generics can go on sale as soon as the FDA approves them. We rate it likely: firm enough to plan around, but a court ruling or a new deal could still move it.

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 Truqap 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.

Truqap by the Numbers

Reason
Patent expiresA patent that protects the brand runs out. After that, approved generics can be sold.
How sure
Likely Firm enough to plan around, but a court ruling or a new deal could still move it.
Price competition
None filed yet No filers on record
Brand sales
$724M a yearBig seller
  • FDA approved 2023 November 2023 FDA Orange Book
  • Patents listed 9 last runs to April 2033 FDA Orange Book
  • Medicare Part D spent $378.3M in 2025, for 4,013 people CMS Part D Spending by Drug
  • Medicaid prescriptions 1,139 in the last four reported quarters, $25.4M CMS Medicaid drug utilization, to Q1 2026

Truqap’s Road to a Generic

Truqap has had the market to itself since the FDA approved it in November 2023 (Astrazeneca Pharmaceuticals LP). Its FDA protection (new use) runs to June 2029. Its 9 listed patents run to April 2033.

The first generic of Truqap is expected in March 2035.

Why that month: patent 8,101,623, on the active ingredient, the product’s formulation and a way of using it, ends then.

Brand alone on the market Since FDA approval, November 2023
New chemical entity Ends November 2028
New use Ends June 2029
Patent 9,492,453 Expires October 2028
Patent 10,059,714 Expires October 2028
Patent 10,654,855 Expires October 2028
Patent 8,101,623 Expires March 2030 The patent behind the expected month of generic availability
Patent 9,487,525 Expires April 2033
Patent 10,039,766 Expires April 2033
Brand alone on the market FDA exclusivity Patent on the active ingredient Patent on a use First generic expected 3 more patents end earlier; every patent is in the table below. Swipe the chart sideways to see every year.

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.

Truqap Patents and FDA Protections

Every patent and exclusivity the FDA Orange Book lists for Truqap’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 8,101,623, which ends in March 2030; the first generic is expected after it, in March 2035, about 8.5 years away.

Patents listed with the FDA (9)
PatentWhat it coversProtects untilStatus
9,492,453 A way of using it (U-4559) October 2028 Active
10,059,714 The active ingredient; the product’s formulation October 2028 Active
10,654,855 A way of using it (U-3762) October 2028 Active
11,236,095 A way of using it (U-4559) October 2028 Active
11,760,760 A way of using it (U-3762) October 2028 Active
12,252,495 A way of using it (U-3762) October 2028 Active
8,101,623 Sets the expected month of generic availability The active ingredient; the product’s formulation; a way of using it (U-3762) March 2030 Active
9,487,525 The active ingredient; the product’s formulation April 2033 Active
10,039,766 A way of using it (U-3762, U-4559) April 2033 Active
FDA exclusivities (2)
ExclusivityWhat it meansEndsStatus
New chemical entity NCEFive years of protection for a medicine whose active ingredient the FDA had never approved before.November 2028Active
New use I-991Three years of protection for a newly approved use (indication).June 2029Active

Source: FDA Orange Book, application 218197. Patent numbers open the patent on Google Patents.

Who Is Lined Up to Make Generic Capivasertib

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.

1

Applied to the FDA

No company is recorded as having applied to the FDA to make a generic Truqap yet.

2

Approved by the FDA

Not yet. The FDA has not approved a generic capivasertib. Final approval often comes close to the day a generic can be sold.

3

For Sale in Pharmacies

Not yet. No company lists a generic capivasertib 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).

Truqap 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 Truqap, 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 Truqap

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 Truqap, before manufacturer rebates.

$113.1M
January to March 2026, the latest CMS has posted
For 2,343 people, about $21,742 per prescription fill
$378.3M
2025, the whole year
For 4,013 people, about $21,230 per prescription fill
See the numbers
PeriodSpendingPeoplePer fill
January to March 2026$113,078,3452,343$21,741.65
2025$378,278,8464,013$21,230.15

Source: CMS Medicare Part D Spending by Drug, matched by the brand name Truqap only, so no generic is counted in it. What CMS says it is used for: Capivasertib is used to treat certain cancers (such as breast, prostate). Capivasertib belongs to a class of drugs known as kinase inhibitors.

Medicaid Prescriptions by Quarter

1,139 prescriptions in the four quarters to Q1 2026, $25.4M paid.

See the numbers
QuarterPrescriptionsMedicaid paid
Q1 2026235$5,294,516
Q4 2025264$5,767,139
Q3 2025359$8,014,096
Q2 2025281$6,302,606
Q1 2025248$5,549,776

Source: CMS Medicaid State Drug Utilization Data, over Truqap’s own package codes.

Truqap Strengths and Forms

StrengthFormHow it is takenApprovedStatus
160MGTabletOralNovember 2023Prescription reference product
200MGTabletOralNovember 2023Prescription reference product

Source: FDA Orange Book, Astrazeneca Pharmaceuticals LP. Listed for sale today by AstraZeneca Pharmaceuticals LP (FDA NDC Directory).

Truqap NDC Codes and Packages

Each Truqap 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.

Truqap packages (8)
NDCProductPackageCompany
00310-9500-01CAPIVASERTIB 160 mg/1 tablet, film coatedbottle of 64 tabletsAstraZeneca Pharmaceuticals LP
00310-9500-01CAPIVASERTIB 160 mg/1 tablet, film coatedbottle of 64 tabletsAstraZeneca Pharmaceuticals LP
00310-9500-02CAPIVASERTIB 160 mg/1 tablet, film coatedcarton of 4 blister packs of 16 tabletsAstraZeneca Pharmaceuticals LP
00310-9501-01CAPIVASERTIB 200 mg/1 tablet, film coatedbottle of 64 tabletsAstraZeneca Pharmaceuticals LP
00310-9501-01CAPIVASERTIB 200 mg/1 tablet, film coatedbottle of 64 tabletsAstraZeneca Pharmaceuticals LP
00310-9501-02CAPIVASERTIB 200 mg/1 tablet, film coatedcarton of 4 blister packs of 16 tabletsAstraZeneca Pharmaceuticals LP
00310-9501-04CAPIVASERTIB 200 mg/1 tablet, film coatedcarton of 4 blister packs of 8 tabletsAstraZeneca Pharmaceuticals LP
00310-9501-96CAPIVASERTIB 200 mg/1 tablet, film coatedcarton of 4 blister packs of 16 tabletsAstraZeneca Pharmaceuticals LP

Source: the FDA NDC Directory, current listings only. Only packages sold under Truqap’s own FDA approval (NDA 218197) are listed, never a generic. Some codes belong to companies that repackage Truqap: it is the same medicine in a different package.

What a Generic Truqap Means for You

Nothing Changes Until It Is in Pharmacies

Until a generic is actually for sale, keep filling Truqap 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 Truqap”. 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 Truqap

Is there a generic for Truqap right now?

No. As of October 9, 2026 no generic capivasertib is listed for sale in the FDA NDC Directory.

When will Truqap go generic?

March 2035 is the expected month, and that is likely but not certain. It is when Truqap’s patent 8,101,623 ends. That patent covers the active ingredient, the product’s formulation and a way of using it, and once it ends, generics can go on sale as soon as the FDA approves them.

Will generic capivasertib be the same as Truqap?

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 Truqap?

Not yet. The FDA Orange Book lists no approved generic version of Truqap.

When does the Truqap patent expire?

The FDA Orange Book lists 9 patents for Truqap; the last runs to April 2033. The one behind the expected month is patent 8,101,623, which ends in March 2030. 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 (March 2035) weighs all of that.

Changes to This Projection

  • First generic expected March 2035 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

All upcoming generics

About Truqap

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.